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, 2017 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 |
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33-0960223 |
(State or other jurisdiction of incorporation or organization) |
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(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 |
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Non-accelerated filer |
☐ (Do not check if a smaller reporting company) |
Smaller reporting company |
☐ |
Emerging growth company |
☐ |
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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 28, 2017 there were 27,761,188 shares of the registrant's common stock, par value $0.001 per share, outstanding.
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Item 1. |
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2 |
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Condensed Consolidated Balance Sheets as of June 30, 2017 and December 31, 2016 |
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2 |
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3 |
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Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2017 and 2016 |
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4 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
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5 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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22 |
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Item 3. |
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33 |
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Item 4. |
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34 |
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Item 1. |
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34 |
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Item 1A. |
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35 |
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Item 6. |
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35 |
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36 |
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1
PART I – FINANCI AL INFORMATION
Paratek Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except for share and par value amounts)
(unaudited)
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June 30, 2017 |
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December 31, 2016 |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
51,587 |
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$ |
52,962 |
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Available-for-sale securities |
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123,751 |
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75,076 |
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Restricted cash |
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115 |
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817 |
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Other receivable |
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23 |
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323 |
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Prepaid and other current assets |
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2,967 |
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2,922 |
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Total current assets |
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178,443 |
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132,100 |
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Restricted cash |
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250 |
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250 |
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Fixed assets, net |
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2,038 |
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1,188 |
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Intangible assets, net |
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255 |
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1,015 |
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Goodwill |
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828 |
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829 |
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Other long-term assets |
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315 |
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350 |
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Total assets |
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$ |
182,129 |
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$ |
135,732 |
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Liabilities and stockholders’ equity |
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Current liabilities |
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Accounts payable |
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$ |
3,274 |
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$ |
4,418 |
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Other accrued expenses |
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6,083 |
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6,428 |
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Accrued contract research |
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5,668 |
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9,566 |
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Total current liabilities |
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15,025 |
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20,412 |
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Long-term debt |
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48,975 |
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38,974 |
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Contingent obligations |
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106 |
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655 |
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Other liabilities |
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4,639 |
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4,099 |
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Total liabilities |
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68,745 |
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64,140 |
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Commitments and contingencies (Note 15) |
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Stockholders’ equity |
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Preferred stock: |
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Undesignated preferred stock: $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding |
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— |
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— |
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Common stock, $0.001 par value; 100,000,000 shares authorized; 27,600,155 and 23,358,637 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively |
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28 |
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23 |
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Additional paid-in capital |
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540,347 |
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451,947 |
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Accumulated other comprehensive loss |
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(96 |
) |
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(16 |
) |
Accumulated deficit |
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(426,895 |
) |
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(380,362 |
) |
Total stockholders’ equity |
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113,384 |
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71,592 |
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Total liabilities and stockholders’ equity |
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$ |
182,129 |
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$ |
135,732 |
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See accompanying notes to unaudited condensed consolidated financial statements.
2
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
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Three months ended June 30, |
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Six months ended June 30, |
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2017 |
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2016 |
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2017 |
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2016 |
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License and royalty revenue |
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$ |
7,514 |
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$ |
— |
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$ |
7,532 |
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$ |
— |
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Operating expenses: |
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Research and development |
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15,079 |
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22,135 |
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33,735 |
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46,423 |
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General and administrative |
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8,716 |
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7,602 |
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17,080 |
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13,941 |
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Impairment of intangible asset |
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682 |
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— |
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682 |
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— |
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Changes in fair value of contingent consideration |
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(318 |
) |
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15 |
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(549 |
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120 |
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Total operating expenses |
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24,159 |
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29,752 |
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50,948 |
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60,484 |
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Loss from operations |
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(16,645 |
) |
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(29,752 |
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(43,416 |
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(60,484 |
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Other income and expenses: |
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Interest expense |
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(1,126 |
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(818 |
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(2,258 |
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(1,548 |
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Interest income |
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349 |
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288 |
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590 |
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479 |
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Other loss, net |
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(8 |
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(1 |
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(15 |
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(1 |
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Loss before income taxes |
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$ |
(17,430 |
) |
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$ |
(30,283 |
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$ |
(45,099 |
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$ |
(61,554 |
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Provision for income taxes |
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753 |
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— |
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753 |
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— |
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Net loss |
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$ |
(18,183 |
) |
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$ |
(30,283 |
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$ |
(45,852 |
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$ |
(61,554 |
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Other comprehensive income: |
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Unrealized (loss) gain on available-for-sale securities, net of tax |
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(42 |
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33 |
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(80 |
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34 |
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Comprehensive loss |
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$ |
(18,225 |
) |
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$ |
(30,250 |
) |
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$ |
(45,932 |
) |
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$ |
(61,520 |
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Net loss per share - basic and diluted |
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$ |
(0.66 |
) |
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$ |
(1.69 |
) |
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$ |
(1.78 |
) |
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$ |
(3.47 |
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Weighted average common shares outstanding |
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Basic and diluted |
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27,347,941 |
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17,895,301 |
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25,780,756 |
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17,755,528 |
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See accompanying notes to unaudited condensed consolidated financial statements.
3
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
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Six months ended June 30, |
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2017 |
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2016 |
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Net loss |
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$ |
(45,852 |
) |
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$ |
(61,554 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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655 |
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583 |
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Stock-based compensation expense |
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8,936 |
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5,443 |
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Noncash interest expense |
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293 |
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563 |
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Noncash interest income |
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— |
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(479 |
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Impairment of intangible asset |
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682 |
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— |
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Change in fair value of contingent consideration |
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(549 |
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120 |
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Changes in operating assets and liabilities |
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Accounts receivable and other current assets |
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646 |
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7,102 |
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Purchase of prepaid interest - marketable securities |
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(207 |
) |
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— |
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Accounts payable and accrued expenses |
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(5,809 |
) |
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7,527 |
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Other liabilities and other assets |
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519 |
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(120 |
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Net cash used in operating activities |
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(40,686 |
) |
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(40,815 |
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Investing activities |
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Purchase of fixed assets, net |
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(1,128 |
) |
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(374 |
) |
Purchase of marketable securities |
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(93,887 |
) |
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(68,209 |
) |
Proceeds from maturities of marketable securities |
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45,000 |
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5,000 |
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Increase (decrease) in restricted cash |
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701 |
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(1,105 |
) |
Net cash used in investing activities |
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(49,314 |
) |
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(64,688 |
) |
Financing activities |
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Proceeds from issuance of long-term debt, net of costs |
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9,915 |
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— |
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Proceeds from exercise of stock options |
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20 |
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11 |
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Proceeds from sale of common stock |
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78,690 |
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61,617 |
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Net cash provided by financing activities |
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88,625 |
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61,628 |
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Net decrease in cash and cash equivalents |
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(1,375 |
) |
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(43,875 |
) |
Cash and cash equivalents at beginning of period |
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52,962 |
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131,302 |
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Cash and cash equivalents at end of period |
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$ |
51,587 |
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$ |
87,427 |
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SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION |
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Public offering costs incurred but unpaid at period end |
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$ |
— |
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$ |
334 |
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Cash paid for interest |
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$ |
1,606 |
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$ |
864 |
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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 has 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. The Company’s two lead product candidates are the antibacterials omadacycline and sarecycline. Omadacycline and sarecycline are examples of molecules that were synthesized from this chemistry discovery platform.
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. The Company believes 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. The Company believes omadacycline, if approved, will be used in the emergency room, hospital and community care settings. The Company has 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 known drug interactions, and a favorable safety and tolerability profile.
The Company’s second antibacterial product candidate, sarecycline, also known as WC3035, is a new, once-daily, tetracycline-derived compound designed for use in the treatment of acne and rosacea. The Company believes 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, or PK, properties that the Company believes make it particularly well-suited for the treatment of inflammatory acne in the community setting. The Company has 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.
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, or the Merger, 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., Tigris Acquisition Sub, LLC and Old Paratek, or the Merger Agreement.
The Company has incurred significant losses since its inception in 1996. The Company has generated an accumulated deficit of $426.9 million through June 30, 2017 and will require substantial additional funding in connection with the Company’s continuing operations to support commercial activities associated with its lead product candidate, omadacycline. B ased upon the Company’s current operating plan, the Company anticipates that its existing cash, cash equivalents and marketable securities will enable the Company to fund its operating expenses and capital expenditure requirements through at least the next twelve 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 and private equity offerings, debt or other structured financings and strategic collaborations. 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 our Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the SEC on March 2, 2017, and elsewhere in this report.
5
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, 2016, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission, or the SEC, on March 2, 2017.
As of January 1, 2017, the Company adopted ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting , or ASU 2016-09 . Upon adoption, the Company adjusted retained earnings for amendments related to an entity-wide accounting policy election to recognize the impact of share-based award forfeitures only as they occur rather than by applying an estimated forfeiture rate as previously required. ASU 2016-09 requires that this change be applied using a modified-retrospective transition method by means of a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year in which the guidance is adopted. The following table summarizes the impact to the Company’s consolidated balance sheet, including the amount charged to retained earnings as of January 1, 2017 (in thousands):
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Balance sheet reclassification |
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Amount ($) |
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Increase to additional paid-in capital resulting from the Company's election to recognize forfeitures as they occur rather than applying an estimated forfeiture rate |
Additional paid-in-capital |
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681 |
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Charge to accumulated deficit for cumulative-effect adjustment from adoption of ASU 2016-09 |
Accumulated deficit |
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|
681 |
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There have been no other material changes in the Company’s significant accounting policies during the six months ended June 30, 2017.
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 Accounting Standards Codification, or ASC, and Accounting Standards Update, or 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, 2016, and, in the opinion of management, reflect all normal recurring adjustments necessary for the fair presentation of the Company’s financial position, results of operations and cash flows for the interim periods ended June 30, 2017 and 2016.
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, 2017. 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, 2016, and notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the SEC on March 2, 2017.
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 and Paratek Bermuda Ltd. 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.
6
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, 2017 and December 31, 2016 (in thousands):
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Amortized Cost |
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Unrealized Gains |
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Unrealized Losses |
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Fair Value |
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June 30, 2017 |
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U.S. treasury securities |
|
$ |
123,847 |
|
|
$ |
— |
|
|
$ |
(96 |
) |
|
$ |
123,751 |
|
Total |
|
$ |
123,847 |
|
|
$ |
— |
|
|
$ |
(96 |
) |
|
$ |
123,751 |
|
December 31, 2016 |
|
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|
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U.S. treasury securities |
|
$ |
62,574 |
|
|
$ |
— |
|
|
$ |
(18 |
) |
|
$ |
62,556 |
|
Government agencies |
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|
12,518 |
|
|
|
2 |
|
|
|
— |
|
|
|
12,520 |
|
Total |
|
$ |
75,092 |
|
|
$ |
2 |
|
|
$ |
(18 |
) |
|
$ |
75,076 |
|
No available-for-sale securities held as of June 30, 2017 and December 31, 2016 had remaining maturities greater than one year.
4. Restricted Cash
Short-term restricted cash
Intermezzo Reserve
As of June 30, 2017, restricted cash of $0.1 million represents royalty income received but not yet paid to former Transcept stockholders as part of the Royalty Sharing Agreement. Included in the balance as of December 31, 2016, was the remainder of the Intermezzo reserve of $0.1 million, established in accordance with the Merger Agreement, which was comprised of unpaid legal fees.
Letter of Credit
During the year ended December 31, 2016, the Company obtained a letter of credit in the amount of $0.8 million, which was collateralized with a bank account at a financial institution, to secure value-added tax registration in certain foreign countries. The letter of credit was cancelled by the Company during the first quarter of 2017.
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, 2017 and December 31, 2016, naming the landlord as beneficiary.
5. Fixed Assets
Fixed assets, net, consists of the following (in thousands):
|
|
June 30, 2017 |
|
|
December 31, 2016 |
|
||
Office equipment |
|
$ |
923 |
|
|
$ |
443 |
|
Computer equipment |
|
|
531 |
|
|
|
251 |
|
Computer software |
|
|
787 |
|
|
|
787 |
|
Leasehold improvements |
|
|
859 |
|
|
|
137 |
|
Construction-in-progress |
|
|
— |
|
|
|
391 |
|
Gross fixed assets |
|
|
3,100 |
|
|
|
2,009 |
|
Less: Accumulated depreciation and amortization |
|
|
(1,062 |
) |
|
|
(821 |
) |
Net fixed assets |
|
$ |
2,038 |
|
|
$ |
1,188 |
|
7
Intangible assets consist of the following (in thousands):
|
|
June 30, 2017 |
|
|
December 31, 2016 |
|
||
Intermezzo product rights |
|
$ |
212 |
|
|
$ |
1,410 |
|
TO-2070 asset |
|
|
170 |
|
|
|
170 |
|
Gross intangible assets |
|
|
382 |
|
|
|
1,580 |
|
Less: Accumulated amortization |
|
|
(127 |
) |
|
|
(565 |
) |
Net intangible assets |
|
$ |
255 |
|
|
$ |
1,015 |
|
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 and TO-2070. Intangible assets are reviewed when events or circumstances indicate 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.
In April 2016, the first generic equivalent of Intermezzo was launched. Although the generic was off the market for a short period, it re-entered in September 2016. Since the generic launch, a recoverability test has been performed each reporting period and the Company determined that the summation of the undiscounted cash flows through the year of patent expiration, or the estimated useful life of the asset, exceeded the carrying value of the asset in periods up to and including March 31, 2017. During the quarter ended June 30, 2017, Intermezzo product sales projections significantly declined. As such, the Company performed a recoverability test and it was determined that the summation of the undiscounted future cash flow of the Intermezzo product rights were less than its carrying value. As a result, the Company recorded an impairment charge during the three months ended June 30, 2017 of $0.7 million. No impairment was recorded during the year ended December 31, 2016.
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, and warrants to purchase common stock 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, restricted stock units, and warrants to purchase common stock 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, 2017 and 2016 as indicated below:
|
|
June 30, |
|
|||||
|
|
2017 |
|
|
2016 |
|
||
Excluded potentially dilutive securities (1) : |
|
|
|
|
|
|
|
|
Shares subject to outstanding options to purchase common stock |
|
|
3,467,049 |
|
|
|
2,863,382 |
|
Unvested restricted stock units |
|
|
954,003 |
|
|
|
475,500 |
|
Shares subject to warrants to purchase common stock |
|
|
84,828 |
|
|
|
42,306 |
|
Shares issuable under employee stock purchase plan |
|
|
36,539 |
|
|
|
36,539 |
|
Totals |
|
|
4,542,419 |
|
|
|
3,417,727 |
|
(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, 2017 and 2016. Such amounts have not been adjusted for the treasury stock method or weighted average outstanding calculations as required if the securities were dilutive. |
8
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 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.
The Zai Collaboration Agreement will continue, 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 patents 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 commercial sale of such licensed product in such region.
The Company evaluated the Zai Collaboration Agreement under ASC Subtopic 605-25, “ Multiple Element Arrangements”. The Company determined that there were five deliverables under the Zai Collaboration Agreement: (i) an exclusive license to develop, manufacture and commercialize omadacycline in the territory; (ii) an initial transfer of technology ; (iii) a transfer of certain materials and materials know-how (iv) an additional transfer of materials; and (v) participation on a joint steering committee (JSC) and joint development committee (JDC).
The consideration allocable to the delivered unit or units of accounting is limited to the amount that is not contingent upon the delivery of additional items or meeting other specified performance conditions. Therefore, the Company excluded from the allocable consideration the milestone payments and royalties, regardless of the probability that such milestone and royalty payments will be made, until the events that give rise to such payments occur.
The Company determined that all five deliverables listed above had value to the Company on a stand-alone basis and therefore five units of accounting were identified. The Company determined, however, that the best estimate for the selling price of the initial transfer of technology, transfer of certain materials and materials know-how, the additional transfer of materials and participation on the JSC and JDC were all inconsequential. As such, the Company recognized the total arrangement consideration as revenue during the quarter ended June 30, 2017.
Under the Zai Collaboration Agreement, Zai will pay taxes incurred in the territory by Paratek on Paratek’s behalf and deduct these taxes from the payments due to Paratek. Withholding and other value-added taxes of $0.8 million were incurred on the $7.5 million upfront payment. As such, the Company received $6.7 million, net of taxes, during the quarter ended June 30, 2017. These taxes were paid by Zai on behalf of the Company.
During the three months and six months ended June 30, 2017, the Company recognized revenue under the Zai agreement of $7.5 million, which represents the upfront payment.
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.
9
Und er 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 ter m 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.
The Company earned 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, and $2.5 million upon initiation of Phase 2 trials in 2012. In December 2014, the Company also earned $4.0 million upon initiation of Phase 3 trials associated with the Allergan Collaboration Agreement. In addition, Allergan may be required to pay the Company an aggregate of approximately $17.0 million upon the achievement of specified future regulatory milestones, the next being $5.0 million upon acceptance by the FDA of a NDA submission. 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 received any amounts or recognized any revenue under this arrangement since 2014.
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 ten 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. 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 Tufts License Agreement, based on the applicable field of use for such product, the Company agreed to pay Tufts a percentage, ranging from 10% to 14% (ten percent to fourteen percent), 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 the lesser of 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 the amount of royalty payments that would have been paid by the Company to Tufts if the Company had sold the product. The Company paid $0.1 million, or 1.5%, of a sublicense issue fee to Tufts during the six months ended June 30, 2017 upon earning the $7.5 million upfront payment under the Zai Collaboration Agreement.
Unless terminated earlier, the Tufts License Agreement 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 property 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.
10
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, that 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. |
The Purdue Collaboration Agreement expires on the expiration of Purdue Pharma’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 Pharma 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.
Shin Nippon Biomedical Laboratories Ltd.
In September 2013, the Company and Shin Nippon Biomedical Laboratories Ltd., or SNBL, entered into a license agreement, or the SNBL License Agreement, pursuant to which SNBL granted the Company an exclusive worldwide license to commercialize SNBL’s proprietary nasal drug delivery technology to develop TO-2070. The Company was developing TO-2070 as a treatment for acute migraine using SNBL’s proprietary nasal powder drug delivery system. Under the SNBL License Agreement, the Company was required to fund all development and regulatory approval with respect to TO-2070. Pursuant to the SNBL License Agreement, the Company paid an upfront nonrefundable technology license fee of $1.0 million, and the Company was also obligated to pay up to an aggregate of $41.5 million upon the achievement of certain development, regulatory and sales milestones, and tiered, low double-digit royalties on annual net sales of TO-2070.
11
In September 2014, the Company and SNBL entered into a termination agreement and release, or the SNBL Termination Agreement, pursuant to which, among other things, the SNBL License Agreement was terminated and the Company assigned all of its rights, interest and title to the TO-2070 asset to SNBL in exchange for a portion of certain future net revenue received by SNBL as set forth in the SNBL Termination Agreement, up to an aggregate of $2.0 million.
9. Capital Stock
In October 2015 and February 2017, Paratek Pharmaceuticals, Inc. 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 $36.9 million in proceeds, after deducting commissions of $1.1 million, from the sale of 2,326,119 shares of common stock under the 2015 Sales Agreement during the six months ended June 30, 2017. The Company received $41.8 million in proceeds, after deducting commissions of $1.3 million, from the sale of 1,854,013 shares of common stock during the six months ended June 30, 2017 under the 2017 Sales Agreement. As of June 30, 2017, $6.9 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.
As described in Note 13, Long-term Debt , in connection with a Loan and Security Agreement, or the Loan Agreement, into which the Company entered 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), 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, Long-term Debt , in connection with the Loan Agreement Amendment (as defined in Note 13, Long-term Debt ), 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, Long-term 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 Warrants. The Additional Warrants’ total relative fair value of $0.1 million was determined using a Black-Scholes option-pricing model with the following assumptions:
|
|
June 30, 2017 |
|
|
Volatility |
|
|
67.8 |
% |
Weighted average risk-free interest rate |
|
|
1.8 |
% |
Expected dividend yield |
|
|
0.0 |
% |
Expected life of options (in years) |
|
|
5.0 |
|
Each Loan Amendment Warrant may be exercised on a cashless basis. The Loan Amendment Warrants are 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 Loan Amendment Warrants.
12
Other accrued expenses consist of the following (in thousands):
|
|
June 30, 2017 |
|
|
December 31, 2016 |
|
||
Accrued legal costs |
|
|
247 |
|
|
|
358 |
|
Accrued compensation |
|
|
1,976 |
|
|
|
2,609 |
|
Intermezzo payable |
|
|
81 |
|
|
|
105 |
|
Accrued professional fees |
|
|
1,052 |
|
|
|
1,118 |
|
Accrued contract manufacturing |
|
|
2,414 |
|
|
|
1,940 |
|
Accrued other |
|
|
313 |
|
|
|
298 |
|
Total |
|
$ |
6,083 |
|
|
$ |
6,428 |
|
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 long-term debt approximates its fair value as the interest rate is near current market rates. The fair value of the Company’s long-term 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.
The following table presents information about the Company’s financial assets and liabilities that have been measured at fair value as of June 30, 2017 and December 31, 2016, and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value. In general, fair values 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 liability (in thousands):
Description |
|
Quoted Prices in Active Markets (Level 1) |
|
|
Significant Other Observable Inputs (Level 2) |
|
|
Significant Unobservable Inputs (Level 3) |
|
|
Total |
|
||||
June 30, 2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury securities |
|
$ |
123,751 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
123,751 |
|
Total Assets |
|
$ |
123,751 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
123,751 |
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent obligations |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
106 |
|
|
$ |
106 |
|
Total Liabilities |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
106 |
|
|
$ |
106 |
|
December 31, 2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury securities |
|
$ |
62,556 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
62,556 |
|
Government agencies |
|
|
— |
|
|
|
12,520 |
|
|
|
— |
|
|
|
12,520 |
|
Total Assets |
|
$ |
62,556 |
|
|
$ |
12,520 |
|
|
$ |
— |
|
|
$ |
75,076 |
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent obligations |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
655 |
|
|
$ |
655 |
|
Total Liabilities |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
655 |
|
|
$ |
655 |
|
13
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 Company determined that the Royalty Sharing Agreement represents a modification to the original contingent obligations established under the Merger Agreement in accordance with ASC 805, Business Combinations.
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, 2017 and December 31, 2016 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 $0.3 million and $0.5 million during the three and six months ended June 30, 2017, respectively. Significant increases or decreases in any of those inputs would result in a substantially lower or higher fair value measurement.
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, 2017 (in thousands):
|
|
Contingent liability— former Transcept stockholders |
|
|
Balances at December 31, 2016 |
|
$ |
655 |
|
Change in fair value |
|
|
(549 |
) |
Balances at June 30, 2017 |
|
$ |
106 |
|
12. Stock-Based Compensation
As described in Note 2, Summary of Significant Accounting Policies and Basis of Presentation , the Company adopted ASU 2016-09. ASU 2016-09 requires the Company to recognize compensation expense of stock-based awards over the vesting periods of the awards, and realize forfeitures when they occur. 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, |
|
||||||||||
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
||||
Research and development expense |
|
$ |
1,714 |
|
|
$ |
961 |
|
|
$ |
3,055 |
|
|
$ |
1,659 |
|
General and administrative expense |
|
|
3,177 |
|
|
|
2,062 |
|
|
|
5,881 |
|
|
|
3,784 |
|
Total stock-based compensation expense |
|
$ |
4,891 |
|
|
$ |
3,023 |
|
|
$ |
8,936 |
|
|
$ |
5,443 |
|
14
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 pe riod, 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 31, |
|
|||||
|
|
2017 |
|
|
2016 |
|
||
Volatility |
|
|
76.2 |
% |
|
|
73.5 |
% |
Weighted average risk-free interest rate |
|
|
2.0 |
% |
|
|
1.4 |
% |
Expected dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
Expected life of options (in years) |
|
|
5.8 |
|
|
|
5.8 |
|
Stock Option Plan Activity
The number of shares of the Company’s common stock available for issuance under the Paratek Pharmaceuticals, Inc. 2015 Equity Incentive Plan, or the 2015 Plan, was initially 1,200,000 shares. The initial number of shares authorized under the 2015 Plan may be increased by the number of shares that again become available for grant as a result of forfeited or terminated awards or shares withheld in satisfaction of the exercise price or tax withholding obligations associated with awards under the Paratek Pharmaceuticals, Inc. 2006 Incentive Award Plan, as amended, and the Paratek Pharmaceuticals, Inc. 2014 Equity Incentive Plan, with the total amount of the initial shares plus the forfeited or terminated shares not to exceed 2,000,000 shares. In addition, the number of shares authorized for issuance under the 2015 Plan will be automatically increased each year pursuant to an “evergreen” provision contained in the 2015 Plan. The number of shares available for issuance will automatically increase on January 1 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 of the preceding calendar year. Notwithstanding the foregoing, the Board of Directors of the Company may act prior to January 1 of a given year to provide that there will be no January 1 increase in the number of shares available for issuance for such year or that the increase in the number of shares available for issuance for such year will be a lesser number of shares of common stock than would otherwise occur. On January 1, 2017, 1,167,931 shares of common stock were automatically added to the shares authorized for issuance under the 2015 Plan pursuant to the evergreen provision.
During the quarter ended June 30, 2017, the Company’s Board of Directors adopted a 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 to new employees. During the quarter ended June 30, 2017, the Company’s Board of Directors granted 18,000 stock options and 5,000 restricted stock unit awards, or 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 made to an employee of the Company is subject to time-based vesting, with 100% of the shares of common stock subject to the RSUs vesting three years from the grant date. The Company also has 73,167 shares remaining available under the Paratek Pharmaceuticals, Inc. 2015 Inducement Plan.
During the six months ended June 30, 2017, the Company’s Board of Directors granted 719,750 stock options and 562,500 restricted stock units 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 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 grants also included performance-based RSU, or PRSU, awards to certain executives and employees of the Company. The PRSUs will vest as follows: 20% of the PRSUs shall vest upon achievement of data lock for Study 16301 (oral only ABSSSI), which occurred subsequent to the six months ended June 30, 2017, or the First Milestone; 30% of the PRSUs shall vest upon achievement of IV and oral NDA filing acceptances, or the Second Milestone; and 50% of the PRSUs shall vest upon FDA approval of omadacycline, or the Third Milestone, provided, that, each of the First Milestone, the Second Milestone and the Third Milestone must occur no later than the fifth anniversary of the date of grant for the applicable portion of the PRSUs to vest. The Company recognizes compensation cost for awards with performance conditions if and when the Company concludes that it is probable that the performance condition will be achieved over the requisite service period. Since the Company believes it is more likely than not that the First Milestone and Second Milestone will be achieved prior to the fifth anniversary of the date of grant, the Company recognized compensation cost, for a total of $1.4 million and $2.4 million, for both performance conditions during the three and six months ended June 30, 2017, respectively, using the accelerated attribution method.
As of June 30, 2017, no additional shares remained available for issuance under either the Paratek Pharmaceuticals, Inc. 2006 Equity Incentive Plan, as amended, or the Paratek Pharmaceuticals, Inc. 2014 Equity Incentive Plan. However, 4,110 stock options and RSUs granted under both plans were cancelled during the six months ended June 30, 2017 and 40,708 were cancelled during the year ended December 31, 2016, and the shares underlying such awards became available for grant under the 2015 Plan.
Total shares available for future issuance under the 2015 Plan are 276,820 shares as of June 30, 2017.
15
A summary of stock option activity for the six months ended June 30, 2017 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, 2016 |
|
|
2,780,791 |
|
|
$ |
16.63 |
|
|
|
8.27 |
|
|
$ |
8,809 |
|
Granted |
|
|
737,750 |
|
|
|
15.44 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(1,389 |
) |
|
|
14.05 |
|
|
|
|
|
|
|
|
|
Expired or Forfeited |
|
|
(50,103 |
) |
|
|
17.04 |
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2017 |
|
|
3,467,049 |
|
|
$ |
16.37 |
|
|
|
8.14 |
|
|
$ |
28,324 |
|
Exercisable at June 30, 2017 |
|
|
1,816,617 |
|
|
$ |
15.50 |
|
|
|
7.58 |
|
|
$ |
16,606 |
|
Vested and expected to vest at June 30, 2017 |
|
|
3,467,049 |
|
|
$ |
16.37 |
|
|
|
8.14 |
|
|
$ |
28,324 |
|
Restricted Stock Units
A summary of restricted stock unit activity for the six months ended June 30, 2017 is as follows:
|
|
Number of Shares |
|
|
Weighted Average Grant Date Fair Value |
|
||
Unvested balance at December 31, 2016 |
|
|
454,000 |
|
|
$ |
19.67 |
|
Granted |
|
|
567,500 |
|
|
|
15.21 |
|
Released |
|
|
(59,997 |
) |
|
|
14.05 |
|
Cancelled |
|
|
(7,500 |
) |
|
|
13.73 |
|
Unvested balance at June 30, 2017 |
|
|
954,003 |
|
|
$ |
17.42 |
|
Total unrecognized compensation expense for all stock-based awards was $22.2 million as of June 30, 2017. This amount will be recognized over a weighted average period of 1.92 years.
13. Long-term Debt
On September 30, 2015, the Company entered into the Loan Agreement with Hercules and certain other lenders, and Hercules Technology Growth Capital, Inc. (as agent). Under the 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 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 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 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 Loan Agreement; (v) insolvency, as described in the 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 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, 2017, has been classified as long-term as the Company determined that a material adverse effect resulting in Hercules exercising its rights under the subjective acceleration clause is remote.
16
Subject to certain terms, pursuant to the Loan Agreement, Hercules was also granted the right to participate in an amount of up to $2.0 million in subsequ ent 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.
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 consolidated 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 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 Loan Agreement, or the Second Amendment, which extended the date on which the Company must begin making amortization payments under the 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 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 shares.
Under the Second Amendment, discussed above, the end of term charge was equal to 4.5% of the issued principal balance of the 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 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 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, is available at the Company’s option through December 15, 2017. If drawn, the Fourth Tranche shall bear interest and have the same maturity as all other loans outstanding under the Loan Agreement.
The Company borrowed the first tranche of $20.0 million upon the closing of the 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 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, January 1, 2020, the Company will make payments in equal monthly installments of principal and interest, with the balance of outstanding loans due on the original maturity date of the Loan Agreement. In connection with the Third Amendment, the Company paid Hercules a $0.1 million amendment fee.
17
The Third Amendment reduces the end of term charge due with respect to the Third Tranche from to 4.5% to 2.25% if the obli gations under the Loan Agreement are 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 resp ect to the Fourth Tranche, if drawn, is 2.25%.
If the Company prepays the loan prior to maturity, it will pay a prepayment charge, based on a percentage of the then outstanding principal balance, equal to (i) 1% with respect to the Third Tranche and the Fourth Tranche (if drawn) or (ii) 2% with respect to the Initial Tranches if the prepayment occurs prior to April 1, 2019, or equal to 0% if the prepayment occurs on or after April 1, 2019.
In connection with the borrowing of the Third Tranche, on June 27, 2017, the Company issued a warrant to Hercules Capital, Inc. that is exercisable for an aggregate of 5,374 shares of Common Stock at an exercise price of $23.26 per share, or the Additional Warrant. 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.
As of June 30, 2017, the Company has recorded a long-term debt obligation of $49.0 million, net of debt discount of $1.0 million.
Future principal payments, which exclude the 4.5% end of term charge of $0.5 million included within other liabilities on the balance sheet, in connection with the Loan Agreement, as of June 30, 2017, are as follows (in thousands):
Fiscal Year |
|
|
|
|
2017 |
|
$ |
— |
|
2018 |
|
|
— |
|
2019 |
|
|
27,616 |
|
2020 |
|
|
22,384 |
|
2021 and thereafter |
|
|
— |
|
Total |
|
$ |
50,000 |
|
14 . Income Taxes
The Company recorded a provision for income taxes in the three 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.
Previously, a component of the Company’s net operating losses related to tax deductions for the stock based compensation in excess of book compensation, or additional paid-in-capital net operating losses, would have been credited to additional paid-in-capital if they became utilizable in future periods. Under ASU 2016-09, any such excess deductions will be added to the existing net operating losses. This is not expected to have a material impact on the Company’s deferred tax assets or related disclosures.
15. Commitments and Contingencies
Leases
The Company’s contractual obligations and commitments were reported in its Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the SEC on March 2, 2017. The Company leases its Boston, Massachusetts and King of Prussia, Pennsylvania office spaces under non-cancelable operating leases expiring in 2021 and 2024, respectively.
18
The Company executed the third amendment to the lease agreement on its King of Prussia office space in October 2016. The lease agreement, as amended, is for 19,708 rentable square feet of office space, for a total commitment of $3.3 million with respect to which lease payments became due beginning once Paratek took control of such office space during the first qua rter of 2017. The total lease commitment is over a seven-year and seven-month lease term. The lease contains rent escalation and a partial rent abatement period, which is being accounted for as rent expense under the straight-line method. The Company is r equired to make additional payments under the operating leases for taxes, insurance, and other operating expenses incurred during the operating lease periods.
As of June 30, 2017, future minimum lease payments under operating leases are as follows:
Fiscal Year |
|
|
|
|
Remainder of 2017 |
|
$ |
353 |
|
2018 |
|
|
1,084 |
|
2019 |
|
|
1,156 |
|
2020 |
|
|
1,178 |
|
2021 |
|
|
964 |
|
2022 and thereafter |
|
|
1,422 |
|
Total |
|
$ |
6,157 |
|
Commercial Supply Agreements
In July 2017, the Company entered into a master manufacturing services agreement and corresponding product agreement with Patheon UK Limited, or Patheon. The agreements provide for the terms and conditions under which Patheon will manufacture, package and supply to the Company omadacycline in injectable form, or the Patheon Products. Under these agreements, the Company is required to deliver to Patheon the active pharmaceutical ingredient needed to manufacture the Patheon Products. The Company is obligated to pay a supply price in the six-digit dollar range per batch of the Patheon Products, subject to adjustments as provided in the agreements. If the Company’s omadacycline product is approved, the Company will also be subject to an annual minimum purchase requirement in the six-digit euro range. If the Company desires for Patheon to conduct additional services other than those expressly set forth in the agreements, those would be subject to additional fees.
The Company’s agreements with Patheon will remain in effect for a fixed initial term, after which they will continue for successive renewal terms unless either the Company or Patheon have given written notice of termination within a certain period prior to the expiration of the applicable initial or then-current renewal term. The agreements may also be terminated under certain other circumstances, including by either party due to a material uncured breach of the other party or the other party’s insolvency.
Intermezzo Patent Litigation
In July 2012, the Company received notifications from three companies, Actavis Elizabeth LLC, or Actavis Elizabeth, Watson Laboratories, Inc.—Florida, or Watson, and Novel Laboratories, Inc., or Novel, in September 2012, from each of Par Pharmaceutical, Inc. and Par Formulations Private Ltd., together, the Par Entities, in February 2013 from Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd., together, Dr. Reddy’s, and in July 2013 from TWi Pharmaceuticals, Inc., or Twi, stating that each has filed with the FDA an ANDA, that references Intermezzo. Refer to Item 3, Legal Proceedings, of the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the SEC on March 9, 2016, for a full description of the history of this litigation.
The United States District Court for the District of New Jersey, or the New Jersey District Court, held a consolidated trial between December 1, 2014 and December 15, 2014 involving Paratek, Purdue Pharma, and their patent infringement claims against Actavis Elizabeth, Novel, and Dr. Reddy’s. The New Jersey District Court then received post-trial briefing and held a February 13, 2015 post-trial hearing. On March 27, 2015, the New Jersey District Court issued an order and accompanying opinion finding that: (a) the asserted claims of U.S. Patent Nos. 7,682,628, 8,242,131, and 8,252,809, are invalid as obvious; (b) Actavis Elizabeth, Novel, and Dr. Reddy’s infringe the ‘131 patent; (c) Novel infringes the ‘628 patent; and (d) Novel and Dr. Reddy’s infringe the ‘809 patent. On April 9, 2015, the New Jersey District Court entered final judgment consistent with the March 27, 2015 opinion and order referenced above. As a result of the New Jersey District Court’s findings, the intangible assets representing Intermezzo product rights were impaired and the related contingent obligation was reduced in light of an expected decline in Intermezzo sales for the six months ended June 30, 2015.
The Company and Purdue Pharma jointly appealed the New Jersey District Court’s final judgment as to the '131 patent to the United States Court of Appeals for the Federal Circuit on May 6, 2015. On January 8, 2016, the United States Court of Appeals for the Federal Circuit affirmed the decision of the New Jersey District Court, and no opinion accompanied the judgment. On September 14, 2016, the defendants filed a warrant of satisfaction of judgment in the New Jersey District Court for the costs having been fully paid to the defendants.
19
In January 2013, the Company filed suit in the Eastern District of Virginia against the United States Patent and Trademark Office, or the USPTO, seeking recalculation of the patent term adjustment of the ’131 Patent. Purdue Pharma has agreed to bear the costs and expenses associated with this litigation. In June 2013, the judge granted a joint motion to stay the proceedings pending a remand to the USPTO, in which the USPTO is expected to reconsider its patent term adjustment award in light of decisions in a number of appeals to the Federal Circuit, including Novartis AG v. Lee 740 F.3d 593 (Fed. Cir. 2014), or the Novartis decision. Since having issued final rules implementing the Novartis decision, the USPTO has been working through the civil action cases and issuing remand decisions. The Company’s case was on remand until the USPTO made its decision on the recalculation of the patent term adjustment. On September 28, 2016, the USPTO issued a decision that the patent term adjustment is 1,038 days, from which the ‘131 Patent expiration would be March 26, 2029.
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, 2017, 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.
Between May 2014 and May 2016, the FASB issued three ASUs changing the requirements for recognizing and reporting revenue, or together, herein referred to as the revenue ASUs: (i) ASU No. 2014-09, Revenue from Contracts with Customers , or ASU 2014-09, (ii) ASU No. 2016-08, Principal versus Agent Considerations (Reporting Revenue Gross versus Net), or ASU 2016-08, and (iii) ASU No. 2016-12, Narrow-Scope Improvements and Practical Expedients , or ASU 2016-12. ASU 2014-09 provides guidance for revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2016-08 is intended to improve the operability and understandability of the implementation guidance on principal versus agent considerations. ASU 2016-12 provides practical expedients and improvements on the previously narrow scope of ASU 2014-09. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, or ASU 2015-14. ASU 2015-14 defers the effective date of ASU 2014-09 by one year to fiscal years beginning, and interim periods after, December 15, 2017. All subsequent ASUs related to ASU 2014-09, including ASU 2016-08 and ASU 2016-12, assumed the deferred effective date enforced by ASU 2015-14. Early adoption of the revenue ASUs is permitted for annual periods beginning, and interim periods after, December 15, 2016. A reporting entity may apply the amendments in the revenue ASUs using either a modified retrospective approach, by recording a cumulative-effect adjustment to equity as of the beginning of the fiscal year of adoption or full retrospective approach. The Company is evaluating the impact of the adoption of the revenue ASUs to its consolidated financial position and results of operations. Based on the Company’s current assessment of the effect of the revenue ASUs on historical revenue under its current collaboration agreements related to upfront and milestone payments, the Company believes these historical amounts will not have a material impact on its consolidated financial statements. The new revenue ASUs may have a material impact on future revenue to be recognized under the Company’s Allergan Collaboration Agreement and Zai Collaboration Agreement. The Company does not believe the new revenue ASUs will have a material impact on revenue recognized related to its Purdue Collaboration Agreement. The Company expects to elect the full retrospective application as its transition method.
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. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, including those interim periods within those fiscal years. The Company is currently evaluating the impact the adoption of ASU 2016-02 will have on its consolidated financial statements.
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In August 2016, the FASB i ssued ASU No. 2016-15, Statement of Cash Flows (Topic 230), which simplifies certain elements of cash flow classification. The new guidance is intended to reduce diversity in practice in how certain transactions are classified in the statement of cash flow s. ASU 2016-15 is effective for annual periods beginning after December 15, 2017. The Company is currently evaluating the impact the adoption of ASU 2016-15 will have on its consolidated financial statements.
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 beginning, and interim periods 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 is evaluating the impact of the adoption of ASU 2016-16 to its consolidated financial position and results of operations. The Company does not expect the adoption of ASU 2016-16 to have a material impact to its consolidated financial position or results of operations.
In November 2016, the FASB issued ASU No. 2016-18, Restricted Cash , or ASU 2016-18. ASU 2016-18 requires an entity to reconcile and explain the period-over-period change in total cash, cash equivalents and restricted cash within its statements of cash flows. ASU 2016-18 is effective for fiscal years beginning, and interim periods after, December 15, 2017. Early adoption is permitted. A reporting entity must apply the amendments in ASU 2016-18 using a full retrospective approach. The Company is currently evaluating the impact the adoption of the ASU will have on its consolidated financial statements.
In January 2017, the FASB issued ASU No. 2017-04, Simplifying the Test for Goodwill Impairment , or ASU 2017-04. ASU 2017-04 eliminates the current two-step approach used to test goodwill for impairment and requires 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 beginning, including interim periods, 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.
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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, 2016, as filed with the SEC on March 2, 2017 and elsewhere in this report. 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 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 known drug interactions, and a favorable safety and tolerability 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. In addition to Qualified Infectious Disease Product, or QIDP, designation, on November 4, 2015, the FDA granted omadacycline Fast Track designation for the development of omadacycline in ABSSSI, CABP, and complicated Urinary Tract Infections. 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 a pediatric program associated with the Pediatric Research and Equity Act. The FDA has granted Paratek a waiver from conducting studies with omadacycline in children less than eight years old due the risk of teeth discoloration, a known class effects 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 industry.
Scientific advice received through the centralized procedure in Europe confirmed general agreement on the design and choice of comparators of the Phase 3 trials for ABSSSI and CABP and noted that approval based on a single study in each indication could be possible but would be 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 the data package for submission of an MAA filing for approval in the European Union, or EU.
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We recently held two pre-NDA meetings with the FDA. The first meeting was to discuss clinical and non-clinical topics and the second meeting was to discuss the CMC data components of our proposed submission package, the result of which was confirmation that we have a clear path towards our NDA submission. Following these regulatory meetings, we plan to begin a rolling submission of our NDAs to the FDA in December 2017. The final NDA submissions for both formulations are expected to be submitted during the first quarter of 2018.
To date, we have conducted more than 20 Phase 1 studies in omadacycline to characterize the effects of the drug on humans including how it is absorbed, metabolized, and excreted. These Phase 1 studies also included this 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), respectively. Both studies utilized initiation of IV therapy with transitions to oral-based treatment on 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. We plan to include these clinical data in the NDA submission to the FDA for the treatment of ABSSSI and CABP in the first quarter of 2018 with the European Medicines Agency, or EMA, submission later in 2018.
In the OPTIC study, 774 patients were randomized. Omadacycline met the FDA-specified primary efficacy endpoint of statistical non-inferiority, or NI, in the intent-to-treat, or ITT, population (10% NI margin, 95% confidence interval) compared to moxifloxacin at the early clinical response, or ECR, 72-120 hours after initiation of therapy. The ECR rates for the omadacycline and moxifloxacin treatment arms were 81.1% and 82.7%, respectively. Additionally, the FDA-specified secondary endpoints evaluated omadacycline at the post treatment evaluation, or PTE, visit 5-10 days after therapy in both the ITT population (87.6% for omadacycline vs. 85.1% for moxifloxacin) and clinically evaluable, or CE, population (92.9% for omadacycline vs. 90.4% for moxifloxacin) as determined by investigators. The secondary endpoints also achieved statistical non-inferiority. The co-primary endpoints for the EMA were non-inferiority in the ITT and CE CABP populations in those patients with Pneumonia Severity Index, or PORT, III/IV CABP at the PTE time point. Omadacycline demonstrated a high response rate and met statistical non-inferiority to moxifloxacin for both populations using a prespecified 97.5% confidence interval. High success rates were observed with response rates of 88.4% (omadacycline) vs. 85.2% (moxifloxacin) and 92.5% (omadacycline) vs. 90.5% (moxifloxacin), respectively.
Omadacycline was shown to be generally safe and well tolerated in the OPTIC study, consistent with prior studies of omadacycline. The most common treatment emergent adverse events, or TEAEs, in omadacycline-treated patients (occurring in ≥ 3% of patients) were alanine aminotransferase, or ALT, increase (3.7% with omadacycline vs. 4.6% with moxifloxacin) and hypertension (3.4% with omadacycline vs. 2.8% with moxifloxacin). Gastrointestinal adverse events of interest for omadacycline vs. moxifloxacin included: vomiting (2.6% vs. 1.5%), nausea (2.4% vs. 5.4%), diarrhea (1.0% vs. 8.0%), respectively. There were no cases of clostridium difficile colitis or infection in patients treated with omadacycline, compared with seven cases (1.8%) of clostridium difficile colitis and 1 case of pseudomembranous colitis in patients treated with moxifloxacin. Rates of TEAEs were 41.1% for omadacycline vs. 48.5% for moxifloxacin. Drug-related TEAEs were 10.2% for omadacycline vs. 17.8% for moxifloxacin. Discontinuation for TEAEs was uncommon, 5.5% for omadacycline vs. 7.0% for moxifloxacin. Serious TEAEs occurred in 6.0% of omadacycline patients and 6.7% of moxifloxacin patients; four of these were considered related to study drug, two for omadacycline and two for moxifloxacin. The mortality rate was 2.1% with omadacycline and 1.0% with moxifloxacin. Drug-related serious TEAEs leading to premature discontinuation of test article were 2.6% with omadacycline and 2.8% with moxifloxacin.
In the OASIS-2 study, 735 patients were randomized. Oral, once daily omadacycline met the FDA-specified primary efficacy endpoint of statistical NI in the modified intent-to-treat, or mITT, population (10% NI margin, 95% confidence interval) compared to oral, twice daily linezolid at the early clinical response, or ECR, 48-72 hours after initiation of therapy. The ECR rates for the omadacycline and linezolid treatment arms were 87.5% and 82.5%, respectively. In addition, omadacycline met specified co-primary endpoints for the EMA, which are key secondary endpoints for the FDA. For these endpoints, non-inferiority in the mITT and CE populations in at the PTE, 7 to 14 days after end of treatment, omadacycline demonstrated a high response rate and met statistical non-inferiority to linezolid for both populations using a prespecified 95% confidence interval. High success rates were observed with response rates of 84.2% (omadacycline) vs. 80.8% (linezolid) and 97.9% (omadacycline) vs. 95.5% (linezolid), respectively.
Omadacycline was shown to be generally safe and well tolerated in the OASIS-2 study, consistent with prior studies of omadacycline. The most common TEAEs in omadacycline-treated patients (occurring in ≥ 3% of patients) were Gastrointestinal adverse events of omadacycline vs. linezolid included: vomiting (16.8% vs. 3.0%), nausea (30.2% vs. 7.6%), diarrhea (4.1% vs. 2.7%). In addition, alanine aminotransferase, or ALT, increase (5.2% with omadacycline vs. 3.0% with linezolid), AST increases (4.6% with omadacycline vs. 3.3 for linezolid) and headache (3.5% with omadacycline vs. 2.2% with linezolid). Drug-related TEAEs were 37.8% for omadacycline vs. 14.2% for linezolid (including GI events). Discontinuation for TEAEs was uncommon, 1.6% for omadacycline vs. 0.8% for linezolid. Serious TEAEs occurred in 1.4% of omadacycline patients and 1.4% of linezolid patients; four of these were considered related to study drug, two for omadacycline and two for linezolid. The mortality rate was 0.0% with
23
omadacycline and 0..3 with linezolid. Drug-related serious TEAEs leading to premature discontinuation of test article were 0.8% with omadacycline and 0.5% with linezolid.
Across the entire Phase 3 pivotal study program, we have observed the following frequent adverse events along with the following incidence range: Nausea (2.4% to 30.2%), Vomiting (2.6% to 16.8%), Headache (2.1% to 3.5%), ALT increased (2.8% to 5.2%), AST increased (2.1% to 4.6%), and Diarrhea (1.0% to 4.1%). Importantly, we have not had any reported cases of clostridium difficile colitis or infection in patients treated with omadacycline in the entire safety database to date.
In May 2016, we initiated our first oral-only and IV-to-oral study of omadacycline dosed for five days in a Phase 1b clinical study in patients with a UTI. This Phase 1b UTI study was completed. Data from this study showed that omadacycline achieved proof of principle, by demonstrating high concentration levels of omadacycline in urine, across IV-to-oral and oral-only dosing regimens.
In October 2016, we announced that we entered into a Cooperative Research and Development Agreement, or CRADA, with the U.S. Army Medical Research Institute of Infectious Diseases, or USAMRIID, 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.
Our second Phase 3 antibacterial product candidate, sarecycline, also known as WC3035, 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 PK 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. Allergan currently holds a non-exclusive license to develop and commercialize sarecycline for the treatment of rosacea in the United States. There are currently no clinical trials with sarecycline in rosacea underway. 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 9-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 intends to file an NDA with the FDA in the fourth quarter of 2017 for the treatment of acne.
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 product candidates for approval by regulatory authorities, and 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.
In April 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, the Company granted Zai an exclusive license to develop, manufacture and commercialize omadacycline 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 the Company. Under the terms of the Zai Collaboration Agreement, Paratek Bermuda Ltd. earned an upfront, nonrefundable license payment of $7.5 million during the six months ended June 30, 2017.
We have incurred significant losses since our inception in 1996. Our accumulated deficit at June 30, 2017 was $426.9 million and our net loss for the six months ended June 30, 2017 was $45.9 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.
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We do not expect to generate revenue from product sales unless and until we or either of our partners, A llergan or Zai, successfully complete development and obtain marketing approval for 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 o f 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 publ ic and private equity offerings, debt or other structured financings and strategic collaborations. 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 c ommercialization 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. We received $36.9 million in proceeds, after deducting commissions of $1.1 million, from the sale of 2,326,119 shares of common stock under the 2015 Sales Agreement during the six months ended June 30, 2017. We received an additional $41.8 million in proceeds, after deducting commissions of $1.3 million, from the sale of 1,854,013 shares of common stock during the six months ended June 30, 2017under the 2017 Sales Agreement. As of June 30, 2017 $6.9 million remains available for sale under the 2017 Sales Agreement.
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, or NIH, and other non-profit organizations. We do not expect to generate revenue from product sales prior to 2018, at the earliest.
License 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 entered into in October 2016.
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 will 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.
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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 an y 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.
We are using available cash, cash equivalents, and marketable securities on hand and borrowings under our Loan Agreement, as amended, with Hercules to complete our clinical studies of omadacycline as well as activities required to support an NDA submission for omadacycline for the treatment of ABSSSI and CABP, the manufacture of validation batches and commercial supply, to build our commercial and medical affairs teams, and for working capital and other general corporate purposes.
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 costs 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 and 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, 2017 and 2016 are as follows (in thousands):
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
||||
Omadacycline costs |
|
$ |
9,632 |
|
|
$ |
19,181 |
|
|
$ |
23,993 |
|
|
$ |
40,667 |
|
Other research and development costs |
|
|
5,447 |
|
|
|
2,954 |
|
|
|
9,742 |
|
|
|
5,756 |
|
Total |
|
$ |
15,079 |
|
|
$ |
22,135 |
|
|
$ |
33,735 |
|
|
$ |
46,423 |
|
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 represents interest incurred on the Hercules Term Loan and the adjustment of our marketable securities to amortized cost.
Interest Income
Interest income represents interest earned on our money market funds and marketable securities.
26
Comparison of the three months ended June 30, 2017 and 2016
|
|
Three Months Ended June 30, |
|
|
|
|
|
|||||
(in thousands) |
|
2017 |
|
|
2016 |
|
|
$ Change |
|
|||
License and royalty revenue |
|
$ |
7,514 |
|
|
$ |
— |
|
|
$ |
7,514 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
15,079 |
|
|
|
22,135 |
|
|
|
(7,056 |
) |
General and administrative |
|
|
8,716 |
|
|
|
7,602 |
|
|
|
1,114 |
|
Impairment of intangible asset |
|
|
682 |
|
|
|
— |
|
|
|
682 |
|
Changes in fair value of contingent consideration |
|
|
(318 |
) |
|
|
15 |
|
|
|
(333 |
) |
Total operating expenses |
|
|
24,159 |
|
|
|
29,752 |
|
|
|
(5,593 |
) |
Loss from operations |
|
|
(16,645 |
) |
|
|
(29,752 |
) |
|
|
13,107 |
|
Other income and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(1,126 |
) |
|
|
(818 |
) |
|
|
(308 |
) |
Interest income |
|
|
349 |
|
|
|
288 |
|
|
|
61 |
|
Other loss, net |
|
|
(8 |
) |
|
|
(1 |
) |
|
|
(7 |
) |
Loss before income taxes |
|
$ |
(17,430 |
) |
|
$ |
(30,283 |
) |
|
$ |
12,853 |
|
Provision for income taxes |
|
|
753 |
|
|
|
— |
|
|
|
753 |
|
Net Loss |
|
$ |
(18,183 |
) |
|
$ |
(30,283 |
) |
|
$ |
12,100 |
|
Revenue
During the three months ended June 30, 2017, we recognized revenue of $7.5 million under the Zai Collaboration Agreement, which represents the upfront license payment. Revenue also represents fifty percent of net royalties received pursuant to the Royalty Sharing Agreement entered into in October 2016. We did not earn revenue during the three months ended June 30, 2016.
Research and Development Expense
Research and development expenses were $15.1 million for the three months ended June 30, 2017 compared to $22.1 million for the same period in 2016. The decrease was driven primarily by lower clinical study costs as we neared completion of our planned Phase 3 pivotal study program in omadacycline.
We anticipate that our research and development expenses will decrease in the future as we complete our clinical and non-clinical studies, complete production of omadacycline validation batches, and finalize our NDA filing for submission.
General and Administrative Expense
General and administrative expenses were $8.7 million for the three months ended June 30, 2017 compared to $7.6 million for the same period in 2016. The increase was driven primarily by higher employee compensation costs as we continue to expand our team.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support potential commercialization of omadacycline.
Impairment of Intangible Assets
We recorded an impairment charge of $0.7 million during the three months ended June 30, 2017. No such impairment was recorded during the three months ended June 30, 2016. The impairment charge was recorded in connection with an expected decline in Intermezzo sales.
Changes in Fair Value of Contingent Obligations
During the three months ended June 30, 2017 and 2016, we recorded a $0.3 million decrease and $15,000 increase, respectively, in the fair value of our contingent obligations to former Transcept stockholders. The decrease in the fair value of our contingent obligation for the three months ended June 30, 2017 reflects a corresponding significant decline in projected Intermezzo sales. The
27
increase in the fair value of our contingent obligation for the three months ended June 30, 2016 was associated with an inc rease in the present value of the obligation as we approached the second anniversary of the Merger.
Other Income and Expenses
Interest expense for the three months ended June 30, 2017 represents interest incurred on the 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. Interest expense for the three months ended June 30, 2016 represented interest incurred on the Loan Agreement of $0.6 million and the net amortization of our marketable securities of $0.2 million. Interest income for the three months ended June 30, 2016 represents interest earned on our money market funds and marketable securities purchased during the three months ended June 30, 2016 of $0.3 million.
Provision for Income Taxes
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. We recorded no provision for income taxes for the three months ended June 30, 2016.
Results of Operations
Comparison of the six months ended June 30, 2017 and 2016
|
|
Six Months Ended June 30, |
|
|
|
|
|
|||||
(in thousands) |
|
2017 |
|
|
2016 |
|
|
$ Change |
|
|||
License and royalty revenue |
|
$ |
7,532 |
|
|
$ |
— |
|
|
$ |
7,532 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
33,735 |
|
|
|
46,423 |
|
|
|
(12,688 |
) |
General and administrative |
|
|
17,080 |
|
|
|
13,941 |
|
|
|
3,139 |
|
Impairment of intangible asset |
|
|
682 |
|
|
|
— |
|
|
|
682 |
|
Changes in fair value of contingent consideration |
|
|
(549 |
) |
|
|
120 |
|
|
|
(669 |
) |
Total operating expenses |
|
|
50,948 |
|
|
|
60,484 |
|
|
|
(9,536 |
) |
Loss from operations |
|
|
(43,416 |
) |
|
|
(60,484 |
) |
|
|
17,068 |
|
Other income and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(2,258 |
) |
|
|
(1,548 |
) |
|
|
(710 |
) |
Interest income |
|
|
590 |
|
|
|
479 |
|
|
|
111 |
|
Other loss, net |
|
|
(15 |
) |
|
|
(1 |
) |
|
|
(14 |
) |
Net loss |
|
$ |
(45,099 |
) |
|
$ |
(61,554 |
) |
|
$ |
16,455 |
|
Provision for income taxes |
|
|
753 |
|
|
|
— |
|
|
|
753 |
|
Net Loss |
|
$ |
(45,852 |
) |
|
$ |
(61,554 |
) |
|
$ |
15,702 |
|
Revenue
During the six months ended June 30, 2017, we recognized revenue of $7.5 million under the Zai Collaboration Agreement, which represents the upfront license payment. Revenue also represents fifty percent of net royalties received pursuant to the Royalty Sharing Agreement entered into in October 2016. We did not earn revenue during the six months ended June 30, 2016.
Research and Development Expense
Research and development expenses were $33.7 million for the six months ended June 30, 2017 compared to $46.4 million for the same period in 2016. The decrease was driven primarily by lower clinical study costs as we neared completion of our planned Phase 3 pivotal study program in omadacycline. The decrease is also attributable to reduced manufacturing production costs for omadacycline since fewer production runs fell within the six months ended June 30, 2017 compared to the same period in prior year.
We anticipate that our research and development expenses will decrease in the future as we complete our clinical and non-clinical studies, complete production of omadacycline validation batches, and finalize our NDA filing for submission.
28
General and Administrative Expense
\
General and administrative expenses were $17.1 million for the six months ended June 30, 2017 compared to $13.9 million for the same period in 2016. The increase was driven primarily by incremental employee compensation costs and higher consulting and legal fees.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support potential commercialization of omadacycline.
Impairment of Intangible Assets
We recorded an impairment charge of $0.7 million during the six months ended June 30, 2017. No such impairment was recorded during the six months ended June 30, 2016. The impairment charge was recorded in connection with an expected decline in Intermezzo sales.
Changes in Fair Value of Contingent Obligations
During the six months ended June 30, 2017 and 2016, we recorded a $0.5 million decrease and $0.1 million increase, respectively, in the fair value of our contingent obligations to former Transcept stockholders. The decrease in the fair value of our contingent obligation for the six months ended June 30, 2017 reflects a corresponding significant decline in projected Intermezzo sales. The increase in the fair value of our contingent obligation for the six months ended June 30, 2016 was associated with an increase in the present value of the obligation as we approached the second anniversary of the Merger.
Other Income and Expenses
Interest expense for the six months ended June 30, 2017 represents interest incurred on the 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. Interest expense for the six months ended June 30, 2016 represents interest incurred on the Term Loan entered into with Hercules on September 30, 2015 of $1.2 million and the net amortization of our marketable securities of $0.3 million. Interest income for the six months ended June 30, 2016 represents interest earned on our money market funds and marketable securities purchased during the six months ended June 30, 2016 of $0.5 million.
Provision for Income Taxes
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. We recorded no provision for income taxes for the six months ended June 30, 2016.
Liquidity and Capital Resources
On January 12, 2015, we filed a registration statement on Form S-3 with the SEC, as amended on April 24, 2015 and declared effective on April 27, 2015, to sell shares of our common stock, par value $0.001 per share, in an aggregate amount of up to $200.0 million to the public in one or more registered offerings. Under this shelf registration statement, we completed an underwritten offering on May 5, 2015 of 3,089,000 shares of common stock at a public offering price of $24.50 per share, which includes 229,000 shares of common stock issued upon the exercise, in part, by the underwriters of an option to purchase additional shares. The aggregate proceeds received by us, after underwriting discounts and commissions and other offering expenses, were $70.4 million. We completed an underwritten offering in June 2016 of 4,887,500 shares of common stock at a public offering price of $13.00 per share, which includes 637,500 shares of common stock issued upon the exercise, in full, by the underwriters of an option to purchase additional shares from us. The net proceeds received by us, after underwriting discounts and commissions and other estimated offering expenses, were $59.3 million.
On September 30, 2015, we entered into a Loan and Security Agreement, or the 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 three amendments to the 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, 2016, we have drawn down on $50.0 million of the $60.0 million available to us. An additional $10.0 million tranche is available at our option through December 15, 2017. The last amendment executed during the quarter ended June 30, 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,
29
omadacycline, or the Interest Only Perio d Extension Event. Beginning on January 1, 2019, or, if we achieve the Interest Only Period Extension Event, January 1, 2020, we will make payments in equal monthly installments of principal and interest, with the balance of outstanding loans due on the o riginal maturity date of the Loan Agreement. 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 aggr egate of 5,374 shares of common stock at an exercise price of $23.26 per share.
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 of 1933, as amended. We received $36.9 million in proceeds, after deducting commissions of $1.1 million, from the sale of 2,326,119 shares of common stock under the 2015 Sales Agreement during the six months ended June 30, 2017. We received an additional $41.8 million in proceeds, after deducting commissions of $1.3 million, from the sale of 1,854,013 shares of common stock during the six months ended June 30, 2017 under the 2017 Sales Agreement. As of June 30, 2017 $6.9 million remains available for sale under the 2017 Sales Agreement.
We have used and we intend to continue to use the net proceeds from the above-described offerings, as well as the Loan Agreement, as amended, together with our existing capital resources, to complete our clinical studies of omadacycline as well as activities required to support an NDA submission for omadacycline for the treatment of ABSSSI and CABP, the manufacture of validation batches and commercial supply, to build our commercial and medical affairs teams, and for working capital and other general corporate purposes.
As of June 30, 2017, we had cash, cash equivalents and marketable securities of $175.3 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) |
|
2017 |
|
|
2016 |
|
||
Net cash used in operating activities |
|
$ |
(40,686 |
) |
|
$ |
(40,815 |
) |
Net cash used in investing activities |
|
$ |
(49,314 |
) |
|
$ |
(64,688 |
) |
Net cash provided by financing activities |
|
$ |
88,625 |
|
|
$ |
61,628 |
|
30
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 accounting receivable and other assets. Cash used in operating activities for the six months ended June 30, 2016 of $40.8 million is primarily the result of our $61.5 million net loss offset in part by a $7.7 million increase in accounts payable and accrued expenses, and a decrease of $7.1 million in prepaid expenses mainly associated with the clinical development of omadacycline. The remainder is the net impact of $6.2 million in non-cash items, including $6.0 million in depreciation, amortization and stock-based compensation expense, $0.6 million in non-cash interest expense, a $0.1 million increase in contingent obligations to former Transcept stockholders offset by $0.5 million of interest earned on our marketable securities.
Investing Activities
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 new offices in Boston and King of Prussia and received a refund for an existing letter of credit of $0.8 million. Net cash used in investing activities during the six months ended June 30, 2016 due to investments of $68.2 million of our cash in short-term marketable securities (U.S. treasury and government agency securities), an increase in restricted cash primarily representing a letter of credit of $0.8 million, and purchases of fixed assets of $0.4 million, partially offset by proceeds from maturities of marketable securities of $5.0 million.
Financing Activities
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 Loan Agreement, as amended. Net cash provided by financing activities for the six months ended June 30, 2016 is the result of net proceeds of $2.0 million received from the sale of shares of our common stock under the Sales Agreement, net proceeds of $59.6 million from a public offering of 4,887,500 shares of common stock in June 2016, and the exercise of stock options.
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 of 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 our clinical trials of omadacycline; |
|
• |
seek regulatory approvals for omadacycline, assuming that it successfully completes clinical trials; |
|
• |
establish a sales, marketing and distribution infrastructure and increases to our manufacturing demand and capabilities to commercialize omadacycline; and |
|
• |
add operational, financial and management information systems and personnel, including personnel to support our product development and planned commercialization efforts. |
31
Based upon our current operating plan, we anticipate that our existing cash, cash equivalents and marketable securities, the remaining $10.0 million we may borrow under the Loan Agreement and anticipated regulatory and commercial milestone payments from our collaborations with Allergan and Zai will enable us to fund our operating expenses and capital expenditure requirements through the second quarter of 2019. 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 commercial ization 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. |
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 and private equity offerings, debt or other structured financings and strategic collaborations. We do not have any committed external sources of funds other than contingent milestone payments and royalties under the Allergan Collaboration Agreement and Zai Collaboration Agreement, which are terminable by Allergan and Zai, respectively, upon prior written notice, and the undrawn balance of $10.0 million on the Third Amendment, available to use through December 15, 2017. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership 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 covenants 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 collaborations, 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.
As of January 1, 2017, we adopted ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting , or ASU 2016-09 . In connection with the adoption, we made an accounting policy change. Prior to adoption, we estimated forfeitures at the time of grant and revised those estimates in subsequent periods if actual forfeitures differed from the estimates. We used historical data to estimate pre-vesting option forfeitures to the extent that actual forfeitures differed from our estimates, the difference was recorded as a cumulative adjustment in the period the estimates were revised. Upon adoption, we recognize the effect of forfeitures in compensation cost when they occur. We recorded a cumulative-effect catch-up adjustment to equity of $0.7 million upon adoption.
32
There have been no other material changes in our critical accounting policies during the six months ended June 30 , 2017, 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, 2016, as filed with the SEC on March 2, 2017.
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, 2017 and the year ended December 31, 2016 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 Commi tments
We executed the third amendment to the lease agreement on our King of Prussia office space in October 2016. The lease agreement, as amended, was for 19,708 rentable square feet of office space, for a total commitment of $3.3 million, with respect to which lease payments became due beginning once we took control of such office space during the quarter ended March 31, 2017. The total lease commitment is over a seven-year and seven-month lease term. The lease contains rent escalation and a partial rent abatement period, which will be accounted for as rent expense under the straight-line method. We are required to make additional payments under the operating lease for taxes, insurance, and other operating expenses incurred during the operating lease period.
In July 2017, we entered into a master manufacturing services agreement and corresponding product agreement with Patheon UK Limited, or Patheon. The agreements provide for the terms and conditions under which Patheon will manufacture, package and supply to us omadacycline in injectable form, or the Patheon Products. Under these agreements, we are required to deliver to Patheon the active pharmaceutical ingredient needed to manufacture the Patheon Products. We are obligated to pay a supply price in the six-digit dollar range per batch of the Patheon Products, subject to adjustments as provided in the agreements. If our omadacycline product is approved, we will also be subject to an annual minimum purchase requirement in the six-digit euro range. If we desire for Patheon to conduct additional services other than those expressly set forth in the agreements, those would be subject to additional fees.
Our agreements with Patheon will remain in effect for a fixed initial term, after which they will continue for successive renewal terms unless either we or Patheon have given written notice of termination within a certain period prior to the expiration of the applicable initial or then-current renewal term. The agreements may also be terminated under certain other circumstances, including by either party due to a material uncured breach of the other party or the other party’s insolvency.
For further details, refer to Note 15, Commitments and Contingencies , to our Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q.
Other than as described above, there have been no other material changes in our contractual obligations and commitments as of June 30, 2017, 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, 2016, as filed with the SEC on March 2, 2017.
Our cash, cash equivalents and investments balance as of June 30, 2017 consisted of cash and cash equivalents and U.S. treasury 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.
33
We engage CROs and contract manufacturers on a global scale. We may be subject to fluctuations in foreign currency rates in co nnection 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 w ere less than 10% of total liabilities as of June 30, 2017.
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, 2017, 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, 2017, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
During the three months ended June 30, 2017, there have been no 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.
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.
34
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, 2016, as filed with the SEC on March 2, 2017, and in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, as filed with the SEC on May 4, 2017.
Reference is made to the Exhibit Index attached to this Report, which is incorporated by reference here.
35
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, 2017.
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) |
36
|
|
|
|
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 |
|
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 |
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001-36066 |
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4.1 |
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December 13, 2016 |
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4.4 |
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Warrant, dated as of April 7, 2014 issued to HBM Healthcare Investments (Cayman) Ltd. |
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Form 10-K |
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001-36066 |
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10.22 |
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April 2, 2015 |
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4.5 |
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Warrant, dated as of April 18, 2014 issued to K/S Danish BioVenture. |
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Form 10-K |
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001-36066 |
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10.23 |
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April 2, 2015 |
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4.6 |
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Warrant, dated as of April 7, 2014 issued to Omega Fund III, L.P. |
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Form 10-K |
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001-36066 |
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10.24 |
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April 2, 2015 |
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10.1 |
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Amendment No. 3 to Loan and Security Agreement dated June 27, 2017, by and between Paratek Pharmaceuticals, Inc., Paratek Pharma, LLC, Hercules Technology II, L.P., Hercules Technology III, L.P., certain other lenders and Hercules Technology Growth Capital, Inc. |
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Form 8-K |
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001-36066 |
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10.1 |
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June 29, 2017 |
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10.2+ |
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Paratek Pharmaceuticals, Inc. 2017 Inducement Plan. |
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Form 8-K |
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001-36066 |
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10.1 |
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June 16, 2017 |
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10.3+ |
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Form of Stock Option Grant Notice and Form of Option Agreement under the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan. |
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Form 8-K |
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001-36066 |
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10.2 |
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June 16, 2017 |
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10.4+ |
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Form of Restricted Stock Unit Award Grant Notice and Form of Restricted Stock Unit Award Agreement under the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan |
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Form 8-K |
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001-36066 |
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10.3 |
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June 16, 2017 |
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37
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Incorporated by Reference |
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Exhibit No. |
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Exhibit Description |
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Schedule/ Form |
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File Number |
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Exhibit |
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Filing Date |
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Paratek Pharmaceuticals, Inc. Annual Incentive Plan. |
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Form 8-K |
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001-36066 |
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10.4 |
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June 16, 2017 |
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10.6*+ |
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10.7*+ |
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10.8*+ |
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10.9*+ |
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10.10*+ |
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10.11*^ |
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10.12*^ |
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31.1* |
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31.2* |
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32.1* |
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32.2* |
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101.INS* |
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XBRL Instance Document. |
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101.SCH* |
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XBRL Taxonomy Extension Schema Document. |
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101.CAL* |
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XBRL Taxonomy Extension Calculation Linkbase Document. |
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101.DEF* |
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XBRL Taxonomy Extension Definition Linkbase Document. |
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101 . L A B* |
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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 . |
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101.PRE* |
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XBRL Taxonomy Extension Presentation Linkbase Document. |
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* |
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. |
38
39
Exhibit 10.6
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PARATEK PHARMACEUTICALS paratekpharma.com |
75 Park Plaza Boston, MA 02116 617.807.6600 617.275.0039 fax |
June 16, 2017
Michael F. Bigham
By Hand
Re: |
Amended and Restated Employment Agreement |
Dear Michael:
On behalf of the Board of Directors (the “Board”) of Paratek Pharmaceuticals, Inc. (“Paratek” or the “Company”), I am pleased to offer you continued employment under the terms of this Amended and Restated Employment Agreement (the “Agreement”). In this Agreement, you and the Company hereby further amend, supersede, and restate in its entirety that certain amended and restated employment agreement between the Company and you dated February 4, 2015 (the “Employment Agreement”).
Employment Position and Duties
You will continue to be employed in the position of Chairman of the Board and Chief Executive Officer (“CEO”). You will be expected to perform the customary duties of your position, duties specified in the Bylaws of the Company, and as may be required by the Board. You will report to the Board, and work at the Company’s corporate headquarters in Boston, Massachusetts. The Company reserves the right to reasonably require you to perform your duties at places other than its corporate headquarters from time to time, and to require reasonable business travel, including international travel, at the Company’s expense.
You will generally devote at least ninety percent (90%) of your business time and attention to the business of the Company. At all times, the Company shall provide you with full-time executive secretarial support based at your Company office.
Your employment relationship with the Company will also be governed by the general employment policies and practices of the Company, except that if the terms of this Agreement conflict, this Agreement will control. The Board reserves the right to change your position, duties, and work location, from time to time in its discretion.
Board Membership
You agree to continue to serve as a director of the Company and as Chairman of the Board while you remain employed as the CEO of the Company. You agree that, unless otherwise requested by the Board, in the event your employment with the Company is terminated for any reason, either voluntarily or involuntarily, with or without Cause, you shall resign as a member of the Board and as its Chairman simultaneously with the termination of your employment.
Base Salary
You will earn a salary at the rate of $19,166.67 semi-monthly ($460,000 annualized), less payroll deductions and withholdings (“Base Salary”), payable on the Company’s regular payroll schedule.
The Base Salary will be reviewed on an annual or more frequent basis by the Board (or any authorized committee thereof), and may be subject to increase in the discretion of the Board (or any authorized committee thereof).
62414929_3
Discretionary Performance Bonus
You will be eligible to earn a discretionary performance bonus of up to fifty percent (50%) of your Base Salary, subject to applicable payroll deductions and withholdings (“Bonus”), based upon the Board’s assessment of your performance, and the Company’s attainment of written targeted goals as determined by the Board in its sole discretion. Following the close of each calendar year, the Board will determine in its discretion whether you have earned a Bonus, and the amount of any Bonus. You will be eligible to earn a Bonus for any full calendar year provided that you remain employed by the Company as of December 31 of that year. The Bonus, if earned, will be paid no later than March 15 of the calendar year after the year to which it relates.
Employee Benefits
As a regular employee, you will be eligible to participate in the Company’s standard employee benefits, pursuant to the terms and conditions of the benefit plans and applicable policies, and for any additional benefits provided to the Company’s executive employees generally. You will also be entitled to four (4) weeks of paid vacation each calendar year, in accordance with the terms of the Company’s vacation policy. The Company may change employee benefits from time to time in its discretion. Details about these benefits are provided in the employee handbook and Summary Plan Descriptions, available for your review.
Business Expenses
The Company will pay or reimburse you for all reasonable business expenses incurred or paid by you in the performance of your duties and responsibilities for the Company, subject to such reasonable substantiation and documentation as may be required by the Company, and subject to any maximum annual limit and other restrictions on or policies governing such expenses as set by the Company from time to time.
Equity Compensation
You will be eligible for future equity awards granted in accordance with the Company’s plans as in effect from time to time at levels commensurate with your position and responsibilities and subject to such terms as shall be determined by the Board or one of its committees in its or their sole discretion.
Notwithstanding the foregoing, the options and any other equity awards that may be granted to you by the Company after June 26, 2014 (collectively, the “Company Equity”) will be subject to earlier vesting upon your termination by the Company without Cause or by you with Good Reason, or upon a Change in Control, under the conditions described below. For the avoidance of doubt, any award agreement granting you Company Equity shall provide that the award cannot be amended without your consent.
At-Will Employment Relationship
You may terminate your employment with the Company at any time, with or without Good Reason, and with or without advance notice, and for any reason whatsoever simply by notifying the Company. Likewise, the Company may terminate your employment at any time, with or without Cause, and with or without advance notice. Your employment at-will status can only be modified in a written agreement approved by the Board and signed by you and a duly authorized Member of the Board.
Payments upon Termination other than without Cause or with Good Reason
Upon termination of your employment for any reason other than by the Company without Cause or by you with Good Reason, you shall be paid all accrued but unpaid Base Salary, any earned but unpaid Bonus, reimbursement for business expenses incurred by you but not yet paid to you as of the date your employment terminates, and all accrued but unused vacation (collectively, the “Accrued Payments”). Your outstanding and unvested Company Equity shall terminate as of your termination date.
62414929_3
Termination without Cause or with Good Reason
Upon termination of your employment at any time (whether before, in connection with, or following a Change in Control) by the Company without Cause or by you with Good Reason, you will receive the Accrued Payments. In addition, subject to your fulfillment of the Release Obligation, as defined below, you will be eligible for the following severance benefits:
1. Cash Severance Payments. You will be eligible to receive cash severance equal to twelve (12) months of Base Salary following the termination date, subject to payroll withholding and deduction (“Severance Payments”), and paid according to the Company’s regular payroll procedures. Payment of Severance Payments shall commence on the sixtieth (60th) day following your employment termination, which initial payment shall include a lump sum payment equal to the aggregate semi-monthly installments that would otherwise have been due during the period between the termination date and the sixtieth (60 th ) day, but for the sixty (60)-day delay in this provision. Thereafter, the remaining installments shall be paid on the Company’s regular paydays.
2. Pro-Rata Severance Bonus. You will also be eligible to receive an amount (the “Pro-Rata Bonus”) equal to the Bonus you would have earned for the year in which your employment terminates, prorated by multiplying the Bonus that you would have earned if you had remained employed through December 31 by the portion of the year that you had actually remained employed, and subject to payroll withholding and deduction. The determination by the Board of the Bonus amount you would have earned shall be based on actual performance for the full calendar year, except that any applicable subjective performance conditions will be disregarded in determining actual performance, and the entire amount of the Bonus, if any, will be determined based on applicable objective performance conditions. Any Pro-Rata Bonus will be paid at the same time bonuses are paid to the other executives of the Company, but in no event later than March 15 of the calendar year after the year to which it relates.
3. Paid Health Care Coverage; Other Benefits Continuation.
a. If at the time of your employment termination you participate in health care coverage through the Company’s plan, then provided that you timely elect continued coverage under COBRA, the Company will pay your COBRA premiums (less your standard employee contribution) to continue your coverage (including coverage for eligible dependents, if applicable) (“COBRA Premiums”) through the period (the “COBRA Premium Period”) starting on the termination date and ending on the earliest to occur of the date: (i) twelve (12) months after the termination date; (ii) you become eligible for group health insurance coverage through a new employer; or (iii) you cease to be eligible for COBRA continuation coverage for any reason, including plan termination. In the event you become covered under another employer’s group health plan or otherwise cease to be eligible for COBRA during the COBRA Premium Period, you must immediately notify the Company of such event.
b. Notwithstanding the foregoing, if the payment by the Company of the COBRA Premiums will subject or expose the Company to taxes or penalties, you and the Company agree to renegotiate the provisions of paragraph 3(a) in good faith and enter into a substitute arrangement pursuant to which the Company will not be subjected or exposed to taxes or penalties and you will be provided with payments or benefits with an economic value that is no less than the economic value of the COBRA Premiums.
4. Equity Acceleration. All outstanding unvested Company Equity shall vest in full, effective as of the termination date of your employment; provided, however, that any Company Equity that is subject to performance-based vesting conditions will be deemed to have been achieved at target.
62414929_3
For purposes of this Agreement, the following definitions shall apply:
1. “Cause” shall mean the occurrence of any of the following events: (a) your indictment for any felony or any crime involving fraud, embezzlement, dishonesty or moral turpitude under the laws of the United States or any state thereof; (b) your attempted commission of, or participation in, a fraud, embezzlement or act of material dishonesty against the Company or a Company affiliate; (c) your intentional, material violation of any contract or agreement between you and the Company or a Company affiliate or of any statutory duty owed to the Company or a Company affiliate which, if curable, remains uncured after a period of thirty (30) days following your receipt of notice from the Company that it deems such conduct Cause for termination of your employment; (d) your intentional unauthorized use or disclosure of the Company’s or a Company affiliate’s confidential information or trade secrets; (e) the refusal or willful omission by you to perform any duties required of you by the Board, which continues after a period of thirty (30) days following your receipt of notice from the Company that it deems such conduct Cause for termination of your employment hereunder; or (f) your gross misconduct, which continues after a period of thirty (30) days following your receipt of notice from the Company that it deems such conduct Cause for termination of your employment.
Notwithstanding anything to the contrary in this Agreement or any other agreement between the Company and you, “Cause” shall not include or be predicated upon any act or omission by you, which is taken or made (a) in good faith, under your reasonable belief that the act or omission was in the best interests of the Company; (b) to comply with a lawful court order, directive from a federal, state or local government agency or industry regulatory authority, or subpoena; or (c) at the direction of the Board or upon the advice of counsel for the Company.
2. “Good Reason” shall exist for resignation from employment with the Company if any of the following actions are taken by the Company without your prior consent: (a) a reduction in your Base Salary or Bonus target percentage of Base Salary, unless the salaries or bonus target percentages of all other senior executive officers of the Company are correspondingly and proportionately reduced; (b) any loss of or change in your position and title as both Chairman of the Board and CEO, or any other reduction in your title, authority, duties, or responsibilities to a level materially inconsistent with the position and titles you hold; (c) a change in your reporting structure such that you no longer report directly to the Company’s Board; or (d) a relocation of your principal place of employment to a place that increases your one-way commute by more than thirty-five (35) miles as compared to your then-current principal place of employment immediately prior to such relocation. In order for you to resign for Good Reason, each of the following requirements must be met: (w) you must provide written notice to the Board within thirty (30) days after first becoming aware of the first occurrence of the event giving rise to Good Reason setting forth the basis for your resignation, (x) you must allow the Company at least thirty (30) days from receipt of such written notice (the “Cure Period”) to cure such event, (y) such event is not reasonably cured by the Company within the Cure Period, and (z) you must resign from all positions you then hold with the Company not later than sixty (60) days after the expiration of the Cure Period.
3. “Release Obligation” means that: (a) you have signed a general release and waiver of claims in favor of the Company and its affiliates, as part of a termination agreement reasonably acceptable to you and to the Company, and (b) you have allowed the release and waiver to become fully effective without revocation during any applicable revocation period.
Change in Control
Upon a Change in Control, all outstanding unvested Company Equity will either be accelerated or assumed consistent with the terms of the Company equity plan under which it was granted, and as the award agreements for such Company Equity will so provide; provided, however, that if in connection with a Change in Control, the vesting of any incentive equity issued by the Company to any other employee, director or service provider will be accelerated, then any outstanding unvested Company Equity which you hold shall also vest in full immediately prior to such Change in Control; provided, however, that any Company Equity that is subject to performance-based vesting conditions will be deemed to have been achieved at target.
62414929_3
Upon the termination of your employment by the Company without Cause, or by you with Good Reason, in either case during a time period starting on the date three (3) months before the closing of a Change in Control and ending on the date twenty-four (24) months after the closing of a Change in Control, provided that you meet the Release Obligation and provide continued services through your termination date, then all outstanding unvested Company Equity shall vest in full, effective as of the termination date of your employment ; provided, however, that any Company Equity that is subject to performance-based vesting conditions will be deemed to have been achieved at target .
A “Change in Control” shall mean any of the following: (a) a merger or consolidation in which the Company is a constituent party (or if a subsidiary of the Company is a constituent party and the Company issues shares of its capital stock pursuant to such merger or consolidation), other than a merger or consolidation in which the voting securities of the Company outstanding immediately prior to such merger or consolidation continue to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) more than fifty percent (50%) of the combined voting power of the voting securities of the surviving entity outstanding immediately after such merger or consolidation, or (b) any transaction or series of related transactions in which in excess of fifty percent (50%) of the Company’s voting power is transferred, other than the sale by the Company of stock in transactions the primary purpose of which is to raise capital for the Company’s operations and activities, or (c) a sale, lease, exclusive license or other disposition of all or substantially all (as determined by the Board in its sole discretion) of the assets of the Company.
Section 280G
If any payment or benefit (including payments and benefits pursuant to this Agreement) that you would receive in connection with a Change in Control from the Company or otherwise (“Transaction Payment”) would (i) constitute a “parachute payment” within the meaning of Section 280G of the Internal Revenue Code (the “Code”), and (ii) but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then the Company shall cause to be determined, before any amounts of the Transaction Payment are paid to you, which of the following two alternative forms of payment would result in your receipt, on an after-tax basis, of the greater amount of the Transaction Payment notwithstanding that all or some portion of the Transaction Payment may be subject to the Excise Tax: (1) payment in full of the entire amount of the Transaction Payment (a “Full Payment”), or (2) payment of only a part of the Transaction Payment so that you receive the largest payment possible without the imposition of the Excise Tax (a “Reduced Payment”). For purposes of determining whether to make a Full Payment or a Reduced Payment, the Company shall cause to be taken into account all applicable federal, state and local income and employment taxes and the Excise Tax (all computed at the highest applicable marginal rate, net of the maximum reduction in federal income taxes which could be obtained from a deduction of such state and local taxes). If a Reduced Payment is made, (x) you shall have no rights to any additional payments and/or benefits constituting the Transaction Payment, and (y) reduction in payments and/or benefits shall occur in the manner that results in the greatest economic benefit to you as determined in this paragraph. If more than one method of reduction will result in the same economic benefit, the portions of the Transaction Payment shall be reduced pro rata. Unless you and the Company otherwise agree in writing, any determination required under this paragraph shall be made in writing by the Company’s independent public accountants (the “Accountants”), whose determination shall be conclusive and binding upon you and the Company for all purposes. For purposes of making the calculations required by this paragraph, the Accountants may make reasonable assumptions and approximations concerning applicable taxes and may rely on reasonable, good faith interpretations concerning the application of Sections 280G and 4999 of the Code. You and the Company shall furnish to the Accountants such information and documents as the Accountants may reasonably request in order to make a determination under this paragraph. The Company shall bear all costs the Accountants may reasonably incur in connection with any calculations contemplated by this paragraph as well as any costs incurred by you with the Accountants for tax planning under Sections 280G and 4999 of the Code.
Indemnification; D&O Insurance
You will be entitled to the indemnification and liability insurance coverage as described in the indemnification agreement that you entered into with the Company on October 30, 2014 (the “Indemnification Agreement”).
62414929_3
Compliance with Proprietary Information Agreement and Company Policies
As a condition of employment, you have signed and must continue to comply with the Company’s standard form of Employee Proprietary Information, Inventions Assignment, Non-Competition and Non-Solicitation Agreement (the “Proprietary Information Agreement”, a copy of which is attached hereto as Exhibit A) which prohibits unauthorized use or disclosure of the Company’s proprietary information, among other obligations. As a Paratek employee, you will be expected to abide by Company policies and practices, as may be changed from time to time in the Company’s discretion, and acknowledge in writing that you have read the Company’s employee handbook.
Protection of Third Party Information
In your work for the Company, you will be expected not to use or disclose any confidential information, including trade secrets, of any former employer or other person to whom you have an obligation of confidentiality. Rather, you will be expected to use only that information which is generally known and used by persons with training and experience comparable to your own, which is common knowledge in the industry or otherwise legally in the public domain, or which is otherwise provided or developed by the Company. You agree that you will not bring onto Company premises, or use in the performance of your duties, any unpublished documents or property belonging to any former employer or other person to whom you have an obligation of confidentiality. You hereby represent that you have disclosed to the Company any contract you have signed that may restrict your activities on behalf of the Company.
Outside Activities
Provided that such activities do not interfere with your duties for Paratek and your agreed time commitments to Paratek, the Company has no objection to your conducting the business activities specified on Exhibit B , while you are the CEO of Paratek. You may also engage in any other business, civic and not-for-profit activities so long as such activities do not materially interfere with the performance of your duties under this Agreement and are not otherwise in conflict with the Proprietary Information Agreement. You may purchase or otherwise acquire up to one percent (1%), or any higher percentage if agreed to by the Board, of any class of securities of any enterprise if such securities are listed on any national or regional securities exchange, provided that you refrain from participating in the business activities of such enterprise.
Agreement to Arbitrate
To ensure the rapid and economical resolution of disputes that may arise in connection with your employment with the Company, you and the Company both agree that any and all disputes, claims, or causes of action, in law or equity, including but not limited to statutory claims, arising from or relating to the enforcement, breach, performance, or interpretation of this Agreement, your employment with the Company, or the termination of your employment with the Company, will be resolved pursuant to the Federal Arbitration Act, 9 U.S.C. §1-16, and to the fullest extent permitted by law, by final, binding and confidential arbitration conducted in Boston, Massachusetts by JAMS, Inc. (“JAMS”) or its successors.
Both you and the Company acknowledge that by agreeing to this arbitration procedure, you each waive the right to resolve any such dispute through a trial by jury or judge or administrative proceeding.
Any such arbitration proceeding will be governed by JAMS’ then applicable rules and procedures for employment disputes, which can be found at http://www.jamsadr.com/rules-employment-arbitration/, and which will be provided to you upon request. In any such proceeding, the arbitrator shall: (i) have the authority to compel adequate discovery for the resolution of the dispute and to award such relief as would otherwise be permitted by law; and (ii) issue a written arbitration decision including the arbitrator’s essential findings and conclusions and a statement of the award. You and the Company each shall be entitled to all rights and remedies that either would be entitled to pursue in a court of law. Nothing in this Agreement is intended to prevent either the Company or you from obtaining injunctive relief in court to prevent irreparable harm pending the conclusion of any such arbitration pursuant to applicable law.
62414929_3
1. Specified Employee . Notwithstanding anything to the contrary in the Agreement, if at the time your employment terminates, you are a “specified employee,” as defined below, any and all amounts payable under the Agreement on account of such separation from service that would (but for this provision) be payable within six (6) months following the date of termination, shall instead be paid on the next business day following the expiration of such six (6) month period or, if earlier, upon your death; except (A) to the extent of amounts that do not constitute a deferral of compensation within the meaning of Treasury regulation Section 1.409A-1(b) (including without limitation by reason of the safe harbor set forth in Section 1.409A-1(b)(9)(iii), as determined by the Company in its reasonable good faith discretion); (B) benefits which qualify as excepted welfare benefits pursuant to Treasury regulation Section 1.409A-1(a)(5); or (C) other amounts or benefits that are not subject to the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (“Section 409A”).
2. Termination of Employment . For purposes of the Agreement, all references to “termination of employment” and correlative phrases shall be construed to require a “separation from service” (as defined in Treasury regulation Section 1.409A-1(h) after giving effect to the presumptions contained therein), and the term “specified employee” means an individual determined by the Company to be a specified employee under Treasury regulation Section 1.409A-1(i).
3. Reimbursement for Expenses . Any reimbursement for expenses that would constitute nonqualified deferred compensation subject to Section 409A shall be subject to the following additional rules: (i) no reimbursement of any such expense shall affect your right to reimbursement of any such expense in any other taxable year; (ii) reimbursement of the expense shall be made, if at all, promptly, but not later than the end of the calendar year following the calendar year in which the expense was incurred; and (iii) the right to reimbursement shall not be subject to liquidation or exchange for any other benefit.
4. Separate Payments . Each payment made under the Agreement shall be treated as a separate payment and the right to a series of installment payments under the Agreement is to be treated as a right to a series of separate payments.
5. Limitation on Liability . In no event shall the Company have any liability relating to the failure or alleged failure of any payment or benefit under the Agreement to comply with, or be exempt from, the requirements of Section 409A.
Entire Agreement; Contingencies
This Agreement, together with your Proprietary Information Agreement and the Indemnification Agreement, forms the complete and exclusive statement of your employment agreement with the Company. It supersedes any other prior agreements or promises made to you by anyone, whether oral or written, including the Employment Agreement. Changes in your employment terms, other than those changes expressly reserved to the Company’s or Board’s discretion in this Agreement, require a written modification approved by the Board and signed by a duly authorized Member of the Board.
This Agreement will bind the heirs, personal representatives, successors and assigns of both you and the Company, and inure to the benefit of both you and the Company, their heirs, successors and assigns. If any provision of this Agreement is determined to be invalid or unenforceable, in whole or in part, this determination shall not affect any other provision of this Agreement and the provision in question shall be modified so as to be rendered enforceable in a manner consistent with the intent of the parties insofar as possible under applicable law.
This Agreement shall be construed and enforced in accordance with the laws of the Commonwealth of Massachusetts without regard to conflicts of law principles. Any waiver of a breach of this Agreement, or rights hereunder, shall be in writing and shall not be deemed to be a waiver of any successive breach or rights hereunder. This Agreement may be executed in counterparts which shall be deemed to be part of one original, and pdf or other facsimile signatures shall be equivalent to original signatures.
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Please sign and date this Agreement to indicate your acceptance of continued employment at Paratek under the terms described above. We look forward to a continued productive and enjoyable work relationship.
Sincerely,
Paratek Pharmaceuticals, Inc.
/s/ Jeffrey Stein |
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Jeffrey Stein, Director on behalf of the Board |
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Accepted: |
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/s/ Michael F. Bigham |
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Michael F. Bigham |
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June 16, 2017 |
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EMPLOYEE PROPRIETARY INFORMATION, INVENTIONS ASSIGNMENT, NON-COMPETITION AND NON-SOLICITATION AGREEMENT
EMPLOYEE PROPRIETARY INFORMATION, INVENTIONS ASSIGNMENT, NON-COMPETITION
AND NON-SOLICITATION AGREEMENT
In consideration of my employment or continued employment by Paratek Pharmaceuticals, Inc. , its subsidiaries, parents, affiliates, successors and assigns (together, the “ Company ”) and the compensation now and hereafter paid to me, I hereby enter into this Employee Proprietary Information, Inventions Assignment, Non-Competition and Non-Solicitation Agreement (the “ Agreement ”) and agree as follows:
1.1 Recognition of Company’s Rights; Nondisclosure. I understand and acknowledge that my employment by the Company creates a relationship of confidence and trust with respect to the Company’s Proprietary Information (defined below) and that the Company has a protectable interest therein. At all times during my employment and thereafter, I will hold in strictest confidence and will not disclose, use, lecture upon or publish any of the Company’s Proprietary Information, except as such disclosure, use or publication may be required in connection with my work for the Company, or unless an authorized officer of the Company expressly authorizes such in writing. I will obtain the Company’s written approval before publishing or submitting for publication any material (written, verbal, or otherwise) that relates to my work at the Company and/or incorporates any Proprietary Information. I hereby assign to the Company any rights I may have or acquire in such Proprietary Information and recognize that all Proprietary Information shall be the sole property of the Company and its assigns. I will take all reasonable precautions to prevent the inadvertent or accidental disclosure of Proprietary Information.
1.2 Proprietary Information. The term “ Proprietary Information ” shall mean any and all confidential and/or proprietary knowledge, data or information of the Company, its affiliates, parents and subsidiaries, whether having existed, now existing, or to be developed during my employment. By way of illustration but not limitation, “ Proprietary Information ” includes (a) trade secrets, inventions, ideas, processes, formulas, assay components, biological materials, cell lines, and clinical data, data, programs, other works of authorship, know-how, improvements, discoveries, developments, designs and techniques and any other proprietary technology and all Proprietary Rights therein (hereinafter collectively referred to as “ Inventions ”); (b) information regarding research, development, new products, marketing and selling, business plans, budgets and unpublished financial statements, licenses, prices and costs, margins, discounts, credit terms, pricing and billing policies, quoting procedures, methods of obtaining business, forecasts, future plans and potential strategies,
financial projections and business strategies, operational plans, financing and capital-raising plans, activities and agreements, internal services and operational manuals, methods of conducting Company business, suppliers and supplier information, and purchasing; (c) information regarding customers and potential customers of the Company, including customer lists, names, representatives, their needs or desires with respect to the types of products or services offered by the Company, proposals, bids, contracts and their contents and parties, the type and quantity of products and services provided or sought to be provided to customers and potential customers of the Company and other non-public information relating to customers and potential customers; (d) information regarding any of the Company’s business partners and their services, including names; representatives, proposals, bids, contracts and their contents and parties, the type and quantity of products and services received by the Company, and other non-public information relating to business partners; (e) information regarding personnel, employee lists, compensation, and employee skills; and (f) any other non-public information which a competitor of the Company could use to the competitive disadvantage of the Company. Notwithstanding the foregoing, it is understood that, at all such times, I am free to use information which is generally known in the trade or industry through no breach of this Agreement or other act or omission by me, and I am free to discuss the terms and conditions of my employment with others to the extent expressly permitted by Section 7 of the National Labor Relations Act.
1.3 Third Party Information. I understand, in addition, that the Company has received and in the future will receive confidential and/or proprietary knowledge, data, or information from third parties (“ Third Party Information ”). During my employment and thereafter, I will hold Third Party Information in the strictest confidence and will not disclose to anyone (other than Company personnel who need to know such information in connection with their work for the Company) or use, except in connection with my work for the Company, Third Party Information unless expressly authorized by an authorized officer of the Company in writing.
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1.4 Term of Nondisclosure Restrictions. I understand that Proprietary Information and Third Party Information is never to be used or disclosed by me, as provided in this Section 1. If, however, a court decides that this Section 1 or any of its provisions is unenforceable for lack of reasonable temporal limitation and the Agreement or its restriction(s) cannot otherwise be enforced, I agree and the Company agrees that the two (2) year period after the date my employment ends shall be the temporal limitation relevant to the contested restriction, provided, however, that this sentence shall not apply to trade secrets protected without temporal limitation under applicable law.
1.5 No Improper Use of Information of Prior Employers and Others. During my employment by the Company I will not improperly use or disclose any confidential information or trade secrets, if any, of any former employer or any other person to whom I have an obligation of confidentiality, and I will not bring onto the premises of the Company any unpublished documents or any property belonging to any former employer or any other person to whom I have an obligation of confidentiality unless consented to in writing by that former employer or person.
2. Assignment of Inventions.
2.1 Proprietary Rights. The term “ Proprietary Rights ” shall mean all trade secrets, patents, copyrights, trademarks and other intellectual property rights throughout the world.
2.2 Prior Inventions. Inventions, if any, patented or unpatented, which I made prior to the commencement of my employment with the Company are excluded from the scope of this Agreement. To preclude any possible uncertainty, I have set forth on Exhibit 1 (Prior Inventions) attached hereto a complete list of all Inventions that I have, alone or jointly with others, conceived, developed or reduced to practice or caused to be conceived, developed or reduced to practice prior to the commencement of my employment with the Company, that I consider to be my property or the property of third parties, and that I wish to have excluded from the scope of this Agreement (collectively referred to as “ Prior Inventions ”). If disclosure of any such Prior Invention would cause me to violate any prior confidentiality agreement, I understand that I am not to list such Prior Inventions in Exhibit 1 but am only to disclose a cursory name for each such invention, a listing of the party(ies) to
whom it belongs and the fact that full disclosure as to such inventions has not been made for that reason. A space is provided on Exhibit 1 for such purpose. If no such disclosure is attached, I represent that there are no Prior Inventions. If, in the course of my employment with the Company, I incorporate a Prior Invention into a Company product, process or machine, the Company is hereby granted and shall have a nonexclusive, royalty-free, irrevocable, perpetual, fully-paid, worldwide license (with rights to sublicense through multiple tiers of sub-licensees) to make, have made, modify, make derivative works of, publicly perform, use, sell, import, and exercise any and all present and future rights in such Prior Invention. Notwithstanding the foregoing, I agree that I will not incorporate, or permit to be incorporated, Prior Inventions in any Company Inventions without the Company’s prior written consent.
2.3 Assignment of Inventions. Subject to Subsection 2.4, I hereby assign, grant and convey to the Company all my right, title and interest in and to any and all Inventions (and all Proprietary Rights with respect thereto) whether or not patentable or registrable under copyright or similar statutes, made or conceived or reduced to practice or learned by me, either alone or jointly with others, during the period of my employment with the Company. Inventions assigned to the Company or its designees are hereinafter referred to as “ Company Inventions .”
2.4 Unassigned or Nonassignable Inventions. I recognize that this Agreement will not be deemed to require assignment of any Invention that I developed entirely on my own time without using the Company’s equipment, supplies, facilities, trade secrets, or Proprietary Information, except for those Inventions that either (i) relate to the Company’s actual or anticipated business, research or development, or (ii) result from or are connected with work performed by me for the Company. In addition, this Agreement does not apply to any Invention which qualifies fully for protection from assignment to the Company under any specifically applicable state law, regulation, rule, or public policy (“ Specific Inventions Law ”).
2.5 Obligation to Keep Company Informed. During the period of my employment and for six (6) months after termination of my employment with the Company, I will promptly disclose to the Company fully and in writing all Inventions authored, conceived or reduced to practice by me, either alone or jointly with others. In addition, I will promptly disclose to the Company all
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patent applications filed by me or on my behalf within a year after termination of employment. At the time of each such disclosure, I will advise the Company in writing of any Inventions that I believe fully qualify for protection under the provisions of a Specific Inventions Law; and I will at that time provide to the Company in writing all evidence necessary to substantiate that belief. The Company will keep in confidence and will not use for any purpose or disclose to third parties without my consent any confidential information disclosed in writing to the Company pursuant to this Agreement relating to Inventions that qualify fully for protection under a Specific Inventions Law. I will preserve the confidentiality of any Invention that does not fully qualify for protection under a Specific Inventions Law.
2.6 Ownership of Work Product. I agree that the Company will exclusively own all work product that is made by me (solely or jointly with others) within the scope of my employment, and I hereby irrevocably and unconditionally assign to the Company all right, title, and interest worldwide in and to such work product. I acknowledge that all original works of authorship which are made by me (solely or jointly with others) within the scope of my employment and which are protectable by copyright are “works made for hire,” pursuant to United States Copyright Act (17 U.S.C., Section 101). I understand and agree that I have no right to publish on, submit for publishing, or use for any publication any work product protected by this Section, except as necessary to perform services for the Company.
2.7 Enforcement of Proprietary Rights. I will assist the Company in every proper way to obtain, and from time to time enforce, United States and foreign Proprietary Rights relating to Company Inventions in any and all countries. To that end I will execute, verify and deliver such documents and perform such other acts (including appearances as a witness) as the Company may reasonably request for use in applying for, obtaining, perfecting, evidencing, sustaining and enforcing such Proprietary Rights and the assignment thereof. In addition, I will execute, verify and deliver assignments of such Proprietary Rights to the Company or its designee, including the United States or any third party designated by the Company. My obligation to assist the Company with respect to Proprietary Rights relating to such Company Inventions in any and all countries shall continue beyond the termination of my employment, but the Company shall compensate me at a reasonable rate after my termination for the time actually spent by me at the Company’s request on such assistance.
In the event the Company is unable for any reason, after reasonable effort, to secure my signature on any document needed in connection with the actions specified in the preceding paragraph, I hereby irrevocably designate and appoint the Company and its duly authorized officers and agents as my agent and attorney in fact, which appointment is coupled with an interest, to act for and in my behalf to execute, verify and file any such documents and to do all other lawfully permitted acts to further the purposes of the preceding paragraph with the same legal force and effect as if executed by me. I hereby waive and quitclaim to the Company any and all claims, of any nature whatsoever, which I now or may hereafter have for infringement of any Proprietary Rights assigned under this Agreement to the Company.
3. Records. I agree to keep and maintain adequate and current records (in the form of notes, sketches, drawings and in any other form that may be required by the Company) of all Proprietary Information developed by me and all Inventions made by me during the period of my employment at the Company, which records shall be available to and remain the sole property of the Company at all times.
4. Duty of Loyalty During Employment. I agree that during the period of my employment by the Company I will not, without the Company’s express written consent, directly or indirectly engage in any employment or business activity which is directly or indirectly competitive with, or would otherwise conflict with, my employment by the Company.
5. No Solicitation of Employees, Consultants, Contractors, or Customers or Potential Customers. I agree that during the period of my employment and for the one (1) year period after the date my employment ends for any reason, including but not limited to voluntary termination by me or involuntary termination by the Company, I will not, as an officer, director, employee, consultant, owner, partner, or in any other capacity, either directly or through others, except on behalf of the Company:
5.1 solicit, induce, encourage, or participate in soliciting, inducing, or encouraging any employee of the Company to terminate his or her relationship with the Company;
5.2 hire, employ, or engage in business with or attempt to hire, employ, or engage in business with any person employed by the Company or who has left the employment of the Company within the preceding three (3) months of any such prohibited
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activity or discuss any potential employment or business association with such person, even if I did not initiate the discussion or seek out the contact;
5.3 solicit, induce or attempt to induce any Customer or Potential Customer, or any consultant or independent contractor with whom I had direct or indirect contact during my employment with the Company or whose identity I learned as a result of my employment with the Company, to terminate, diminish, or materially alter in a manner harmful to the Company its relationship with the Company; or
5.4 solicit, perform, provide or attempt to perform or provide any Conflicting Services (as defined in Section 6 below) for a Customer or Potential Customer. The parties agree that for purposes of this Agreement, a “ Customer or Potential Customer ” is any person or entity who or which, at any time during the one (1) year prior to the date my employment with the Company ends, (i) contracted for, was billed for, or received from the Company any product, service or process with which I worked directly or indirectly during my employment by the Company or about which I acquired Proprietary Information; or (ii) was in contact with me or in contact with any other employee, owner, or agent of the Company, of which contact I was or should have been aware, concerning any product, service or process with which I worked directly or indirectly during my employment with the Company or about which I acquired Proprietary Information; or (iii) was solicited by the Company in an effort in which I was involved or of which I was or should have been aware.
6. Non-Compete Provision. I agree that for the one (1) year period after the date my employment ends for any reason, including but not limited to voluntary termination by me or involuntary termination by the Company, I will not, directly or indirectly, as an officer, director, employee, consultant, owner, manager, member, partner, or in any other capacity solicit, perform, or provide, or attempt to perform or provide Conflicting Services anywhere in the world where the Company conducts business, including but not limited to locations where the Company performs research or development activities related to the Company’s products, services or processes (such locations the “ Restricted Territory ”), nor will I assist another person to solicit, perform or provide or attempt to perform or provide Conflicting Services in the Restricted Territory.
The parties agree that for purposes of this Agreement, “ Conflicting Services ” means any product, service, or process or the research and development thereof, of any person or organization other than the Company that has antibiotics as its principal business, unless otherwise expressly
excluded from this definition in advance by the Company’s Board of Directors.
7. Reasonableness of Restrictions .
7.1 I agree that I have read this entire Agreement and understand it. I agree that this Agreement does not prevent me from earning a living or pursuing my career and that I have the ability to secure other non-competitive employment using my marketable skills. I agree that the restrictions contained in this Agreement are reasonable, proper, and necessitated by the Company’s legitimate business interests, including without limitation, the Company’s Proprietary Rights, Proprietary Information and the goodwill of its customers. I represent and agree that I am entering into this Agreement freely and with knowledge of its contents with the intent to be bound by the Agreement and the restrictions contained in it.
7.2 In the event that a court finds this Agreement, or any of its restrictions, to be ambiguous, unenforceable, or invalid, the Company and I agree that the court shall read the Agreement as a whole and interpret the restriction(s) at issue to be enforceable and valid to the maximum extent allowed by law.
7.3 If the court declines to enforce this Agreement in the manner provided in subsection 7.2, I and the Company agree that this Agreement will be automatically modified to provide the Company with the maximum protection of its business interests allowed by law and I agree to be bound by this Agreement as modified.
8. No Conflicting Agreement or Obligation. I represent that my performance of all the terms of this Agreement and as an employee of the Company does not and will not breach any agreement or obligation of any kind to keep in confidence information acquired by me in confidence or in trust prior to my employment by the Company. I have not entered into, and I agree I will not enter into, any agreement either written or oral in conflict with this Agreement.
9. Return of Company Property. Upon termination of my employment or upon Company’s request at any other time, I will deliver to Company all of Company’s property, equipment, and documents, together with all copies thereof, and any other material containing or disclosing any Inventions, Third Party Information or Proprietary Information and certify in writing that I have fully complied with the foregoing obligation. I agree that I will not copy, delete, or alter any information contained upon my Company computer or Company equipment before I return it to Company. In addition,
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if I have used any personal computer, server, or e-mail system to receive, store, review, prepare or transmit any Company information, including but not limited to, Proprietary Information, I agree to provide the Company with a computer-useable copy of all such Proprietary Information and then permanently delete and expunge such Proprietary Information from those systems; and I agree to provide the Company access to my system as reasonably requested to verify that the necessary copying and/or deletion is completed. I further agree that any property situated on Company’s premises and owned by Company is subject to inspection by Company’s personnel at any time with or without notice. Prior to the termination of my employment or promptly after termination of my employment, I will cooperate with Company in attending an exit interview and certify in writing that I have complied with the requirements of this section.
10. Legal and Equitable Remedies.
10.1 I agree that it may be impossible to assess the damages caused by my violation of this Agreement or any of its terms. I agree that any threatened or actual violation of this Agreement or any of its terms will constitute immediate and irreparable injury to the Company and the Company shall have the right to enforce this Agreement and any of its provisions by injunction, specific performance or other equitable relief, without bond and without prejudice to any other rights and remedies that the Company may have for a breach or threatened breach of this Agreement.
10.2 I agree that if the Company is successful in whole or in part in any legal or equitable action against me under this Agreement, the Company shall be entitled to payment of all costs, including reasonable attorney’s fees, from me.
10.3 In the event the Company enforces this Agreement through a court order, I agree that the restrictions of Sections 5 and 6 shall remain in effect for a period of twelve (12) months from the effective date of the Order enforcing the Agreement.
11. Notices. Any notices required or permitted under this Agreement will be given to the Company at its headquarters location at the time notice is given, labeled “Attention Chief Executive Officer,” and to me at my address as listed on the Company payroll, or at such other address as the Company or I may designate by written notice to the other. Notice will be effective upon receipt or refusal of delivery. If delivered by certified or registered mail, notice will
be considered to have been given five (5) business days after it was mailed, as evidenced by the postmark. If delivered by courier or express mail service, notice will be considered to have been given on the delivery date reflected by the courier or express mail service receipt.
12. Publication of This Agreement to Subsequent Employers or Business Associates of Employee .
12.1 If I am offered employment or the opportunity to enter into any business venture as owner, partner, consultant or other capacity while the restrictions described in Sections 5 and 6 of this Agreement are in effect I agree to inform my potential employer, partner, co-owner and/or others involved in managing the business with which I have an opportunity to be associated of my obligations under this Agreement and also agree to provide such person or persons with a copy of this Agreement.
12.2 I agree to inform the Company of all employment and business ventures which I enter into while the restrictions described in Sections 5 and 6 of this Agreement are in effect and I also authorize the Company to provide copies of this Agreement to my employer, partner, co-owner and/or others involved in managing the business with which I am employed or associated and to make such persons aware of my obligations under this Agreement.
13. General Provisions.
13.1 Governing Law; Consent to Personal Jurisdiction. This Agreement will be governed by and construed according to the laws of the Commonwealth of Pennsylvania as such laws are applied to agreements entered into and to be performed entirely within the Commonwealth of Pennsylvania between Pennsylvania residents. I hereby expressly consent to the personal jurisdiction and venue of the state and federal courts located in the Commonwealth of Massachusetts for any lawsuit filed there against me by Company arising from or related to this Agreement.
13.2 Severability. In case any one or more of the provisions, subsections, or sentences contained in this Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect the other provisions of this Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained in this Agreement. If moreover, any one or
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more of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it shall be construed by limiting and reducing it, so as to be enforceable to the extent compatible with the applicable law as it shall then appear.
13.3 Successors and Assigns. This Agreement is for my benefit and the benefit of the Company, its successors, assigns, parent corporations, subsidiaries, affiliates, and purchasers, and will be binding upon my heirs, executors, administrators and other legal representatives.
13.4 Survival. The provisions of this Agreement shall survive the termination of my employment, regardless of the reason, and the assignment of this Agreement by the Company to any successor in interest or other assignee. I understand that my obligations under this Agreement will continue in accordance with its express terms regardless of any change in my title, position, status, role, duties, salary, compensation or benefits or other terms and conditions of employment or service.
13.5 Employment At-Will. I agree and understand that nothing in this Agreement shall change my at-will employment status or confer any right with respect to continuation of employment by the Company, nor shall it interfere in any way with my right or the Company’s right to terminate my employment at any time, with or without cause or advance notice.
13.6 Waiver. No waiver by the Company of any breach of this Agreement shall be a waiver of any preceding or succeeding breach. No waiver by the Company of any right under this Agreement shall be construed as a waiver of any other right. The
Company shall not be required to give notice to enforce strict adherence to all terms of this Agreement.
13.7 Advice of Counsel. I ACKNOWLEDGE THAT, IN EXECUTING THIS AGREEMENT, I HAVE HAD THE OPPORTUNITY TO SEEK THE ADVICE OF INDEPENDENT LEGAL COUNSEL, AND I HAVE READ AND UNDERSTOOD ALL OF THE TERMS AND PROVISIONS OF THIS AGREEMENT. THIS AGREEMENT SHALL NOT BE CONSTRUED AGAINST ANY PARTY BY REASON OF THE DRAFTING OR PREPARATION OF THIS AGREEMENT.
13.8 Entire Agreement. The obligations pursuant to Sections 1 and 2 (except Subsection 2.6) of this Agreement shall apply to any time during which I was previously engaged, or am in the future engaged, by the Company as a consultant if no other agreement governs nondisclosure and assignment of inventions during such period. This Agreement is the final, complete and exclusive agreement of the parties with respect to the subject matter of this Agreement and supersedes and merges all prior discussions between us. No modification of or amendment to this Agreement, nor any waiver of any rights under this Agreement, will be effective unless in writing and signed by the party to be charged. Any subsequent change or changes in my title, position, status, role, duties, salary, compensation or benefits or other terms and conditions of employment or service will not affect the validity or scope of this Agreement.
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This Agreement shall be effective as of the first day of my employment with the Company.
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I have read, understand, and Accept this agreement and have been given the opportunity to Review it with independent legal counsel . |
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Address: 75 Park Plaza, 4 th Floor, Boston, Massachusetts 02116 |
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Prior Inventions
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1. Except as listed in Section 2 below, the following is a complete list of all inventions or improvements relevant to the subject matter of my employment by Paratek Pharmaceuticals, Inc. (the “ Company ”) that have been made or conceived or first reduced to practice by me alone or jointly with others prior to my engagement by the Company:
☐ No inventions or improvements.
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2. Due to a prior confidentiality agreement, I cannot complete the disclosure under Section 1 above with respect to inventions or improvements generally listed below, the proprietary rights and duty of confidentiality with respect to which I owe to the following party(ies):
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MICHAEL F. BIGHAM OUTSIDE BUSINESS ACTIVITIES
Mr. Bigham will be spending approximately 10% of his time on non-Paratek activities which will include efforts on behalf of Abingworth LLP, a venture capital firm where he is an Executive Partner.
Exhibit 10.7
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PARATEK PHARMACEUTICALS paratekpharma.com |
75 Park Plaza Boston, MA 02116 617.807.6600 617.275.0039 fax |
June 16, 2017
William M. Haskel
93 Bernard Drive
Basking Ridge, NJ 07920
Re: Amended and Restated Employment Agreement
Dear Bill:
On behalf of Paratek Pharmaceuticals, Inc. (“Paratek” or the “Company”), I am pleased to offer you continued employment under the terms of this Amended and Restated Employment Agreement (the “Agreement”). In this Agreement, you and the Company hereby amend, supersede, and restate in its entirety that certain offer letter agreement between the Company and you dated June 12, 2015 (the “Employment Agreement”).
Employment Positions and Duties
You will continue to be employed in the positions of Senior Vice President, General Counsel, and Secretary. You will be expected to perform the customary duties of your positions, duties specified in the Bylaws of the Company, and as may be required by the Company’s Board of Directors (the “Board”). You will report to the Chief Executive Officer (“CEO”), and work at the Company’s corporate headquarters in Boston, Massachusetts. During your employment with the Company, you will devote your full-time best efforts and business time and attention to the business of the Company. As an exempt salaried employee, you will be expected to be available and working during the Company’s regular business hours, and such additional time as appropriate to manage your responsibilities. The Company reserves the right to reasonably require you to perform your duties at places other than its corporate headquarters from time to time, and to require reasonable business travel, including international travel, at the Company’s expense.
Your employment relationship with the Company will also be governed by the general employment policies and practices of the Company, except that if the terms of this Agreement conflict, this Agreement will control.
Base Salary
You will earn a salary at the rate of $14,508.33 semimonthly ($348,200.00 annualized), less payroll deductions and withholdings (“Base Salary”), payable on the Company’s regular payroll schedule. The Base Salary will be reviewed on an annual or more frequent basis by the Board (or any authorized committee thereof), and is subject to change in the discretion of the Board (or any authorized committee thereof).
Discretionary Performance Bonus
You will be eligible to earn a discretionary performance bonus of up to thirty-five percent (35%) of your Base Salary, subject to applicable payroll deductions and withholdings (“Bonus”), based upon the Board’s assessment of your performance, and the Company’s attainment of written targeted goals as determined by the Board in its sole discretion. Following the close of each calendar year, the Board will determine in its discretion whether you have earned a Bonus, and the amount of any Bonus. You will be eligible to earn a Bonus for any full calendar year provided that you remain employed by the Company as of December 31 of that year. The Bonus, if earned, will be paid no later than March 15 of the calendar year after the year to which it relates.
Employee Benefits
As a regular employee, you will be eligible to participate in the Company’s standard employee benefits, pursuant to the terms and conditions of the benefit plans and applicable policies, and for any additional benefits provided to the
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Company’s executive employees generally. You will also be entitled to four (4) weeks of paid vacation each calendar year, in accordance with the terms of the Company’s vacation policy. The Company may change employee benefits from time to time in its discretion. Details about these benefits are provided in the employee handbook and Summary Plan Descriptions, available for your review.
Business Expenses
The Company will pay or reimburse you for all reasonable business expenses incurred or paid by you in the performance of your duties and responsibilities for the Company, subject to such reasonable substantiation and documentation as may be required by the Company, and subject to any maximum annual limit and other restrictions on or policies governing such expenses as set by the Company from time to time.
Equity Compensation
You will be eligible for future equity awards granted in accordance with the Company’s plans as in effect from time to time at levels commensurate with your position and responsibilities and subject to such terms as shall be determined by the Board or one of its committees in its or their sole discretion.
At-Will Employment Relationship
You may terminate your employment with the Company at any time, with or without Good Reason, and with or without advance notice, and for any reason whatsoever simply by notifying the Company. Likewise, the Company may terminate your employment at any time, with or without Cause, and with or without advance notice. Your employment at-will status can only be modified in a written agreement approved by the Board and signed by you and a duly authorized Member of the Board.
Payments upon Termination other than without Cause or with Good Reason
Upon termination of your employment for any reason other than by the Company without Cause or by you with Good Reason, you shall be paid all accrued but unpaid Base Salary, any earned but unpaid Bonus, reimbursement for business expenses incurred by you but not yet paid to you as of the date your employment terminates, and all accrued but unused vacation (collectively, the “Accrued Payments”). Any unvested Company equity awards that you hold, including any unvested options and restricted stock units (collectively, “Outstanding Equity”), shall terminate as of your termination date.
Termination without Cause or with Good Reason
Upon termination of your employment at any time by the Company without Cause or by you with Good Reason, you will receive the Accrued Payments. In addition, subject to your fulfillment of the Release Obligation, as defined below, you will be eligible for the following severance benefits:
1. Cash Severance Payments. You will be eligible to receive cash severance equal to twelve (12) months of Base Salary following the termination date, subject to payroll withholding and deduction (“Severance Payments”), and paid according to the Company’s regular payroll procedures. Payment of Severance Payments shall commence on the sixtieth (60 th ) day following your employment termination, which initial payment shall include a lump sum payment equal to the aggregate semi-monthly installments that would otherwise have been due during the period between the termination date and the sixtieth (60 th ) day, but for the sixty (60)-day delay in this provision. Thereafter, the remaining installments shall be paid on the Company’s regular paydays.
2. Pro-Rata Severance Bonus. You will also be eligible to receive an amount (the “Pro-Rata Bonus”) equal to the Bonus you would have earned for the year in which your employment terminates, prorated by multiplying the Bonus that you would have earned if you had remained employed through December 31 by the portion of the year that you had actually remained employed, and subject to payroll withholding and deduction. The determination by the Board of the Bonus amount you would have earned
shall be based on actual performance for the full calendar year, except that any applicable subjective performance conditions will be disregarded in determining actual performance, and the entire amount of the Bonus, if any, will be determined based on applicable objective performance conditions. Any Pro-Rata Bonus will be paid at the same time bonuses are paid to the other executives of the Company, but in no event later than March 15 of the calendar year after the year to which it relates.
3. Paid Health Care Coverage; Other Benefits Continuation.
a. If at the time of your employment termination you participate in health care coverage through the Company’s plan, then provided that you timely elect continued coverage under COBRA, the Company will pay your COBRA premiums (less your standard employee contribution) to continue your coverage (including coverage for eligible dependents, if applicable) (“COBRA Premiums”) through the period (the “COBRA Premium Period”) starting on the termination date and ending on the earliest to occur of the date: (i) twelve (12) months after the termination date; (ii) you become eligible for group health insurance coverage through a new employer; or (iii) you cease to be eligible for COBRA continuation coverage for any reason, including plan termination. In the event you become covered under another employer’s group health plan or otherwise cease to be eligible for COBRA during the COBRA Premium Period, you must immediately notify the Company of such event.
b. Notwithstanding the foregoing, if the payment by the Company of the COBRA Premiums will subject or expose the Company to taxes or penalties, you and the Company agree to renegotiate the provisions of paragraph 3(a) in good faith and enter into a substitute arrangement pursuant to which the Company will not be subjected or exposed to taxes or penalties and you will be provided with payments or benefits with an economic value that is no less than the economic value of the COBRA Premiums.
Definitions
For purposes of this Agreement, the following definitions shall apply:
1. “Cause” shall mean the occurrence of any of the following events: (a) your indictment for any felony or any crime involving fraud, embezzlement, dishonesty or moral turpitude under the laws of the United States or any state thereof; (b) your attempted commission of, or participation in, a fraud, embezzlement or act of material dishonesty against the Company or a Company affiliate; (c) your intentional, material violation of any contract or agreement between you and the Company or a Company affiliate or of any statutory duty owed to the Company or a Company affiliate; (d) your intentional unauthorized use or disclosure of the Company’s or a Company affiliate’s confidential information or trade secrets; (e) your refusal or failure to perform any duties required of you, if such duties are consistent with duties customary for your positions, or other persistent unsatisfactory performance or neglect of your job duties which continues after a period of thirty (30) days following your receipt of notice from the Company that it deems such conduct Cause for termination of your employment hereunder; or (f) your gross misconduct.
Notwithstanding anything to the contrary in this Agreement or any other agreement between the Company and you, “Cause” shall not include or be predicated upon any act or omission by you, which is taken or made (a) in good faith, under your reasonable belief that the act or omission was in the best interests of the Company; (b) to comply with a lawful court order, directive from a federal, state or local government agency or industry regulatory authority, or subpoena; or (c) at the direction of the Board or upon the advice of counsel for the Company.
2. “Good Reason” shall exist for resignation from employment with the Company if any of the following actions are taken by the Company without your prior consent: (a) a reduction in your Base Salary or Bonus target percentage of Base Salary, unless the salaries or bonus target percentages of all other senior executive officers of the Company are correspondingly and proportionately reduced; (b) a removal from your position of General Counsel and Secretary of a public company or a material and adverse change in the duties and responsibilities of your positions or reporting relationship; or (c) a relocation of your principal place of employment to a place that increases your one-way commute by more than thirty-five (35) miles as compared to your then-current principal place of
employment immediately prior to such relocation. In order for you to resign for Good Reason, each of the following requirements must be met: (w) you must provide written notice to the Board within thirty (30) days after first becoming aware of the first occurrence of the event giving rise to Good Reason setting forth the basis for your resignation, (x) you must allow the Company at least thirty (30) days from receipt of such written notice (the “Cure Period”) to cure such event, (y) such event is not reasonably cured by the Company within the Cure Period, and (z) you must resign from all positions you then hold with the Company not later than sixty (60) days after the expiration of the Cure Period.
3. “Release Obligation” means that: (a) you have signed a general release and waiver of claims in favor of the Company and its affiliates, as part of a termination agreement acceptable to the Company that contains standard provisions including a non-disparagement provision and restrictive covenants to the maximum enforceable extent including without limitation a noncompetition covenant during the period you are eligible to receive Severance Payments, and (b) you have allowed the release and waiver to become fully effective without revocation during any applicable revocation period.
Change in Control
Upon the termination of your employment by the Company without Cause, or by you with Good Reason, in either case during a time period starting on the date ninety (90) days before the closing of a Change in Control and ending on the date twelve (12) months after the closing of a Change in Control, provided that you meet the Release Obligation and you provide continued services through your termination date, then your Outstanding Equity shall vest in full (“Accelerated Vesting”), effective as of the termination date of your employment; provided, however, that any Outstanding Equity that is subject to performance-based vesting conditions will be deemed to have been achieved at target.
A “Change in Control” shall mean any of the following: (a) a merger or consolidation in which the Company is a constituent party (or if a subsidiary of the Company is a constituent party and the Company issues shares of its capital stock pursuant to such merger or consolidation), other than a merger or consolidation in which the voting securities of the Company outstanding immediately prior to such merger or consolidation continue to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) more than fifty percent (50%) of the combined voting power of the voting securities of the surviving entity outstanding immediately after such merger or consolidation, or (b) any transaction or series of related transactions in which in excess of fifty percent (50%) of the Company’s voting power is transferred, other than the sale by the Company of stock in transactions the primary purpose of which is to raise capital for the Company’s operations and activities, or (c) a sale, lease, exclusive license or other disposition of all or substantially all (as determined by the Board in its sole discretion) of the assets of the Company.
Section 280G
If any payment or benefit (including payments and benefits pursuant to this Agreement) that you would receive in connection with a Change in Control from the Company or otherwise (“Transaction Payment”) would (i) constitute a “parachute payment” within the meaning of Section 280G of the Internal Revenue Code (the “Code”), and (ii) but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then the Company shall cause to be determined, before any amounts of the Transaction Payment are paid to you, which of the following two alternative forms of payment would result in your receipt, on an after-tax basis, of the greater amount of the Transaction Payment notwithstanding that all or some portion of the Transaction Payment may be subject to the Excise Tax: (1) payment in full of the entire amount of the Transaction Payment (a “Full Payment”), or (2) payment of only a part of the Transaction Payment so that you receive the largest payment possible without the imposition of the Excise Tax (a “Reduced Payment”). For purposes of determining whether to make a Full Payment or a Reduced Payment, the Company shall cause to be taken into account all applicable federal, state and local income and employment taxes and the Excise Tax (all computed at the highest applicable marginal rate, net of the maximum reduction in federal income taxes which could be obtained from a deduction of such state and local taxes). If a Reduced Payment is made, (x) you shall have no rights to any additional payments and/or benefits constituting the Transaction Payment, and (y) reduction in payments and/or benefits shall occur in the manner that results in the greatest economic benefit to you as determined in this paragraph. If more than one method of reduction will result in the same economic benefit, the portions of the Transaction Payment shall be reduced pro
rata. Unless you and the Company otherwise agree in writing, any determination required under this paragraph shall be made in writing by the Company’s independent public accountants (the “Accountants”), whose determination shall be conclusive and binding upon you and the Company for all purposes. For purposes of making the calculations required by this paragraph, the Accountants may make reasonable assumptions and approximations concerning applicable taxes and may rely on reasonable, good faith interpretations concerning the application of Sections 280G and 4999 of the Code. You and the Company shall furnish to the Accountants such information and documents as the Accountants may reasonably request in order to make a determination under this paragraph. The Company shall bear all costs the Accountants may reasonably incur in connection with any calculations contemplated by this paragraph as well as any costs incurred by you with the Accountants for tax planning under Sections 280G and 4999 of the Code.
Indemnification; D&O Insurance
You will be entitled to the indemnification and liability insurance coverage as described in the indemnification agreement that you entered into with the Company on June 29, 2015 (the “Indemnification Agreement”).
Compliance with Proprietary Information Agreement and Company Policies
As a condition of employment, you have signed and must continue to comply with the Company’s standard form of Employee Proprietary Information, Inventions Assignment, Non-Competition and Non-Solicitation Agreement (the “Proprietary Information Agreement”, a copy of which is attached hereto as Exhibit A ) which prohibits unauthorized use or disclosure of the Company’s proprietary information, among other obligations. As a Paratek employee, you will be expected to abide by Company policies and practices, as may be changed from time to time in the Company’s discretion, and acknowledge in writing that you have read the Company’s employee handbook.
Protection of Third Party Information
In your work for the Company, you will be expected not to use or disclose any confidential information, including trade secrets, of any former employer or other person to whom you have an obligation of confidentiality. Rather, you will be expected to use only that information which is generally known and used by persons with training and experience comparable to your own, which is common knowledge in the industry or otherwise legally in the public domain, or which is otherwise provided or developed by the Company. You agree that you will not bring onto Company premises, or use in the performance of your duties, any unpublished documents or property belonging to any former employer or other person to whom you have an obligation of confidentiality. You hereby represent that you have disclosed to the Company any contract you have signed that may restrict your activities on behalf of the Company.
Outside Activities
Except with the prior written consent of the CEO, you will not during your employment engage in any other employment, occupation or business enterprise, other than ones in which you are a passive investor. You may engage in civic and not-for-profit activities so long as such activities do not materially interfere with the performance of your duties. During your employment, you agree not to acquire, assume or participate in, directly or indirectly, any entity, investment, or interest known by you to be adverse or antagonistic to the Company, its business or prospects, financial or otherwise, including any person, corporation, firm, partnership or other entity whatsoever known by you to compete with the Company (or is planning or preparing to compete with the Company), anywhere in the world, in any line of business engaged in (or planned to be engaged in) by the Company. You may purchase or otherwise acquire up to one percent (1%) of any class of securities of any enterprise if such securities are listed on any national or regional securities exchange, provided that you refrain from participating in the business activities of such enterprise.
Agreement to Arbitrate
To ensure the rapid and economical resolution of disputes that may arise in connection with your employment with the Company, you and the Company both agree that any and all disputes, claims, or causes of action, in law or
equity, including but not limited to statutory claims, arising from or relating to the enforcement, breach, performance, or interpretation of this Agreement, your employment with the Company, or the termination of your employment with the Company, will be resolved pursuant to the Federal Arbitration Act, 9 U.S.C. §1-16, and to the fullest extent permitted by law, by final, binding and confidential arbitration conducted in Boston, Massachusetts by JAMS, Inc. (“JAMS”) or its successors.
Both you and the Company acknowledge that by agreeing to this arbitration procedure, you each waive the right to resolve any such dispute through a trial by jury or judge or administrative proceeding.
Any such arbitration proceeding will be governed by JAMS’ then applicable rules and procedures for employment disputes, which can be found at http://www.jamsadr.com/rules-employment-arbitration/ , and which will be provided to you upon request. In any such proceeding, the arbitrator shall: (i) have the authority to compel adequate discovery for the resolution of the dispute and to award such relief as would otherwise be permitted by law; and (ii) issue a written arbitration decision including the arbitrator’s essential findings and conclusions and a statement of the award. You and the Company each shall be entitled to all rights and remedies that either would be entitled to pursue in a court of law. Nothing in this Agreement is intended to prevent either the Company or you from obtaining injunctive relief in court to prevent irreparable harm pending the conclusion of any such arbitration pursuant to applicable law.
Section 409A
1. Specified Employee . Notwithstanding anything to the contrary in the Agreement, if at the time your employment terminates, you are a “specified employee,” as defined below, any and all amounts payable under the Agreement on account of such separation from service that would (but for this provision) be payable within six (6) months following the date of termination, shall instead be paid on the next business day following the expiration of such six (6) month period or, if earlier, upon your death; except (A) to the extent of amounts that do not constitute a deferral of compensation within the meaning of Treasury regulation Section 1.409A-1(b) (including without limitation by reason of the safe harbor set forth in Section 1.409A-1(b)(9)(iii), as determined by the Company in its reasonable good faith discretion); (B) benefits which qualify as excepted welfare benefits pursuant to Treasury regulation Section 1.409A-1(a)(5); or (C) other amounts or benefits that are not subject to the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (“Section 409A”).
2. Termination of Employment . For purposes of the Agreement, all references to “termination of employment” and correlative phrases shall be construed to require a “separation from service” (as defined in Treasury regulation Section 1.409A-1(h) after giving effect to the presumptions contained therein), and the term “specified employee” means an individual determined by the Company to be a specified employee under Treasury regulation Section 1.409A-1(i).
3. Reimbursement for Expenses . Any reimbursement for expenses that would constitute nonqualified deferred compensation subject to Section 409A shall be subject to the following additional rules: (i) no reimbursement of any such expense shall affect your right to reimbursement of any such expense in any other taxable year; (ii) reimbursement of the expense shall be made, if at all, promptly, but not later than the end of the calendar year following the calendar year in which the expense was incurred; and (iii) the right to reimbursement shall not be subject to liquidation or exchange for any other benefit.
4. Separate Payments . Each payment made under the Agreement shall be treated as a separate payment and the right to a series of installment payments under the Agreement is to be treated as a right to a series of separate payments.
5. Limitation on Liability . In no event shall the Company have any liability relating to the failure or alleged failure of any payment or benefit under the Agreement to comply with, or be exempt from, the requirements of Section 409A.
Entire Agreement; Contingencies
This Agreement, together with your Proprietary Information Agreement and the Indemnification Agreement, forms the complete and exclusive statement of your employment agreement with the Company. It supersedes any other prior agreements or promises made to you by anyone, whether oral or written, including the Employment Agreement. Changes in your employment terms, other than those changes expressly reserved to the Company’s or Board’s discretion in this Agreement, require a written modification approved by the Board and signed by a duly authorized Member of the Board.
This Agreement will bind the heirs, personal representatives, successors and assigns of both you and the Company, and inure to the benefit of both you and the Company, their heirs, successors and assigns. If any provision of this Agreement is determined to be invalid or unenforceable, in whole or in part, this determination shall not affect any other provision of this Agreement and the provision in question shall be modified so as to be rendered enforceable in a manner consistent with the intent of the parties insofar as possible under applicable law.
This Agreement shall be construed and enforced in accordance with the laws of the Commonwealth of Massachusetts without regard to conflicts of law principles. Any waiver of a breach of this Agreement, or rights hereunder, shall be in writing and shall not be deemed to be a waiver of any successive breach or rights hereunder. This Agreement may be executed in counterparts which shall be deemed to be part of one original, and pdf or other facsimile signatures shall be equivalent to original signatures.
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PARATEK PHARMACEUTICALS paratekpharma.com |
75 Park Plaza Boston, MA 02116 617.807.6600 617.275.0039 fax |
Please sign and date this Agreement to indicate your acceptance of continued employment at Paratek under the terms described above. We look forward to a continued productive and enjoyable work relationship.
Sincerely,
Paratek Pharmaceuticals, Inc.
/s/ Michael F. Bigham |
Michael F. Bigham |
Chairman of the Board and Chief Executive Officer |
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Accepted: |
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/s/ William M. Haskel |
William M. Haskel |
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June 16, 2017 |
Date |
62419120_3
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PARATEK PHARMACEUTICALS paratekpharma.com |
75 Park Plaza Boston, MA 02116 617.807.6600 617.275.0039 fax |
EMPLOYEE PROPRIETARY INFORMATION, INVENTIONS ASSIGNMENT, NON-COMPETITION AND NON-SOLICITATION AGREEMENT
EMPLOYEE PROPRIETARY INFORMATION, INVENTIONS ASSIGNMENT, NON-COMPETITION
AND NON-SOLICITATION AGREEMENT
In consideration of my employment or continued employment by Paratek Pharmaceuticals, Inc. , its subsidiaries, parents, affiliates, successors and assigns (together, the “ Company ”) and the compensation now and hereafter paid to me, I hereby enter into this Employee Proprietary Information, Inventions Assignment, Non-Competition and Non-Solicitation Agreement (the “ Agreement ”) and agree as follows:
1.1 Recognition of Company’s Rights; Nondisclosure. I understand and acknowledge that my employment by the Company creates a relationship of confidence and trust with respect to the Company’s Proprietary Information (defined below) and that the Company has a protectable interest therein. At all times during my employment and thereafter, I will hold in strictest confidence and will not disclose, use, lecture upon or publish any of the Company’s Proprietary Information, except as such disclosure, use or publication may be required in connection with my work for the Company, or unless an authorized officer of the Company expressly authorizes such in writing. I will obtain the Company’s written approval before publishing or submitting for publication any material (written, verbal, or otherwise) that relates to my work at the Company and/or incorporates any Proprietary Information. I hereby assign to the Company any rights I may have or acquire in such Proprietary Information and recognize that all Proprietary Information shall be the sole property of the Company and its assigns. I will take all reasonable precautions to prevent the inadvertent or accidental disclosure of Proprietary Information.
1.2 Proprietary Information. The term “ Proprietary Information ” shall mean any and all confidential and/or proprietary knowledge, data or information of the Company, its affiliates, parents and subsidiaries, whether having existed, now existing, or to be developed during my employment. By way of illustration but not limitation, “ Proprietary Information ” includes (a) trade secrets, inventions, ideas, processes, formulas, assay components, biological materials, cell lines, and clinical data, data, programs, other works of authorship, know-how, improvements, discoveries, developments, designs and techniques and any other proprietary technology and all Proprietary Rights therein (hereinafter collectively referred to as “ Inventions ”); (b) information regarding research, development, new products, marketing and selling, business plans, budgets and unpublished financial statements, licenses, prices and costs, margins,
discounts, credit terms, pricing and billing policies, quoting procedures, methods of obtaining business, forecasts, future plans and potential strategies, financial projections and business strategies, operational plans, financing and capital-raising plans, activities and agreements, internal services and operational manuals, methods of conducting Company business, suppliers and supplier information, and purchasing; (c) information regarding customers and potential customers of the Company, including customer lists, names, representatives, their needs or desires with respect to the types of products or services offered by the Company, proposals, bids, contracts and their contents and parties, the type and quantity of products and services provided or sought to be provided to customers and potential customers of the Company and other non-public information relating to customers and potential customers; (d) information regarding any of the Company’s business partners and their services, including names; representatives, proposals, bids, contracts and their contents and parties, the type and quantity of products and services received by the Company, and other non-public information relating to business partners; (e) information regarding personnel, employee lists, compensation, and employee skills; and (f) any other non-public information which a competitor of the Company could use to the competitive disadvantage of the Company. Notwithstanding the foregoing, it is understood that, at all such times, I am free to use information which is generally known in the trade or industry through no breach of this Agreement or other act or omission by me, and I am free to discuss the terms and conditions of my employment with others to the extent expressly permitted by Section 7 of the National Labor Relations Act.
1.3 Third Party Information. I understand, in addition, that the Company has received and in the future will receive confidential and/or proprietary knowledge, data, or information from third parties (“ Third Party Information ”). During my employment and thereafter, I will hold Third Party Information in the strictest confidence and will not disclose to anyone (other than Company personnel who need to know such information in
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connection with their work for the Company) or use, except in connection with my work for the Company, Third Party Information unless expressly authorized by an authorized officer of the Company in writing.
1.4 Term of Nondisclosure Restrictions. I understand that Proprietary Information and Third Party Information is never to be used or disclosed by me, as provided in this Section 1. If, however, a court decides that this Section 1 or any of its provisions is unenforceable for lack of reasonable temporal limitation and the Agreement or its restriction(s) cannot otherwise be enforced, I agree and the Company agrees that the two (2) year period after the date my employment ends shall be the temporal limitation relevant to the contested restriction, provided, however, that this sentence shall not apply to trade secrets protected without temporal limitation under applicable law.
1.5 No Improper Use of Information of Prior Employers and Others. During my employment by the Company I will not improperly use or disclose any confidential information or trade secrets, if any, of any former employer or any other person to whom I have an obligation of confidentiality, and I will not bring onto the premises of the Company any unpublished documents or any property belonging to any former employer or any other person to whom I have an obligation of confidentiality unless consented to in writing by that former employer or person.
2. Assignment of Inventions.
2.1 Proprietary Rights. The term “ Proprietary Rights ” shall mean all trade secrets, patents, copyrights, trademarks and other intellectual property rights throughout the world.
2.2 Prior Inventions. Inventions, if any, patented or unpatented, which I made prior to the commencement of my employment with the Company are excluded from the scope of this Agreement. To preclude any possible uncertainty, I have set forth on Exhibit 1 (Prior Inventions) attached hereto a complete list of all Inventions that I have, alone or jointly with others, conceived, developed or reduced to practice or caused to be conceived, developed or reduced to practice prior to the commencement of my employment with the Company, that I consider to be my property or the property of third parties, and that I wish to have excluded from the scope of this Agreement (collectively referred to as “ Prior Inventions ”). If disclosure of any such Prior Invention would cause
me to violate any prior confidentiality agreement, I understand that I am not to list such Prior Inventions in Exhibit 1 but am only to disclose a cursory name for each such invention, a listing of the party(ies) to whom it belongs and the fact that full disclosure as to such inventions has not been made for that reason. A space is provided on Exhibit 1 for such purpose. If no such disclosure is attached, I represent that there are no Prior Inventions. If, in the course of my employment with the Company, I incorporate a Prior Invention into a Company product, process or machine, the Company is hereby granted and shall have a nonexclusive, royalty-free, irrevocable, perpetual, fully-paid, worldwide license (with rights to sublicense through multiple tiers of sub-licensees) to make, have made, modify, make derivative works of, publicly perform, use, sell, import, and exercise any and all present and future rights in such Prior Invention. Notwithstanding the foregoing, I agree that I will not incorporate, or permit to be incorporated, Prior Inventions in any Company Inventions without the Company’s prior written consent.
2.3 Assignment of Inventions. Subject to Subsection 2.4, I hereby assign, grant and convey to the Company all my right, title and interest in and to any and all Inventions (and all Proprietary Rights with respect thereto) whether or not patentable or registrable under copyright or similar statutes, made or conceived or reduced to practice or learned by me, either alone or jointly with others, during the period of my employment with the Company. Inventions assigned to the Company or its designees are hereinafter referred to as “ Company Inventions .”
2.4 Unassigned or Nonassignable Inventions. I recognize that this Agreement will not be deemed to require assignment of any Invention that I developed entirely on my own time without using the Company’s equipment, supplies, facilities, trade secrets, or Proprietary Information, except for those Inventions that either (i) relate to the Company’s actual or anticipated business, research or development, or (ii) result from or are connected with work performed by me for the Company. In addition, this Agreement does not apply to any Invention which qualifies fully for protection from assignment to the Company under any specifically applicable state law, regulation, rule, or public policy (“ Specific Inventions Law ”).
2.5 Obligation to Keep Company Informed. During the period of my employment and for six (6) months after termination of my employment with the Company, I will promptly
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disclose to the Company fully and in writing all Inventions authored, conceived or reduced to practice by me, either alone or jointly with others. In addition, I will promptly disclose to the Company all patent applications filed by me or on my behalf within a year after termination of employment. At the time of each such disclosure, I will advise the Company in writing of any Inventions that I believe fully qualify for protection under the provisions of a Specific Inventions Law; and I will at that time provide to the Company in writing all evidence necessary to substantiate that belief. The Company will keep in confidence and will not use for any purpose or disclose to third parties without my consent any confidential information disclosed in writing to the Company pursuant to this Agreement relating to Inventions that qualify fully for protection under a Specific Inventions Law. I will preserve the confidentiality of any Invention that does not fully qualify for protection under a Specific Inventions Law.
2.6 Ownership of Work Product. I agree that the Company will exclusively own all work product that is made by me (solely or jointly with others) within the scope of my employment, and I hereby irrevocably and unconditionally assign to the Company all right, title, and interest worldwide in and to such work product. I acknowledge that all original works of authorship which are made by me (solely or jointly with others) within the scope of my employment and which are protectable by copyright are “works made for hire,” pursuant to United States Copyright Act (17 U.S.C., Section 101). I understand and agree that I have no right to publish on, submit for publishing, or use for any publication any work product protected by this Section, except as necessary to perform services for the Company.
2.7 Enforcement of Proprietary Rights. I will assist the Company in every proper way to obtain, and from time to time enforce, United States and foreign Proprietary Rights relating to Company Inventions in any and all countries. To that end I will execute, verify and deliver such documents and perform such other acts (including appearances as a witness) as the Company may reasonably request for use in applying for, obtaining, perfecting, evidencing, sustaining and enforcing such Proprietary Rights and the assignment thereof. In addition, I will execute, verify and deliver assignments of such Proprietary Rights to the Company or its designee, including the United States or any third party designated by the Company. My obligation to assist the Company with respect to Proprietary Rights relating to such Company Inventions in any and all countries shall
continue beyond the termination of my employment, but the Company shall compensate me at a reasonable rate after my termination for the time actually spent by me at the Company’s request on such assistance.
In the event the Company is unable for any reason, after reasonable effort, to secure my signature on any document needed in connection with the actions specified in the preceding paragraph, I hereby irrevocably designate and appoint the Company and its duly authorized officers and agents as my agent and attorney in fact, which appointment is coupled with an interest, to act for and in my behalf to execute, verify and file any such documents and to do all other lawfully permitted acts to further the purposes of the preceding paragraph with the same legal force and effect as if executed by me. I hereby waive and quitclaim to the Company any and all claims, of any nature whatsoever, which I now or may hereafter have for infringement of any Proprietary Rights assigned under this Agreement to the Company.
3. Records. I agree to keep and maintain adequate and current records (in the form of notes, sketches, drawings and in any other form that may be required by the Company) of all Proprietary Information developed by me and all Inventions made by me during the period of my employment at the Company, which records shall be available to and remain the sole property of the Company at all times.
4. Duty of Loyalty During Employment. I agree that during the period of my employment by the Company I will not, without the Company’s express written consent, directly or indirectly engage in any employment or business activity which is directly or indirectly competitive with, or would otherwise conflict with, my employment by the Company.
5. No Solicitation of Employees, Consultants, Contractors, or Customers or Potential Customers. I agree that during the period of my employment and for the one (1) year period after the date my employment ends for any reason, including but not limited to voluntary termination by me or involuntary termination by the Company, I will not, as an officer, director, employee, consultant, owner, partner, or in any other capacity, either directly or through others, except on behalf of the Company:
5.1 solicit, induce, encourage, or participate in soliciting, inducing, or encouraging any
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employee of the Company to terminate his or her relationship with the Company;
5.2 hire, employ, or engage in business with or attempt to hire, employ, or engage in business with any person employed by the Company or who has left the employment of the Company within the preceding three (3) months of any such prohibited activity or discuss any potential employment or business association with such person, even if I did not initiate the discussion or seek out the contact;
5.3 solicit, induce or attempt to induce any Customer or Potential Customer, or any consultant or independent contractor with whom I had direct or indirect contact during my employment with the Company or whose identity I learned as a result of my employment with the Company, to terminate, diminish, or materially alter in a manner harmful to the Company its relationship with the Company; or
5.4 solicit, perform, provide or attempt to perform or provide any Conflicting Services (as defined in Section 6 below) for a Customer or Potential Customer. The parties agree that for purposes of this Agreement, a “ Customer or Potential Customer ” is any person or entity who or which, at any time during the one (1) year prior to the date my employment with the Company ends, (i) contracted for, was billed for, or received from the Company any product, service or process with which I worked directly or indirectly during my employment by the Company or about which I acquired Proprietary Information; or (ii) was in contact with me or in contact with any other employee, owner, or agent of the Company, of which contact I was or should have been aware, concerning any product, service or process with which I worked directly or indirectly during my employment with the Company or about which I acquired Proprietary Information; or (iii) was solicited by the Company in an effort in which I was involved or of which I was or should have been aware.
6. Non-Compete Provision. I agree that for the one (1) year period after the date my employment ends for any reason, including but not limited to voluntary termination by me or involuntary termination by the Company, I will not, directly or indirectly, as an officer, director, employee, consultant, owner, manager, member, partner, or in any other capacity solicit, perform, or provide, or attempt to perform or provide Conflicting Services anywhere in the world where the Company conducts business, including but not limited to locations where the Company performs research or development
activities related to the Company’s products, services or processes (such locations the “ Restricted Territory ”), nor will I assist another person to solicit, perform or provide or attempt to perform or provide Conflicting Services in the Restricted Territory.
The parties agree that for purposes of this Agreement, “ Conflicting Services ” means any product, service, or process or the research and development thereof, of any person or organization other than the Company that has antibiotics as its principal business, unless otherwise expressly excluded from this definition in advance by the Company’s Board of Directors.
7. Reasonableness of Restrictions.
7.1 I agree that I have read this entire Agreement and understand it. I agree that this Agreement does not prevent me from earning a living or pursuing my career and that I have the ability to secure other non-competitive employment using my marketable skills. I agree that the restrictions contained in this Agreement are reasonable, proper, and necessitated by the Company’s legitimate business interests, including without limitation, the Company’s Proprietary Rights, Proprietary Information and the goodwill of its customers. I represent and agree that I am entering into this Agreement freely and with knowledge of its contents with the intent to be bound by the Agreement and the restrictions contained in it.
7.2 In the event that a court finds this Agreement, or any of its restrictions, to be ambiguous, unenforceable, or invalid, the Company and I agree that the court shall read the Agreement as a whole and interpret the restriction(s) at issue to be enforceable and valid to the maximum extent allowed by law.
7.3 If the court declines to enforce this Agreement in the manner provided in subsection 7.2, I and the Company agree that this Agreement will be automatically modified to provide the Company with the maximum protection of its business interests allowed by law and I agree to be bound by this Agreement as modified.
8. No Conflicting Agreement or Obligation. I represent that my performance of all the terms of this Agreement and as an employee of the Company does not and will not breach any agreement or obligation of any kind to keep in confidence information acquired by me in confidence or in trust prior to my employment by the Company.
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I have not entered into, and I agree I will not enter into, any agreement either written or oral in conflict with this Agreement.
9. Return of Company Property. Upon termination of my employment or upon Company’s request at any other time, I will deliver to Company all of Company’s property, equipment, and documents, together with all copies thereof, and any other material containing or disclosing any Inventions, Third Party Information or Proprietary Information and certify in writing that I have fully complied with the foregoing obligation. I agree that I will not copy, delete, or alter any information contained upon my Company computer or Company equipment before I return it to Company. In addition, if I have used any personal computer, server, or e-mail system to receive, store, review, prepare or transmit any Company information, including but not limited to, Proprietary Information, I agree to provide the Company with a computer-useable copy of all such Proprietary Information and then permanently delete and expunge such Proprietary Information from those systems; and I agree to provide the Company access to my system as reasonably requested to verify that the necessary copying and/or deletion is completed. I further agree that any property situated on Company’s premises and owned by Company is subject to inspection by Company’s personnel at any time with or without notice. Prior to the termination of my employment or promptly after termination of my employment, I will cooperate with Company in attending an exit interview and certify in writing that I have complied with the requirements of this section.
10. Legal and Equitable Remedies.
10.1 I agree that it may be impossible to assess the damages caused by my violation of this Agreement or any of its terms. I agree that any threatened or actual violation of this Agreement or any of its terms will constitute immediate and irreparable injury to the Company and the Company shall have the right to enforce this Agreement and any of its provisions by injunction, specific performance or other equitable relief, without bond and without prejudice to any other rights and remedies that the Company may have for a breach or threatened breach of this Agreement.
10.2 I agree that if the Company is successful in whole or in part in any legal or equitable action against me under this Agreement, the Company shall be entitled to payment of all costs, including reasonable attorney’s fees, from me.
10.3 In the event the Company enforces this Agreement through a court order, I agree that the restrictions of Sections 5 and 6 shall remain in effect for a period of twelve (12) months from the effective date of the Order enforcing the Agreement.
11. Notices. Any notices required or permitted under this Agreement will be given to the Company at its headquarters location at the time notice is given, labeled “Attention Chief Executive Officer,” and to me at my address as listed on the Company payroll, or at such other address as the Company or I may designate by written notice to the other. Notice will be effective upon receipt or refusal of delivery. If delivered by certified or registered mail, notice will be considered to have been given five (5) business days after it was mailed, as evidenced by the postmark. If delivered by courier or express mail service, notice will be considered to have been given on the delivery date reflected by the courier or express mail service receipt.
12. Publication of This Agreement to Subsequent Employers or Business Associates of Employee.
12.1 If I am offered employment or the opportunity to enter into any business venture as owner, partner, consultant or other capacity while the restrictions described in Sections 5 and 6 of this Agreement are in effect I agree to inform my potential employer, partner, co-owner and/or others involved in managing the business with which I have an opportunity to be associated of my obligations under this Agreement and also agree to provide such person or persons with a copy of this Agreement.
12.2 I agree to inform the Company of all employment and business ventures which I enter into while the restrictions described in Sections 5 and 6 of this Agreement are in effect and I also authorize the Company to provide copies of this Agreement to my employer, partner, co-owner and/or others involved in managing the business with which I am employed or associated and to make such persons aware of my obligations under this Agreement.
13. General Provisions.
13.1 Governing Law; Consent to Personal Jurisdiction. This Agreement will be governed by and construed according to the laws of the Commonwealth of Pennsylvania as such laws are applied to agreements entered into and to be performed entirely within the Commonwealth of Pennsylvania between Pennsylvania residents. I
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hereby expressly consent to the personal jurisdiction and venue of the state and federal courts located in the Commonwealth of Massachusetts for any lawsuit filed there against me by Company arising from or related to this Agreement.
13.2 Severability. In case any one or more of the provisions, subsections, or sentences contained in this Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect the other provisions of this Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained in this Agreement. If moreover, any one or more of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it shall be construed by limiting and reducing it, so as to be enforceable to the extent compatible with the applicable law as it shall then appear.
13.3 Successors and Assigns. This Agreement is for my benefit and the benefit of the Company, its successors, assigns, parent corporations, subsidiaries, affiliates, and purchasers, and will be binding upon my heirs, executors, administrators and other legal representatives.
13.4 Survival. The provisions of this Agreement shall survive the termination of my employment, regardless of the reason, and the assignment of this Agreement by the Company to any successor in interest or other assignee. I understand that my obligations under this Agreement will continue in accordance with its express terms regardless of any change in my title, position, status, role, duties, salary, compensation or benefits or other terms and conditions of employment or service.
13.5 Employment At-Will. I agree and understand that nothing in this Agreement shall change my at-will employment status or confer any right with respect to continuation of employment by the Company, nor shall it interfere in any way with
my right or the Company’s right to terminate my employment at any time, with or without cause or advance notice.
13.6 Waiver. No waiver by the Company of any breach of this Agreement shall be a waiver of any preceding or succeeding breach. No waiver by the Company of any right under this Agreement shall be construed as a waiver of any other right. The Company shall not be required to give notice to enforce strict adherence to all terms of this Agreement.
13.7 Advice of Counsel. I ACKNOWLEDGE THAT, IN EXECUTING THIS AGREEMENT, I HAVE HAD THE OPPORTUNITY TO SEEK THE ADVICE OF INDEPENDENT LEGAL COUNSEL, AND I HAVE READ AND UNDERSTOOD ALL OF THE TERMS AND PROVISIONS OF THIS AGREEMENT. THIS AGREEMENT SHALL NOT BE CONSTRUED AGAINST ANY PARTY BY REASON OF THE DRAFTING OR PREPARATION OF THIS AGREEMENT.
13.8 Entire Agreement. The obligations pursuant to Sections 1 and 2 (except Subsection 2.6) of this Agreement shall apply to any time during which I was previously engaged, or am in the future engaged, by the Company as a consultant if no other agreement governs nondisclosure and assignment of inventions during such period. This Agreement is the final, complete and exclusive agreement of the parties with respect to the subject matter of this Agreement and supersedes and merges all prior discussions between us. No modification of or amendment to this Agreement, nor any waiver of any rights under this Agreement, will be effective unless in writing and signed by the party to be charged. Any subsequent change or changes in my title, position, status, role, duties, salary, compensation or benefits or other terms and conditions of employment or service will not affect the validity or scope of this Agreement.
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This Agreement shall be effective as of the first day of my employment with the Company.
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1. Except as listed in Section 2 below, the following is a complete list of all inventions or improvements relevant to the subject matter of my employment by Paratek Pharmaceuticals, Inc. (the “ Company ”) that have been made or conceived or first reduced to practice by me alone or jointly with others prior to my engagement by the Company:
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62419120_3
Exhibit 10.8
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PARATEK PHARMACEUTICALS paratekpharma.com |
75 Park Plaza Boston, MA 02116 617.807.6600 617.275.0039 fax |
June 16, 2017
Evan Loh, M.D.
423 Brookway Road
Merion Station, PA 19066
Re: Amended and Restated Employment Agreement
Dear Evan:
On behalf of Paratek Pharmaceuticals, Inc. (“Paratek” or the “Company”), I am pleased to offer you continued employment under the terms of this Amended and Restated Employment Agreement (the “Agreement”). In this Agreement, you and the Company hereby further amend, supersede, and restate in its entirety that certain amended and restated employment agreement between the Company and you dated February 4, 2015 (the “Employment Agreement”).
Employment Position and Duties
You will continue to be employed in the position of President, Chief Operating Officer and Chief Medical Officer. You will be expected to perform the customary duties of your positions, duties specified in the Bylaws of the Company, and as may be required by the Company’s Board of Directors (the “Board”). You will report to the Chief Executive Officer. You will be expected to work as needed at the Company’s corporate headquarters in Boston, Massachusetts, but the Company’s King of Prussia facility will be your principal work location. During your employment with the Company, you will devote your full-time best efforts and business time and attention to the business of the Company. As an exempt salaried employee, you will be expected to be available and working during the Company’s regular business hours, and such additional time as appropriate to manage your responsibilities. The Company reserves the right to reasonably require you to perform your duties at places other than its Boston and King of Prussia facilities from time to time, and to require reasonable business travel, including international travel, at the Company’s expense.
Your employment relationship with the Company will also be governed by the general employment policies and practices of the Company, except that if the terms of this Agreement conflict, this Agreement will control.
Board Membership
You agree to continue to serve as a member of the Board while you remain employed as the President, Chief Operating Officer and Chief Medical Officer of the Company. You agree that, unless otherwise requested by the Board, in the event your employment with the Company is terminated for any reason, either voluntarily or involuntarily, with or without Cause, you shall resign as a member of the Board simultaneously with the termination of your employment.
Base Salary
You will earn a salary at the rate of $18,750 semimonthly ($450,000 annualized), less payroll deductions and withholdings (“Base Salary”), payable on the Company’s regular payroll schedule. The Base Salary will be reviewed on an annual or more frequent basis by the Board (or any authorized committee thereof), and is subject to change in the discretion of the Board (or any authorized committee thereof).
Discretionary Performance Bonus
You will be eligible to earn a discretionary performance bonus of up to forty-five percent (45%) of your Base Salary, subject to applicable payroll deductions and withholdings (“Bonus”), based upon the Board’s assessment of
your performance, and the Company’s attainment of written targeted goals as determined by the Board in its sole discretion. Following the close of each calendar year, the Board will determine in its discretion whether you have earned a Bonus, and the amount of any Bonus. You will be eligible to earn a Bonus for any full calendar year provided that you remain employed by the Company as of December 31 of that year. The Bonus, if earned, will be paid no later than March 15 of the calendar year after the year to which it relates.
Employee Benefits
As a regular employee, you will be eligible to participate in the Company’s standard employee benefits, pursuant to the terms and conditions of the benefit plans and applicable policies, and for any additional benefits provided to the Company’s executive employees generally. You will also be entitled to four (4) weeks of paid vacation each calendar year, in accordance with the terms of the Company’s vacation policy. The Company may change employee benefits from time to time in its discretion. Details about these benefits are provided in the employee handbook and Summary Plan Descriptions, available for your review.
Business Expenses
The Company will pay or reimburse you for all reasonable business expenses incurred or paid by you in the performance of your duties and responsibilities for the Company, subject to such reasonable substantiation and documentation as may be required by the Company, and subject to any maximum annual limit and other restrictions on or policies governing such expenses as set by the Company from time to time.
Equity Compensation
You will be eligible for future equity awards granted in accordance with the Company’s plans as in effect from time to time at levels commensurate with your position and responsibilities and subject to such terms as shall be determined by the Board or one of its committees in its or their sole discretion.
At-Will Employment Relationship
You may terminate your employment with the Company at any time, with or without Good Reason, and with or without advance notice, and for any reason whatsoever simply by notifying the Company. Likewise, the Company may terminate your employment at any time, with or without Cause, and with or without advance notice. Your employment at-will status can only be modified in a written agreement approved by the Board and signed by you and a duly authorized Member of the Board.
Payments upon Termination other than without Cause or with Good Reason
Upon termination of your employment for any reason other than by the Company without Cause or by you with Good Reason, you shall be paid all accrued but unpaid Base Salary, any earned but unpaid Bonus, reimbursement for business expenses incurred by you but not yet paid to you as of the date your employment terminates, and all accrued but unused vacation (collectively, the “Accrued Payments”). Any unvested Company equity awards that you hold, including any unvested options and restricted stock units (collectively, “Outstanding Equity”), shall terminate as of your termination date.
Termination without Cause or with Good Reason
Upon termination of your employment at any time by the Company without Cause or by you with Good Reason, you will receive the Accrued Payments. In addition, subject to your fulfillment of the Release Obligation, as defined below, you will be eligible for the following severance benefits:
1. Cash Severance Payments . You will be eligible to receive cash severance equal to twelve (12) months of Base Salary following the termination date, subject to payroll withholding and deduction (“Severance Payments”), and paid according to the Company’s regular payroll procedures. Payment of Severance Payments shall commence on the sixtieth (60th) day following your employment termination,
which initial payment shall include a lump sum payment equal to the aggregate semi-monthly installments that would otherwise have been due during the period between the termination date and the sixtieth (60th) day, but for the sixty (60)-day delay in this provision. Thereafter, the remaining installments shall be paid on the Company’s regular paydays.
2. Pro-Rata Severance Bonus. You will also be eligible to receive an amount (the “Pro-Rata Bonus”) equal to the Bonus you would have earned for the year in which your employment terminates, prorated by multiplying the Bonus that you would have earned if you had remained employed through December 31 by the portion of the year that you had actually remained employed, and subject to payroll withholding and deduction. The determination by the Board of the Bonus amount you would have earned shall be based on actual performance for the full calendar year, except that any applicable subjective performance conditions will be disregarded in determining actual performance, and the entire amount of the Bonus, if any, will be determined based on applicable objective performance conditions. Any Pro-Rata Bonus will be paid at the same time bonuses are paid to the other executives of the Company, but in no event later than March 15 of the calendar year after the year to which it relates.
3. Paid Health Care Coverage; Other Benefits Continuation .
a. If at the time of your employment termination you participate in health care coverage through the Company’s plan, then provided that you timely elect continued coverage under COBRA, the Company will pay your COBRA premiums (less your standard employee contribution) to continue your coverage (including coverage for eligible dependents, if applicable) (“COBRA Premiums”) through the period (the “COBRA Premium Period”) starting on the termination date and ending on the earliest to occur of the date: (i) twelve (12) months after the termination date; (ii) you become eligible for group health insurance coverage through a new employer; or (iii) you cease to be eligible for COBRA continuation coverage for any reason, including plan termination. In the event you become covered under another employer’s group health plan or otherwise cease to be eligible for COBRA during the COBRA Premium Period, you must immediately notify the Company of such event.
b. Notwithstanding the foregoing, if the payment by the Company of the COBRA Premiums will subject or expose the Company to taxes or penalties, you and the Company agree to renegotiate the provisions of paragraph 3(a) in good faith and enter into a substitute arrangement pursuant to which the Company will not be subjected or exposed to taxes or penalties and you will be provided with payments or benefits with an economic value that is no less than the economic value of the COBRA Premiums.
Definitions
For purposes of this Agreement, the following definitions shall apply:
1. “Cause” shall mean the occurrence of any of the following events: (a) your indictment for any felony or any crime involving fraud, embezzlement, dishonesty or moral turpitude under the laws of the United States or any state thereof; (b) your attempted commission of, or participation in, a fraud, embezzlement or act of material dishonesty against the Company or a Company affiliate; (c) your intentional, material violation of any contract or agreement between you and the Company or a Company affiliate or of any statutory duty owed to the Company or a Company affiliate; (d) your intentional unauthorized use or disclosure of the Company’s or a Company affiliate’s confidential information or trade secrets; (e) your refusal or failure to perform any duties required of you, if such duties are consistent with duties customary for your position, or other persistent unsatisfactory performance or neglect of your job duties, which continues after a period of thirty (30) days following your receipt of notice from the Company that it deems such conduct Cause for termination of your employment hereunder; or (f) your gross misconduct.
Notwithstanding anything to the contrary in this Agreement or any other agreement between the Company and you, “Cause” shall not include or be predicated upon any act or omission by you, which is taken or made (a) in good faith, under your reasonable belief that the act or omission was in the best interests of the Company; (b) to comply with a lawful court order, directive from a federal, state or local government agency or industry regulatory authority, or subpoena; or (c) at the direction of the Board or upon the advice of counsel for the Company.
2. “Good Reason” shall exist for resignation from employment with the Company if any of the following actions are taken by the Company without your prior consent: (a) a reduction in your Base Salary or Bonus target percentage of Base Salary, unless the salaries or bonus target percentages of all other senior executive officers of the Company are correspondingly and proportionately reduced; (b) a removal from your position as the Company’s President, Chief Operating Officer and Chief Medical Officer or a material and adverse change in the duties and responsibilities of your positions or reporting relationship; or (c) a relocation of your principal place of employment to a place (other than the Company’s facility in the greater Philadelphia area) that increases your one-way commute by more than thirty-five (35) miles as compared to your then-current principal place of employment immediately prior to such relocation. In order for you to resign for Good Reason, each of the following requirements must be met: (w) you must provide written notice to the Board within thirty (30) days after first becoming aware of the first occurrence of the event giving rise to Good Reason setting forth the basis for your resignation, (x) you must allow the Company at least thirty (30) days from receipt of such written notice (the “Cure Period”) to cure such event, (y) such event is not reasonably cured by the Company within the Cure Period, and (z) you must resign from all positions you then hold with the Company not later than sixty (60) days after the expiration of the Cure Period.
3. “Release Obligation” means that: (a) you have signed a general release and waiver of claims in favor of the Company and its affiliates, as part of a termination agreement acceptable to the Company that contains standard provisions including a non-disparagement provision and restrictive covenants to the maximum enforceable extent including without limitation a noncompetition covenant during the period you are eligible to receive Severance Payments, and (b) you have allowed the release and waiver to become fully effective without revocation during any applicable revocation period.
Change in Control
Upon the termination of your employment by the Company without Cause, or by you with Good Reason, in either case during a time period starting on the date ninety (90) days before the closing of a Change in Control and ending on the date twelve (12) months after the closing of a Change in Control, provided that you meet the Release Obligation and you provide continued services through your termination date, then your Outstanding Equity shall vest in full (“Accelerated Vesting”), effective as of the termination date of your employment; provided, however, that any Outstanding Equity that is subject to performance-based vesting conditions will be deemed to have been achieved at target.
A “Change in Control” shall mean any of the following: (a) a merger or consolidation in which the Company is a constituent party (or if a subsidiary of the Company is a constituent party and the Company issues shares of its capital stock pursuant to such merger or consolidation), other than a merger or consolidation in which the voting securities of the Company outstanding immediately prior to such merger or consolidation continue to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) more than fifty percent (50%) of the combined voting power of the voting securities of the surviving entity outstanding immediately after such merger or consolidation, or (b) any transaction or series of related transactions in which in excess of fifty percent (50%) of the Company’s voting power is transferred, other than the sale by the Company of stock in transactions the primary purpose of which is to raise capital for the Company’s operations and activities, or (c) a sale, lease, exclusive license or other disposition of all or substantially all (as determined by the Board in its sole discretion) of the assets of the Company.
Section 280G
If any payment or benefit (including payments and benefits pursuant to this Agreement) that you would receive in connection with a Change in Control from the Company or otherwise (“Transaction Payment”) would (i) constitute a “parachute payment” within the meaning of Section 280G of the Internal Revenue Code (the “Code”), and (ii) but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then the Company shall cause to be determined, before any amounts of the Transaction Payment are paid to you, which of the following two alternative forms of payment would result in your receipt, on an after-tax basis, of the greater amount of the Transaction Payment notwithstanding that all or some portion of the Transaction Payment may be subject to the Excise Tax: (1) payment in full of the entire amount of the Transaction Payment (a “Full Payment”), or (2) payment of only a part of the Transaction Payment so that you receive the largest payment possible without the imposition of the Excise Tax (a “Reduced Payment”). For purposes of determining whether to make a Full Payment or a Reduced Payment, the Company shall cause to be taken into account all applicable federal, state and local income and employment taxes and the Excise Tax (all computed at the highest applicable marginal rate, net of the maximum reduction in federal income taxes which could be obtained from a deduction of such state and local taxes). If a Reduced Payment is made, (x) you shall have no rights to any additional payments and/or benefits constituting the Transaction Payment, and (y) reduction in payments and/or benefits shall occur in the manner that results in the greatest economic benefit to you as determined in this paragraph. If more than one method of reduction will result in the same economic benefit, the portions of the Transaction Payment shall be reduced pro rata. Unless you and the Company otherwise agree in writing, any determination required under this paragraph shall be made in writing by the Company’s independent public accountants (the “Accountants”), whose determination shall be conclusive and binding upon you and the Company for all purposes. For purposes of making the calculations required by this paragraph, the Accountants may make reasonable assumptions and approximations concerning applicable taxes and may rely on reasonable, good faith interpretations concerning the application of Sections 280G and 4999 of the Code. You and the Company shall furnish to the Accountants such information and documents as the Accountants may reasonably request in order to make a determination under this paragraph. The Company shall bear all costs the Accountants may reasonably incur in connection with any calculations contemplated by this paragraph as well as any costs incurred by you with the Accountants for tax planning under Sections 280G and 4999 of the Code.
Indemnification; D&O Insurance
You will be entitled to the indemnification and liability insurance coverage as described in the indemnification agreement that you entered into with the Company on October 30, 2014 (the “Indemnification Agreement”).
Compliance with Proprietary Information Agreement and Company Policies
As a condition of employment, you have signed and must continue to comply with the Company’s standard form of Employee Proprietary Information, Inventions Assignment, Non-Competition and Non-Solicitation Agreement (the “Proprietary Information Agreement”, a copy of which is attached hereto as Exhibit A ) which prohibits unauthorized use or disclosure of the Company’s proprietary information, among other obligations. As a Paratek employee, you will be expected to abide by Company policies and practices, as may be changed from time to time in the Company’s discretion, and acknowledge in writing that you have read the Company’s employee handbook.
Protection of Third Party Information
In your work for the Company, you will be expected not to use or disclose any confidential information, including trade secrets, of any former employer or other person to whom you have an obligation of confidentiality. Rather, you will be expected to use only that information which is generally known and used by persons with training and experience comparable to your own, which is common knowledge in the industry or otherwise legally in the public domain, or which is otherwise provided or developed by the Company. You agree that you will not bring onto Company premises, or use in the performance of your duties, any unpublished documents or property belonging to any former employer or other person to whom you have an obligation of confidentiality. You hereby represent that you have disclosed to the Company any contract you have signed that may restrict your activities on behalf of the Company.
Outside Activities
Except with the prior written consent of the Board, you will not during your employment engage in any other employment, occupation or business enterprise, other than ones in which you are a passive investor. You may engage in civic and not-for-profit activities so long as such activities do not materially interfere with the performance of your duties. During your employment, you agree not to acquire, assume or participate in, directly or indirectly, any entity, investment, or interest known by you to be adverse or antagonistic to the Company, its business or prospects, financial or otherwise, including any person, corporation, firm, partnership or other entity whatsoever known by you to compete with the Company (or is planning or preparing to compete with the Company), anywhere in the world, in any line of business engaged in (or planned to be engaged in) by the Company. You may purchase or otherwise acquire up to one percent (1 %) of any class of securities of any enterprise if such securities are listed on any national or regional securities exchange, provided that you refrain from participating in the business activities of such enterprise.
Agreement to Arbitrate
To ensure the rapid and economical resolution of disputes that may arise in connection with your employment with the Company, you and the Company both agree that any and all disputes, claims, or causes of action, in law or equity, including but not limited to statutory claims, arising from or relating to the enforcement, breach, performance, or interpretation of this Agreement, your employment with the Company, or the termination of your employment with the Company, will be resolved pursuant to the Federal Arbitration Act, 9 U.S.C. §1-16, and to the fullest extent permitted by law, by final, binding and confidential arbitration conducted in Boston, Massachusetts by JAMS, Inc. (“JAMS”) or its successors.
Both you and the Company acknowledge that by agreeing to this arbitration procedure, you each waive the right to resolve any such dispute through a trial by jury or judge or administrative proceeding.
Any such arbitration proceeding will be governed by JAMS’ then applicable rules and procedures for employment disputes, which can be found at http://www.jamsadr.com/rules-employment-arbitration/ , and which will be provided to you upon request. In any such proceeding, the arbitrator shall: (i) have the authority to compel adequate discovery for the resolution of the dispute and to award such relief as would otherwise be permitted by law; and (ii) issue a written arbitration decision including the arbitrator’s essential findings and conclusions and a statement of the award. You and the Company each shall be entitled to all rights and remedies that either would be entitled to pursue in a court of law. Nothing in this Agreement is intended to prevent either the Company or you from obtaining injunctive relief in court to prevent irreparable harm pending the conclusion of any such arbitration pursuant to applicable law.
Section 409A
1. Specified Employee . Notwithstanding anything to the contrary in the Agreement, if at the time your employment terminates, you are a “specified employee,” as defined below, any and all amounts payable under the Agreement on account of such separation from service that would (but for this provision) be payable within six (6) months following the date of termination, shall instead be paid on the next business day following the expiration of such six (6) month period or, if earlier, upon your death; except (A) to the extent of amounts that do not constitute a deferral of compensation within the meaning of Treasury regulation Section 1.409A-1(b) (including without limitation by reason of the safe harbor set forth in Section 1.409A-1(b)(9)(iii), as determined by the Company in its reasonable good faith discretion); (B) benefits which qualify as excepted welfare benefits pursuant to Treasury regulation Section 1.409A-1(a)(5); or (C) other amounts or benefits that are not subject to the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (“Section 409A”).
2. Termination of Employment . For purposes of the Agreement, all references to “termination of employment” and correlative phrases shall be construed to require a “separation from service” (as defined in Treasury regulation Section 1.409A-1(h) after giving effect to the presumptions contained therein), and the term “specified employee” means an individual determined by the Company to be a specified employee under Treasury regulation Section 1.409A-1(i).
3. Reimbursement for Expenses . Any reimbursement for expenses that would constitute nonqualified deferred compensation subject to Section 409A shall be subject to the following additional rules: (i) no reimbursement of any such expense shall affect your right to reimbursement of any such expense in any other taxable year; (ii) reimbursement of the expense shall be made, if at all, promptly, but not later than the end of the calendar year following the calendar year in which the expense was incurred; and (iii) the right to reimbursement shall not be subject to liquidation or exchange for any other benefit.
4. Separate Payments . Each payment made under the Agreement shall be treated as a separate payment and the right to a series of installment payments under the Agreement is to be treated as a right to a series of separate payments.
5. Limitation on Liability . In no event shall the Company have any liability relating to the failure or alleged failure of any payment or benefit under the Agreement to comply with, or be exempt from, the requirements of Section 409A.
Entire Agreement; Contingencies
This Agreement, together with your Proprietary Information Agreement and the Indemnification Agreement, forms the complete and exclusive statement of your employment agreement with the Company. It supersedes any other prior agreements or promises made to you by anyone, whether oral or written, including the Employment Agreement. Changes in your employment terms, other than those changes expressly reserved to the Company’s or Board’s discretion in this Agreement, require a written modification approved by the Board and signed by a duly authorized Member of the Board.
This Agreement will bind the heirs, personal representatives, successors and assigns of both you and the Company, and inure to the benefit of both you and the Company, their heirs, successors and assigns. If any provision of this Agreement is determined to be invalid or unenforceable, in whole or in part, this determination shall not affect any other provision of this Agreement and the provision in question shall be modified so as to be rendered enforceable in a manner consistent with the intent of the parties insofar as possible under applicable law.
This Agreement shall be construed and enforced in accordance with the laws of the Commonwealth of Massachusetts without regard to conflicts of law principles. Any waiver of a breach of this Agreement, or rights hereunder, shall be in writing and shall not be deemed to be a waiver of any successive breach or rights hereunder. This Agreement may be executed in counterparts which shall be deemed to be part of one original, and pdf or other facsimile signatures shall be equivalent to original signatures.
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PARATEK PHARMACEUTICALS paratekpharma.com |
75 Park Plaza Boston, MA 02116 617.807.6600 617.275.0039 fax |
Please sign and date this Agreement to indicate your acceptance of continued employment at Paratek under the terms described above. We look forward to a continued productive and enjoyable work relationship.
Sincerely,
Paratek Pharmaceuticals, Inc.
/s/ Michael F. Bigham |
Michael F. Bigham |
Chairman of the Board and Chief Executive Officer |
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Accepted: |
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/s/ Evan Loh, M.D. |
Evan Loh, M.D. |
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June 16, 2017 |
Date |
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PARATEK PHARMACEUTICALS paratekpharma.com |
75 Park Plaza Boston, MA 02116 617.807.6600 617.275.0039 fax |
EMPLOYEE PROPRIETARY INFORMATION, INVENTIONS ASSIGNMENT, NON-COMPETITION AND NON-SOLICITATION AGREEMENT
EMPLOYEE PROPRIETARY INFORMATION, INVENTIONS ASSIGNMENT, NON-COMPETITION
AND NON-SOLICITATION AGREEMENT
In consideration of my employment or continued employment by Paratek Pharmaceuticals, Inc. , its subsidiaries, parents, affiliates, successors and assigns (together, the “ Company ”) and the compensation now and hereafter paid to me, I hereby enter into this Employee Proprietary Information, Inventions Assignment, Non-Competition and Non-Solicitation Agreement (the “ Agreement ”) and agree as follows:
1.1 Recognition of Company’s Rights; Nondisclosure. I understand and acknowledge that my employment by the Company creates a relationship of confidence and trust with respect to the Company’s Proprietary Information (defined below) and that the Company has a protectable interest therein. At all times during my employment and thereafter, I will hold in strictest confidence and will not disclose, use, lecture upon or publish any of the Company’s Proprietary Information, except as such disclosure, use or publication may be required in connection with my work for the Company, or unless an authorized officer of the Company expressly authorizes such in writing. I will obtain the Company’s written approval before publishing or submitting for publication any material (written, verbal, or otherwise) that relates to my work at the Company and/or incorporates any Proprietary Information. I hereby assign to the Company any rights I may have or acquire in such Proprietary Information and recognize that all Proprietary Information shall be the sole property of the Company and its assigns. I will take all reasonable precautions to prevent the inadvertent or accidental disclosure of Proprietary Information.
1.2 Proprietary Information. The term “ Proprietary Information ” shall mean any and all confidential and/or proprietary knowledge, data or information of the Company, its affiliates, parents and subsidiaries, whether having existed, now existing, or to be developed during my employment. By way of illustration but not limitation, “ Proprietary Information ” includes (a) trade secrets, inventions, ideas, processes, formulas, assay components, biological materials, cell lines, and clinical data, data, programs, other works of authorship, know-how, improvements, discoveries, developments, designs and techniques and any other proprietary technology and all Proprietary Rights therein (hereinafter collectively referred to as “ Inventions ”); (b) information regarding research, development, new products, marketing and selling, business plans, budgets and unpublished financial statements, licenses, prices and costs, margins, discounts, credit terms, pricing and billing policies,
quoting procedures, methods of obtaining business, forecasts, future plans and potential strategies, financial projections and business strategies, operational plans, financing and capital-raising plans, activities and agreements, internal services and operational manuals, methods of conducting Company business, suppliers and supplier information, and purchasing; (c) information regarding customers and potential customers of the Company, including customer lists, names, representatives, their needs or desires with respect to the types of products or services offered by the Company, proposals, bids, contracts and their contents and parties, the type and quantity of products and services provided or sought to be provided to customers and potential customers of the Company and other non-public information relating to customers and potential customers; (d) information regarding any of the Company’s business partners and their services, including names; representatives, proposals, bids, contracts and their contents and parties, the type and quantity of products and services received by the Company, and other non-public information relating to business partners; (e) information regarding personnel, employee lists, compensation, and employee skills; and (f) any other non-public information which a competitor of the Company could use to the competitive disadvantage of the Company. Notwithstanding the foregoing, it is understood that, at all such times, I am free to use information which is generally known in the trade or industry through no breach of this Agreement or other act or omission by me, and I am free to discuss the terms and conditions of my employment with others to the extent expressly permitted by Section 7 of the National Labor Relations Act.
1.3 Third Party Information. I understand, in addition, that the Company has received and in the future will receive confidential and/or proprietary knowledge, data, or information from third parties (“ Third Party Information ”). During my employment and thereafter, I will hold Third Party Information in the strictest confidence and will not disclose to anyone (other than Company personnel who need to know such information in connection with their work for the Company) or use, except in connection with my work for the Company,
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Third Party Information unless expressly authorized by an authorized officer of the Company in writing.
1.4 Term of Nondisclosure Restrictions. I understand that Proprietary Information and Third Party Information is never to be used or disclosed by me, as provided in this Section 1. If, however, a court decides that this Section 1 or any of its provisions is unenforceable for lack of reasonable temporal limitation and the Agreement or its restriction(s) cannot otherwise be enforced, I agree and the Company agrees that the two (2) year period after the date my employment ends shall be the temporal limitation relevant to the contested restriction, provided, however, that this sentence shall not apply to trade secrets protected without temporal limitation under applicable law.
1.5 No Improper Use of Information of Prior Employers and Others. During my employment by the Company I will not improperly use or disclose any confidential information or trade secrets, if any, of any former employer or any other person to whom I have an obligation of confidentiality, and I will not bring onto the premises of the Company any unpublished documents or any property belonging to any former employer or any other person to whom I have an obligation of confidentiality unless consented to in writing by that former employer or person.
2. Assignment of Inventions.
2.1 Proprietary Rights. The term “ Proprietary Rights ” shall mean all trade secrets, patents, copyrights, trademarks and other intellectual property rights throughout the world.
2.2 Prior Inventions. Inventions, if any, patented or unpatented, which I made prior to the commencement of my employment with the Company are excluded from the scope of this Agreement. To preclude any possible uncertainty, I have set forth on Exhibit 1 (Prior Inventions) attached hereto a complete list of all Inventions that I have, alone or jointly with others, conceived, developed or reduced to practice or caused to be conceived, developed or reduced to practice prior to the commencement of my employment with the Company, that I consider to be my property or the property of third parties, and that I wish to have excluded from the scope of this Agreement (collectively referred to as “ Prior Inventions ”). If disclosure of any such Prior Invention would cause me to violate any prior confidentiality agreement, I understand that I am not to list such Prior Inventions
in Exhibit 1 but am only to disclose a cursory name for each such invention, a listing of the party(ies) to whom it belongs and the fact that full disclosure as to such inventions has not been made for that reason. A space is provided on Exhibit 1 for such purpose. If no such disclosure is attached, I represent that there are no Prior Inventions. If, in the course of my employment with the Company, I incorporate a Prior Invention into a Company product, process or machine, the Company is hereby granted and shall have a nonexclusive, royalty-free, irrevocable, perpetual, fully-paid, worldwide license (with rights to sublicense through multiple tiers of sub-licensees) to make, have made, modify, make derivative works of, publicly perform, use, sell, import, and exercise any and all present and future rights in such Prior Invention. Notwithstanding the foregoing, I agree that I will not incorporate, or permit to be incorporated, Prior Inventions in any Company Inventions without the Company’s prior written consent.
2.3 Assignment of Inventions. Subject to Subsection 2.4, I hereby assign, grant and convey to the Company all my right, title and interest in and to any and all Inventions (and all Proprietary Rights with respect thereto) whether or not patentable or registrable under copyright or similar statutes, made or conceived or reduced to practice or learned by me, either alone or jointly with others, during the period of my employment with the Company. Inventions assigned to the Company or its designees are hereinafter referred to as “ Company Inventions .”
2.4 Unassigned or Nonassignable Inventions. I recognize that this Agreement will not be deemed to require assignment of any Invention that I developed entirely on my own time without using the Company’s equipment, supplies, facilities, trade secrets, or Proprietary Information, except for those Inventions that either (i) relate to the Company’s actual or anticipated business, research or development, or (ii) result from or are connected with work performed by me for the Company. In addition, this Agreement does not apply to any Invention which qualifies fully for protection from assignment to the Company under any specifically applicable state law, regulation, rule, or public policy (“ Specific Inventions Law ”).
2.5 Obligation to Keep Company Informed. During the period of my employment and for six (6) months after termination of my employment with the Company, I will promptly disclose to the Company fully and in writing all Inventions authored, conceived or reduced to practice
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by me, either alone or jointly with others. In addition, I will promptly disclose to the Company all patent applications filed by me or on my behalf within a year after termination of employment. At the time of each such disclosure, I will advise the Company in writing of any Inventions that I believe fully qualify for protection under the provisions of a Specific Inventions Law; and I will at that time provide to the Company in writing all evidence necessary to substantiate that belief. The Company will keep in confidence and will not use for any purpose or disclose to third parties without my consent any confidential information disclosed in writing to the Company pursuant to this Agreement relating to Inventions that qualify fully for protection under a Specific Inventions Law. I will preserve the confidentiality of any Invention that does not fully qualify for protection under a Specific Inventions Law.
2.6 Ownership of Work Product. I agree that the Company will exclusively own all work product that is made by me (solely or jointly with others) within the scope of my employment, and I hereby irrevocably and unconditionally assign to the Company all right, title, and interest worldwide in and to such work product. I acknowledge that all original works of authorship which are made by me (solely or jointly with others) within the scope of my employment and which are protectable by copyright are “works made for hire,” pursuant to United States Copyright Act (17 U.S.C., Section 101). I understand and agree that I have no right to publish on, submit for publishing, or use for any publication any work product protected by this Section, except as necessary to perform services for the Company.
2.7 Enforcement of Proprietary Rights. I will assist the Company in every proper way to obtain, and from time to time enforce, United States and foreign Proprietary Rights relating to Company Inventions in any and all countries. To that end I will execute, verify and deliver such documents and perform such other acts (including appearances as a witness) as the Company may reasonably request for use in applying for, obtaining, perfecting, evidencing, sustaining and enforcing such Proprietary Rights and the assignment thereof. In addition, I will execute, verify and deliver assignments of such Proprietary Rights to the Company or its designee, including the United States or any third party designated by the Company. My obligation to assist the Company with respect to Proprietary Rights relating to such Company Inventions in any and all countries shall continue beyond the termination of my employment, but the Company shall compensate me at a
reasonable rate after my termination for the time actually spent by me at the Company’s request on such assistance.
In the event the Company is unable for any reason, after reasonable effort, to secure my signature on any document needed in connection with the actions specified in the preceding paragraph, I hereby irrevocably designate and appoint the Company and its duly authorized officers and agents as my agent and attorney in fact, which appointment is coupled with an interest, to act for and in my behalf to execute, verify and file any such documents and to do all other lawfully permitted acts to further the purposes of the preceding paragraph with the same legal force and effect as if executed by me. I hereby waive and quitclaim to the Company any and all claims, of any nature whatsoever, which I now or may hereafter have for infringement of any Proprietary Rights assigned under this Agreement to the Company.
3. Records. I agree to keep and maintain adequate and current records (in the form of notes, sketches, drawings and in any other form that may be required by the Company) of all Proprietary Information developed by me and all Inventions made by me during the period of my employment at the Company, which records shall be available to and remain the sole property of the Company at all times.
4. Duty of Loyalty During Employment. I agree that during the period of my employment by the Company I will not, without the Company’s express written consent, directly or indirectly engage in any employment or business activity which is directly or indirectly competitive with, or would otherwise conflict with, my employment by the Company.
5. No Solicitation of Employees, Consultants, Contractors, or Customers or Potential Customers. I agree that during the period of my employment and for the one (1) year period after the date my employment ends for any reason, including but not limited to voluntary termination by me or involuntary termination by the Company, I will not, as an officer, director, employee, consultant, owner, partner, or in any other capacity, either directly or through others, except on behalf of the Company:
5.1 solicit, induce, encourage, or participate in soliciting, inducing, or encouraging any employee of the Company to terminate his or her relationship with the Company;
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5.2 hire, employ, or engage in business with or attempt to hire, employ, or engage in business with any person employed by the Company or who has left the employment of the Company within the preceding three (3) months of any such prohibited activity or discuss any potential employment or business association with such person, even if I did not initiate the discussion or seek out the contact;
5.3 solicit, induce or attempt to induce any Customer or Potential Customer, or any consultant or independent contractor with whom I had direct or indirect contact during my employment with the Company or whose identity I learned as a result of my employment with the Company, to terminate, diminish, or materially alter in a manner harmful to the Company its relationship with the Company; or
5.4 solicit, perform, provide or attempt to perform or provide any Conflicting Services (as defined in Section 6 below) for a Customer or Potential Customer. The parties agree that for purposes of this Agreement, a “ Customer or Potential Customer ” is any person or entity who or which, at any time during the one (1) year prior to the date my employment with the Company ends, (i) contracted for, was billed for, or received from the Company any product, service or process with which I worked directly or indirectly during my employment by the Company or about which I acquired Proprietary Information; or (ii) was in contact with me or in contact with any other employee, owner, or agent of the Company, of which contact I was or should have been aware, concerning any product, service or process with which I worked directly or indirectly during my employment with the Company or about which I acquired Proprietary Information; or (iii) was solicited by the Company in an effort in which I was involved or of which I was or should have been aware.
6. Non-Compete Provision. I agree that for the one (1) year period after the date my employment ends for any reason, including but not limited to voluntary termination by me or involuntary termination by the Company, I will not, directly or indirectly, as an officer, director, employee, consultant, owner, manager, member, partner, or in any other capacity solicit, perform, or provide, or attempt to perform or provide Conflicting Services anywhere in the world where the Company conducts business, including but not limited to locations where the Company performs research or development activities related to the Company’s products, services or processes (such locations the “ Restricted
Territory ”), nor will I assist another person to solicit, perform or provide or attempt to perform or provide Conflicting Services in the Restricted Territory.
The parties agree that for purposes of this Agreement, “ Conflicting Services ” means any product, service, or process or the research and development thereof, of any person or organization other than the Company that has antibiotics as its principal business, unless otherwise expressly excluded from this definition in advance by the Company’s Board of Directors.
7. Reasonableness of Restrictions .
7.1 I agree that I have read this entire Agreement and understand it. I agree that this Agreement does not prevent me from earning a living or pursuing my career and that I have the ability to secure other non-competitive employment using my marketable skills. I agree that the restrictions contained in this Agreement are reasonable, proper, and necessitated by the Company’s legitimate business interests, including without limitation, the Company’s Proprietary Rights, Proprietary Information and the goodwill of its customers. I represent and agree that I am entering into this Agreement freely and with knowledge of its contents with the intent to be bound by the Agreement and the restrictions contained in it.
7.2 In the event that a court finds this Agreement, or any of its restrictions, to be ambiguous, unenforceable, or invalid, the Company and I agree that the court shall read the Agreement as a whole and interpret the restriction(s) at issue to be enforceable and valid to the maximum extent allowed by law.
7.3 If the court declines to enforce this Agreement in the manner provided in subsection 7.2, I and the Company agree that this Agreement will be automatically modified to provide the Company with the maximum protection of its business interests allowed by law and I agree to be bound by this Agreement as modified.
8. No Conflicting Agreement or Obligation. I represent that my performance of all the terms of this Agreement and as an employee of the Company does not and will not breach any agreement or obligation of any kind to keep in confidence information acquired by me in confidence or in trust prior to my employment by the Company. I have not entered into, and I agree I will not enter
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into, any agreement either written or oral in conflict with this Agreement.
9. Return of Company Property. Upon termination of my employment or upon Company’s request at any other time, I will deliver to Company all of Company’s property, equipment, and documents, together with all copies thereof, and any other material containing or disclosing any Inventions, Third Party Information or Proprietary Information and certify in writing that I have fully complied with the foregoing obligation. I agree that I will not copy, delete, or alter any information contained upon my Company computer or Company equipment before I return it to Company. In addition, if I have used any personal computer, server, or e-mail system to receive, store, review, prepare or transmit any Company information, including but not limited to, Proprietary Information, I agree to provide the Company with a computer-useable copy of all such Proprietary Information and then permanently delete and expunge such Proprietary Information from those systems; and I agree to provide the Company access to my system as reasonably requested to verify that the necessary copying and/or deletion is completed. I further agree that any property situated on Company’s premises and owned by Company is subject to inspection by Company’s personnel at any time with or without notice. Prior to the termination of my employment or promptly after termination of my employment, I will cooperate with Company in attending an exit interview and certify in writing that I have complied with the requirements of this section.
10. Legal and Equitable Remedies.
10.1 I agree that it may be impossible to assess the damages caused by my violation of this Agreement or any of its terms. I agree that any threatened or actual violation of this Agreement or any of its terms will constitute immediate and irreparable injury to the Company and the Company shall have the right to enforce this Agreement and any of its provisions by injunction, specific performance or other equitable relief, without bond and without prejudice to any other rights and remedies that the Company may have for a breach or threatened breach of this Agreement.
10.2 I agree that if the Company is successful in whole or in part in any legal or equitable action against me under this Agreement, the Company shall be entitled to payment of all costs, including reasonable attorney’s fees, from me.
10.3 In the event the Company enforces this Agreement through a court order, I agree that the restrictions of Sections 5 and 6 shall remain in effect for a period of twelve (12) months from the effective date of the Order enforcing the Agreement.
11. Notices. Any notices required or permitted under this Agreement will be given to the Company at its headquarters location at the time notice is given, labeled “Attention Chief Executive Officer,” and to me at my address as listed on the Company payroll, or at such other address as the Company or I may designate by written notice to the other. Notice will be effective upon receipt or refusal of delivery. If delivered by certified or registered mail, notice will be considered to have been given five (5) business days after it was mailed, as evidenced by the postmark. If delivered by courier or express mail service, notice will be considered to have been given on the delivery date reflected by the courier or express mail service receipt.
12. Publication of This Agreement to Subsequent Employers or Business Associates of Employee .
12.1 If I am offered employment or the opportunity to enter into any business venture as owner, partner, consultant or other capacity while the restrictions described in Sections 5 and 6 of this Agreement are in effect I agree to inform my potential employer, partner, co-owner and/or others involved in managing the business with which I have an opportunity to be associated of my obligations under this Agreement and also agree to provide such person or persons with a copy of this Agreement.
12.2 I agree to inform the Company of all employment and business ventures which I enter into while the restrictions described in Sections 5 and 6 of this Agreement are in effect and I also authorize the Company to provide copies of this Agreement to my employer, partner, co-owner and/or others involved in managing the business with which I am employed or associated and to make such persons aware of my obligations under this Agreement.
13. General Provisions.
13.1 Governing Law; Consent to Personal Jurisdiction. This Agreement will be governed by and construed according to the laws of the Commonwealth of Pennsylvania as such laws are applied to agreements entered into and to be performed entirely within the Commonwealth of Pennsylvania between Pennsylvania residents. I
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hereby expressly consent to the personal jurisdiction and venue of the state and federal courts located in the Commonwealth of Massachusetts for any lawsuit filed there against me by Company arising from or related to this Agreement.
13.2 Severability. In case any one or more of the provisions, subsections, or sentences contained in this Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect the other provisions of this Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained in this Agreement. If moreover, any one or more of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it shall be construed by limiting and reducing it, so as to be enforceable to the extent compatible with the applicable law as it shall then appear.
13.3 Successors and Assigns. This Agreement is for my benefit and the benefit of the Company, its successors, assigns, parent corporations, subsidiaries, affiliates, and purchasers, and will be binding upon my heirs, executors, administrators and other legal representatives.
13.4 Survival. The provisions of this Agreement shall survive the termination of my employment, regardless of the reason, and the assignment of this Agreement by the Company to any successor in interest or other assignee. I understand that my obligations under this Agreement will continue in accordance with its express terms regardless of any change in my title, position, status, role, duties, salary, compensation or benefits or other terms and conditions of employment or service.
13.5 Employment At-Will. I agree and understand that nothing in this Agreement shall change my at-will employment status or confer any right with respect to continuation of employment by the Company, nor shall it interfere in any way with my right or the Company’s right to terminate my
employment at any time, with or without cause or advance notice.
13.6 Waiver. No waiver by the Company of any breach of this Agreement shall be a waiver of any preceding or succeeding breach. No waiver by the Company of any right under this Agreement shall be construed as a waiver of any other right. The Company shall not be required to give notice to enforce strict adherence to all terms of this Agreement.
13.7 Advice of Counsel. I ACKNOWLEDGE THAT, IN EXECUTING THIS AGREEMENT, I HAVE HAD THE OPPORTUNITY TO SEEK THE ADVICE OF INDEPENDENT LEGAL COUNSEL, AND I HAVE READ AND UNDERSTOOD ALL OF THE TERMS AND PROVISIONS OF THIS AGREEMENT. THIS AGREEMENT SHALL NOT BE CONSTRUED AGAINST ANY PARTY BY REASON OF THE DRAFTING OR PREPARATION OF THIS AGREEMENT.
13.8 Entire Agreement. The obligations pursuant to Sections 1 and 2 (except Subsection 2.6) of this Agreement shall apply to any time during which I was previously engaged, or am in the future engaged, by the Company as a consultant if no other agreement governs nondisclosure and assignment of inventions during such period. This Agreement is the final, complete and exclusive agreement of the parties with respect to the subject matter of this Agreement and supersedes and merges all prior discussions between us. No modification of or amendment to this Agreement, nor any waiver of any rights under this Agreement, will be effective unless in writing and signed by the party to be charged. Any subsequent change or changes in my title, position, status, role, duties, salary, compensation or benefits or other terms and conditions of employment or service will not affect the validity or scope of this Agreement.
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This Agreement shall be effective as of the first day of my employment with the Company.
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Prior Inventions
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1. Except as listed in Section 2 below, the following is a complete list of all inventions or improvements relevant to the subject matter of my employment by Paratek Pharmaceuticals, Inc. (the “ Company ”) that have been made or conceived or first reduced to practice by me alone or jointly with others prior to my engagement by the Company:
☐ No inventions or improvements.
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2. Due to a prior confidentiality agreement, I cannot complete the disclosure under Section 1 above with respect to inventions or improvements generally listed below, the proprietary rights and duty of confidentiality with respect to which I owe to the following party(ies):
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Exhibit 10.9
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PARATEK PHARMACEUTICALS paratekpharma.com |
75 Park Plaza Boston, MA 02116 617.807.6600 617.275.0039 fax |
June 16, 2017
Douglas Pagán
(Hand Delivery)
Re: Amended and Restated Employment Agreement
Dear Doug:
On behalf of Paratek Pharmaceuticals, Inc. (“Paratek” or the “Company”), I am pleased to offer you continued employment under the terms of this Amended and Restated Employment Agreement (the “Agreement”). In this Agreement, you and the Company hereby further amend, supersede, and restate in its entirety that certain amended and restated employment agreement between the Company and you dated February 4, 2015 (the “Employment Agreement”).
Employment Position and Duties
You will continue to be employed in the position of Chief Financial Officer (“CFO”). You will be expected to perform the customary duties of your position, duties specified in the Bylaws of the Company, and as may be required by the Company’s Board of Directors (the “Board”) consistent with your position as CFO. You will report to the Chief Executive Officer, and work at the Company’s corporate headquarters in Boston, Massachusetts. During your employment with the Company, you will devote your full-time best efforts and business time and attention to the business of the Company. As an exempt salaried employee, you will be expected to be available and working during the Company’s regular business hours, and such additional time as appropriate to manage your responsibilities. The Company reserves the right to reasonably require you to perform your duties at places other than its corporate headquarters from time to time, and to require reasonable business travel, including international travel, at the Company’s expense.
Your employment relationship with the Company will also be governed by the general employment policies and practices of the Company, except that if the terms of this Agreement conflict, this Agreement will control.
Base Salary
You will earn a salary at the rate of $14,666.67 semimonthly ($352,000 annualized), less payroll deductions and withholdings (“Base Salary”), payable on the Company’s regular payroll schedule. The Base Salary will be reviewed on an annual or more frequent basis by the Board (or any authorized committee thereof), and is subject to change in the discretion of the Board (or any authorized committee thereof).
Discretionary Performance Bonus
You will be eligible to earn a discretionary performance bonus of up to thirty-five percent (35%) of your Base Salary, subject to applicable payroll deductions and withholdings (“Bonus”), based upon the Board’s assessment of your performance, and the Company’s attainment of written targeted goals as determined by the Board in its sole discretion. Following the close of each calendar year, the Board will determine in its discretion whether you have earned a Bonus, and the amount of any Bonus. You will be eligible to earn a Bonus for any full calendar year provided that you remain employed by the Company as of December 31 of that year. The Bonus, if earned, will be paid no later than March 15 of the calendar year after the year to which it relates.
As a regular employee, you will be eligible to participate in the Company’s standard employee benefits, pursuant to the terms and conditions of the benefit plans and applicable policies, and for any additional benefits provided to the Company’s executive employees generally. You will also be entitled to four (4) weeks of paid vacation each calendar year, in accordance with the terms of the Company’s vacation policy. The Company may change employee benefits from time to time in its discretion. Details about these benefits are provided in the employee handbook and Summary Plan Descriptions, available for your review.
Business Expenses
The Company will pay or reimburse you for all reasonable business expenses incurred or paid by you in the performance of your duties and responsibilities for the Company, subject to such reasonable substantiation and documentation as may be required by the Company, and subject to any maximum annual limit and other restrictions on or policies governing such expenses as set by the Company from time to time.
Equity Compensation
You will be eligible for future equity awards granted in accordance with the Company’s plans as in effect from time to time at levels commensurate with your position and responsibilities and subject to such terms as shall be determined by the Board or one of its committees in its or their sole discretion.
At-Will Employment Relationship
You may terminate your employment with the Company at any time, with or without Good Reason, and with or without advance notice, and for any reason whatsoever simply by notifying the Company. Likewise, the Company may terminate your employment at any time, with or without Cause, and with or without advance notice. Your employment at-will status can only be modified in a written agreement approved by the Board and signed by you and a duly authorized Member of the Board.
Payments upon Termination other than without Cause or with Good Reason
Upon termination of your employment for any reason other than by the Company without Cause or by you with Good Reason, you shall be paid all accrued but unpaid Base Salary, any earned but unpaid Bonus, reimbursement for business expenses incurred by you but not yet paid to you as of the date your employment terminates, and all accrued but unused vacation (collectively, the “Accrued Payments”). Any unvested Company equity awards that you hold, including any unvested options and restricted stock units (collectively, “Outstanding Equity”) shall terminate as of your termination date.
Termination without Cause or with Good Reason
Upon termination of your employment at any time by the Company without Cause or by you with Good Reason, you will receive the Accrued Payments. In addition, subject to your fulfillment of the Release Obligation, as defined below, you will be eligible for the following severance benefits:
1. Cash Severance Payments . You will be eligible to receive cash severance equal to twelve (12) months of Base Salary following the termination date, subject to payroll withholding and deduction (“Severance Payments”), and paid according to the Company’s regular payroll procedures. Payment of Severance Payments shall commence on the sixtieth (60 th ) day following your employment termination, which initial payment shall include a lump sum payment equal to the aggregate semi-monthly installments that would otherwise have been due during the period between the termination date and the sixtieth (60 th ) day, but for the sixty (60)-day delay in this provision. Thereafter, the remaining installments shall be paid on the Company’s regular paydays.
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2. Pro-Rata Severance Bonus . You will also be eligible to receive an amount (the “Pro-Rata Bonus”) equal to the Bonus you would have earned for the year in which your employment terminates, prorated by multiplying the Bonus that you would have earned if you had remained employed through December 31 by the portion of the year that you had actually remained employed, and subject to payroll withholding and deduction. The determination by the Board of the Bonus amount you would have earned shall be based on actual performance for the full calendar year, except that any applicable subjective performance conditions will be disregarded in determining actual performance, and the entire amount of the Bonus, if any, will be determined based on applicable objective performance conditions. Any Pro-Rata Bonus will be paid at the same time bonuses are paid to the other executives of the Company, but in no event later than March 15 of the calendar year after the year to which it relates.
3. Paid Health Care Coverage; Other Benefits Continuation .
a. If at the time of your employment termination you participate in health care coverage through the Company’s plan, then provided that you timely elect continued coverage under COBRA, the Company will pay your COBRA premiums (less your standard employee contribution) to continue your coverage (including coverage for eligible dependents, if applicable) (“COBRA Premiums”) through the period (the “COBRA Premium Period”) starting on the termination date and ending on the earliest to occur of the date: (i) twelve (12) months after the termination date; (ii) you become eligible for group health insurance coverage through a new employer; or (iii) you cease to be eligible for COBRA continuation coverage for any reason, including plan termination. In the event you become covered under another employer’s group health plan or otherwise cease to be eligible for COBRA during the COBRA Premium Period, you must immediately notify the Company of such event.
b. Notwithstanding the foregoing, if the payment by the Company of the COBRA Premiums will subject or expose the Company to taxes or penalties, you and the Company agree to renegotiate the provisions of paragraph 3(a) in good faith and enter into a substitute arrangement pursuant to which the Company will not be subjected or exposed to taxes or penalties and you will be provided with payments or benefits with an economic value that is no less than the economic value of the COBRA Premiums.
Definitions
For purposes of this Agreement, the following definitions shall apply:
1. “Cause” shall mean the occurrence of any of the following events: (a) your indictment for any felony or any crime involving fraud, embezzlement, dishonesty or moral turpitude under the laws of the United States or any state thereof; (b) your attempted commission of, or participation in, a fraud, embezzlement or act of material dishonesty against the Company or a Company affiliate; (c) your intentional, material violation of any contract or agreement between you and the Company or a Company affiliate or of any statutory duty owed to the Company or a Company affiliate; (d) your intentional unauthorized use or disclosure of the Company’s or a Company affiliate’s confidential information or trade secrets; (e) your refusal or failure to perform any duties required of you, if such duties are consistent with duties customary for your position, or other persistent unsatisfactory performance or neglect of your job duties, which continues after a period of thirty (30) days following your receipt of notice from the Company that it deems such conduct Cause for termination of your employment hereunder; or (f) your gross misconduct.
Notwithstanding anything to the contrary in this Agreement or any other agreement between the Company and you, “Cause” shall not include or be predicated upon any act or omission by you, which is taken or made (a) in good faith, under your reasonable belief that the act or omission was in the best interests of the Company; (b) to comply with a lawful court order, directive from a federal, state or local government agency or industry regulatory authority, or subpoena; or (c) at the direction of the Board or upon the advice of counsel for the Company.
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2. “Good Reason” shall exist for resignation from employment with the Company if any of the following actions are taken by the Company without your prior consent: (a) a reduction in your Base Salary or Bonus target percentage of Base Salary, unless the salaries or bonus target percentages of all other senior executive officers of the Company are correspondingly and proportionately reduced; (b) a removal f rom your position as the Company’s CFO or a material and adverse change in the duties and responsibilities of your position or reporting relationship ; or (c) a relocation of your principal place of employment to a place that increases your one-way commute by more than thirty-five (35) miles as compared to your then-current principal place of employment immediately prior to such relocation. In order for you to resign for Good Reason, each of the following requirements must be met: (w) you must provide written notice to the Board within thirty (30) days after first becoming aware of the first occurrence of the event giving rise to Good Reason setting forth the basis for your resignation, (x) you must allow the Company at least thirty (30) days from receipt of such written notice (the “Cure Period”) to cure such event, (y) such event is not reasonably cured by the Company within the Cure Period, and (z) you must resign from all positions you then hold with the Company not later than sixty (60) days after the expiration of the Cure Period.
3. “Release Obligation” means that: (a) you have signed a general release and waiver of claims in favor of the Company and its affiliates, as part of a termination agreement acceptable to the Company that contains standard provisions including (i) a mutual non-disparagement provision, (ii) a provision providing that, notwithstanding anything to the contrary in any agreement between you and the Company, each party will be responsible for its own expenses incurred in connection with the enforcement of such agreement, and (iii) customary exclusions from your release of claims including (A) any claims with respect to amounts due and owing to you pursuant to the terms and conditions of this Agreement or under any other employee benefit plan of the Company or its affiliates; (B) any claims or rights you may have to indemnification or advancement of expenses under the by-laws or other applicable corporate governing documents of the Company or any other plan, policy, agreement, or arrangement, or under applicable law; (C) any rights, coverage or entitlements provided to you under any D&O insurance policies paid for by the Company (or its affiliates); and (D) any rights or claims you may have against the Company or its affiliates which arise after the date of the termination agreement, and (b) you have allowed the release and waiver to become fully effective without revocation during any applicable revocation period.
Change in Control
Upon the termination of your employment by the Company without Cause, or by you with Good Reason, in either case during a time period starting on the date ninety (90) days before the closing of a Change in Control and ending on the date twelve (12) months after the closing of a Change in Control, provided that you meet the Release Obligation and you provide continued services through your termination date, then your Outstanding Equity shall vest in full (“Accelerated Vesting”), effective as of the termination date of your employment; provided, however, that any Outstanding Equity that is subject to performance-based vesting conditions will be deemed to have been achieved at target.
A “Change in Control” shall mean any of the following: (a) a merger or consolidation in which the Company is a constituent party (or if a subsidiary of the Company is a constituent party and the Company issues shares of its capital stock pursuant to such merger or consolidation), other than a merger or consolidation in which the voting securities of the Company outstanding immediately prior to such merger or consolidation continue to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) more than fifty percent (50%) of the combined voting power of the voting securities of the surviving entity outstanding immediately after such merger or consolidation, or (b) any transaction or series of related transactions in which in excess of fifty percent (50%) of the Company’s voting power is transferred, other than the sale by the Company of stock in transactions the primary purpose of which is to raise capital for the Company’s operations and activities, or (c) a sale, lease, exclusive license or other disposition of all or substantially all (as determined by the Board in its sole discretion) of the assets of the Company.
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If any payment or benefit (including payments and benefits pursuant to this Agreement) that you would receive in connection with a Change in Control from the Company or otherwise (“Transaction Payment”) would (i) constitute a “parachute payment” within the meaning of Section 280G of the Internal Revenue Code (the “Code”), and (ii) but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then the Company shall cause to be determined, before any amounts of the Transaction Payment are paid to you, which of the following two alternative forms of payment would result in your receipt, on an after-tax basis, of the greater amount of the Transaction Payment notwithstanding that all or some portion of the Transaction Payment may be subject to the Excise Tax: (1) payment in full of the entire amount of the Transaction Payment (a “Full Payment”), or (2) payment of only a part of the Transaction Payment so that you receive the largest payment possible without the imposition of the Excise Tax (a “Reduced Payment”). For purposes of determining whether to make a Full Payment or a Reduced Payment, the Company shall cause to be taken into account all applicable federal, state and local income and employment taxes and the Excise Tax (all computed at the highest applicable marginal rate, net of the maximum reduction in federal income taxes which could be obtained from a deduction of such state and local taxes). If a Reduced Payment is made, (x) you shall have no rights to any additional payments and/or benefits constituting the Transaction Payment, and (y) reduction in payments and/or benefits shall occur in the manner that results in the greatest economic benefit to you as determined in this paragraph. If more than one method of reduction will result in the same economic benefit, the portions of the Transaction Payment shall be reduced pro rata. Unless you and the Company otherwise agree in writing, any determination required under this paragraph shall be made in writing by the Company’s independent public accountants (the “Accountants”), whose determination shall be conclusive and binding upon you and the Company for all purposes. For purposes of making the calculations required by this paragraph, the Accountants may make reasonable assumptions and approximations concerning applicable taxes and may rely on reasonable, good faith interpretations concerning the application of Sections 280G and 4999 of the Code. You and the Company shall furnish to the Accountants such information and documents as the Accountants may reasonably request in order to make a determination under this paragraph. The Company shall bear all costs the Accountants may reasonably incur in connection with any calculations contemplated by this paragraph as well as any costs incurred by you with the Accountants for tax planning under Sections 280G and 4999 of the Code.
Indemnification; D&O Insurance
You will be entitled to the indemnification and liability insurance coverage as described in the indemnification agreement that you entered into with the Company on December 18, 2014 (the “Indemnification Agreement”).
Compliance with Proprietary Information Agreement and Company Policies
As a condition of employment, you have signed and must continue to comply with the Company’s standard form of Employee Proprietary Information, Inventions Assignment, Non-Competition and Non-Solicitation Agreement (the “Proprietary Information Agreement”, a copy of which is attached hereto as Exhibit A) which prohibits unauthorized use or disclosure of the Company’s proprietary information, among other obligations. As a Paratek employee, you will be expected to abide by Company policies and practices, as may be changed from time to time in the Company’s discretion, and acknowledge in writing that you have read the Company’s employee handbook.
Protection of Third Party Information
In your work for the Company, you will be expected not to use or disclose any confidential information, including trade secrets, of any former employer or other person to whom you have an obligation of confidentiality. Rather, you will be expected to use only that information which is generally known and used by persons with training and experience comparable to your own, which is common knowledge in the industry or otherwise legally in the public domain, or which is otherwise provided or developed by the Company. You agree that you will not bring onto Company premises, or use in the performance of your duties, any unpublished documents or property belonging to any former employer or other person to whom you have an obligation of confidentiality. You hereby represent that you have disclosed to the Company any contract you have signed that may restrict your activities on behalf of the Company.
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Except with the prior written consent of the Board, you will not during your employment engage in any other employment, occupation or business enterprise, other than ones in which you are a passive investor. You may engage in civic and not-for-profit activities so long as such activities do not materially interfere with the performance of your duties. During your employment, you agree not to acquire, assume or participate in, directly or indirectly, any entity, investment, or interest known by you to be adverse or antagonistic to the Company, its business or prospects, financial or otherwise, including any person, corporation, firm, partnership or other entity whatsoever known by you to compete with the Company (or is planning or preparing to compete with the Company), anywhere in the world, in any line of business engaged in (or planned to be engaged in) by the Company. You may purchase or otherwise acquire up to one percent (1%) of any class of securities of any enterprise if such securities are listed on any national or regional securities exchange, provided that you refrain from participating in the business activities of such enterprise.
Agreement to Arbitrate
To ensure the rapid and economical resolution of disputes that may arise in connection with your employment with the Company, you and the Company both agree that any and all disputes, claims, or causes of action, in law or equity, including but not limited to statutory claims, arising from or relating to the enforcement, breach, performance, or interpretation of this Agreement, your employment with the Company, or the termination of your employment with the Company, will be resolved pursuant to the Federal Arbitration Act, 9 U.S.C. §1-16, and to the fullest extent permitted by law, by final, binding and confidential arbitration conducted in Boston, Massachusetts by JAMS, Inc. (“JAMS”) or its successors.
Both you and the Company acknowledge that by agreeing to this arbitration procedure, you each waive the right to resolve any such dispute through a trial by jury or judge or administrative proceeding.
Any such arbitration proceeding will be governed by JAMS’ then applicable rules and procedures for employment disputes, which can be found at http://www.jamsadr.com/rules-employment-arbitration/ , and which will be provided to you upon request. In any such proceeding, the arbitrator shall: (i) have the authority to compel adequate discovery for the resolution of the dispute and to award such relief as would otherwise be permitted by law; and (ii) issue a written arbitration decision including the arbitrator’s essential findings and conclusions and a statement of the award. You and the Company each shall be entitled to all rights and remedies that either would be entitled to pursue in a court of law. Nothing in this Agreement is intended to prevent either the Company or you from obtaining injunctive relief in court to prevent irreparable harm pending the conclusion of any such arbitration pursuant to applicable law.
Section 409A
1. Specified Employee . Notwithstanding anything to the contrary in the Agreement, if at the time your employment terminates, you are a “specified employee,” as defined below, any and all amounts payable under the Agreement on account of such separation from service that would (but for this provision) be payable within six (6) months following the date of termination, shall instead be paid on the next business day following the expiration of such six (6) month period or, if earlier, upon your death; except (A) to the extent of amounts that do not constitute a deferral of compensation within the meaning of Treasury regulation Section 1.409A-1(b) (including without limitation by reason of the safe harbor set forth in Section 1.409A-1(b)(9)(iii), as determined by the Company in its reasonable good faith discretion); (B) benefits which qualify as excepted welfare benefits pursuant to Treasury regulation Section 1.409A-1(a)(5); or (C) other amounts or benefits that are not subject to the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (“Section 409A”).
2. Termination of Employment . For purposes of the Agreement, all references to “termination of employment” and correlative phrases shall be construed to require a “separation from service” (as defined in Treasury regulation Section 1.409A-1(h) after giving effect to the presumptions contained therein), and the term “specified employee” means an individual determined by the Company to be a specified employee under Treasury regulation Section 1.409A-1(i).
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3. Reimbursement for Expenses . Any reimbursement for expenses that would constitute nonqualified deferred compensation subject to Section 409A shall be subject to the following additional rules: (i) no reimbursement of any such expense shall affect your right to reimbursement of any such expense in any other taxable year; (ii) reimbursement of the expense shall be made, if at all, promptly, but not later than the end of the calendar year following the calendar year in which the expense was incurred; and (iii) the right to reimbursement shall not be subject to liquidation or exchange for any other benefit.
4. Separate Payments . Each payment made under the Agreement shall be treated as a separate payment and the right to a series of installment payments under the Agreement is to be treated as a right to a series of separate payments.
5. Limitation on Liability . In no event shall the Company have any liability relating to the failure or alleged failure of any payment or benefit under the Agreement to comply with, or be exempt from, the requirements of Section 409A.
Entire Agreement; Contingencies
This Agreement, together with your Proprietary Information Agreement and the Indemnification Agreement, forms the complete and exclusive statement of your employment agreement with the Company. It supersedes any other prior agreements or promises made to you by anyone, whether oral or written, including the Employment Agreement. Changes in your employment terms, other than those changes expressly reserved to the Company’s or Board’s discretion in this Agreement, require a written modification approved by the Board and signed by a duly authorized Member of the Board.
This Agreement will bind the heirs, personal representatives, successors and assigns of both you and the Company, and inure to the benefit of both you and the Company, their heirs, successors and assigns. If any provision of this Agreement is determined to be invalid or unenforceable, in whole or in part, this determination shall not affect any other provision of this Agreement and the provision in question shall be modified so as to be rendered enforceable in a manner consistent with the intent of the parties insofar as possible under applicable law.
This Agreement shall be construed and enforced in accordance with the laws of the Commonwealth of Massachusetts without regard to conflicts of law principles. Any waiver of a breach of this Agreement, or rights hereunder, shall be in writing and shall not be deemed to be a waiver of any successive breach or rights hereunder. This Agreement may be executed in counterparts which shall be deemed to be part of one original, and pdf or other facsimile signatures shall be equivalent to original signatures.
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Please sign and date this Agreement to indicate your acceptance of continued employment at Paratek under the terms described above. We look forward to a continued productive and enjoyable work relationship.
Sincerely,
Paratek Pharmaceuticals, Inc. |
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/s/ Michael F. Bigham |
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Michael F. Bigham |
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Chairman of the Board and Chief Executive Officer |
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Accepted: |
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/s/ Douglas Pagán |
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Douglas Pagán |
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June 16, 2017 |
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Date |
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EMPLOYEE PROPRIETARY INFORMATION, INVENTIONS ASSIGNMENT, NON-COMPETITION AND NON-SOLICITATION AGREEMENT
EMPLOYEE PROPRIETARY INFORMATION, INVENTIONS ASSIGNMENT, NON-COMPETITION
AND NON-SOLICITATION AGREEMENT
In consideration of my employment or continued employment by Paratek Pharmaceuticals, Inc. , its subsidiaries, parents, affiliates, successors and assigns (together, the “ Company ”) and the compensation now and hereafter paid to me, I hereby enter into this Employee Proprietary Information, Inventions Assignment, Non-Competition and Non-Solicitation Agreement (the “ Agreement ”) and agree as follows:
1.1 Recognition of Company’s Rights; Nondisclosure. I understand and acknowledge that my employment by the Company creates a relationship of confidence and trust with respect to the Company’s Proprietary Information (defined below) and that the Company has a protectable interest therein. At all times during my employment and thereafter, I will hold in strictest confidence and will not disclose, use, lecture upon or publish any of the Company’s Proprietary Information, except as such disclosure, use or publication may be required in connection with my work for the Company, or unless an authorized officer of the Company expressly authorizes such in writing. I will obtain the Company’s written approval before publishing or submitting for publication any material (written, verbal, or otherwise) that relates to my work at the Company and/or incorporates any Proprietary Information. I hereby assign to the Company any rights I may have or acquire in such Proprietary Information and recognize that all Proprietary Information shall be the sole property of the Company and its assigns. I will take all reasonable precautions to prevent the inadvertent or accidental disclosure of Proprietary Information.
1.2 Proprietary Information. The term “ Proprietary Information ” shall mean any and all confidential and/or proprietary knowledge, data or information of the Company, its affiliates, parents and subsidiaries, whether having existed, now existing, or to be developed during my employment. By way of illustration but not limitation, “ Proprietary Information ” includes (a) trade secrets, inventions, ideas, processes, formulas, assay components, biological materials, cell lines, and clinical data, data, programs, other works of authorship, know-how, improvements, discoveries, developments, designs and techniques and any other proprietary technology and all Proprietary Rights therein (hereinafter collectively referred to as “ Inventions ”); (b) information regarding research, development, new products, marketing and selling, business plans, budgets and unpublished financial statements, licenses, prices and costs, margins, discounts, credit terms, pricing and billing policies,
quoting procedures, methods of obtaining business, forecasts, future plans and potential strategies, financial projections and business strategies, operational plans, financing and capital-raising plans, activities and agreements, internal services and operational manuals, methods of conducting Company business, suppliers and supplier information, and purchasing; (c) information regarding customers and potential customers of the Company, including customer lists, names, representatives, their needs or desires with respect to the types of products or services offered by the Company, proposals, bids, contracts and their contents and parties, the type and quantity of products and services provided or sought to be provided to customers and potential customers of the Company and other non-public information relating to customers and potential customers; (d) information regarding any of the Company’s business partners and their services, including names; representatives, proposals, bids, contracts and their contents and parties, the type and quantity of products and services received by the Company, and other non-public information relating to business partners; (e) information regarding personnel, employee lists, compensation, and employee skills; and (f) any other non-public information which a competitor of the Company could use to the competitive disadvantage of the Company. Notwithstanding the foregoing, it is understood that, at all such times, I am free to use information which is generally known in the trade or industry through no breach of this Agreement or other act or omission by me, and I am free to discuss the terms and conditions of my employment with others to the extent expressly permitted by Section 7 of the National Labor Relations Act.
1.3 Third Party Information. I understand, in addition, that the Company has received and in the future will receive confidential and/or proprietary knowledge, data, or information from third parties (“ Third Party Information ”). During my employment and thereafter, I will hold Third Party Information in the strictest confidence and will not disclose to anyone (other than Company personnel who need to know such information in connection with their work for the Company) or use,
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except in connection with my work for the Company, Third Party Information unless expressly authorized by an authorized officer of the Company in writing.
1.4 Term of Nondisclosure Restrictions. I understand that Proprietary Information and Third Party Information is never to be used or disclosed by me, as provided in this Section 1. If, however, a court decides that this Section 1 or any of its provisions is unenforceable for lack of reasonable temporal limitation and the Agreement or its restriction(s) cannot otherwise be enforced, I agree and the Company agrees that the two (2) year period after the date my employment ends shall be the temporal limitation relevant to the contested restriction, provided, however, that this sentence shall not apply to trade secrets protected without temporal limitation under applicable law.
1.5 No Improper Use of Information of Prior Employers and Others. During my employment by the Company I will not improperly use or disclose any confidential information or trade secrets, if any, of any former employer or any other person to whom I have an obligation of confidentiality, and I will not bring onto the premises of the Company any unpublished documents or any property belonging to any former employer or any other person to whom I have an obligation of confidentiality unless consented to in writing by that former employer or person.
2. Assignment of Inventions.
2.1 Proprietary Rights. The term “ Proprietary Rights ” shall mean all trade secrets, patents, copyrights, trademarks and other intellectual property rights throughout the world.
2.2 Prior Inventions. Inventions, if any, patented or unpatented, which I made prior to the commencement of my employment with the Company are excluded from the scope of this Agreement. To preclude any possible uncertainty, I have set forth on Exhibit 1 (Prior Inventions) attached hereto a complete list of all Inventions that I have, alone or jointly with others, conceived, developed or reduced to practice or caused to be conceived, developed or reduced to practice prior to the commencement of my employment with the Company, that I consider to be my property or the property of third parties, and that I wish to have excluded from the scope of this Agreement (collectively referred to as “ Prior Inventions ”). If disclosure of any such Prior Invention would cause
me to violate any prior confidentiality agreement, I understand that I am not to list such Prior Inventions in Exhibit 1 but am only to disclose a cursory name for each such invention, a listing of the party(ies) to whom it belongs and the fact that full disclosure as to such inventions has not been made for that reason. A space is provided on Exhibit 1 for such purpose. If no such disclosure is attached, I represent that there are no Prior Inventions. If, in the course of my employment with the Company, I incorporate a Prior Invention into a Company product, process or machine, the Company is hereby granted and shall have a nonexclusive, royalty-free, irrevocable, perpetual, fully-paid, worldwide license (with rights to sublicense through multiple tiers of sub-licensees) to make, have made, modify, make derivative works of, publicly perform, use, sell, import, and exercise any and all present and future rights in such Prior Invention. Notwithstanding the foregoing, I agree that I will not incorporate, or permit to be incorporated, Prior Inventions in any Company Inventions without the Company’s prior written consent.
2.3 Assignment of Inventions. Subject to Subsection 2.4, I hereby assign, grant and convey to the Company all my right, title and interest in and to any and all Inventions (and all Proprietary Rights with respect thereto) whether or not patentable or registrable under copyright or similar statutes, made or conceived or reduced to practice or learned by me, either alone or jointly with others, during the period of my employment with the Company. Inventions assigned to the Company or its designees are hereinafter referred to as “ Company Inventions .”
2.4 Unassigned or Nonassignable Inventions. I recognize that this Agreement will not be deemed to require assignment of any Invention that I developed entirely on my own time without using the Company’s equipment, supplies, facilities, trade secrets, or Proprietary Information, except for those Inventions that either (i) relate to the Company’s actual or anticipated business, research or development, or (ii) result from or are connected with work performed by me for the Company. In addition, this Agreement does not apply to any Invention which qualifies fully for protection from assignment to the Company under any specifically applicable state law, regulation, rule, or public policy (“ Specific Inventions Law ”).
2.5 Obligation to Keep Company Informed. During the period of my employment and for six (6) months after termination of my employment with the Company, I will promptly
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disclose to the Company fully and in writing all Inventions authored, conceived or reduced to practice by me, either alone or jointly with others. In addition, I will promptly disclose to the Company all patent applications filed by me or on my behalf within a year after termination of employment. At the time of each such disclosure, I will advise the Company in writing of any Inventions that I believe fully qualify for protection under the provisions of a Specific Inventions Law; and I will at that time provide to the Company in writing all evidence necessary to substantiate that belief. The Company will keep in confidence and will not use for any purpose or disclose to third parties without my consent any confidential information disclosed in writing to the Company pursuant to this Agreement relating to Inventions that qualify fully for protection under a Specific Inventions Law. I will preserve the confidentiality of any Invention that does not fully qualify for protection under a Specific Inventions Law.
2.6 Ownership of Work Product. I agree that the Company will exclusively own all work product that is made by me (solely or jointly with others) within the scope of my employment, and I hereby irrevocably and unconditionally assign to the Company all right, title, and interest worldwide in and to such work product. I acknowledge that all original works of authorship which are made by me (solely or jointly with others) within the scope of my employment and which are protectable by copyright are “works made for hire,” pursuant to United States Copyright Act (17 U.S.C., Section 101). I understand and agree that I have no right to publish on, submit for publishing, or use for any publication any work product protected by this Section, except as necessary to perform services for the Company.
2.7 Enforcement of Proprietary Rights. I will assist the Company in every proper way to obtain, and from time to time enforce, United States and foreign Proprietary Rights relating to Company Inventions in any and all countries. To that end I will execute, verify and deliver such documents and perform such other acts (including appearances as a witness) as the Company may reasonably request for use in applying for, obtaining, perfecting, evidencing, sustaining and enforcing such Proprietary Rights and the assignment thereof. In addition, I will execute, verify and deliver assignments of such Proprietary Rights to the Company or its designee, including the United States or any third party designated by the Company. My obligation to assist the Company with respect to
Proprietary Rights relating to such Company Inventions in any and all countries shall continue beyond the termination of my employment, but the Company shall compensate me at a reasonable rate after my termination for the time actually spent by me at the Company’s request on such assistance.
In the event the Company is unable for any reason, after reasonable effort, to secure my signature on any document needed in connection with the actions specified in the preceding paragraph, I hereby irrevocably designate and appoint the Company and its duly authorized officers and agents as my agent and attorney in fact, which appointment is coupled with an interest, to act for and in my behalf to execute, verify and file any such documents and to do all other lawfully permitted acts to further the purposes of the preceding paragraph with the same legal force and effect as if executed by me. I hereby waive and quitclaim to the Company any and all claims, of any nature whatsoever, which I now or may hereafter have for infringement of any Proprietary Rights assigned under this Agreement to the Company.
3. Records. I agree to keep and maintain adequate and current records (in the form of notes, sketches, drawings and in any other form that may be required by the Company) of all Proprietary Information developed by me and all Inventions made by me during the period of my employment at the Company, which records shall be available to and remain the sole property of the Company at all times.
4. Duty of Loyalty During Employment. I agree that during the period of my employment by the Company I will not, without the Company’s express written consent, directly or indirectly engage in any employment or business activity which is directly or indirectly competitive with, or would otherwise conflict with, my employment by the Company.
5. No Solicitation of Employees, Consultants, Contractors, or Customers or Potential Customers. I agree that during the period of my employment and for the one (1) year period after the date my employment ends for any reason, including but not limited to voluntary termination by me or involuntary termination by the Company, I will not, as an officer, director, employee, consultant, owner, partner, or in any other capacity, either directly or through others, except on behalf of the Company:
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5.1 solicit, induce, encourage, or participate in soliciting, inducing, or encouraging any employee of the Company to terminate his or her relationship with the Company;
5.2 hire, employ, or engage in business with or attempt to hire, employ, or engage in business with any person employed by the Company or who has left the employment of the Company within the preceding three (3) months of any such prohibited activity or discuss any potential employment or business association with such person, even if I did not initiate the discussion or seek out the contact;
5.3 solicit, induce or attempt to induce any Customer or Potential Customer, or any consultant or independent contractor with whom I had direct or indirect contact during my employment with the Company or whose identity I learned as a result of my employment with the Company, to terminate, diminish, or materially alter in a manner harmful to the Company its relationship with the Company; or
5.4 solicit, perform, provide or attempt to perform or provide any Conflicting Services (as defined in Section 6 below) for a Customer or Potential Customer. The parties agree that for purposes of this Agreement, a “ Customer or Potential Customer ” is any person or entity who or which, at any time during the one (1) year prior to the date my employment with the Company ends, (i) contracted for, was billed for, or received from the Company any product, service or process with which I worked directly or indirectly during my employment by the Company or about which I acquired Proprietary Information; or (ii) was in contact with me or in contact with any other employee, owner, or agent of the Company, of which contact I was or should have been aware, concerning any product, service or process with which I worked directly or indirectly during my employment with the Company or about which I acquired Proprietary Information; or (iii) was solicited by the Company in an effort in which I was involved or of which I was or should have been aware.
6. Non-Compete Provision. I agree that for the one (1) year period after the date my employment ends for any reason, including but not limited to voluntary termination by me or involuntary termination by the Company, I will not, directly or indirectly, as an officer, director, employee, consultant, owner, manager, member,
partner, or in any other capacity solicit, perform, or provide, or attempt to perform or provide Conflicting Services anywhere in the world where the Company conducts business, including but not limited to locations where the Company performs research or development activities related to the Company’s products, services or processes (such locations the “ Restricted Territory ”), nor will I assist another person to solicit, perform or provide or attempt to perform or provide Conflicting Services in the Restricted Territory.
The parties agree that for purposes of this Agreement, “ Conflicting Services ” means any product, service, or process or the research and development thereof, of any person or organization other than the Company that has antibiotics as its principal business, unless otherwise expressly excluded from this definition in advance by the Company’s Board of Directors.
7. Reasonableness of Restrictions .
7.1 I agree that I have read this entire Agreement and understand it. I agree that this Agreement does not prevent me from earning a living or pursuing my career and that I have the ability to secure other non-competitive employment using my marketable skills. I agree that the restrictions contained in this Agreement are reasonable, proper, and necessitated by the Company’s legitimate business interests, including without limitation, the Company’s Proprietary Rights, Proprietary Information and the goodwill of its customers. I represent and agree that I am entering into this Agreement freely and with knowledge of its contents with the intent to be bound by the Agreement and the restrictions contained in it.
7.2 In the event that a court finds this Agreement, or any of its restrictions, to be ambiguous, unenforceable, or invalid, the Company and I agree that the court shall read the Agreement as a whole and interpret the restriction(s) at issue to be enforceable and valid to the maximum extent allowed by law.
7.3 If the court declines to enforce this Agreement in the manner provided in subsection 7.2, I and the Company agree that this Agreement will be automatically modified to provide the Company with the maximum protection of its business interests allowed by law and I agree to be bound by this Agreement as modified.
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8. No Conflicting Agreement or Obligation. I represent that my performance of all the terms of this Agreement and as an employee of the Company does not and will not breach any agreement or obligation of any kind to keep in confidence information acquired by me in confidence or in trust prior to my employment by the Company. I have not entered into, and I agree I will not enter into, any agreement either written or oral in conflict with this Agreement.
9. Return of Company Property. Upon termination of my employment or upon Company’s request at any other time, I will deliver to Company all of Company’s property, equipment, and documents, together with all copies thereof, and any other material containing or disclosing any Inventions, Third Party Information or Proprietary Information and certify in writing that I have fully complied with the foregoing obligation. I agree that I will not copy, delete, or alter any information contained upon my Company computer or Company equipment before I return it to Company. In addition, if I have used any personal computer, server, or e-mail system to receive, store, review, prepare or transmit any Company information, including but not limited to, Proprietary Information, I agree to provide the Company with a computer-useable copy of all such Proprietary Information and then permanently delete and expunge such Proprietary Information from those systems; and I agree to provide the Company access to my system as reasonably requested to verify that the necessary copying and/or deletion is completed. I further agree that any property situated on Company’s premises and owned by Company is subject to inspection by Company’s personnel at any time with or without notice. Prior to the termination of my employment or promptly after termination of my employment, I will cooperate with Company in attending an exit interview and certify in writing that I have complied with the requirements of this section.
10. Legal and Equitable Remedies.
10.1 I agree that it may be impossible to assess the damages caused by my violation of this Agreement or any of its terms. I agree that any threatened or actual violation of this Agreement or any of its terms will constitute immediate and irreparable injury to the Company and the Company shall have the right to enforce this Agreement and any of its provisions by injunction, specific performance or other equitable relief, without bond and without prejudice to any other rights and
remedies that the Company may have for a breach or threatened breach of this Agreement.
10.2 I agree that if the Company is successful in whole or in part in any legal or equitable action against me under this Agreement, the Company shall be entitled to payment of all costs, including reasonable attorney’s fees, from me.
10.3 In the event the Company enforces this Agreement through a court order, I agree that the restrictions of Sections 5 and 6 shall remain in effect for a period of twelve (12) months from the effective date of the Order enforcing the Agreement.
11. Notices. Any notices required or permitted under this Agreement will be given to the Company at its headquarters location at the time notice is given, labeled “Attention Chief Executive Officer,” and to me at my address as listed on the Company payroll, or at such other address as the Company or I may designate by written notice to the other. Notice will be effective upon receipt or refusal of delivery. If delivered by certified or registered mail, notice will be considered to have been given five (5) business days after it was mailed, as evidenced by the postmark. If delivered by courier or express mail service, notice will be considered to have been given on the delivery date reflected by the courier or express mail service receipt.
12. Publication of This Agreement to Subsequent Employers or Business Associates of Employee .
12.1 If I am offered employment or the opportunity to enter into any business venture as owner, partner, consultant or other capacity while the restrictions described in Sections 5 and 6 of this Agreement are in effect I agree to inform my potential employer, partner, co-owner and/or others involved in managing the business with which I have an opportunity to be associated of my obligations under this Agreement and also agree to provide such person or persons with a copy of this Agreement.
12.2 I agree to inform the Company of all employment and business ventures which I enter into while the restrictions described in Sections 5 and 6 of this Agreement are in effect and I also authorize the Company to provide copies of this Agreement to my employer, partner, co-owner and/or others involved in managing the business with which I am employed or associated and to make such persons aware of my obligations under this Agreement.
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13.1 Governing Law; Consent to Personal Jurisdiction. This Agreement will be governed by and construed according to the laws of the Commonwealth of Pennsylvania as such laws are applied to agreements entered into and to be performed entirely within the Commonwealth of Pennsylvania between Pennsylvania residents. I hereby expressly consent to the personal jurisdiction and venue of the state and federal courts located in the Commonwealth of Massachusetts for any lawsuit filed there against me by Company arising from or related to this Agreement.
13.2 Severability. In case any one or more of the provisions, subsections, or sentences contained in this Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect the other provisions of this Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained in this Agreement. If moreover, any one or more of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it shall be construed by limiting and reducing it, so as to be enforceable to the extent compatible with the applicable law as it shall then appear.
13.3 Successors and Assigns. This Agreement is for my benefit and the benefit of the Company, its successors, assigns, parent corporations, subsidiaries, affiliates, and purchasers, and will be binding upon my heirs, executors, administrators and other legal representatives.
13.4 Survival. The provisions of this Agreement shall survive the termination of my employment, regardless of the reason, and the assignment of this Agreement by the Company to any successor in interest or other assignee. I understand that my obligations under this Agreement will continue in accordance with its express terms regardless of any change in my title, position, status, role, duties, salary, compensation or benefits or other terms and conditions of employment or service.
13.5 Employment At-Will. I agree and understand that nothing in this Agreement shall change my at-will employment status or confer any right with respect to continuation of employment by the Company, nor shall it interfere in any way with my right or the Company’s right to terminate my employment at any time, with or without cause or advance notice.
13.6 Waiver. No waiver by the Company of any breach of this Agreement shall be a waiver of any preceding or succeeding breach. No waiver by the Company of any right under this Agreement shall be construed as a waiver of any other right. The Company shall not be required to give notice to enforce strict adherence to all terms of this Agreement.
13.7 Advice of Counsel. I ACKNOWLEDGE THAT, IN EXECUTING THIS AGREEMENT, I HAVE HAD THE OPPORTUNITY TO SEEK THE ADVICE OF INDEPENDENT LEGAL COUNSEL, AND I HAVE READ AND UNDERSTOOD ALL OF THE TERMS AND PROVISIONS OF THIS AGREEMENT. THIS AGREEMENT SHALL NOT BE CONSTRUED AGAINST ANY PARTY BY REASON OF THE DRAFTING OR PREPARATION OF THIS AGREEMENT.
13.8 Entire Agreement. The obligations pursuant to Sections 1 and 2 (except Subsection 2.6) of this Agreement shall apply to any time during which I was previously engaged, or am in the future engaged, by the Company as a consultant if no other agreement governs nondisclosure and assignment of inventions during such period. This Agreement is the final, complete and exclusive agreement of the parties with respect to the subject matter of this Agreement and supersedes and merges all prior discussions between us. No modification of or amendment to this Agreement, nor any waiver of any rights under this Agreement, will be effective unless in writing and signed by the party to be charged. Any subsequent change or changes in my title, position, status, role, duties, salary, compensation or benefits or other terms and conditions of employment or service will not affect the validity or scope of this Agreement.
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This Agreement shall be effective as of the first day of my employment with the Company.
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Address: 75 Park Plaza, 4 th Floor, Boston, Massachusetts 02116 |
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Exhibit 1
Prior Inventions
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Prior Inventions |
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1. Except as listed in Section 2 below, the following is a complete list of all inventions or improvements relevant to the subject matter of my employment by Paratek Pharmaceuticals, Inc. (the “ Company ”) that have been made or conceived or first reduced to practice by me alone or jointly with others prior to my engagement by the Company:
☐ No inventions or improvements.
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2. Due to a prior confidentiality agreement, I cannot complete the disclosure under Section 1 above with respect to inventions or improvements generally listed below, the proprietary rights and duty of confidentiality with respect to which I owe to the following party(ies):
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Exhibit 10.10
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PARATEK PHARMACEUTICALS paratekpharma.com |
75 Park Plaza Boston, MA 02116 617.807.6600 617.275.0039 fax |
June 16, 2017
Adam Woodrow
1675 Stephens Drive
Wayne, PA 19087
Re: Amended and Restated Employment Agreement
Dear Adam:
On behalf of Paratek Pharmaceuticals, Inc. (“Paratek” or the “Company”), I am pleased to offer you continued employment under the terms of this Amended and Restated Employment Agreement (the “Agreement”). In this Agreement, you and the Company hereby further amend, supersede, and restate in its entirety that certain amended and restated employment agreement between the Company and you dated February 4, 2015 (the “Employment Agreement”).
Employment Position and Duties
You will continue to be employed in the position of Chief Commercialization Officer (“CCO”). In this role, you will be expected to prepare and implement the commercialization strategy for each of the Company’s late stage development candidates, with the current primary focus being on omadacycline and, to the extent necessary, sarecycline. As CCO, you will also be expected to support any and all partnering efforts associated with the Company’s late stage development compounds. In addition you will be expected to perform other customary duties of your position, duties specified in the Bylaws of the Company, and as may be required by the Company’s Board of Directors (the “Board”). You will report to the Chief Executive Officer.
You will work at the Company’s Philadelphia area facility. During your employment with the Company, you will devote your full-time best efforts and business time and attention to the business of the Company. As an exempt salaried employee, you will be expected to be available and working during the Company’s regular business hours, and such additional time as appropriate to manage your responsibilities. The Company reserves the right to reasonably require you to perform your duties at places other than its Philadelphia area facility from time to time, and to require reasonable business travel, including international travel, at the Company’s expense.
Your employment relationship with the Company will also be governed by the general employment policies and practices of the Company, except that if the terms of this Agreement conflict, this Agreement will control.
Base Salary
You will earn a salary at the rate of $14,508.33 semimonthly ($348,200 annualized), less payroll deductions and withholdings (“Base Salary”), payable on the Company’s regular payroll schedule. The Base Salary will be reviewed on an annual or more frequent basis by the Board (or any authorized committee thereof), and is subject to change in the discretion of the Board (or any authorized committee thereof).
Discretionary Performance Bonus
You will be eligible to earn a discretionary performance bonus of up to thirty-five percent (35%) of your Base Salary, subject to applicable payroll deductions and withholdings (“Bonus”), based upon the Board’s assessment of your performance, and the Company’s attainment of written targeted goals as determined by the Board in its sole discretion. Following the close of each calendar year, the Board will determine in its discretion whether you have earned a Bonus, and the amount of any Bonus. You will be eligible to earn a Bonus for any full calendar year provided that you remain employed by the Company as of December 31 of that year. The Bonus, if earned, will be paid no later than March 15 of the calendar year after the year to which it relates.
As a regular employee, you will be eligible to participate in the Company’s standard employee benefits, pursuant to the terms and conditions of the benefit plans and applicable policies, and for any additional benefits provided to the Company’s executive employees generally. You will also be entitled to four (4) weeks of paid vacation each calendar year, in accordance with the terms of the Company’s vacation policy. The Company may change employee benefits from time to time in its discretion. Details about these benefits are provided in the employee handbook and Summary Plan Descriptions, available for your review.
Business Expenses
The Company will pay or reimburse you for all reasonable business expenses incurred or paid by you in the performance of your duties and responsibilities for the Company, subject to such reasonable substantiation and documentation as may be required by the Company, and subject to any maximum annual limit and other restrictions on or policies governing such expenses as set by the Company from time to time.
Equity Compensation
You will be eligible for future equity awards granted in accordance with the Company’s plans as in effect from time to time at levels commensurate with your position and responsibilities and subject to such terms as shall be determined by the Board or one of its committees in its or their sole discretion.
At-Will Employment Relationship
You may terminate your employment with the Company at any time, with or without Good Reason, and with or without advance notice, and for any reason whatsoever simply by notifying the Company. Likewise, the Company may terminate your employment at any time, with or without Cause, and with or without advance notice. Your employment at-will status can only be modified in a written agreement approved by the Board and signed by you and a duly authorized Member of the Board.
Payments upon Termination other than without Cause or with Good Reason
Upon termination of your employment for any reason other than by the Company without Cause or by you with Good Reason, you shall be paid all accrued but unpaid Base Salary, any earned but unpaid Bonus, reimbursement for business expenses incurred by you but not yet paid to you as of the date your employment terminates, and all accrued but unused vacation (collectively, the “Accrued Payments”). Any unvested Company equity awards that you hold, including any unvested options and restricted stock units (collectively, “Outstanding Equity”), shall terminate as of your termination date.
Termination without Cause or with Good Reason
Upon termination of your employment at any time by the Company without Cause or by you with Good Reason, you will receive the Accrued Payments. In addition, subject to your fulfillment of the Release Obligation, as defined below, you will be eligible for the following severance benefits:
1. Cash Severance Payments . You will be eligible to receive cash severance equal to twelve (12) months of Base Salary following the termination date, subject to payroll withholding and deduction (“Severance Payments”), and paid according to the Company’s regular payroll procedures. Payment of Severance Payments shall commence on the sixtieth (60 th ) day following your employment termination, which initial payment shall include a lump sum payment equal to the aggregate semi-monthly installments that would otherwise have been due during the period between the termination date and the sixtieth (60 th ) day, but for the sixty (60)-day delay in this provision. Thereafter, the remaining installments shall be paid on the Company’s regular paydays.
2. Pro-Rata Severance Bonus. You will also be eligible to receive an amount (the “Pro-Rata Bonus”) equal to the Bonus you would have earned for the year in which your employment terminates, prorated by multiplying the Bonus that you would have earned if you had remained employed through December 31 by the portion of the year that you had actually remained employed, and subject to payroll withholding and deduction. The determination by the Board of the Bonus amount you would have earned shall be based on actual performance for the full calendar year, except that any applicable subjective performance conditions will be disregarded in determining actual performance, and the entire amount of the Bonus, if any, will be determined based on applicable objective performance conditions. Any Pro-Rata Bonus will be paid at the same time bonuses are paid to the other executives of the Company, but in no event later than March 15 of the calendar year after the year to which it relates.
3. Paid Health Care Coverage; Other Benefits Continuation .
a. If at the time of your employment termination you participate in health care coverage through the Company’s plan, then provided that you timely elect continued coverage under COBRA, the Company will pay your COBRA premiums (less your standard employee contribution) to continue your coverage (including coverage for eligible dependents, if applicable) (“COBRA Premiums”) through the period (the “COBRA Premium Period”) starting on the termination date and ending on the earliest to occur of the date: (i) twelve (12) months after the termination date; (ii) you become eligible for group health insurance coverage through a new employer; or (iii) you cease to be eligible for COBRA continuation coverage for any reason, including plan termination. In the event you become covered under another employer’s group health plan or otherwise cease to be eligible for COBRA during the COBRA Premium Period, you must immediately notify the Company of such event.
b. Notwithstanding the foregoing, if the payment by the Company of the COBRA Premiums will subject or expose the Company to taxes or penalties, you and the Company agree to renegotiate the provisions of paragraph 3(a) in good faith and enter into a substitute arrangement pursuant to which the Company will not be subjected or exposed to taxes or penalties and you will be provided with payments or benefits with an economic value that is no less than the economic value of the COBRA Premiums.
Definitions
For purposes of this Agreement, the following definitions shall apply:
1. “Cause” shall mean the occurrence of any of the following events: (a) your indictment for any felony or any crime involving fraud, embezzlement, dishonesty or moral turpitude under the laws of the United States or any state thereof; (b) your attempted commission of, or participation in, a fraud, embezzlement or act of material dishonesty against the Company or a Company affiliate; (c) your intentional, material violation of any contract or agreement between you and the Company or a Company affiliate or of any statutory duty owed to the Company or a Company affiliate; (d) your intentional unauthorized use or disclosure of the Company’s or a Company affiliate’s confidential information or trade secrets; (e) your refusal or failure to perform any duties required of you, if such duties are consistent with duties customary for your position, or other persistent unsatisfactory performance or neglect of your job duties, which continues after a period of thirty (30) days following your receipt of notice from the Company that it deems such conduct Cause for termination of your employment hereunder; or (f) your gross misconduct.
Notwithstanding anything to the contrary in this Agreement or any other agreement between the Company and you, “Cause” shall not include or be predicated upon any act or omission by you, which is taken or made (a) in good faith, under your reasonable belief that the act or omission was in the best interests of the Company; (b) to comply with a lawful court order, directive from a federal, state or local government agency or industry regulatory authority, or subpoena; or (c) at the direction of the Board or upon the advice of counsel for the Company.
2. “Good Reason” shall exist for resignation from employment with the Company if any of the following actions are taken by the Company without your prior consent: (a) a reduction in your Base Salary or Bonus target percentage of Base Salary, unless the salaries or bonus target percentages of all other senior executive officers of the Company are correspondingly and proportionately reduced ; (b) a removal from your position as the Company’s CCO or a material and adverse change in the duties and responsibilities of your positions or reporting relationship; or ( c ) a relocation of your principal place of employment to a place that increases your one-way commute by more than thirty-five (35) miles as compared to your then-current principal place of employment immediately prior to such relocation. In order for you to resign for Good Reason, each of the following requirements must be met: (w) you must provide written notice to the Board within thirty (30) days after first becoming aware of the first occurrence of the event giving rise to Good Reason setting forth the basis for your resignation, (x) you must allow the Company at least thirty (30) days from receipt of such written notice (the “Cure Period”) to cure such event, (y) such event is not reasonably cured by the Company within the Cure Period, and (z) you must resign from all positions you then hold with the Company not later than sixty (60) days after the expiration of the Cure Period.
3. “Release Obligation” means that: (a) you have signed a general release and waiver of claims in favor of the Company and its affiliates, as part of a termination agreement acceptable to the Company that contains standard provisions including a non-disparagement provision and restrictive covenants to the maximum enforceable extent including without limitation a noncompetition covenant during the period you are eligible to receive Severance Payments, and (b) you have allowed the release and waiver to become fully effective without revocation during any applicable revocation period.
Change in Control
Upon the termination of your employment by the Company without Cause, or by you with Good Reason, in either case during a time period starting on the date ninety (90) days before the closing of a Change in Control and ending on the date twelve (12) months after the closing of a Change in Control, provided that you meet the Release Obligation and you provide continued services through your termination date, then your Outstanding Equity shall vest in full (“Accelerated Vesting”), effective as of the termination date of your employment; provided, however, that any Outstanding Equity that is subject to performance-based vesting conditions will be deemed to have been achieved at target.
A “Change in Control” shall mean any of the following: (a) a merger or consolidation in which the Company is a constituent party (or if a subsidiary of the Company is a constituent party and the Company issues shares of its capital stock pursuant to such merger or consolidation), other than a merger or consolidation in which the voting securities of the Company outstanding immediately prior to such merger or consolidation continue to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) more than fifty percent (50%) of the combined voting power of the voting securities of the surviving entity outstanding immediately after such merger or consolidation, or (b) any transaction or series of related transactions in which in excess of fifty percent (50%) of the Company’s voting power is transferred, other than the sale by the Company of stock in transactions the primary purpose of which is to raise capital for the Company’s operations and activities, or (c) a sale, lease, exclusive license or other disposition of all or substantially all (as determined by the Board in its sole discretion) of the assets of the Company.
Section 280G
If any payment or benefit (including payments and benefits pursuant to this Agreement) that you would receive in connection with a Change in Control from the Company or otherwise (“Transaction Payment”) would (i) constitute a “parachute payment” within the meaning of Section 280G of the Internal Revenue Code (the “Code”), and (ii) but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then the Company shall cause to be determined, before any amounts of the Transaction Payment are paid to you, which of the following two alternative forms of payment would result in your receipt, on an after-tax basis, of the greater amount of the Transaction Payment notwithstanding that all or some portion of the Transaction Payment may be subject to the Excise Tax: (1) payment in full of the entire amount of the Transaction Payment (a “Full Payment”), or (2) payment of only a part of the Transaction Payment so that you receive the largest payment possible without the imposition of the Excise Tax (a “Reduced Payment”). For purposes of determining whether to make a Full
Payment or a Reduced Payment, the Company shall cause to be taken into account all applicable federal, state and local income and employment taxes and the Excise Tax (all computed at the highest applicable marginal rate, net of the maximum reduction in federal income taxes which could be obtained from a deduction of such state and local taxes). If a Reduced Payment is made, (x) you shall have no rights to any additional payments and/or benefits constituting the Transaction Payment, and (y) reduction in payments and/or benefits shall occur in the manner that results in the greatest economic benefit to you as determined in this paragraph. If more than one method of reduction will result in the same economic benefit, the portions of the Transaction Payment shall be reduced pro rata. Unless you and the Company otherwise agree in writing, any determination required under this paragraph shall be made in writing by the Company’s independent public accountants (the “Accountants”), whose determination shall be conclusive and binding upon you and the Company for all purposes. For purposes of making the calculations required by this paragraph, the Accountants may make reasonable assumptions and approximations concerning applicable taxes and may rely on reasonable, good faith interpretations concerning the application of Sections 280G and 4999 of the Code. You and the Company shall furnish to the Accountants such information and documents as the Accountants may reasonably request in order to make a determination under this paragraph. The Company shall bear all costs the Accountants may reasonably incur in connection with any calculations contemplated by this paragraph as well as any costs incurred by you with the Accountants for tax planning under Sections 280G and 4999 of the Code.
Indemnification; D&O Insurance
You will be entitled to the indemnification and liability insurance coverage as described in the indemnification agreement that you entered into with the Company on April 10, 2015 (the “Indemnification Agreement”).
Compliance with Proprietary Information Agreement and Company Policies
As a condition of employment, you have signed and must continue to comply with the Company’s standard form of Employee Proprietary Information, Inventions Assignment, Non-Competition and Non-Solicitation Agreement (the “Proprietary Information Agreement”, a copy of which is attached hereto as Exhibit A ) which prohibits unauthorized use or disclosure of the Company’s proprietary information, among other obligations. As a Paratek employee, you will be expected to abide by Company policies and practices, as may be changed from time to time in the Company’s discretion, and acknowledge in writing that you have read the Company’s employee handbook.
Protection of Third Party Information
In your work for the Company, you will be expected not to use or disclose any confidential information, including trade secrets, of any former employer or other person to whom you have an obligation of confidentiality. Rather, you will be expected to use only that information which is generally known and used by persons with training and experience comparable to your own, which is common knowledge in the industry or otherwise legally in the public domain, or which is otherwise provided or developed by the Company. You agree that you will not bring onto Company premises, or use in the performance of your duties, any unpublished documents or property belonging to any former employer or other person to whom you have an obligation of confidentiality. You hereby represent that you have disclosed to the Company any contract you have signed that may restrict your activities on behalf of the Company.
Outside Activities
Except with the prior written consent of the Board, you will not during your employment engage in any other employment, occupation or business enterprise, other than ones in which you are a passive investor. You may engage in civic and not-for-profit activities so long as such activities do not materially interfere with the performance of your duties. During your employment, you agree not to acquire, assume or participate in, directly or indirectly, any entity, investment, or interest known by you to be adverse or antagonistic to the Company, its business or prospects, financial or otherwise, including any person, corporation, firm, partnership or other entity whatsoever known by you to compete with the Company (or is planning or preparing to compete with the Company), anywhere in the world, in any line of business engaged in (or planned to be engaged in) by the Company. You may purchase or otherwise acquire up to one percent (1%) of any class of securities of any enterprise if such securities are listed on any national or regional securities exchange, provided that you refrain from participating in the business activities of such enterprise.
To ensure the rapid and economical resolution of disputes that may arise in connection with your employment with the Company, you and the Company both agree that any and all disputes, claims, or causes of action, in law or equity, including but not limited to statutory claims, arising from or relating to the enforcement, breach, performance, or interpretation of this Agreement, your employment with the Company, or the termination of your employment with the Company, will be resolved pursuant to the Federal Arbitration Act, 9 U.S.C. § 1-16, and to the fullest extent permitted by law, by final, binding and confidential arbitration conducted in Boston, Massachusetts by JAMS, Inc. (“JAMS”) or its successors.
Both you and the Company acknowledge that by agreeing to this arbitration procedure, you each waive the right to resolve any such dispute through a trial by jury or judge or administrative proceeding.
Any such arbitration proceeding will be governed by JAMS’ then applicable rules and procedures for employment disputes, which can be found at http://www.jamsadr.com/rules-employment-arbitration/ , and which will be provided to you upon request. In any such proceeding, the arbitrator shall: (i) have the authority to compel adequate discovery for the resolution of the dispute and to award such relief as would otherwise be permitted by law; and (ii) issue a written arbitration decision including the arbitrator’s essential findings and conclusions and a statement of the award. You and the Company each shall be entitled to all rights and remedies that either would be entitled to pursue in a court of law. Nothing in this Agreement is intended to prevent either the Company or you from obtaining injunctive relief in court to prevent irreparable harm pending the conclusion of any such arbitration pursuant to applicable law.
Section 409A
1. Specified Employee . Notwithstanding anything to the contrary in the Agreement, if at the time your employment terminates, you are a “specified employee,” as defined below, any and all amounts payable under the Agreement on account of such separation from service that would (but for this provision) be payable within six (6) months following the date of termination, shall instead be paid on the next business day following the expiration of such six (6) month period or, if earlier, upon your death; except (A) to the extent of amounts that do not constitute a deferral of compensation within the meaning of Treasury regulation Section 1.409A-1(b) (including without limitation by reason of the safe harbor set forth in Section 1.409A-1(b)(9)(iii), as determined by the Company in its reasonable good faith discretion); (B) benefits which qualify as excepted welfare benefits pursuant to Treasury regulation Section 1.409A-1(a)(5); or (C) other amounts or benefits that are not subject to the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (“Section 409A”).
2. Termination of Employment . For purposes of the Agreement, all references to “termination of employment” and correlative phrases shall be construed to require a “separation from service” (as defined in Treasury regulation Section 1.409A-1(h) after giving effect to the presumptions contained therein), and the term “specified employee” means an individual determined by the Company to be a specified employee under Treasury regulation Section 1.409A-1(i).
3. Reimbursement for Expenses . Any reimbursement for expenses that would constitute nonqualified deferred compensation subject to Section 409A shall be subject to the following additional rules: (i) no reimbursement of any such expense shall affect your right to reimbursement of any such expense in any other taxable year; (ii) reimbursement of the expense shall be made, if at all, promptly, but not later than the end of the calendar year following the calendar year in which the expense was incurred; and (iii) the right to reimbursement shall not be subject to liquidation or exchange for any other benefit.
4. Separate Payments . Each payment made under the Agreement shall be treated as a separate payment and the right to a series of installment payments under the Agreement is to be treated as a right to a series of separate payments.
5. Limitation on Liability . In no event shall the Company have any liability relating to the failure or alleged failure of any payment or benefit under the Agreement to comply with, or be exempt from, the requirements of Section 409A.
Entire Agreement; Contingencies
This Agreement, together with your Proprietary Information Agreement and the Indemnification Agreement, forms the complete and exclusive statement of your employment agreement with the Company. It supersedes any other prior agreements or promises made to you by anyone, whether oral or written, including the Employment Agreement. Changes in your employment terms, other than those changes expressly reserved to the Company’s or Board’s discretion in this Agreement, require a written modification approved by the Board and signed by a duly authorized Member of the Board.
This Agreement will bind the heirs, personal representatives, successors and assigns of both you and the Company, and inure to the benefit of both you and the Company, their heirs, successors and assigns. If any provision of this Agreement is determined to be invalid or unenforceable, in whole or in part, this determination shall not affect any other provision of this Agreement and the provision in question shall be modified so as to be rendered enforceable in a manner consistent with the intent of the parties insofar as possible under applicable law.
This Agreement shall be construed and enforced in accordance with the laws of the Commonwealth of Massachusetts without regard to conflicts of law principles. Any waiver of a breach of this Agreement, or rights hereunder, shall be in writing and shall not be deemed to be a waiver of any successive breach or rights hereunder. This Agreement may be executed in counterparts which shall be deemed to be part of one original, and pdf or other facsimile signatures shall be equivalent to original signatures.
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Please sign and date this Agreement to indicate your acceptance of continued employment at Paratek under the terms described above. We look forward to a continued productive and enjoyable work relationship.
Sincerely,
Paratek Pharmaceuticals, Inc. |
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/s/ Michael F. Bigham |
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Michael F. Bigham |
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Chairman of the Board and Chief Executive Officer |
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Accepted: |
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/s/ Adam Woodrow |
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Adam Woodrow |
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June 16, 2017 |
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EMPLOYEE PROPRIETARY INFORMATION, INVENTIONS ASSIGNMENT, NON-COMPETITION AND NON-SOLICITATION AGREEMENT
EMPLOYEE PROPRIETARY INFORMATION, INVENTIONS ASSIGNMENT, NON-COMPETITION
AND NON-SOLICITATION AGREEMENT
In consideration of my employment or continued employment by Paratek Pharmaceuticals, Inc. , its subsidiaries, parents, affiliates, successors and assigns (together, the “ Company ”) and the compensation now and hereafter paid to me, I hereby enter into this Employee Proprietary Information, Inventions Assignment, Non-Competition and Non-Solicitation Agreement (the “ Agreement ”) and agree as follows:
1.1 Recognition of Company’s Rights; Nondisclosure. I understand and acknowledge that my employment by the Company creates a relationship of confidence and trust with respect to the Company’s Proprietary Information (defined below) and that the Company has a protectable interest therein. At all times during my employment and thereafter, I will hold in strictest confidence and will not disclose, use, lecture upon or publish any of the Company’s Proprietary Information, except as such disclosure, use or publication may be required in connection with my work for the Company, or unless an authorized officer of the Company expressly authorizes such in writing. I will obtain the Company’s written approval before publishing or submitting for publication any material (written, verbal, or otherwise) that relates to my work at the Company and/or incorporates any Proprietary Information. I hereby assign to the Company any rights I may have or acquire in such Proprietary Information and recognize that all Proprietary Information shall be the sole property of the Company and its assigns. I will take all reasonable precautions to prevent the inadvertent or accidental disclosure of Proprietary Information.
1.2 Proprietary Information. The term “ Proprietary Information ” shall mean any and all confidential and/or proprietary knowledge, data or information of the Company, its affiliates, parents and subsidiaries, whether having existed, now existing, or to be developed during my employment. By way of illustration but not limitation, “ Proprietary Information ” includes (a) trade secrets, inventions, ideas, processes, formulas, assay components, biological materials, cell lines, and clinical data, data, programs, other works of authorship, know-how, improvements, discoveries, developments, designs and techniques and any other proprietary technology and all Proprietary Rights therein (hereinafter collectively referred to as “ Inventions ”); (b) information regarding research, development, new products, marketing and selling, business plans, budgets and unpublished financial
statements, licenses, prices and costs, margins, discounts, credit terms, pricing and billing policies, quoting procedures, methods of obtaining business, forecasts, future plans and potential strategies, financial projections and business strategies, operational plans, financing and capital-raising plans, activities and agreements, internal services and operational manuals, methods of conducting Company business, suppliers and supplier information, and purchasing; (c) information regarding customers and potential customers of the Company, including customer lists, names, representatives, their needs or desires with respect to the types of products or services offered by the Company, proposals, bids, contracts and their contents and parties, the type and quantity of products and services provided or sought to be provided to customers and potential customers of the Company and other non-public information relating to customers and potential customers; (d) information regarding any of the Company’s business partners and their services, including names; representatives, proposals, bids, contracts and their contents and parties, the type and quantity of products and services received by the Company, and other non-public information relating to business partners; (e) information regarding personnel, employee lists, compensation, and employee skills; and (f) any other non-public information which a competitor of the Company could use to the competitive disadvantage of the Company. Notwithstanding the foregoing, it is understood that, at all such times, I am free to use information which is generally known in the trade or industry through no breach of this Agreement or other act or omission by me, and I am free to discuss the terms and conditions of my employment with others to the extent expressly permitted by Section 7 of the National Labor Relations Act.
1.3 Third Party Information. I understand, in addition, that the Company has received and in the future will receive confidential and/or proprietary knowledge, data, or information from third parties (“ Third Party Information ”). During my employment and thereafter, I will hold Third Party Information in the strictest confidence and will not disclose to anyone (other than Company personnel who need to know such information in
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connection with their work for the Company) or use, except in connection with my work for the Company, Third Party Information unless expressly authorized by an authorized officer of the Company in writing.
1.4 Term of Nondisclosure Restrictions. I understand that Proprietary Information and Third Party Information is never to be used or disclosed by me, as provided in this Section 1. If, however, a court decides that this Section 1 or any of its provisions is unenforceable for lack of reasonable temporal limitation and the Agreement or its restriction(s) cannot otherwise be enforced, I agree and the Company agrees that the two (2) year period after the date my employment ends shall be the temporal limitation relevant to the contested restriction, provided, however, that this sentence shall not apply to trade secrets protected without temporal limitation under applicable law.
1.5 No Improper Use of Information of Prior Employers and Others. During my employment by the Company I will not improperly use or disclose any confidential information or trade secrets, if any, of any former employer or any other person to whom I have an obligation of confidentiality, and I will not bring onto the premises of the Company any unpublished documents or any property belonging to any former employer or any other person to whom I have an obligation of confidentiality unless consented to in writing by that former employer or person.
2. Assignment of Inventions.
2.1 Proprietary Rights. The term “ Proprietary Rights ” shall mean all trade secrets, patents, copyrights, trademarks and other intellectual property rights throughout the world.
2.2 Prior Inventions. Inventions, if any, patented or unpatented, which I made prior to the commencement of my employment with the Company are excluded from the scope of this Agreement. To preclude any possible uncertainty, I have set forth on Exhibit 1 (Prior Inventions) attached hereto a complete list of all Inventions that I have, alone or jointly with others, conceived, developed or reduced to practice or caused to be conceived, developed or reduced to practice prior to the commencement of my employment with the Company, that I consider to be my property or the property of third parties, and that I wish to have excluded from the scope of this Agreement (collectively referred to as “ Prior Inventions ”). If disclosure of any such Prior Invention would cause
me to violate any prior confidentiality agreement, I understand that I am not to list such Prior Inventions in Exhibit 1 but am only to disclose a cursory name for each such invention, a listing of the party(ies) to whom it belongs and the fact that full disclosure as to such inventions has not been made for that reason. A space is provided on Exhibit 1 for such purpose. If no such disclosure is attached, I represent that there are no Prior Inventions. If, in the course of my employment with the Company, I incorporate a Prior Invention into a Company product, process or machine, the Company is hereby granted and shall have a nonexclusive, royalty-free, irrevocable, perpetual, fully-paid, worldwide license (with rights to sublicense through multiple tiers of sub-licensees) to make, have made, modify, make derivative works of, publicly perform, use, sell, import, and exercise any and all present and future rights in such Prior Invention. Notwithstanding the foregoing, I agree that I will not incorporate, or permit to be incorporated, Prior Inventions in any Company Inventions without the Company’s prior written consent.
2.3 Assignment of Inventions. Subject to Subsection 2.4, I hereby assign, grant and convey to the Company all my right, title and interest in and to any and all Inventions (and all Proprietary Rights with respect thereto) whether or not patentable or registrable under copyright or similar statutes, made or conceived or reduced to practice or learned by me, either alone or jointly with others, during the period of my employment with the Company. Inventions assigned to the Company or its designees are hereinafter referred to as “ Company Inventions .”
2.4 Unassigned or Nonassignable Inventions. I recognize that this Agreement will not be deemed to require assignment of any Invention that I developed entirely on my own time without using the Company’s equipment, supplies, facilities, trade secrets, or Proprietary Information, except for those Inventions that either (i) relate to the Company’s actual or anticipated business, research or development, or (ii) result from or are connected with work performed by me for the Company. In addition, this Agreement does not apply to any Invention which qualifies fully for protection from assignment to the Company under any specifically applicable state law, regulation, rule, or public policy (“ Specific Inventions Law ”).
2.5 Obligation to Keep Company Informed. During the period of my employment and for six (6) months after termination of my
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employment with the Company, I will promptly disclose to the Company fully and in writing all Inventions authored, conceived or reduced to practice by me, either alone or jointly with others. In addition, I will promptly disclose to the Company all patent applications filed by me or on my behalf within a year after termination of employment. At the time of each such disclosure, I will advise the Company in writing of any Inventions that I believe fully qualify for protection under the provisions of a Specific Inventions Law; and I will at that time provide to the Company in writing all evidence necessary to substantiate that belief. The Company will keep in confidence and will not use for any purpose or disclose to third parties without my consent any confidential information disclosed in writing to the Company pursuant to this Agreement relating to Inventions that qualify fully for protection under a Specific Inventions Law. I will preserve the confidentiality of any Invention that does not fully qualify for protection under a Specific Inventions Law.
2.6 Ownership of Work Product. I agree that the Company will exclusively own all work product that is made by me (solely or jointly with others) within the scope of my employment, and I hereby irrevocably and unconditionally assign to the Company all right, title, and interest worldwide in and to such work product. I acknowledge that all original works of authorship which are made by me (solely or jointly with others) within the scope of my employment and which are protectable by copyright are “works made for hire,” pursuant to United States Copyright Act (17 U.S.C., Section 101). I understand and agree that I have no right to publish on, submit for publishing, or use for any publication any work product protected by this Section, except as necessary to perform services for the Company.
2.7 Enforcement of Proprietary Rights. I will assist the Company in every proper way to obtain, and from time to time enforce, United States and foreign Proprietary Rights relating to Company Inventions in any and all countries. To that end I will execute, verify and deliver such documents and perform such other acts (including appearances as a witness) as the Company may reasonably request for use in applying for, obtaining, perfecting, evidencing, sustaining and enforcing such Proprietary Rights and the assignment thereof. In addition, I will execute,
verify and deliver assignments of such Proprietary Rights to the Company or its designee, including the United States or any third party designated by the Company. My obligation to assist the Company with respect to Proprietary Rights relating to such Company Inventions in any and all countries shall continue beyond the termination of my employment, but the Company shall compensate me at a reasonable rate after my termination for the time actually spent by me at the Company’s request on such assistance.
In the event the Company is unable for any reason, after reasonable effort, to secure my signature on any document needed in connection with the actions specified in the preceding paragraph, I hereby irrevocably designate and appoint the Company and its duly authorized officers and agents as my agent and attorney in fact, which appointment is coupled with an interest, to act for and in my behalf to execute, verify and file any such documents and to do all other lawfully permitted acts to further the purposes of the preceding paragraph with the same legal force and effect as if executed by me. I hereby waive and quitclaim to the Company any and all claims, of any nature whatsoever, which I now or may hereafter have for infringement of any Proprietary Rights assigned under this Agreement to the Company.
3. Records. I agree to keep and maintain adequate and current records (in the form of notes, sketches, drawings and in any other form that may be required by the Company) of all Proprietary Information developed by me and all Inventions made by me during the period of my employment at the Company, which records shall be available to and remain the sole property of the Company at all times.
4. Duty of Loyalty During Employment . I agree that during the period of my employment by the Company I will not, without the Company’s express written consent, directly or indirectly engage in any employment or business activity which is directly or indirectly competitive with, or would otherwise conflict with, my employment by the Company.
5. No Solicitation of Employees, Consultants, Contractors, or Customers or Potential Customers. I agree that during the period of my employment and for the one (1) year
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period after the date my employment ends for any reason, including but not limited to voluntary termination by me or involuntary termination by the Company, I will not, as an officer, director, employee, consultant, owner, partner, or in any other capacity, either directly or through others, except on behalf of the Company:
5.1 solicit, induce, encourage, or participate in soliciting, inducing, or encouraging any employee of the Company to terminate his or her relationship with the Company;
5.2 hire, employ, or engage in business with or attempt to hire, employ, or engage in business with any person employed by the Company or who has left the employment of the Company within the preceding three (3) months of any such prohibited activity or discuss any potential employment or business association with such person, even if I did not initiate the discussion or seek out the contact;
5.3 solicit, induce or attempt to induce any Customer or Potential Customer, or any consultant or independent contractor with whom I had direct or indirect contact during my employment with the Company or whose identity I learned as a result of my employment with the Company, to terminate, diminish, or materially alter in a manner harmful to the Company its relationship with the Company; or
5.4 solicit, perform, provide or attempt to perform or provide any Conflicting Services (as defined in Section 6 below) for a Customer or Potential Customer. The parties agree that for purposes of this Agreement, a “ Customer or Potential Customer ” is any person or entity who or which, at any time during the one (1) year prior to the date my employment with the Company ends, (i) contracted for, was billed for, or received from the Company any product, service or process with which I worked directly or indirectly during my employment by the Company or about which I acquired Proprietary Information; or (ii) was in contact with me or in contact with any other employee, owner, or agent of the Company, of which contact I was or should have been aware, concerning any product, service or process with which I worked directly or indirectly during my employment with the Company or about which I acquired Proprietary Information; or (iii) was solicited by the Company in an effort in which I was involved or of which I was or should have been aware.
6. Non-Compete Provision . I agree that for the one (1) year period after the date my employment ends for any reason, including but not limited to voluntary termination by me or involuntary termination by the Company, I will not, directly or indirectly, as an officer, director, employee, consultant, owner, manager, member, partner, or in any other capacity solicit, perform, or provide, or attempt to perform or provide Conflicting Services anywhere in the world where the Company conducts business, including but not limited to locations where the Company performs research or development activities related to the Company’s products, services or processes (such locations the “Restricted Territory”), nor will I assist another person to solicit, perform or provide or attempt to perform or provide Conflicting Services in the Restricted Territory.
The parties agree that for purposes of this Agreement, “Conflicting Services” means any product, service, or process or the research and development thereof, of any person or organization other than the Company that has antibiotics as its principal business, unless otherwise expressly excluded from this definition in advance by the Company’s Board of Directors.
7. Reasonableness of Restrictions.
7.1 I agree that I have read this entire Agreement and understand it. I agree that this Agreement does not prevent me from earning a living or pursuing my career and that I have the ability to secure other non-competitive employment using my marketable skills. I agree that the restrictions contained in this Agreement are reasonable, proper, and necessitated by the Company’s legitimate business interests, including without limitation, the Company’s Proprietary Rights, Proprietary Information and the goodwill of its customers. I represent and agree that I am entering into this Agreement freely and with knowledge of its contents with the intent to be bound by the Agreement and the restrictions contained in it.
7.2 In the event that a court finds this Agreement, or any of its restrictions, to be ambiguous, unenforceable, or invalid, the Company and I agree that the court shall read the Agreement as a whole and interpret the restriction(s) at issue to be enforceable and valid to the maximum extent allowed by law.
7.3 If the court declines to enforce this Agreement in the manner provided in subsection 7.2, I and the Company agree that this Agreement will be automatically modified to provide the Company with
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the maximum protection of its business interests allowed by law and I agree to be bound by this Agreement as modified.
8. No Conflicting Agreement or Obligation. I represent that my performance of all the terms of this Agreement and as an employee of the Company does not and will not breach any agreement or obligation of any kind to keep in confidence information acquired by me in confidence or in trust prior to my employment by the Company. I have not entered into, and I agree I will not enter into, any agreement either written or oral in conflict with this Agreement.
9. Return of Company Property. Upon termination of my employment or upon Company’s request at any other time, I will deliver to Company all of Company’s property, equipment, and documents, together with all copies thereof, and any other material containing or disclosing any Inventions, Third Party Information or Proprietary Information and certify in writing that I have fully complied with the foregoing obligation. I agree that I will not copy, delete, or alter any information contained upon my Company computer or Company equipment before I return it to Company. In addition, if I have used any personal computer, server, or e-mail system to receive, store, review, prepare or transmit any Company information, including but not limited to, Proprietary Information, I agree to provide the Company with a computer-useable copy of all such Proprietary Information and then permanently delete and expunge such Proprietary Information from those systems; and I agree to provide the Company access to my system as reasonably requested to verify that the necessary copying and/or deletion is completed. I further agree that any property situated on Company’s premises and owned by Company is subject to inspection by Company’s personnel at any time with or without notice. Prior to the termination of my employment or promptly after termination of my employment, I will cooperate with Company in attending an exit interview and certify in writing that I have complied with the requirements of this section.
10. Legal and Equitable Remedies.
10.1 I agree that it may be impossible to assess the damages caused by my violation of this Agreement or any of its terms. I agree that any threatened or actual violation of this Agreement or any of its terms will constitute immediate and irreparable injury to the Company and the Company shall have the right to enforce this Agreement and any of its provisions by injunction, specific
performance or other equitable relief, without bond and without prejudice to any other rights and remedies that the Company may have for a breach or threatened breach of this Agreement.
10.2 I agree that if the Company is successful in whole or in part in any legal or equitable action against me under this Agreement, the Company shall be entitled to payment of all costs, including reasonable attorney’s fees, from me.
10.3 In the event the Company enforces this Agreement through a court order, I agree that the restrictions of Sections 5 and 6 shall remain in effect for a period of twelve (12) months from the effective date of the Order enforcing the Agreement.
11. Notices. Any notices required or permitted under this Agreement will be given to the Company at its headquarters location at the time notice is given, labeled “Attention Chief Executive Officer,” and to me at my address as listed on the Company payroll, or at such other address as the Company or I may designate by written notice to the other. Notice will be effective upon receipt or refusal of delivery. If delivered by certified or registered mail, notice will be considered to have been given five (5) business days after it was mailed, as evidenced by the postmark. If delivered by courier or express mail service, notice will be considered to have been given on the delivery date reflected by the courier or express mail service receipt.
12. Publication of This Agreement to Subsequent Employers or Business Associates of Employee.
12.1 If I am offered employment or the opportunity to enter into any business venture as owner, partner, consultant or other capacity while the restrictions described in Sections 5 and 6 of this Agreement are in effect I agree to inform my potential employer, partner, co-owner and/or others involved in managing the business with which I have an opportunity to be associated of my obligations under this Agreement and also agree to provide such person or persons with a copy of this Agreement.
12.2 I agree to inform the Company of all employment and business ventures which I enter into while the restrictions described in Sections 5 and 6 of this Agreement are in effect and I also authorize the Company to provide copies of this Agreement to my employer, partner, co-owner and/or others involved in managing the business with which I am employed
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or associated and to make such persons aware of my obligations under this Agreement.
13. General Provisions.
13.1 Governing Law; Consent to Personal Jurisdiction. This Agreement will be governed by and construed according to the laws of the Commonwealth of Pennsylvania as such laws are applied to agreements entered into and to be performed entirely within the Commonwealth of Pennsylvania between Pennsylvania residents. I hereby expressly consent to the personal jurisdiction and venue of the state and federal courts located in the Commonwealth of Massachusetts for any lawsuit filed there against me by Company arising from or related to this Agreement.
13.2 Severability. In case any one or more of the provisions, subsections, or sentences contained in this Agreement shall, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect the other provisions of this Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained in this Agreement. If moreover, any one or more of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it shall be construed by limiting and reducing it, so as to be enforceable to the extent compatible with the applicable law as it shall then appear.
13.3 Successors and Assigns. This Agreement is for my benefit and the benefit of the Company, its successors, assigns, parent corporations, subsidiaries, affiliates, and purchasers, and will be binding upon my heirs, executors, administrators and other legal representatives.
13.4 Survival. The provisions of this Agreement shall survive the termination of my employment, regardless of the reason, and the assignment of this Agreement by the Company to any successor in interest or other assignee. I understand that my obligations under this Agreement will continue in accordance with its express terms regardless of any change in my title, position, status, role, duties, salary, compensation or benefits or other terms and conditions of employment or service.
13.5 Employment At-Will. I agree and understand that nothing in this Agreement shall change my at-will employment status or confer any right with respect to continuation of employment by the Company, nor shall it interfere in any way with my right or the Company’s right to terminate my employment at any time, with or without cause or advance notice.
13.6 Waiver. No waiver by the Company of any breach of this Agreement shall be a waiver of any preceding or succeeding breach. No waiver by the Company of any right under this Agreement shall be construed as a waiver of any other right. The Company shall not be required to give notice to enforce strict adherence to all terms of this Agreement.
13.7 Advice of Counsel. I ACKNOWLEDGE THAT, IN EXECUTING THIS AGREEMENT, I HAVE HAD THE OPPORTUNITY TO SEEK THE ADVICE OF INDEPENDENT LEGAL COUNSEL, AND I HAVE READ AND UNDERSTOOD ALL OF THE TERMS AND PROVISIONS OF THIS AGREEMENT. THIS AGREEMENT SHALL NOT BE CONSTRUED AGAINST ANY PARTY BY REASON OF THE DRAFTING OR PREPARATION OF THIS AGREEMENT.
13.8 Entire Agreement. The obligations pursuant to Sections 1 and 2 (except Subsection 2.6) of this Agreement shall apply to any time during which I was previously engaged, or am in the future engaged, by the Company as a consultant if no other agreement governs nondisclosure and assignment of inventions during such period. This Agreement is the final, complete and exclusive agreement of the parties with respect to the subject matter of this Agreement and supersedes and merges all prior discussions between us. No modification of or amendment to this Agreement, nor any waiver of any rights under this Agreement, will be effective unless in writing and signed by the party to be charged. Any subsequent change or changes in my title, position, status, role, duties, salary, compensation or benefits or other terms and conditions of employment or service will not affect the validity or scope of this Agreement.
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This Agreement shall be effective as of the first day of my employment with the Company.
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Prior Inventions
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1. Except as listed in Section 2 below, the following is a complete list of all inventions or improvements relevant to the subject matter of my employment by Paratek Pharmaceuticals, Inc. (the “ Company ”) that have been made or conceived or first reduced to practice by me alone or jointly with others prior to my engagement by the Company:
☐ No inventions or improvements.
☐ See below:
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2. Due to a prior confidentiality agreement, I cannot complete the disclosure under Section 1 above with respect to inventions or improvements generally listed below, the proprietary rights and duty of confidentiality with respect to which I owe to the following party(ies):
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EXHIBIT 10.11
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.
EXECUTION COPY
CONFIDENTIAL
LICENSE AND COLLABORATION AGREEMENT
This License and Collaboration Agreement (this “ Agreement ”) is made as of April 21, 2017 (the “ Effective Date ”), by and between Paratek Bermuda Ltd. a corporation organized and existing under the laws of Bermuda, located at Clarendon House, 2 Church Street, Hamilton HM 11, Bermuda, (“ Paratek ”), and Zai Lab (Shanghai) Co., Ltd. , an exempted company organized and existing under the laws of P.R. of China , located at 1043 Halei Road, Building 8, Suite 502, Zhangjiang Hi-tech Park, Shanghai, PRC 201203 (“ Zai ”). Paratek and Zai are referred to in this Agreement individually as a “ Party ” and collectively as the “ Parties .”
RECITALS
WHEREAS , Paratek is a pharmaceutical company specializing in anti-infective drug development, and Paratek and its Affiliates own or control rights to the Compound and Licensed Product (as defined herein);
WHEREAS , Zai is a pharmaceutical company having experience in the development, manufacture and commercialization of pharmaceutical products in the Territory;
WHEREAS , Zai is prepared to develop and commercialize the Licensed Product in the Territory, providing it receives supporting materials such as clinical trial data, regulatory submissions, and starting materials that may allow for earlier market entry and market exclusivity of the Licensed Product compared to competitors;
WHEREAS , Paratek wishes to have Licensed Product developed and commercialized in the Territory, and is prepared to provide supporting materials such as clinical trial data, regulatory submissions, and starting materials to Zai, which may allow for earlier market entry and market exclusivity for the Licensed Product compared to competitors.
WHEREAS , Paratek wishes to grant to Zai, and Zai wishes to be granted, an exclusive license under Paratek’s rights to Develop, Manufacture and Commercialize (each as defined herein) the Licensed Product in the Field in the Territory (each as defined herein) in accordance with the terms and conditions set forth below.
AGREEMENT
NOW, THEREFORE , in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
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Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, will have the respective meanings set forth below:
1.1. “Activity Target” will have the meaning set forth in Section 5.3 .
1.2. “Activity Target Deadline” will have the meaning set forth in Section 5.3 .
1.3. “Adverse Event” means any unwanted or harmful medical occurrence in a patient or subject who is administered a Licensed Product, whether or not considered related to such Licensed Product, including any undesirable sign (including abnormal laboratory findings of clinical concern), symptom or disease temporally associated with the use of such Licensed Product.
1.4. “Affiliate” means, with respect to a Party, any entity that directly or indirectly controls, is controlled by or is under common control with such Party. As used in this Section 1.4 , “Control” (and, with correlative meanings, the terms “controlled by” and “under common control with”) means, in the case of a corporation, the ownership of 50% or more of the outstanding voting securities thereof or, in the case of any other type of entity, an interest that results in the ability to direct or cause the direction of the management and policies of such party or the power to appoint 50% or more of the members of the governing body of the party or, where ownership of 50% or more of such securities or interest is prohibited by law, ownership of the maximum amount legally permitted.
1.5. “Agreement” will have the meaning set forth in the introduction to this agreement.
1.6. “Alliance Manager” will have the meaning set forth in Section 3.1 .
1.7. “Anti-Corruption Laws” will have the meaning set forth in Section 11.6(a)(i).
1.8. “Applicable Laws” means all statutes, ordinances, regulations, rules or orders of any kind whatsoever of any Governmental Authority that may be in effect from time to time and applicable to the activities contemplated by this Agreement.
1.9. “Biodefense” means a use related to the defense from Biothreat Agents.
1.10. “Biothreat Agent” means (a) pathogens that cause a high rate of illness in people exposed, result in a high rate of mortality, have a short incubation period, and have a limited number of persons with immunit y, or (b) a bacterium, virus, protozoan, parasite, or fungus that can be used as a weapon in biological warfare.
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1.11. “Business Day” means a day other than Saturday, Sunday or any day on which banks located in the United States or the PRC are authorized or obli gated to close . Whenever this Agreement refers to a number of days, such number will refer to calendar days unless Business Days are specified.
1.12. “Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30 and December 31.
1.13. “Calendar Year” means each 12 month period commencing on January 1.
1.14. “CFDA” means the China Food and Drug Administration, and local counterparts thereto, and any successor agency(ies) or authority thereto having substantially the same function.
1.15. “cGMP” means all applicable current Good Manufacturing Practices including, as applicable, (a) the principles detailed in the U.S . Current Good Manufacturing Practices, 21 C.F.R. Parts 4 , 210 , 211 , 601 , 610 and 820 , (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the ICH Q7 guidelines, and (d) the equivalent Applicable Laws in any relevant country or region, each as may be amended and applicable from time to time.
1.16. “Clinical Trial” means any clinical testing of Licensed Product in human subjects.
1.17. “Clinical Trial Material” means Licensed Product and placebo for administration to humans in a Clinical Trial.
1.18. “CMC” means data, information, or procedures (as applicable) relating to the composition, Manufacture, or control of the Compound or Licensed Product, which may be requested or required by a Regulatory Authority for Regulatory Approval, including but not limited to data, information, and procedures relating to structure, Manufacturing process, validation, characterization, container closure systems, stability, quality, and purity.
1.19. “Combination Product” mean (a) any single product comprising both (i) a Compound and (ii) one or more other therapies or pharmaceutically active compounds or subst ances and do not require the use of any Paratek Technology; (b) any sale of a Licensed Product with another therapy(ies) or product(s) for a single invoice price; or (c) any sale of a Licensed Product as part of a bundle with other therapy(ies), product(s) or service(s) (i.e., where a Licensed Product and such other therapy(ies), product(s) or service(s) are sold for a single invoice price or where a discount, rebate or other amount that reduces the price of a Licensed Product is provided in exchange for (o r otherwise conditioned upon) the purchase of such other therapy(ies), product(s) or services), to the extent not described in clause (a) or (b ) . The Compound portion of any Combination Product shall be deemed the “ Licensed Component ” and the other portion of such Combination Product the “ Other Component ”, and each Combination Product shall be deemed a Licensed Product hereunder.
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1.20. “Commercialization” or “ Commercialize ” means all activities directed to marketing, distribution, detailing or selling of pharmac eutical products (including manufacturing, importing and exporting activities in connection therewith ) .
1.21. “Commercialization Plan” means the written plan for the Commercialization of the Licensed Product.
1.22. “Commercially Reasonable Efforts” means the use of diligent, good faith efforts and resources, in an active and ongoing program, as normally used by a similarly situated company for a product discovered or identified internally that is important to such company’s overall strategy or objectives, which product is at a similar stage in its development or product life and is of similar market potential and intellectual property protection, [* * *]; and in no event will such efforts and resources be less than the applicable Party would apply to achieve its own high priority goals. Commercially Reasonable Efforts requires that a Party, at a minimum, assign responsibility for such obligations to qualified employees, set annual goals and objectives for carrying out such obligations, and allocate adequate resources designed to meet such goals and objectives, in each case, in order to develop the Licensed Product as an active and ongoing program, and obtain Regulatory Approval for the Licensed Product in the Territory in an expeditious manner. Additionally, Commercially Reasonable Efforts requires [* * *] such efforts and resources as described above [* * *] for the Licensed Product, which includes [* * *] for the Licensed Product [* * *].
1.23. “Compound” means (i) omadacycline having the chemical structure set forth in Schedule 1.23 , (ii) a prodrug or metabolite of the compound specified in (i) , and (iii) any salt or polymorph of the compound specified in (i ) .
1.24. “Confidential Information” means all confidential information of the Disclosing Party or its Affiliates, regardless of its form or medium as provided to the Receiving Party or its Affiliates in connection with this Agreement; provided that, Confidential Informati on will not include any information that the Receiving Party can show by competent evidence: (a) is already known to the Receiving Party at the time it is disclosed to the Receiving Party by the Disclosing Party without an obligation of confidentiality and not through a prior disclosure by the Disclosing Party, (b) is or becomes generally known to the public through no act or omission of the Receiving Party in violation of the terms of this Agreement, (c) has been lawfully received by the Receiving Party fr om a Third Party without restriction on its disclosure and without, to the knowledge of the Receiving Party, a breach by such Third Party of an obligation of confidentiality to the Disclosing Party, or (d) has been independently developed by the Receiving Party without use of or reference to the Confidential Information of the Disclosing Party. The terms of this Agreement shall be the Confidential Information of both Parties.
1.25. “Continuing Technology Transfer” will have the meaning set forth in Section 4.1 .
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1.26. “Control” or “Controlled” means, with respect to any Know-How, Patents or other intellectual property rights, that a party has the legal authority o r right (whether by ownership, license or otherwise) to grant a license, sublicense, access or right to use (as applicable) under such Know-How, Patents, or other intellectual property rights, on the terms and conditions set forth herein, in each case with out breaching the terms of any agreement with a Third Party .
1.27. “Develop” or “ Development ” or “ Developing ” means research, discovery, and preclinical and clinical drug or biological development activities, including test method development and stability testing, toxicology, formulation, quality assurance/quality control development, statistical analysis, preclinical and clinical studies and regulatory affairs, approval and registration.
1.28. “Development Plan” will have the meaning set forth in Section 5.2 .
1.29. “Disclosing Party” will have the meaning set forth in Section 10.1(a).
1.30. “Dispute” will have the meaning set forth in Section 15.1 .
1.31. “Effective Date” will have the meaning set forth in the introduction in this Agreement.
1.32. “Executive Officers” will have the meaning set forth in Section 3.2(f).
1.33. “Exploit” or “ Exploitation ” or “ Exploiting ” means to use, Develop and Commercialize, including to have Developed and have Commercialized, and to Manufacture and to have Manufactured to support the foregoing.
1.34. “Field” means, except for Biodefense, all human therapeutic and preventative uses.
1.35. “First Commercial Sale” means, with respect to any Licensed Product, the first arm’s length sale of such Licensed Product to a Third Party in a region of the Territory by Zai, its Affiliate(s) or Sublicensee(s) for use or consumption in such region following Regulatory Approval. Sales prior to receipt of marketing and pricing approvals, such as so-called “treatment IND sales,” “named patient sales” and “compassionate use sales” and any sales to any government, foreign or domestic, including purchases for immediate sale and/or stockpiling purposes, are not a First Commercial Sale in that region.
1.36. “FTE” means the equivalent of the work of a full-time individual for a 12 month period.
1.37. “FTE Rate” means a rate of [* * *] per FTE per year, to be pro-rated on a hourly basis of [* * *] per FTE per hour, assuming [* * *] hours per year for an FTE.
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1.38. “GAAP” means United States generally accepted accounting principles, con sistently applied .
1.39. “GCP” means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinic al practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regul ations Title 21 , Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws in the region in the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.
1.40. “GLP” means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the U.S . Food and Drug Administration as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the region in the Territory, each as may be amended and applicable from time to time.
1.41. “Governmental Authority” means any court, commission, authority, department, ministry, official or other instrumentality of, or being vested with public authority under any law of, any country, region, state or local authority or any political subdivision thereof, or any association of countries.
1.42. “GSP” means all applicable Good Supply Practice standards, including, as applicable, as set forth in the then current good supply practice standards promulgated or endorsed by the CFDA as defined in Good Supply Practice for Pharmaceutical Products or the equivalent Applicable Laws in the region in the Territory, each as may be amended and applicable from time to time.
1.43. “[* * *]” will have the meaning set forth in Section [* * *].
1.44. “Imported Product Agreement” will have the meaning set forth in Section 7.1 .
1.45. “IND” means an investigational new drug application or equivalent application filed with the applicable Regulatory Authority, which application is required to commence Clinical Trials in the applicable country.
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1.46. “Indemnifying Party” will have the meaning set forth in Section 12.3 .
1.47. “Indemnitee” will have the meaning set forth in Section 12.3 .
1.48. “Initial Development Plan” will have the meaning set forth in Section 5.2 .
1.49. “Initial Technology Transfer” will have the meaning set forth in Section 4.1 .
1.50. “Invention” will mean any process, method, composition of matter, article of manufacture, discovery or finding, patentable or otherwise, that is invented as a result of a Party exercising its rights or carrying out its obligations under this Agreement, including all rights, title and interest in and to the intellectual property rights therein.
1.51. “IP Transfer Agreement” means the Intellectual Property Transfer Agreement between Paratek Pharmaceuticals, Inc. and Paratek Bermuda Ltd. dated June 6, 2016, as amended by the First Amendment dated February 27, 2017 and as may be further amended from time to time.
1.52. “Joint Development Committee” or “JDC” will have the meaning set forth in Section 3.3(b)(i).
1.53. “Joint Inventions” will have the meaning set forth in Section 13.1(b).
1.54. “Joint Patents” will have the meaning set forth in Section 13.1(b).
1.55. “Joint Steering Committee” or “JSC” will have the meaning set forth in Section 3.2(a).
1.56. “Know-How” means any proprietary scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including databases, safety information, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data.
1.57. “Licensed Product” means any pharmaceutical product containing the Compound, either alone or in combination with other active ingredients.
1.58. “Losses” will have the meaning set forth in Section 12.1 .
1.59. “Manufacture” or “ Manufacturing ” or “ Manufactured ” means all operations involved in the manufacturing, filling and finishing, quality control testing (including in-process, release and stability testing, if applicable), storage, releasing and packaging.
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1.60. “Material Sublicense” means a sublicense granted, or desired to be granted, by Zai to (a) [* * *], but not [* * *], or (b) [* * *], and/or [* * *] .
1.61. “Material Sublicensee” means a Third Party, or Affiliates granted, or for which Zai desires to grant, a Material Sublicense.
1.62. “Materials” means reference and starting materials including the active pharmaceutical ingredient (API) or other materials as may be defined by the Parties.
1.63. “Milestone Event” will have the meaning set forth in Section 9.3 .
1.64. “Milestone Payment” will have the meaning set forth in Section 9.3 .
1.65. “Net Sales” means the gross price billed or invoiced on sales of the Licensed Product by Zai, its Affiliates, or Sublicensees for sale of the Licensed Product to a Third Party in the Territory, less:
(a) freight expense (actual), including insurance, to the extent it is not charged to or reimbursed by the customer, [* * *];
(b) cash, trade or quantity discounts actually granted and deducted solely on account of sales of the Licensed Product;
(c) rebates actually paid to individual or group purchasers of the Licensed Product that are solely on account of the purchase of such Licensed Product;
(d) credits issued for the Licensed Product recalled or not accepted by customers or other refunds, allowances and chargebacks related to the Licensed Product;
(e) Taxes (including, but not limited to sales, value added, consumption and similar taxes; but excluding income taxes) actually incurred, paid or collected and remitted to the relevant tax authority for the sale of the Licensed Product; and
(f) other similar or customary deductions taken in the ordinary course of business or in accordance with GAAP;
Each of the amounts set forth above will be determined from the books and records of Zai, its Affiliate or Sublicensee, maintained in accordance with GAAP or in the case of Sublicensees, such similar accounting principles, consistently applied.
The transfer of a Licensed Product to an Affiliate, Sublicensee, or other Third Party (w) in connection with the research, development or testing of a Licensed Product (including, without limitation, the condu ct of clinical studies), (x) for purposes of distribution as promotional samples, (y) for indigent or similar public support or compassionate use programs, or (z) by and between Zai and its Affiliates or Sublicensees will not, in any case, be considered a Net Sale of a Licensed Product under this Agreement.
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Net Sales will also include and be deemed to have been made with respect to any Licensed Products used by Zai or any Affiliate, for its own commercial purposes, or transferred to any Third Party for less than the transferee is then charging in normal arms-length sales transactions; and Net Sales in all such cases will be deemed to have been made at the prices therefor at which such Licensed Products are then being sold to the customers of such user or tra nsferor (or of Zai, if an Affiliate is a user but not a seller) in arms-length sales transactions. For clarity, in the event the Product is sold in an arms-length transaction to a governmental agency, a group purchase entity and/or any other entity having the bargaining power to negotiate the purchase price below normal retail price in transactions of lesser volume, Net Sales shall be calculated based on the actual price negotiated and agreed to for such agency and/or entity and not be based on the price c harged in other arms-length sales transactions.
If Zai or any of its Affiliates, or Sublicensees, sells a Licensed Product as a Licensed Component of a Combination Product in the Territory in any Calendar Quarter, then Net Sales will be calculated by multiplying the Net Sales of the Combination Product during such Calendar Quarter by the fraction A/(A+B), where A is the average Net Sales per unit sold of the Licensed Component when sold separately in the Territory during such Calendar Year (calculated by determining the Net Sales of the Licensed Component during such Calendar Quarter in accordance with the definition of Net Sales set forth herein and dividing such Net Sales by the number of units of the Licensed Component during such Calendar Quarter) and B is the average Net Sales per unit sold of the Other Component(s) included in the Combination Product when sold separately during such Calendar Quarter (calculated by determining the Net Sales of such Other Component(s) sold during such Calendar Quarter by applying the definition of Net Sales set forth herein as if it applied to sales of such Other Component(s) and dividing such Net Sales by the number of units of such Other Component(s) sold during such Calendar Quarter).
For purposes of calculating the average Net Sales per unit sold of a Licensed Component and Other Component(s) of a Combination Product, any of the deductions described herein that apply to such Combination Product will be allocated among sales of the Licensed Component and sales of the Oth er Component(s) included in such Combination Product as follows: (1) deductions that are attributable solely to the Licensed Component or one of the Other Component(s) will be allocated solely to Net Sales of the Licensed Component or such Other Component, as applicable, and (2) all other deductions will be allocated among sales of the Licensed Component and sales of the Other Component(s) in proportion to Zai’s and Paratek’s mutual agreement of the fair market value of the Licensed Component and the Other Component(s).
In the event that no separate sales of the Licensed Component or any Other Component(s) included in a Combination Product are made by Zai or its Affiliates, or Sublicensees, during a Calendar Quarter in which such Combination Product is sold, the average Net Sales per unit sold in the above described equation will be replaced with Zai’s and Paratek’s mutual agreement of the fair market value of the Licensed Component and each of the Other Component(s) included in such Combination Product.
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1.66. “Par atek” will have the meaning set forth in the introduction of this Agreement .
1.67. “Paratek Indemnitee(s)” will have the meaning set forth in Section 12.1 .
1.68. “Paratek Know-How” means any and all Know-How Controlled by Paratek, as of the Effective Date or during the Term, that is reasonably necessary or useful in connection with the Exploitation of the Licensed Product in the Field in the Territory.
1.69. “Paratek Patents” means Patents in the Territory Controlled by Paratek as of the Effective Date or during the Term that contain one or more claims that cover the composition of matter or formulation of, or salt of or polymorph forms of, or the method of making or method of using, a Licensed Product, including all Patents which contain a Valid Claim that the Exploitation of a Licensed Product would infringe if unlicensed . The Paratek Patents as of the Effective Date are listed in Schedule 1.69, which shall be updated by the Parties from time to time during the Term.
1.70. “Paratek Prosecution Patents” will have the meaning set forth in Section 13.3(a).
1.71. “Paratek Technology” means the Paratek Know-How, Paratek Patents, Paratek’s interest in Joint Inventions, and Paratek’s interest in Joint Patents.
1.72. “Party” or “Parties” will have the meaning set forth in the introduction to this Agreement.
1.73. “Patent Prosecution” means the responsibility and authority for (a) preparing, filing and prosecuting applications (of all types) for any Patent, (b) managing any interference, opposition, re-issue, reexamination, invalidation proceedings, revocation, nullification, or cancellation proceeding relating to the foregoing, (c) deciding to abandon Patent(s), (d) listing in regulatory publications (as applic able), (e) patent term extension, and (f) settling any interference, opposition, revocation, nullification or cancellation proceeding.
1.74. “Patents” means all national, regional and international patents and patent applications, including divisions, continuations, continuations-in-part, additions, re-issues, renewals, extensions, substitutions, re-examinations or restorations, registrations and revalidations, and supplementary protection certificates and equivalents to any of the foregoing.
1.75. “Phase III Clinical Study” means any pivotal Clinical Trial(s), which Clinical Trial(s) is(are) designed to (a) establish that the Licensed Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with th e Licensed Product in the dosage range to be prescribed; (c) be a pivotal study for submission of an Regulatory Approval Application to obtain regulatory approval for such Licensed Product in any region or regulatory jurisdiction, as defined in 21 C.F.R. § 312.21(c), as may be amended from time to time, or any analogous clinical trial described or defined in Applicable Laws.
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1.76. “PRC” means the People ’ s Republic of China, which for the purposes of this Agreement will exclude Hong Kong, Macau, and Taiwan .
1.77. “Prime Rate” means for any day a per annum rate of interest equal to the “prime rate,” as published in the “Money Rates” column of The Wall Street Journal, from time to time, or if for any reason such rate is no longer available, a rate equivalent to the base rate on corporate loans posted by at least 70% of the ten largest U.S. banks.
1.78. “Product Infringement” will have the meaning set forth in Section 13.5(a).
1.79. “Product Marks” will have the meaning set forth in Section 8.4 .
1.80. “Product Specifications” means the acceptance criteria agreed by the Parties, including numerical limits, ranges or other criteria for the Licensed Product.
1.81. “Public Official” will have the meaning set forth in Section 11.6(d).
1.82. “Receiving Party” will have the meaning set forth in Section 10.1(a).
1.83. “Regulatory Approval” means, with respect to a Licensed Product in a region in the Territory, all approvals from the necessary Governmental Authority or Regulatory Authority to manufacture, import, market and sell such Licensed Product in such region in the Territory (excluding pricing and reimbursement approvals ) .
1.84. “Regulatory Approval Application” means a New Drug Approval Application or Biologics License Application (each, as defined in the U.S. Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et seq.), as amended from time to time) in the U.S., or any corresponding application for approval to market and/or sell a product in any country, region or jurisdiction in the Territory outside the U.S.
1.85. “Regulatory Authority” means any applicable Government Authority responsible for granting Regulatory Approvals for Licensed Products, including the CFDA, and any corresponding national or regional regulatory authorities.
1.86. “Regulatory Submissions” means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.
1.87. “Remedial Action” will have the meaning set forth in Section 6.8 .
1.88. “Retained Rights” will have the meaning set forth in Section 2.3 .
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1.89. “ROFN Compound” will have the meaning set forth in Secti on 2.2 .
1.90. “ROFN Negotiation Period” will have the meaning set forth in Section 2.2 .
1.91. “ROFN Notice Period” will have the meaning set forth in Section 2.2 .
1.92. “ROFN Trigger Notice” will have the meaning set forth in Section 2.2 .
1.93. “Royalty Payment” will have the meaning set forth in Section 9.4(a).
1.94. “Royalty Term” will have the meaning set forth in Section 9.4(c).
1.95. “Safety Agreement” will have the meaning set forth in Section 6.4(a).
1.96. “Sole Inventions” will have the meaning set forth in Section 13.1(b).
1.97. “Subcommittee” will have the meaning set forth in Section 3.2(b).
1.98. “Sublicensee” means a Third Party, or Zai’s Affiliates granted a sublicense by Zai under the license granted in Section 2.1 . For the avoidance of doubt, a Material Sublicensee is a type of Sublicensee.
1.99. “Tax” or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including any interest thereon ) . For the avoidance of doubt, Taxes includes VAT.
1.100. “Technology Transfer” will have the meaning set forth in Section 4.1 .
1.101. “Technology Transfer Plan” will have the meaning set forth in Section 4.1 .
1.102. “Term” will have the meaning set forth in Section 14.1 .
1.103. “Territory” means the PRC, Hong Kong, Macau, and Taiwan (which for purposes of this Agreement will each be deemed a region ) .
1.104. “Third Party” means an entity other than (a) Zai and its Affiliates or (b) Paratek and its Affiliates.
1.105. “Tufts Agreement” means the Tufts University License Agreement executed between Paratek Pharmaceuticals, Inc. and Tufts University dated February 1, 1997, as amended from time to time.
1.106. “U.S. Dollars” or “ $ ” means United States dollars, the lawful currency of the United States.
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1.107. “Upfront Payment” will have the meaning set forth in Section 9.2 .
1.108. “Valid Claim” means (a) a claim of an issued and unexpired Patent included within the Paratek Patents with regard to the Licensed Product in the Territory that has not been permanently revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which decision is not appealable or is not appealed within the time allowed for appeal, and has not been abandoned, disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise or (b) a bona fid e claim of a pending patent application included within the Paratek Patents in the Territory that has not been (i) cancelled, withdrawn or abandoned without being refiled in another application in the applicable jurisdiction or (ii) finally rejected by an administrative agency action from which no appeal can be taken or that has not been appealed within the time allowed for appeal.
1.109. “VAT” means value-added taxes or other similar taxes.
1.110. “Zai” will have the meaning set forth in the introduction of this Agreement.
1.111. “Zai Indemnitee(s)” will have the meaning set forth in Section 12.2 .
1.112. “Zai Know-How” means any and all Know-How, to the extent controlled by Zai as of the Effective Date or during the Term, that is reasonably necessary or useful in connection with the Exploitation of a Licensed Product in the Field in the Territory.
1.113. “Zai Patent” means Patents in the Territory controlled by Zai as of the Effective Date or during the Term that contain one or more claims that cover the composition of matter or formulation of, or salt of or polymorph forms of, or the method of making or method of using, a Licensed Product.
1.114. “Zai Prosecution Patents” will have the meaning set forth in Section 13.3(b).
1.115. “Zai Technology” means Zai Know-How and Zai Patents.
ARTICLE 2
Licenses; Non-Compete
2.1. Exclusive License . Subject to the terms a nd conditions of this Agreement, Paratek hereby grants to Zai, during the Term, an exclusive (subject to the Retained Rights and Section 2.5(c)), royalty-bearing license under the Paratek Technology to Exploit the Licensed Product in the Field in the Territory, including the right to grant sublicenses (subject to Section 2.4 ). For the avoidance of doubt, the license granted pursuant to this Section 2.1 will extend only to the Paratek Technology Controlled by Paratek during the Term, and to the extent any Paratek Technology is no longer Controlled by Paratek, such Paratek Technology will no longer be licensed to Zai. For clarity, Zai has the right pursuant to this Section 2.1 and subject to
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Section 3.2(f) to Exploit the Licensed Product in the form of a Comb ination Product. For further clarity, Paratek will not grant a license after the Effective Date and during the Term that will diminish the Paratek Technology Controlled by Paratek that is exclusively licensed to Zai.
2.2. Right of First Negotiation . During the Term, if Paratek decides to seek a partner to Develop (with the right to Commercialize or the right to obtain or negotiate Commercialization rights) any derivative or modification of omadacycline (a “ ROFN Compound ”) in the Territory, then Paratek will provide Zai with written notice of its decision to do so (the “ ROFN Trigger Notice ”). After Zai’s receipt of the ROFN Trigger Notice, Zai will have [* * *] days (the “ ROFN Notice Period ”) to provide written notice to Paratek of its desire to negotiate with Paratek regarding the partnership for such ROFN Compound. If Zai provides such written notice during the ROFN Notice Period, the Parties will negotiate exclusively for a period of [* * *] days following Paratek’s receipt of such notice from Zai (the “ ROFN Negotiation Period ”) regarding the terms of a definitive agreement. With respect to a ROFN Compound, if (a) Zai does not deliver written notice of its desire to negotiate with Paratek during the ROFN Notice Period or (b) the Parties are unable to reach t erms of a definitive agreement during the ROFN Negotiation Period, then in either case (a) or (b), Paratek will have no further obligation to Zai with respect to such ROFN Compound in the Territory. For the avoidance of doubt, a ROFN Compound is a derivative or modification to omadacycline itself, and not other tetracyclines or derivatives or modifications to other tetracyclines.
2.3. Paratek Retained Rights . Notwithstanding anything to the contrary in this Agreement, Paratek hereby expressly retains, on behalf of itself (and its Affiliates, licensees, and sublicensees) the non-exclusive rights under the Paratek Technology to Manufacture the Compound and Licensed Product in the Territory in compliance with Applicable Laws and to support the Development and Commercialization of the Compound and Licensed Product outside of the Territory (the “ Retained Rights ”). Zai acknowledges and agrees that the Retained Rights includes the right for Paratek to grant licenses under the Retained Rights to its Affiliates and Third Parties in the Field in the Territory, provided that Paratek shall not, and shall obligate its Affiliates, licensees, and sublicensees to not, sell or offer for sale in the Territory any Licensed Product manufactured under the Retained Rights. In addition, Paratek shall obligate, and obligate that its Affiliates, licensees, and sublicensees obligate, any contract manufacturing organization in the Territory to comply with all Applicable Laws, including GMP, and ensure that any such contract manufacturing organization is not, and has not been, debarred or disqualified by any Regulatory Authority. For the avoidance of doubt, the Retained Rights exclude the right under the Paratek Technology to Develop or Commercialize the Compound or Licensed Product in the Territory, and Paratek will not undertake such Development or Commercialization without Zai’s express prior written consent. Zai hereby grants to Paratek a non-exclusive, royalty-free, fully paid-up, sublicensable license under the Zai Technology, solely to exercise the rights set forth in the Retained Rights.
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(a) General. Zai will have the right to grant sublicenses under the license granted in Section 2.1 to Sublicensees, solely for such Sublicensees to perform Zai’ s obligations under this Agreement; provided that if such sublicense is (i) a sublicense of [* * *] under this Agreement, [* * *] such sublicense [* * *], and (ii) a Ma terial Sublicense, then the additional provisions of Section 2.4(b) will also apply. Zai will be liable for Sublicensee conduct that is prohibited under this Agreement, and Sublicensee conduct that would have constituted a breach of this Agreement will be deemed a breach of this Agreement as if it had been engaged in by Zai.
(b) Material Sublicenses . [* * *] Material Sublicenses to a Material Sublicensee [* * *]. Notwithstanding the foregoing, the Parties agree that the Material Sublicensees set forth in Schedule 2.4(b) [* * *].
(c) Restrictions. Zai will not grant a sublicense to any Sublicensee that has been debarred or disqualified by a Regulatory Authority. Zai will ensure that, prior to engaging any Sublicensee that such Sublicensee is subject to written agreements containing the following ter ms and conditions: (i) requiring each such Sublicensee to protect and keep confidential any Confidential Information of the Parties, including in accordance with ARTICLE 10; (ii) providing that Paratek will have the right to audit (either by itself or through Zai or Zai’s designee) the books and records of each such Sublicensee in accordance with this Agreement (including pursuant to Sections 8.6 , 9.6(d) , and 11.6(a)(iv) ); (iii) that does not impose any payment obligations or liability on Paratek; and (iv) that is otherwise consistent with the terms of this Agreement. Zai will provide a copy of the complete executed agreement with each Sublicensee to Paratek, [* * *]. Zai will remain directly responsible for all of its obligations under this Agreement that have been delegated or sublicensed to any Sublicensee.
(a) Zai will, and will cause its Affiliates and Sublicensees to, be bound by and comply with all obligations that the Tufts Agreement states would apply to sublicenses or sublicensees of the Tufts Agreement, [* * *]. Zai’s obligations in relation to the Tufts Agreement and the Sections of the Tufts Agreement stated above will be owed by Zai to Paratek and Tufts University and enforceable by both Paratek and Tufts Unive rsity. Zai expressly permits Paratek to disclose to Tufts University (i) complete copies of agreements Zai enters into with Sublicensees and amendments thereto and (ii) any other information under this Agreement as needed to comply with the provisions of the Tufts Agreement.
(b) During the Term, Paratek will promptly furnish Zai with a copy of (i) the Tufts Agreement (with certain terms that do not apply to Zai redacted) and any relevant ancillary agreements, exhibits, schedules, or other documents which set forth and are sufficient to fully describe all the terms and conditions with which Zai must comply in relation to the Tufts Agreement, (ii) all amendments of the Tufts Agreement, and (iii) all correspondence (or in the
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case of oral discussions, a summary of such discussions) with or from and reports received from or provided to licensors under the Tufts Agreement to the extent material to Zai or the rights granted or to be granted to Zai under this Agreement. In addition, during the Term, Paratek will provi de copies of all notices received by Paratek relating to any alleged breach or default by Paratek under the Tufts Agreement within five Business Days after Paratek ’ s receipt thereof. Paratek will be solely responsible for all payment obligations set forth in the Tufts Agreement.
(c) Zai acknowledges and agrees that (i) Tufts University has the right to convert the License (as defined in the Tufts Agreement) from an exclusive license to a non-exclusive license and (ii) if Tufts University converts the License f rom an exclusive license to a non-exclusive license pursuant to Article VI of the Tufts Agreement, any rights with respect to the License sublicensed by Paratek to Zai (including any such rights sublicensed under Section 2.1 ) will become non-exclusive. For clarity, in such event the foregoing shall only affect Paratek Technology Controlled by Paratek pursuant to the Tufts Agreement, and the license granted by Paratek to Zai with respect to all other Paratek Technology shall in such an event remain exclusive.
2.6. No Implied Licenses; Negative Covenant. Except as set forth herein, neither Party will acquire any license or other intellectual property interest, by implication or otherwise, under any trademarks, patents or patent applications of the other Party. Each Party will not, and will not permit any of its Affiliates or sublicensees to, practice any Patent or Know-How licensed to it by the other Party outside the scope of the license granted to it under this Agreement.
2.7. Non-Compete . During the Term, Zai will not, and will cause its Affiliates and Sublicensees to not, engage in (independently or for or with any Third Party) any Commercialization in the T erritory of (a) [* * *] or (b) [* * *]. Notwithstanding the foregoing clause (a), if [* * *], and [* * *], then the restriction set forth in clause (a) above shall not apply with respect to [* * *].
3.1. Alliance Managers. Within 30 days following the Effective Date, each Party will appoint (and notify the other Party of the identity of) a representative having the appropriate qualifications (including a general understanding of pharmaceutical Development, Manufacturing, and Commercialization issues) to act as its alliance manager under this Agreement (“ Alliance Manager ”). The Alliance Managers will serve as the primary contact points between the Parties regarding the activities contemplated by this Agreement. The Alliance Managers will facilitate the flow of information and otherwise promote communication, coordination and collaboration between the Parties, providing single point communication for seeking consensus both internally within each Party’s respective organization, including facilitating review of external corporate communications, and raising cross-Party and/or cross-functional disputes in a timely manner. Each Party may replace its Alliance Manager by written notice to the other Party.
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3.2. Joint Steering Committee .
(a) Formation. Within 30 days after the Effective Date, the Parties will establish a joint steering committee (the “ Joint Steering Committee ” or the “ JSC ”) to oversee the Development, Manufacture, and Commercialization of the Licensed Products in the Field in the Territory under this Agreement. Each Party will appoint three representatives to the JSC, each of whom will be an officer or employee of the applicable Party having sufficient seniority within such Party to make decisions arising within the scope of the JSC’s responsibilities. Each Party may replace its JSC representatives upon written notice to the other Party. Each Party will appoint one of its JSC representatives to act as a co-chairperson of the JSC.
(b) Role. The JSC will (i) provide a forum for the discussion of the Parties’ activities under this Agreement; (ii) review, discuss and approve the overall strategy for the Development, Manufacture, and Commercialization of the Licensed Product in the Field in the Territory; (iii) review, discuss and approve the Development Pl an and amendments thereto; (iv) review and discuss the Commercialization Plan and amendments thereto; (v) review, discuss and approve the Product Specifications; (vi) review and discuss Manufacturing activities, and approve such Manufacturing activities that could affect Paratek’s global clinical and/or regulatory program outside the Territory and outside the Field; (vii) establish joint subcommittees (each, a “ Subcommittee ”) as necessary or advisable to further the purpose of this Agreement; and (viii) perform such other functions as expressly set forth in this Agreement or allocated to it by the Parties’ written agreement.
(c) Limitation of Authority . The JSC will only have the powers expressly assigned to it in this ARTICLE 3 and elsewhere in this Agreement and will not have the authority to: (i) modify or amend the terms and conditions of this Agreement; (ii) waive either Party’s compliance with the terms and conditions of this Agreement; or (iii) determine any such issue in a manner that would conflict with the express terms and conditions of this Agreement.
(d) Meetings . The JSC will hold meetings at such times as it elects to do so, but in no event wil l such meetings be held less frequently than once every Calendar Quarter until the earlier of (i) three years after the Effective Date, or (ii) Zai’s submission of a Regulatory Submission for Regulatory Approval for the Licensed Product in the Territory. Thereafter, the JSC will hold meeting no less frequently than once every six months. Each Party may call additional ad hoc JSC meetings as the needs arise with reasonable advance notice to the other Party. Meetings of the JSC may be held in person, by audio or video teleconference; provided that at least one meeting per Calendar Year of the JSC will be held in person. In-person JSC meetings will be held at locations selected alternately by the Parties. The co-chairpersons of the JSC will jointly prepare the agenda and minutes for each JSC meeting. Each Party will be responsible for all of its own expenses of participating in the JSC meetings. No action taken at any JSC meeting will be effective unless at least one representative of each Party is participating in such JSC meeting.
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(e) Non-Member Attendance . Each Party may from time to time invite a reasonable number of participants, in addition to its representatives, to attend the JSC meetings in a non ‑voting capacity; provided that if either Party intends to have any Third Party (including any consultant) attend such a meeting, such Party will provide prior written notice to the other Party. Such Party will also ensure that such Third Party is bound by confidentiality and non-use obligations consistent wi th the terms of this Agreement.
(f) Decision-Making. All decisions of the JSC will be made by unanimous vote, with each Party’s representatives having one vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the JSC cannot reach a decision as to such matter within 30 days after such matter was brought to the JSC for resolution, such matter will be referred to the President of Paratek and the Chief Executive Officer of Zai (the “ Executive Officers ”) for resolution. If the Executive Officers cannot resolve such matter within 10 Business Days after such matter has been referred to them, then the Parties will be deemed to be deadlocked and [* * *] final decision making authority over [* * *]; provided that [* * *] final decision making authority over [* * *]; provided further that [* * *] such final decision making authority in a manner that [* * *]. If [* * *] that [* * *] did not have a good faith basis to conclude that such matter [* * *], then [* * *] may submit the matter to arbitration pursuant to Section 15.4; provided that the expedited procedure rules of the [* * *] will apply. For clarity, [* * *] would have the right to [* * *] with respect to the [* * *].
(g) Exchange of Information . The Parties will cooperate to exchange information with respect to Development activities conducted by Paratek outside the Territory that could affect Zai’s activities in the Territory, and Development activities conducted by Zai that could affect Paratek’s global clinical and regulatory program outside the Territory and outside the Field (such as new indications, dosing, and formulations).
(a) General . Pursuant to Section 3.2(b), the JSC will have the authority to establish Subcommittees. Each Subcommittee (including the Joint Development Committee) will be composed of an equal number of representatives from each Party. Each Party may replace its Subcommittee representatives upon written notice to the other Party. All decisions of a Subcommittee will be made by unanimous vote, with each Party’s representatives having one vote. In the event the Parties are unable to reach a unanimous vote with respect to a matter, such matter will be referred to the JSC for resolution.
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(b) Joint Development Committee .
(i) General . Within 30 days of the Effective Date, the Parties will establish a joint development committee (the “ Joint Development Committee ” or the “ JDC ”) to oversee (1) the day-to-day Development of the Licensed Product and the execution of the Development Plans, and (2) the progress of the Regulatory Approvals and Regulatory Submissions for the Licensed Product. Each Party will appoint three representatives to the JDC, each of whom will be an officer or employee of the applicable Party having sufficient knowledge regarding Development and Commercialization of the Licensed Product.
(ii) Meetings. While the Parties are developing and conducting Clinical Trials for Licensed Product in the Territory, the JDC will meet at least once per Calendar Quarter. The Parties will endeavor to schedule meetings of the JDC at least two months in advance.
ARTICLE 4
Technology Transfers
4.1. Technology Transfer . Within 30 days of the Effective Date, the Parties will coordinate and agree to a technology transfer plan for Paratek to provide and transfer to Zai the Paratek Know-How that exists on the Effective Date and was not previously provided to Zai, and a timeline for such technology transfer, which may be updated or amended by the JSC from time to time as needed (such schedule and timeline, the “ Technology Transfer Plan ”). Paratek will transfer the Paratek Know-How to Zai in accordance with the Technology Transfer Plan, and Zai will cooperate to facilitate the receipt of such transfer of Paratek Know-How (the “ Initial Technology Transfer ”). Thereafter, upon Zai’s reasonable request, Paratek will provide Zai with reasonable assistance in the Development and Manufacture of the Licensed Products in the Field in the Territory (the “ Continuing Technology Transfer ,” and together with the Initial Technology Transfer, the “ Technology Transfer ”). The Continuing Technology Transfer will include the transfer of additional Paratek Know-How to Zai and reasonable access to Paratek personnel involved in the research and Development of the Compound and Licensed Products, either in-person at Paratek’s facility or by teleconference, but will not include an obligation for Paratek personnel to travel.
4.2. Transfer of Materials . Paratek will provide a one-time transfer of reasonable quantities of Materials for Zai to conduct its Development activities under this Agreement; provided that the Parties discuss in good faith and enter into a separate materials transfer agreement containing reasonable and customary terms for such transfer of Materials. Zai will [* * *] provide assistance to Zai for the transfer of Materials pursuant this Section 4.2 .
4.3. Technology Transfer Costs . [* * *]
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5.1. Diligence and Responsibilities .
(a) Zai will be responsible for, and use Commercially Reasonable Efforts to Develop the Licensed Product in the Field in the Territory in accordance with the Development Plan, at its sole cost and expense.
(b) Zai will use Commercially Reasonable Efforts to conduct its tasks pursuant to the Development Plan and to attempt to achieve the objectives of the Development Plan. Zai will perform such obligations under the Development Plan in a professional manner, and in compliance in all material respects with the Development Plan and the requirements of Applicable Law, GCP and cGMP. Changes in the scope or direction of the Development work under this Agreement that would require a material deviation from the Development Plan must be approved by the JSC as set forth in Section 3.2(b).
5.2. Development Plan . The Parties will undertake the Development of the Licensed Product in a collaborative and efficient manner in accordance with this ARTICLE 5. The Development of the Licensed Product in the Territory under this Agreement will be governed by a written development plan (the “Development Plan” ), as such Development Plan may be revised from time to time in accordance with this Section 5.2 . The Development Plan will contain in reasonable detail the major Development activities and the timelines for achieving such activities. As of the Effective Date, the Parties have agreed to the initial Development Plan, which is attached hereto as Schedule 5.2 (the “ Initial Development Plan ”). From time to time, but at least every 12 months, Zai will propose updates or amendments, if any, to the Development Plan i n consultation with Paratek and submit such proposed updated or amended plan to the JSC for review, discussion, and approval. In accordance with Section 3.2(b), the JSC will review and approve any updates or amendments to the Development Plan.
5.3. Activity Target . Prior to [* * *], Zai will file an IND with the CFDA for the Licensed Product (the “ Activity Target ,” and the date, the “ Activity Target Deadline” ); provided that (a) if Zai is unable to achieve the Activity Target by the Activity Target Deadline and demonstrates to Paratek that Zai utilized Commercially Reasonable Efforts in Zai’s attempt to satisfy the obligations of this Section 5.3 , or (b) if Zai is unable to achieve the Activity Target by the Activity Target Deadline as a direct result of Paratek [* * *], the Activity Target Deadline will be extended [* * *]. For the avoidance of doubt, with respect to subsection (a) the Activity Target Deadline is [* * *], and with respect to subsection (b), the Activity Target Deadline is [* * *]. [* * *]
5.4. Development Reports. The status, progress and results of Zai’ s Development activities under this Agreement will be discussed at meetings of the JSC. At least five Business Days before each regularly scheduled JSC meeting, Zai will provide the JSC with a written
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report detailing its Development ac tivities and the results thereof, covering subject matter at a level of detail reasonably required by Paratek and sufficient to enable Paratek to determine Zai ’ s compliance with its diligence obligations pursuant to Section 5.1 . In addition, Zai will make available to Paratek such additional information about its Development activities as may be reasonably requested by Paratek from time to time. All updates and reports generated pursuant to this Section 5.4 shall be the Confidential Information of Zai.
5.5. Records . Zai will maintain appropriate rec ords in either tangible or electronic form of (a) all significant Development, Manufacturing, and Commercialization events and activities conducted by it or on its behalf related to a Licensed Product; and (b) all significant information generated by it or on its behalf in connection with Development, Manufacturing, or Commercialization of a Licensed Product under this Agreement, in each case in accordance with Zai’s usual documentation and cGMP record retention practices. Such records will be in sufficient detail to properly reflect, in a good scientific manner, all significant work done and the results of studies and trials undertaken and, further, will be at a level of detail appropriate for patent and regulatory purposes. Zai will document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines. Upon Paratek’s request, Zai will, and will cause its Affiliates and Sublicensees, to provide to Paratek copies of such records (including access to relevant databases, if any) of Development, Manufacturing, and Commercialization activities to the extent necessary or useful for the Development, Manufacturing, and Commercialization of the Compound or Licensed Product outside the Territory, including for regulatory and patent purposes. All such records, reports, information and data provided will be subject to the confidentiality provisions of ARTICLE 10.
6.1. Zai’s Responsibilities . Zai will be responsible for all regulatory activities leading up to and including the obtaining of the Regulatory Approvals for a Licensed Product from the Regulatory Authority on a region-by-region basis, at its sole cost and expense. Zai or its designee will own and hold all Regulatory Approvals for a Licensed Product in the Territory. Zai will keep Paratek informed of regulatory developments related to the Licensed Products in the Territory and will promptly notify Paratek in writing of any decision by any Regulatory Authority in the Territory regarding the Licensed Product. Zai will notify Paratek of any Regulatory Submissions submitted to or received from any Regulatory Authority in the Territory and will provide Paratek with copies thereof within five days after submission or receipt. If any material Regulatory Submission is not in the English language, Zai will also provide Paratek with a summary thereof in English as soon as practicable.
6.2. Paratek’s Responsibilities . [* * *] Paratek will reasonably cooperate with Zai in obtaining any Regulatory Approvals for a Licensed Product in the Territory by providing, to the extent reasonably required by and reasonably useful to Zai, access to regulatory approvals,
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Regulatory Submissions, clinical data, and other data, information, and documentation for the Licensed Product outside of the Territory . In addition, upon Zai ’ s reasonable request, Paratek will, and will cause its Affiliates and sublicensees (to the extent permitted in such sublicensees ’ agreement with Paratek), to provide to Zai copies of such records of Development, Manufacturing, and Commercialization activities to the extent necessary or reasonably useful to obtain Regula tory Approval of the Licensed Product in the Territory. [* * *] provide assistance to Zai for such cooperation.
6.3. Right of Reference. Each Party hereby grants to the other Party the right of reference to all Regulatory Submissions pertaining to the Licensed Product in the Field submitted by or on behalf of such Party. Zai may use such right of reference to Paratek’s Regulatory Submissions in the Field solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of the Licensed Products in Field in the Territory. Paratek may use the right of reference to Zai’s Regulatory Submissions in the Field solely for the purpose of seeking, obtaining and maintaining regulatory approval of the Licensed Products outside the Territory.
6.4. Adverse Events Reporting .
(a) Promptly following the Effective Date, but in no event later than 60 days thereafter, Zai and Paratek will develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “ Safety Agreement ”). Such agreement will describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or sublicensees to comply with its legal obligations. The Safety Agreement will be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 6.4 , Section 6.5 , or any related definitions and the Safety Agreement, the Safety Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters.
(b) Zai will maintain an Adverse Event database for the Licensed Products in the Territory, at its sole cost and expense, and will be responsible for reporting quality complaints, Adverse Events and safety data related to the Licensed Products to the applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to the Licensed Products in the Territory. Zai will provide to Paratek access to, and the information contained in, Zai’s Adverse Event database for the Territory, and Paratek will maintain a global Adverse Event database at its sole cost and expense.
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(c) Zai will be responsible for complying with all Applicable Law governing Adverse Events in the Territory that occur after the Eff ective Date. Zai will notify Paratek on a timely basis of any Adverse Events occurring at or reported by any Clinical Trial location at which Zai is responsible for performing Clinical Trials. Zai will submit copies of reports of Adverse Events to Parate k simultaneously with submission to the applicable Regulatory Authorities. Each Party will notify the other in a timely manner and in any event within 24 hours of receiving any serious Adverse Event reports from Clinical Trials that each Party is monitori ng, notice from a Regulatory Authority, independent review committee, data safety monitoring board or another similar clinical trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue or other material informati on relevant to the safety or efficacy of Licensed Product.
6.5. Safety and Regulatory Audits . Upon reasonable notification, and no more frequently than [* * *] (provided that the foregoing frequency limit shall not apply if Paratek has cause), Paratek will be entitled to conduct an audit of safety and regulatory systems, procedures and practices of Zai, including on-site evaluations to the extent permitting such on-site evaluations is in the control of Zai. Further details including notification, timing, response and scope of such audits will be included in the Safety Agreement.
6.6. No Harmful Actions . If Paratek believes that Zai is taking or intends to take any action with respect to the Licensed Product that could have a material adverse impact upon the regulatory status of the Licensed Product outside the Territory, Paratek will have the right to bring the matter to the attention of the JSC and the Parties will discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties ot herwise agree: (a) Zai will not communicate with any Regulatory Authority having jurisdiction outside the Territory, unless so ordered by such Regulatory Authority, in which case Zai will immediately notify Paratek of such order; and (b) Zai will not submit any Regulatory Submissions or seek regulatory approvals for the Licensed Product outside the Territory. To the extent practicable, Paratek will provide Zai with any information that reasonably could affect the Development or Commercialization of the Licensed Product in the Territory, prior to making such information public.
6.7. Notification of Threatened Action . Each Party will immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may affect the safety or efficacy claims of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.
6.8. Remedial Actions . Each Party will notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other regulatory action by any Governmental Authority or Regulatory Authority (a “ Remedial Action ”). The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of
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conducting a Remedial Action. Zai will have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action. The cost and expenses of any Remedial Action in the Territory will be borne solely by Zai. Zai will, and will ensure that its Affiliates and Sublicensees will, maintain adequate records to permit the Parties to trace the manufacture, distribution and use of the Li censed Product in the Territory.
7.1. Manufacture and Supply . Zai will be responsible for, and use Commercially Reasonable Efforts to Manufacture, or have Manufactured (pursuant to Section 2.4 ), Licensed Products, sufficient and solely to meet the Development and Commercialization requirements of a Licensed Product in the Territory, at its sole cost and expense. Zai will undertake such Manufacturing activities of the Licensed Products in accordance with the Product Specifications. If [* * *], Paratek will permit Paratek’s suppliers to provide such supply to Zai and shall reasonably assist Zai to obtain a supply of Licensed Products for the Development and Commercialization activities contemplated hereunder by introducing Zai to suppliers that Paratek utilizes at that time . Zai will ensure that any arrangement between Zai and such suppliers (a) will not alter or affect Paratek’ s supply related to the Licensed Product, and (b) Paratek will not have any liability or obligation related to such arrangements. If Zai is required by the CFDA to Commercialize the Licensed Product as an imported product, the Parties will negotiate in good faith the terms of an agreement to address this event (an “ Imported Product Agreement ”), and such agreement will include, but not be limited to, provisions whereby Zai will indemnify Paratek for any liability (including product liability) related to Paratek’s involvement in the Development, Manufacture or Commercialization of the Licensed Product as an imported product, and Zai will maintain approp riate minimum liability insurance (to be determined in the Imported Product Agreement) levels. For the avoidance of doubt, (y) Paratek will be adequately protected from any liability based on Zai’s activities in the Territory including Zai’s sourcing of the Compound or Licensed Product, and (z) absent the Parties agreement to terms pursuant to an Imported Product Agreement, Paratek will not have any obligation to (i) accommodate the supply (directly or indirectly) of the Compound or Licensed Product to Zai, or (ii) be an applicant on a regulatory application or holder of a regulatory approval related to Zai’s Exploitation of the Licensed Product as an imported product.
7.2. Transfer of Manufacturing Know-How . As part of the Initial Technology Transfer, in accordance with the Technology Transfer Plan, Paratek will make available to Zai the Paratek Know-How that constitutes the then-current process used by Paratek or its Third Party manufacturer in the manufacture of Licensed Products. In addition, as per the Continuing Technology Transfer, Paratek will provide reasonable technical assistance regarding such manufacturing related Paratek Know-How as requested by Zai in accordance with Section 4.1 . Zai will be responsible for the costs and expenses incurred by Paratek in performing such part of
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the Technology Transfer in accordance with Section 4.3 . After the completion of such part of the Initial Technology Transfer, each Party will promptly notify the other Party of any changes in its manufacturing process for the Licensed Products and upon such other P arty ’ s request, will provide reasonable assistance to enable such other Party to implement such changes, with each Party bearing its own costs.
7.3. Agreement with Contract Manufacturer . To the extent that Zai enters into an agreement with any contract manufacturing organization to manufacture Licensed Product for and on behalf of Zai, such agreement shall set forth the respective responsibilities of the parties with regards to quality assurance for the Licensed Product, and Zai shall obligate such contract manufacturing organization in the Territory to comply with all Applicable Laws, including GMP, and ensure that any such contract manufacturing organization is not, and has not been, debarred or disqualified by any Regulatory Authority.
8.1. Commercialization Diligence. Zai will be responsible for, and use Commercially Reasonable Efforts to Commercialize the Licensed Products in the Field in the Territory in accordance with the Commercialization Plan, at its sole cost and expense. Upon Zai’s reasonable request, Paratek will reasonably assist Zai in such Commercialization of the Licensed Product.
8.2. Commercialization Plan . The Commercialization Plan will contain in reasonable detail the major Commercialization activities and the timelines for achieving such activities. Zai will deliver an initial Commercialization Plan to the JSC for review and discussion no later than 12 months prior to the anticipated date of the first filing of the first Regulatory Approval for a Licensed Product in the Territory. Thereafter, from time to time, but at least every 12 months, Zai will propose updates or amendments to the Commercialization Plan in consultation with Paratek to reflect changes in such plans, including those in response to changes in the marketp lace, relative success of the Licensed Product, and other relevant factors influencing such plan and activities, and submit such proposed updated or amended plan to the JSC for review, discussion, and approval. In accordance with Section 3.2(b), the JSC will review and discuss any updates or amendments to the Commercialization Plan.
8.3. Commercialization Reports . Zai will update the JSC at each regular ly scheduled JSC meeting regarding Zai’s Commercialization activities with respect to the Licensed Products in the Territory. Each such update will be in a form to be agreed by the JSC and will summarize Zai’s, its Affiliates’ and Sublicensees’ significant Commercialization activities with respect to the Licensed Products in the Territory, covering subject matter at a level of detail reasonably required by Paratek and sufficient to enable Paratek to determine Zai’s compliance with its diligence obligations pursuant to Section 8.1 . In addition, Zai will make available to Paratek such additional information about its Commercialization activities as may be reasonably
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requested by Paratek from time to time. For clarity, Zai will not be required to include information in its updates and reports under this Section 8.3 that it does not otherwise create for its own internal purposes. All updates and reports generated pursuant to t his Section 8.3 shall be the Confidential Information of Zai.
8.4. Product Trademarks. Zai will have the right to brand the Licensed Products in the Territory using trademarks, logos, and trade names it determines appropriate for the Licensed Products, which may vary by region or within a region (the “ Product Marks ”). Zai will own all rights in the Product Marks in the Territory and will register and maintain the Product Marks in the Territory that it determines reasonably necessary, at Zai’s cost and expense. Upon Zai’s request, Paratek will reasonably assist Zai in the selection and design of the Product Marks. Zai will also have the right (pursuant to this Section 8.4 ) to use certain trademarks in the Territory as set forth in Schedule 8.4 (the “ Paratek Product Marks ”). If Zai elects to use the Paratek Product Marks in connection with the Commercialization of the Licensed Products in the Territory, Paratek will and hereby does grant to Zai, during the Term and subject to the terms and conditions of this Agreement, a royalty-free, exclusive license under Paratek’s rights to use such Paratek Product Marks in connection with the Commercialization of the Licensed Products in the Field in the Territory in compliance with Applicable Laws. Zai will comply with Paratek’ s brand usage guidelines provided to Zai in its use of the Paratek Product Marks. For the avoidance of doubt, Paratek (a) has sole discretion regarding prosecution and maintenance of the Paratek Product Marks, provided that, after Zai has initiated launch efforts to Commercialize the Product under any particular Paratek Product Mark, Paratek shall notify Zai in writing of any decision to modify and/or discontinue the application or registration of such Paratek Product Mark in the Territory, and shall not carry out such modification or discontinuation without Zai’s prior written consent (not to be unreasonably withheld), further provided that Paratek shall not be required to obtain Zai’ s consent if such modification and/or discontinuation is required by the applicable Regulatory Authority in the Territory or is necessary to avoid any potential infringement of the rights of any Third Party, and (b) has no obligation to ensure that, and provides no guarantee that, any applications included in the Paratek Products Marks issues to a registered trademark in the Territory.
8.5. Commercialization Assistance . Zai will reimburse Paratek’s actual internal expenses and costs at the FTE Rate for FTEs engaged to, and out-of-pocket expenses and costs incurred by Paratek to, provide assistance to Zai Commercialization activities, including assistance pursuant to Sections 8.1 and 8.4 .
8.6. Compliance . Zai will (a) comply, and will cause its Affiliates and Sublicensees to comply, with all Applicable Laws and all applicable cGMP, GCP, GLP and GSP (or similar standards) in their conduct of the Development, Manufacturing, and Commercialization activities under this Agreement and (b) ensure that its Affiliates and Sublicensees do not transfer or divert the Compound or Licensed Product to an entity other than Zai, or an entity approved by Zai, in each case in a manner that would cause the sale of such Compound or Licensed Product in the
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chain of distribution (from Zai or its Affiliates or Sublicensees to the end user) to be excluded (except as an exception provided in the Net Sales definition) in the calculation of Net Sales, provided that for each unit of the Compound and/or Licensed Product, the inclusion of such sales in the calculation of Net Sales shall occur only once. Upon reasonable notification, but no more than [* * *] (provided that the foregoing frequency limit shall not apply if Paratek has cause), Paratek will have the r ight to conduct audits of Zai, and Zai will procure such right for Paratek to audit Zai ’ s Affiliates and Sublicensees (either directly or through Zai and its designee), to ensure (y) compliance with applicable cGMP, GCP, GLP, and GSP standards, including o n-site evaluations (to the extent permitting such evaluations is under the control of the audited Party), and (z) compliance with Section 8.6(b) .
ARTICLE 9
Payments and Milestones
9.1. Tufts Agreement and IP Transfer Agreement Payments .
(a) Paratek will be responsible, at its costs, for all payments, royalties or milestones under the Tufts Agreement.
(b) Paratek will be responsible, at its costs, for all payments under the IP Transfer Agreement.
9.2. Upfront Payment . In partial consideration of the rights granted by Paratek to Zai hereunder, Zai will pay to Paratek US$7,500,000 (the “ Upfront Payment ”) within [* * *] days of the Effective Date.
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9.3. Milestones Payments to Paratek .
(a) In partial consideration of the rights granted herein, Zai will pay to Paratek the following milestone payments (each such payment, a “ Milestone Payment” ) within [* * *] days of the achievement of the corresponding milestone events set forth below (each such event, a “ Milestone Event ”), or in the case of Net Sales Milestone Events, within [* * *] days after the end of the Calendar Quarter in which the Net Sales Milestone Event occurs.
Milestone Event |
Milestone Payment |
First regulatory approval for a Licensed Product in the U.S. for the CABP indication |
US$5,000,000 |
[* * *] |
US$[* * *] |
[* * *] |
US$[* * *] |
First time that Net Sales of Licensed Products in a Calendar Year exceeds US$[* * *] |
US$[* * *] |
First time that Net Sales of Licensed Products in a Calendar Year exceeds US$[* * *] |
US$[* * *] |
First time that Net Sales of Licensed Products in a Calendar Year exceeds US$[* * *] |
US$[* * *] |
(b) For the avoidance of doubt (i) each Milestone Payment will be payable on the first occurrence of the corresponding Milestone Event, and (ii) none of the Milestone Payments will be payable more than once.
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(a) Royalty Payment . During the Royalty Term, Zai will pay to Paratek tiered royalties based on annual Net Sales of Licensed Product in the Territory in a Calendar Year (a “ Royalty Payment ”). The royalty rates will be as set forth below (subject to Section 9.4(d)):
Tier |
Royalty % |
≥ US$[* * *] and ≤ US$[* * *] |
[* * *]% |
> US$[* * *] and ≤ US$[* * *] |
[* * *]% |
> US$[* * *] and ≤ US$[* * *] |
[* * *]% |
> US$[* * *] |
[* * *]% |
(b) Example . By way of example, if the Net Sales in a Calendar Year of Licensed Product within the Territory equals $[* * *], the royalty amount owed by Zai to Paratek would be US$[* * *].
(c) Royalty Term. The Royalty Payments payable under this Section 9.4 will be payable on a region-by-region basis from the First Commercial Sale of the Licensed Produc t in such region until the later of: (i) the abandonment, expiry or final determination of invalidity of the last Valid Claim within the Paratek Patents that covers the Exploitation of the Licensed Products 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 close of business of the day that is exactly 11 years after the date of the First Commercial Sale of such Licensed Product in such region (the “ Royalty Term ”).
(d) Royalty Rate Reduction for Generic Product Market Effect . If there is no longer a Valid Claim within the Paratek Patents covering a Licensed Product in a region in the Territory, then Zai may reduce the Royalty Payments for Net Sales in such region by (i) [* * *]% in any Calendar Quarter that Zai can demonstrate that one or more generic equivalent products are on the market in such region and sales of such generic equivalent product(s) in the region constitute [* * *]% or more of the total sales of such generic equivalent product(s) and Licensed Product in such region or (ii) [* * *]% in any Calendar Quarter that Zai can demonstrate that one or more generic equivalent products are on the market in such region and sales of such generic equivalent product(s) in the region constitute [* * *]% or more of the total sales of such generic equivalent product(s) and Licensed Product in such region.
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(e) Royalty Estimates and Royalty Reports . Following the First Commercial Sale of any L icensed Product for which royalties are due pursuant to this Section 9.4 , and continuing for so long as royalties are due hereunder:
(i) Zai will, within [* * *] days after the end of each Calendar Quarter, provide Paratek a good faith estimate of the royalties due for such Calendar Quarter; and
(ii) Zai will, within [* * *] days after the end of each Calendar Quarter, provide a royalty report showing, on a region-by-region basis:
(1) the Net Sales of each Licensed Product sold by Zai, its Affiliates and Sublicensees during such Calendar Quarter reporting period;
(2) the Royalty Payments in United States dollars which will have accrued hereunder with respect to such Net Sales, with supporting calculations showing the applicable royalty rate applied;
(3) the rate of exchange with supporting calculations, determined in accordance with Section 9.5(b), used by Zai in determining the amount of United States dollars payable hereunder.
(f) Royalty Payment. Zai will pay to Paratek the royalties for each Calendar Quarter within [* * *] days after the end of such Calendar Quarter. If no royalty is due for any Calendar Quarter following commencement of the reporting obligation, Zai will so report.
(a) Mode of Payment. All payments to be made under this Agreement will be made in U.S. Dollars and will be paid by electronic transfer in immediately available funds to such bank account in the United States as is designated in writing by a Party. All payments will be free and clear of any transfer fees or charges.
(b) Currency Exchange Rate. All payments under this Agreement will be payable in U.S. Dollars. All expense amounts will be calculated in the foreign currency for the country or region in which expenses are incurred, and will then be converted into U.S. Dollars by applying the rate of exchange used by a Party for its own financial reporting purposes in connection with its other products or accounts, consistently applied, which will be consistent with US GAAP. The rate of exchange to be used in computing the amount of currency equivalent in U.S. Dollars for calculating Net Sales in a Calendar Quarter (for purposes of both the royalty calculation and whether a Net Sales milestone has been achieved) shall be made at the exchange rate as published by the Wall Street Journal on the last Business Day of such Calendar Quarter, or such other source as the Parties may agree in writing.
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(a) Zai will keep, and will require its Affiliates and Sublicensees to keep (all in accordance with US GAAP, consistently applied), for a period not less than [* * *] complete and accurate records in sufficient detail to properly reflect Net Sales and to enable any Milestone Payment payable hereunder to be determined.
(b) Upon the written request of Paratek, Zai will permit, and will cause its Affiliates and Sublicensees to permit, an independent certified public accounting firm of nationally recognized standing selected by Paratek and reasonably acceptable to Zai, at Paratek’s expense, to have access during normal business hours to such records of Zai and/or its Affiliates as may be reasonably necessary to verify the accuracy of the payments hereunder for any Calendar Year ending not more than [* * *] prior to the date of such request. These rights with respect to any Calendar Year will terminate [* * *] after the end of any such Calendar Year and shall be limited to (i) [* * *] and (ii) [* * *] with respect to records covering any specific period of time (provided that the foregoing frequency limits ((i) and (ii)) shall not apply if Paratek has cause). Paratek will provide Zai with a copy of the accounting firm’s written report within [* * *] days of completion of such report. If such accounting firm correctly concludes that an underpayment was made, then Zai will pay the amount due within [* * *] days of the date Paratek delivers to Zai such accounting firm’s written report so correctly concluding. Paratek will bear the full cost of such audit unless such audit correctly discloses that the additional payment payable by Zai for the audited period is more than [* * *]% of the amount otherwise paid for that audited period, in which case Zai will pay the reasonable fees and expenses charged by the accounting firm.
(c) Paratek will treat all financial information, subject to review under this Section 9.6 in accordance with the confidentiality provisions of ARTICLE 10, and, prior to commencing such audit, will cause its accounting firm to enter into a confidentiality agreement with Zai obligating it to treat all such financial information in confidence pursuant to such confidentiality provisions. Such accounting firm shall not disclose Zai’s Confidential Information to Paratek, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by Zai or the amount of payments to or by Zai under this Agreement.
(d) Zai will include in each relevant sublicense granted by it a provision requiring any Sublicensee to maintain records of sales of Licensed Products made pursuant to such sublicense, and to grant access to such records by an accounting firm to the same extent and under the same obligations as required of Zai under this Agreement. Paratek will advise Zai in advance of each audit of any such Sublicensee with respect to Licensed Product sales either by Paratek or its designated auditor under the terms of such Sublicensee agreement. Paratek will provide Zai with a summary of the results received from the audit and, if Zai so requests, a copy of the audit report. Paratek will pay the full costs charged by the accounting firm, unless the audit discloses that the additional payments payable to Paratek for the audited period is more than [* * *]% from the amounts otherwise paid for that audited period, in which case Zai will pay the reasonable fees and expenses charged by the accounting firm.
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9.7. Interest . Each Party will pay interest on any amounts overdue under this Agreement at a per annum rate of [* * *] point above the Prime Rate assessed from the day payment was initially due; provided, however, that in no case will su ch interest rate exceed the highest rate permitted by Applicable Law. The payment of such interest will not foreclose a Party from exercising any other rights it may have because any payment is overdue.
(a) [* * *] any VAT required to be deducted or withheld by Zai under Applicable Law on payments payable by Zai under this Agreement, and will [* * *] the deduction or withholding for VAT. If Zai is required to deduct or withhold Taxes (including VAT) on any payments payable by Zai under this Agreement, Zai will (i) pay such Tax on behalf of Paratek to the appropriate Governmental Authority, (ii) furnish Paratek with proof of payment of such Tax, and (iii) [* * *] required to be deducted or withheld [* * *] as set forth in the Agreement. For example, if Paratek is due US[* * *] under this Agreement, and Zai is required by Applicable Law to withhold [* * *], [* * *] and [* * *].
(b) Zai and Paratek will cooperate with respect to all documentation required by any taxing authority or reasonably requested by Zai to secure a reduction in the rate of applicable Taxes.
ARTICLE 10
Confidentiality; Publication
10.1. Nondisclosure Obligation .
(a) For the Term of this Agreement and [* * *] thereafter, the Party receiving the Confidential Information of the other Party (such receiving Party, the “ Receiving Party ”) will keep confidential and not publish, make available or otherwise disclose any Confidential Information to any Third Party, without the express prior written consent of the Party that disclosed such Confidential Information (the “ Disclosing Party ”); provided however, the Receiving Party may disclose the Confidential Information to those of its Affiliates, officers, directors, employees, agents, consultants and/or independent contractors (including sublicensees) of such Receiving Party who need to know the Confidential Information in connection with this Agreement and are bound by confidentiality obligations with respect to such Confidential Information. The Receiving Party will exercise at a minimum the same degree of care it would exercise to protect its own confidential information (and in no event less than a reasonable standard of care) to keep confidential the Confidential Information. The Receiving Party will use the Confidential Information solely in connection with the purposes of this Agreement.
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(b) It will not be considered a breach of this Agreement if the Receiving Party discloses Confidential Information in order to comply with a lawfully issued court or governmental order or with a requirement of Applicable Law or the rule s of any internationally recognized stock exchange; provided that: (i) the Receiving Party gives prompt written notice of such disclosure requirement to the Disclosing Party and cooperates with the Disclosing Party ’ s efforts to oppose such disclosure or ob tain a protective order for such Confidential Information, and (ii) if such disclosure requirement is not quashed or a protective order is not obtained, the Receiving Party will only disclose those portions of the Confidential Information that it is legall y required to disclose and will make a reasonable effort to obtain confidential treatment for the disclosed Confidential Information. To the extent there is any conflict between this ARTICLE 10 and any other agreement related to Confidential Information entered into between the Parties, the terms of this ARTICLE 10 will control to the extent of such conflict.
10.2. Scientific Publication. The JDC will discuss the publication strategy for the publication of scientific papers, abstracts, meeting presentations and other disclosure of the results of the studies carried out under this Agreement, taking into consideration the Parties’ interest in publishing the results of the Development work in order to obtain recognition within the scientific community and to advance the state of scientific knowledge, and the need to protect Confidential Information, intellectual property rights and other business interests of the Parties. Zai will provide Paratek with the opportunity to review and comment on any proposed publication that pertains to the Compound or Licensed Products at least [* * *] days prior to its intended submission for publication. Paratek will provide Zai with its comments, if any, within [* * *] days after the receipt of such proposed publication. Zai will consider in good faith the comments provided by Paratek and will comply with Paratek’ s request to: (a) remove any and all Confidential Information of Paratek from such proposed publication; and (b) delay the submission for a period up to [* * *] days as may be reasonably necessary to seek patent protection for the information disclosed in the proposed publication. Zai agrees to acknowledge the contribution of Paratek and Paratek’s employees in all publication as scientifically appropriate.
10.3. Publicity; Use of Names .
(a) Each of the Parties agrees not to disclose to any Third Party the terms and conditions of this Agreement without the prior approval of the other Party, except to (i) advisors (including consultants, financial advisors, attorneys and accountants), (ii) bona fide potential and existing investors and acquirers on a need to know basis, in each case under circumstances that reasonably protect the confidentiality thereof, (iii) to the extent necessary to comply with the terms of agreements with Third Parties, or (iv) to the extent required by Applicable Laws, including securities laws and regulations. Notwithstanding the foregoing, the Parties must agree upon the initial press release(s) to announce the execution of this Agreement; thereafter, Paratek and Zai may each disclose to Third Parties the information contained in such press release(s) without the need for further approval by the other.
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(b) The Parties acknowledge the importance of supporting each other ’ s efforts to publicly disclose results and significant de velopments regarding a Licensed Product for use in the Field in the Territory and other activities in connection with this Agreement, beyond what may be strictly required by Applicable Laws and the rules of a recognized stock exchange, and Zai may make suc h disclosures from time to time with respect to the Licensed Product with the approval of Paratek, which approval will not be unreasonably withheld, conditioned or delayed. Such disclosures may include achievement of significant events in the Development (including regulatory process) or Commercialization of a Licensed Product for use in the Field in the Territory. Unless otherwise requested by the applicable Party, each Party will indicate that Paratek is the licensor of a Licensed Product, Paratek Paten ts, and Paratek Know-How, as applicable, in each public disclosure issued by such Party regarding a Licensed Product. When Zai elects to make any public disclosure under this Section 10.3(b) , it will give Paratek reasonable notice to review and comment on such statement, it being understood that (i) if Paratek does not notify Zai in writing within [* * *] days or such shorter period if required by A pplicable Laws of any reasonable objections, as contemplated in this Section 10.3(b) , such disclosure will be deemed approved, and (ii) if Paratek d oes notify Zai in writing within the time period set forth in clause (i) above, and reasonably determines that such public disclosure would entail the public disclosure of Paratek ’ s Confidential Information or of patentable inventions upon which patent app lications should be filed prior to such public disclosure, such public disclosure will be delayed for such period as may be reasonably necessary for deleting any such Confidential Information of Paratek, or the drafting and filing of a patent application c overing such inventions, provided such additional period will not exceed [* * *] days from the proposed date of the public disclosure, and, in any event, Paratek will work diligently and reasonably to agree on the text of any proposed disclosure in an expe ditious manner. The principles to be observed in such disclosures will be accuracy, compliance with Applicable Laws and regulatory guidance documents, and reasonable sensitivity to potential negative reactions of applicable Regulatory Authorities.
(c) The Parties acknowledge the need to keep investors and others informed regarding such Party’s business under this Agreement, including as required by the rules of a recognized stock exchange. To the extent a Party is publicly listed or becomes publicly listed, a nd subject to Sections 10.3(a) and 10.3(b), such Party may issue press releases or make disclosures to the SEC or other applicable agency as it determines, based on advice of counsel, as reasonably necessary to comply with laws or regulations or for appropriate market disclosure; provided that each Party shall provide the other Party with advance notice of legally required disclosures to the extent practicable. The Parties will consult with each other on the provisions of this Agreement to be redacted in any filings made by a Party with the SEC or as otherwise required by Applicable Laws; provided that each Party shall have the right to make any such filing as it reasonably determines necessary under Applicable Laws.
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ARTICLE 11
Representations, Warranties, and Covenants
11.1. Representations, Warranties, and Covenants of Each Party. Each Party represents and warrants, and covenants to the other Party as of the Effective Date that:
(a) it is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including, without limitation, the right to grant the licenses granted by it hereunder; and
(b) (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder; and (iii) the Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms;
(c) it is not a party to any agreement that would prevent it from granting the rights granted to the other Party under this Agreement or performing its obligations under the Agreement;
(d) in the course of performing its obligations or exercising its rights under this Agreement, it will comply with all Applicable Laws, including as applicable, cGMP, GCP, GLP, and GSP standards, and will not employ or engage any party who has been debarred by any Regulatory Authority, or, to such Party’s knowledge, is the subject of debarment proceedings by a Regulatory Authority.
11.2. Additional Representations and Warranties of Paratek . Paratek represents and warrants to Zai that as of the Effective Date:
(a) it has the right under the Paratek Technology to grant the licenses to Zai as purported to be granted pursuant to this Agreement;
(b) to Paratek’s actual knowledge, the Manufacture, use or sale of the Licensed Product in the Territory for the purposes set forth in the Development Plan will not infringe any issued claim of an issued Patent of any Third Party (except Patents for which Paratek has a license);
(c) Schedule 1.69 lists all Patents in the Territory Controlled by Paratek that cover the composition of matter or formulation of, or salt of or polymorph forms of, or the method of making or method of using, a Licensed Product;
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(d) it has not granted any liens or security interests on the Paratek Technology;
(e) Paratek has not as of the Effective Date, and will not during the Term, grant any right to any Third Party under the Paratek Technology that would conflict with the rights granted to Zai hereunder;
(f) Paratek and its Affiliates is not, and has not been, debarred or disqualified by any Regulatory Authority;
(g) no claim or action has been brought against Paratek or, to Paratek’s knowledge, threatened in writing to Paratek, by any Third Party alleging that the Paratek Patents are invalid or unenforceable, and no interference, opposition, cancellation or other protest proceeding has been filed against a Paratek Patent owned by Paratek; and
(h) Paratek has made available to Zai, via the virtual data room, copies of all patient safety and efficacy data tables, in all material respects, that are in Paratek’s possession as of the Effective Date, in connection with the global Phase III Clinical Study conducted by Paratek for acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
(a) Paratek will not modify, amend, or terminate the Tufts Agreement in a manner that is materially adverse to Zai without Zai’s prior written consent.
(b) Paratek will not modify, amend, or terminate, or cause to modify, amend or terminate, the IP Transfer Agreement in a manner that is materially adverse to Zai without Zai’s prior written consent.
11.4. Representations, Warranties, and Covenants of Zai . Zai represents, warrants, and covenants to Paratek that as of the Effective Date:
(a) there are no legal claims, judgments or settlements against or owed by Zai, or pending or, to Zai’s actual knowledge, threatened, legal claims or litigation, in each case, relating to antitrust, anti-competition, anti-bribery or corruption violations;
(b) Zai and its Affiliates is not, and has not been, debarred or disqualified by any Regulatory Authority;
(c) Zai has sufficient financial wherewithal to (i) perform all of its obligations pursuant to this Agreement, and (ii) meet all of its obligations that come due in the ordinary course of business;
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(d) Zai has, or will obtain, sufficient technical, clinical, and regulatory expertise to perform all of its obligations pursuant to this Agreement, including its obligations relating to Development, Manufacturing, Commercialization, and obtaining Regulatory Approvals; and
(e) Zai will, and will cause its Affiliates and Sublicensees to, be bound by and comply with all obligations that the Tufts Agreement states would apply to sublicenses or sublicensees of the Tufts Agreement.
11.5. NO OTHER REPRESENTATIONS OR WARRANTIES . EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL SUCH REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
11.6. Compliance with Anti-Corruption Laws .
(a) Notwithstanding anything to the contrary in the Agreement, Zai hereby agrees that:
(i) it will not, in the performance of this Agreement, perform any actions that are prohibited by local and other anti-corruption laws (including the provisions of the U.S. Foreign Corrupt Practices Act, collectively “ Anti-Corruption Laws ”) that may be applicable to one or both Parties to the Agreement;
(ii) it will not, in the performance of this Agreement, directly or indirectly, make any payment, or offer or transfer anything of value, or agree or promise to make any payment or offer or transfer anything of value, to a government official or government employee, to any political party or any candidate for political office or to any other Third Party with the purpose of influencing decisions related to either Party and/or its business in a manner that would violate Anti-Corruption Laws;
(iii) it will, on an annual basis upon request by the other Party, verify in writing that to the best of such Party’s knowledge, there have been no violations of Anti-Corruption Laws by such Party or persons employed by or subcontractors used by such Party in the performance of the Agreement, or will provide details of any exception to the foregoing; and
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(iv) it will maintain records (financial and otherwise) and supporting documentation related to the subject matter of the Agreement in order to document or verify compliance with the provisions of this Section 11.6 , and upon request of the other Party, up to once per year and upon reasonable advance notice, will provide a Third Party auditor mutually acceptable to the Parties with access to such records for p urposes of verifying compliance with the provisions of this Section 11.6 . Acceptance of a proposed Third Party auditor may not be unreasonably with held by either Party. It is expressly agreed that the costs related to the Third Party auditor will be fully paid by the Party requesting the audit, and that any auditing activities may not unduly interfere with the normal business operations of Party sub ject to such auditing activities. The audited Party may require the Third Party auditor to enter into a reasonable confidentiality agreement in connection with such an audit.
(b) To its knowledge as of the Effective Date, neither Zai nor any of its subsidiaries nor any of their Affiliates, directors, officers, employees, distributors, agents, representatives, sales intermediaries or other Third Parties acting on behalf of Zai or any of its subsidiaries or any of their Affiliates:
(i) has taken any action in violation of any applicable anticorruption law, including the U.S. Foreign Corrupt Practices Act (15 U.S.C. § 78 dd-1 et seq.); or
(ii) has corruptly, offered, paid, given, promised to pay or give, or authorized the payment or gift of an ything of value, directly or indirectly, to any Public Official (as defined in Section 11.6(d) below), for the purposes of:
(iii) influencing any act or decision of any Public Official in his official capacity;
(iv) inducing such Public Official to do or omit to do any act in violation of his lawful duty;
(v) securing any improper advantage; or
(vi) inducing such Public Official to use his or her influence with a government, governmental entity, or commercial enterprise owned or controlled by any government (including state-owned or controlled veterinary or medical facilities) in obtaining or retaining any business whatsoever.
(c) As of the Effective Date, none of the officers, directors, employees, of Zai or of any of its Affiliates or agents acting on behalf of Zai or any of its Affiliates, in each case that are employed or reside outside the United States, are themselves Public Officials.
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(d) For purposes of this Section 11.6 , “ Public Official ” means (i) any officer, employee or representative of any regional, federal, state, provincial, county or municipal government or g overnment department, agency or other division; (ii) any officer, employee or representative of any commercial enterprise that is owned or controlled by a government, including any state-owned or controlled veterinary or medical facility; (iii) any officer , employee or representative of any public international organization, such as the African Union, the International Monetary Fund, the United Nations or the World Bank; and (iv) any person acting in an official capacity for any government or government ent ity, enterprise or organization identified above.
12.1. By Zai . Zai will indemnify and hold harmless Paratek, its Affiliates, and their directors, officers, employees and agents (individually and collectively, the “ Paratek Indemnitee(s) ”) from and against all losses, liabilities, damages and expenses (including reasonable attorneys’ fees and costs) incurred in connection with any claims, demands, actions or other proceedings by any Third Party (individually and collectively, “ Losses ”) first aris ing after the Effective Date to the extent arising from (a) Manufacturing, Development, and Commercialization activities, including the promotion of a Licensed Product and product liability claims relating to the Licensed Product, by Zai or any of its Affi liates or Sublicensees, (b) the [* * *], illegal conduct or willful misconduct of Zai, or (c) Zai’s breach of any of its representations or warranties made in or pursuant to this Agreement or any covenants or obligations set forth in or entered into pursua nt to this Agreement, in each case of clauses (a) through (c) above except to the extent such Losses arise out of an Paratek Indemnitee’s gross negligence, illegal conduct or willful misconduct, or breach of this Agreement.
12.2. By Paratek . Paratek will indemnify and hold harmless Zai, its Affiliates, and their directors, officers, employees and agents (individually and collectively, the “ Zai Indemnitee(s) ”) from and against all Losses to the extent arising from (a) to the extent any of the following occur, Manufacturing, Development and Commercialization activities in the Territory, including the promotion of a Licensed Product and product liability claims relating to the Licensed Product in the Territory, by Paratek or any of its Affiliates or licensees (other than Zai), (b) the [* * *], illegal conduct or willful misconduct of Paratek, or (c) Paratek’s breach of any of its representations or warranties made in or pursuant to this Agreement or any covenants or obligations set forth in or entered into purs uant to this Agreement, in each case of clauses (a) through (c) above, except to the extent such Losses arise out of any of a Zai Indemnitee’s gross negligence, illegal conduct or willful misconduct, or breach of this Agreement.
12.3. Defined Indemnification Terms . Either of the Zai Indemnitee or the Paratek Indemnitee will be an “ Indemnitee ” for the purpose of this ARTICLE 12, and the Party that is obligated to indemnify the Indemnitee under Section 12.1 or Section 12.2 will be the “ Indemnifying Party .”
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12.4. Defense . If any such claims or actions are made, the Indemnitee will be defended at the Indemnifying Party ’ s sole expense by counsel selected by the Indemni fying Party and reasonably acceptable to the Indemnitee, provided that the Indemnitee may, at its own expense, also be represented by counsel of its own choosing. The Indemnifying Party will have the sole right to control the defense of any such claim or action, subject to the terms of this ARTICLE 12 .
12.5. Settlement . The Indemnifying Party may settle any such claim, demand, action or other proceeding or otherwise consent to an adverse judgment (a) with prior written notice to the Indemnitee but without the consent of the Indemnitee where the only liability to the Indemnitee is the payment of money and the Indemnifying Party makes such payment, or (b) in all other cases, only with the prior written consent of the Indemnitee, such consent not to be unreasonably withheld or delayed.
12.6. Notice . The Indemnitee will notify the Indemnifying Party promptly of any claim, demand, action or other proceeding under Sections 12.1 or 12.2 and will reasonably cooperate with all reasonable requests of the Indemnifying Party with respect thereto.
12.7. Permission by Indemnifying Party . The Indemnitee may not settle any such claim, demand, action or other proceeding or otherwise consent to an adverse judgment in any such action or other proceeding or make any admission as to liability or fault without the express written permission of the Indemnifying Party.
12.8. LIMITATION OF LIABILITY . SUBJECT TO AND WITHOUT LIMITING THE INDEMNIFICATION OBLIGATIONS OF EACH PARTY WITH RESPECT TO THIRD PARTY CLAIMS UNDER SECTIONS 12.1 OR 12.2 OR LIABILITY AS A RESULT OF A BREACH OF ARTICLE 10, NO PARTY OR ANY OF ITS AFFILIATES WILL BE LIABLE TO THE OTHER PARTY UNDER ANY CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, MULTIPLIED OR CONSEQUENTIAL DAMAGES OR FOR LOST PROFITS (EVEN IF DEEMED DIRECT DAMAGES) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT.
ARTICLE 13
Intellectual Property
13.1. Ownership of Intellectual Property .
(a) As between the Parties, (i) Paratek will remain the sole and exclusive owner of all Paratek Technology, and (ii) Zai will remain the sole and exclusive owner of all Zai Technology.
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(b) Ownership of all Inventions will be assigned based on inventorship, as determined in accordance with the rules of inventorship under United States patent laws. Each Party will own all Inventions, that are made solely by its and its Affiliates ’ employees, agents, and independent contractors, that are made during the performance of activities under this Agree ment (“ Sole Inventions ”). The Parties will jointly own all Inventions that are made jointly by the employees, agents, and independent contractors of one Party and its Affiliates together with the employees, agents, and independent contractors of the other Party and its Affiliates (“ Joint Inventions ”). Patents covering the Joint Inventions will be referred to as “ Joint Patents .” Each Party will own an undivided half interest in the Joint Inventions, without a duty of accounting or an obligation to seek con sent from the other Party for the exploitation or license of the Joint Inventions (subject to the licenses granted to the other Party under this Agreement). Zai hereby grants to Paratek a non-exclusive, royalty-free, fully paid-up, sublicensable license u nder Zai ’ s Sole Inventions, solely for Paratek to Develop, Manufacture, or Commercialize products outside of the Territory and Manufacture products in the Territory.
13.2. Disclosure of Inventions. Each Party will promptly disclose to the other Party all Inventions, including all invention disclosure or other similar documents submitted to such party by its or its Affiliates’ employees, agents, or independent contractors relating to such Inventions, and will also promptly respond to reasonable requests from the other Party for additional information relating to such Inventions.
(a) Paratek Responsibilities . Subject to Section 13.5(b), Para tek will have sole decision making authority, at its sole cost and expense, over Patent Prosecution and maintenance of applications and registrations covering (i) Paratek Know-How, Paratek Patents, and Paratek’s Sole Inventions (such applications and registrations, the “ Paratek Prosecution Patents ”) and (ii) Joint Inventions that are specific to the Licensed Products. Paratek will keep Zai reasonably informed of the status of all actions taken, and will consider in good faith Zai’s recommendations with respect to the Paratek Prosecution Patents in the Territory and Joint Inventions that are specific to the Licensed Products worldwide.
(b) Zai Responsibilities. Zai will have sole decision making authority, at its sole cost and expense, over the Patent Prosecuti on and maintenance of patent applications and registrations covering (i) Zai Technology and (ii) Zai’s Sole Inventions (such applications and registrations, the “ Zai Prosecution Patents ”). Zai will keep Paratek reasonably informed of the status of all actions taken, and will consider in good faith Paratek’s recommendations with respect to the Zai Prosecution Patents and Joint Inventions prosecuted by Zai.
(c) The Parties will discuss the appropriate allocation of responsibility with respect to Joint Inventions that are not specific to the Licensed Products.
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(i) Paratek Responsibilities . Paratek will notify Zai of any decision to cease Patent Prosecution or maintenance of any Paratek Prosecution Patents owned by Paratek in the Territory, or Joint Patents prosecuted by Paratek, and will provide such notice at least 60 days prior to any filing or payment due date, or any other due date that requires action, in connection with such Paratek Prosecution Patent in the Territory or such Joint Patent. In such event, Paratek will permit Zai, at its sole cost and expense, to continue Patent Prosecution or maintenance of such Paratek Prosecution Patent in the Territory or such Joint Patent. If Zai decides to take over Patent Prosecution or maintenance of such Paratek Prosecution Patent or such Joint Patent, then Paratek will promptly deliver to Zai copies of all necessary files related to such Paratek Prosecution Patent or such Joint Patent and will take all actions and execute all documents reasonably necessary for Zai to assume such responsibility. For the avoidance of doubt, Zai’s maintenance or Patent Prosecution of such Paratek Prosecution Patent or such Joint Patent will not change the Parties’ respective ownership rights with respect to such Paratek Prosecution Patent or such Joint Patent.
(ii) Zai Responsibilities . Zai will notify Paratek of any decision to cease Patent Prosecution or maintenance of any Zai Prosecution Patents or Joint Patents prosecuted by Zai (if any), and will provide such notice at least 60 days prior to any filing or payment due date, or any other due date that requires action, in connection with such Zai Prosecution Patent (to the extent relating to the Licensed Product) or such Joint Patent. In such event, Zai will permit Paratek, at its sole cost and expense, to continue Patent Prosecution or maintenance of such Zai Prosecution Patent or such Joint Patent. If Paratek decides to take over Patent Prosecution or maintenance for a Zai Prosecution Patent or a Joint Patent, then Zai will promptly deliver to Paratek copies of all necessary files related to such Zai Prosecution Patent or such Joint Patent and will take all actions and execute all documents reasonably necessary for Paratek to assume such responsibility. For the avoidance of doubt, Paratek’s maintenance or Patent Prosecution of such Zai Prosecution Patent or such Joint Patent will not change the Parties’ respective ownership rights with respect to such Zai Prosecution Patent or such Joint Patent.
13.4. Patent and Trademark Prosecution Cooperation . With respect to all Patent Prosecution or trademark prosecution each Party will:
(a) execute any instruments to document their respective ownership consistent with this Agreement as reasonably requested by the other Party;
(b) make its employees, agents and consultants reasonably available to the other Party (or to the other Party’s authorized attorneys, agents or representatives), to the extent reasonably necessary to enable the appropriate Party hereunder to undertake its Patent Prosecution responsibilities;
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(c) cooperate, if necessary, with the other Party in gaining Patent term extensions; and
(d) act in good faith to coordinate its efforts under this Agreement with the other Party to minimize or avoid interference with the Patent Prosecution of the other Party’s Patents to a Licensed Product or trademarks.
(a) Each Party will notify the other within 30 Business Days of becoming aware of any alleged or threatened infringement by a Third Party of any of the Paratek Patents, Zai Patents, or Joint Patents which infringement adversely affects or is expected to adversely affect any Licensed Product, and any related declaratory judgment, opposition, or similar action alleging the invalidity, unenforceability or non-infringement of any of the Paratek Patents, Zai Patents, or Joint Patents (collectively “ Product Infringement ”).
(b) Zai will have the first right to bring and control any legal action in connection with such Product Infringement in the Territory at its own expense as it reasonably determines appropriate. If Zai decides not to bring such legal action, it will so inform Paratek promptly and Paratek will have the right to bring and control any legal action in connection with such Product Infringement in the Territory at its own expense as it reasonably determines appropriate.
(c) Paratek will have the exclusive right to bring and control any legal action in connection with Product Infringement outside the Territory at its own expense as it reasonably determines appropriate.
(d) Each Party will have the first right in its territory to enforce the Joint Patents for any infringement that is not a Product Infringement at its own expense as it reasonably determines appropriate. If such Party decides not to bring such legal action, it will so inform the other Party promptly and the other Party will have the right to bring and control any legal action in connection with such infringement at its own expense as it reasonably determines appropriate.
(e) At the request of the Party bringing an action related to Product Infringement, the other Party will provide reasonable assistance in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action if required by Applicable Law to pursue such action, at each such Party’s sole cost and expense. In connection with an action related to Product Infringement, the Party bringing the action will not enter into any settlement admitting the invalidity or non-infringement of, or otherwise impairing the other Party’s rights in the Paratek Patents, Zai Patents or Joint Patents (as applicable) without the prior written consent of the other Party.
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(f) Any recoveries resulting from enforcement action relating to a claim of Product Infringement in the Territory will be first applied against payment of each Party ’ s cost s and expenses in connection therewith. Any such recoveries in excess of such costs and expenses will be split as follows: [* * *]
(a) Each Party will notify the other in writing of any allegations it receives from a Third Party that the Exploitation of any Licensed Product or any embodiment of any technology or intellectual property licensed by a Party under this Agreement infringes the intellectual property rights of such Third Party. Such notice will be provided promptly, but in no event after more than 15 days following receipt of such allegations. Such written notice will include a copy of any summons or complaint (or the equivalent thereof) received regarding the foregoing. Each Party will assert and not waive the joint defense privilege with respect to all communications between the Parties.
(b) In such event, the Parties will agree how best to mitigate or control the defense of any such legal proceeding, agree whether to enter into a joint defense agreement to, among other reasons, preserve the confidentiality of communications or cooperation between the Parties in relation to such defense, and determine which Party is best suited to assume the primary responsibility for the conduct of the defense of any such claim at their expense. The other Party will have the right, but not the obligation, to participate and be separately represented in any such suit at its sole option and at its own expense. Each Party will reasonably cooperate with the Party conducting the defense of the claim. If a Party or any of its Affiliates have been individually named as a defendant in a legal proceeding relating to the alleged infringement of a Third Party’s Patents or other intellectual property right as a result of the Exploitation of a Licensed Product, then that Party will conduct the defense and the other Party will be allowed to join in such action, at its own expense.
(c) The Parties will keep each other informed of the status of and of their respective activities regarding any infringement litigation initiated by a Third Party concerning a Party’s Exploitation of a Licensed Product or settlement thereof; provided, however, that no settlement or consent judgment or other voluntary final disposition of a suit under this Section 13.6 may be undertaken by a Party without the consent of the other Party which consent will not be unreasonably withheld or delayed.
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ARTICLE 14
Terms and Termination
14.1. Term . This Agreement will be effective as of the Effective Date, and will continue, on a region-by-region basis, in effect until the expiration of and payment by Zai of all Zai’ s payment obligations set forth in Section 9.4(c) applicable to such region (the “ Term ”). On a region-by-region basis, upon the natural expiration of this Agreement as contemplated in this Section 14.1 , the licenses granted by Paratek to Zai under this Agreement in such region will become a fully paid-up, non-exclusive, perpetual, and irrevocable license.
14.2. Termination for Convenience . At any time prior to [* * *], Zai will have the right to terminate this Agreement in its entirety for any or no reason upon [* * *] written notice to Paratek. Following [* * *], Zai will have the right to terminate this Agreement in its entirety for any or no reason upon [* * *] written notice to Paratek. Zai shall terminate this Agreement if it determines that it will permanently discontinue all Development and Commercialization activities with respect to the Licensed Product under this Agreement.
14.3. Termination for Material Breach .
(a) This Agreement may be terminated in its entirety at any time during the Term upon written notice by either Party if the other Party materially breaches a material term of the Agreement and, if such breach is curable, such breach has not been cured within [* * *] ([* * *] if such breach is a material breach of any obligation under the Tufts Agreement) after notice requesting cure of such breach; provided that the applicable material breach cure period will not apply to [* * *], and [* * *] will have the right to terminate this Agreement, with immediate effect, upon written notice [* * *].
(b) For the avoidance of doubt, the Parties agree that [* * *] will be deemed material terms of the Agreement.
14.4. Termination for Patent Challenge . Except to the extent the following is unenforceable under the laws of a particular jurisdiction, Paratek may terminate this Agreement in its entirety, immediately if Zai or its Affiliates or Sublicensees, individually or in association with any other person or entity, commences a legal action challenging the validity, enforceability or scope of any Patents owned or Controlled by Paratek anywhere in the world Notwithstanding the foregoing, if Zai promptly terminates the sublicense agreement of any Sublicensee that commences a legal action challenging the validity, enforceability or scope of any Patents owned or Controlled by Paratek anywhere in the world, Paratek shall not have the right to terminate this Agreement under this Section 14.4 .
14.5. Termination for Insolvency . Each Party will have the right to terminate this Agreement upon delivery of written notice to the other Party in the event that (a) such other Party files in any court or agency pursuant to any statute or regulation of any jurisdiction a
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petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of such other Party or its assets, (b) such other Party is served with an involuntary petition against it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within [* * *] of its filing, or (c) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors.
14.6. Election to Terminate . If either Party has the right to terminate under Sections 14.2 through 14.5 , it may at its sole option, elect either to (a) terminate this Agreement and pursue any legal or equitable remedy available to it or (b) maintain this Agreement in effect and pursue any legal or equitable remedy available to it.
(a) Upon the termination of this Agreement for any reason, all rights and licenses (including the rights and licenses with respect to the Licensed Product) granted to a Party herein will immediately terminate, and all sublicenses of such rights and licenses will also terminate; provided that the licenses granted by Zai to Paratek pursuant to Sections 2.3 and 13.1(b) will become perpetual and irrevocable to Develop, Manufacture and Commercialize Licensed Products worldwide. Termination of this Agreement for any reason will not release either Party of any obligation or liability which, at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such termination. Notwithstanding anything herein to the contrary, termination of this Agreement by a Party will be without prejudice to other remedies such Party may have at law or equity.
(b) Upon termination of this Agreement for any reason (other than termination by Zai pursuant to Section 14.3 ), the following additional provisions will apply:
(i) Reversion of Rights to Paratek . Any rights and licenses with respect to the Licensed Product granted to Zai under this Agreement will immediately terminate, and all such rights will revert back to Paratek.
(ii) Regulatory Materials; Data. Zai will, and will cause its Affiliates and Sublicensees to, at no cost to Paratek, (1) assign all Regulatory Materials and Regulatory Approvals of Licensed Products to Paratek to the maximum extent permitted by Applicable Law at the time of any such termination, and (2) assign all data generated by or on behalf of Zai while conducting Development, Manufacturing, or Commercialization activities under the Agreement to Paratek, including non-clinical and clinical studies conducted by or on behalf of Zai on Licensed Products and all pharmacovigilance data (including all Adverse Event database information) on Licensed Products.
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(iii) Trademarks. Zai will, and will cause its Affiliates and Sublicensees, to promptly transfer and assign to Paratek, at no cost to Paratek, all Product Marks (excluding any such mark that include, in whole or in part, any corporate name or logos of Zai or its Affiliates).
(iv) Transition Assistance . Zai will, and will cause its Affiliates and Sublicensees, to provide assistance, [* * *], as may be reasonably necessary or useful for Paratek to commence or continue Developing, Manufacturing or Commercializing Licensed Products in the Territory, to the extent Zai is then performing or having performed such activities, including without limitation transferring or amending as appropriate, upon request of Paratek, any agreements or arrangements with Third Party to Develop, Manufacture, and Commercialize the Licensed Products in the Territory. To the extent that any such contract between Zai and a Third Party is not assignable to Paratek, then Zai will reasonably cooperate with Paratek to arrange to continue to and provide such services from such entity.
(v) Ongoing Clinical Trial. If at the time of such termination, any Clinical Trials for the Licensed Products are being conducted by or on behalf of Zai, then, at Paratek’ s election on a trial-by-trial basis: (1) Zai will, and will cause its Affiliates and Sublicensees to, fully c ooperate with Paratek to transfer the conduct of all such Clinical Trials to Paratek and Paratek will assume any and all liability and costs for such Clinical Trials after the effective date of such termination; or (2) Zai will, and will cause its Affiliat es and Sublicensees to, [* * *], orderly wind down the conduct of any such Clinical Trial which is not assumed by Paratek under clause (1).
(c) Termination by Zai Due to Material Breach . Upon termination of this Agreement by Zai pursuant to Section 14.3 , [* * *] to the extent [* * *], including [* * *].
(d) Royalty after Termination . If (i) [* * *] terminates this Agreement pursuant to [* * *] or (ii) this Agreement is terminated [* * *], and if Paratek, itself or through an Affiliate or a Third Party, Commercializes any Licensed Product in the Territory, Paratek shall pay Zai a commercially reasonable royalty on the Net Sales of all such Licensed Products in the Territory at a royalty rate and duration to be determined by the Parties by good faith negotiations. If the Parties are unable to agree to terms within [* * *] of commencing such negotiations, the disputed terms will be resolved by arbitration as set forth in Section 15.4 .
14.8. Survival . Termination or expiration of this Agreement shall not affect any rights or obligations of the Parties under this Agreement that have accrued prior to the date of termination or expiration. The following provisions will survive the termination or expiration of this Agreement for any reason: [* * *].
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15.1. General . The Parties recognize that a dispute may arise relating to this Agreement (a “ Dispute ”). Any Dispute, including Disputes that may involve the Affiliates of any Party, will be resolved in accordance with this ARTICLE 15.
15.2. Continuance of Rights and Obligations During Pendency of Dispute Resolution . If there are any Disputes in connection with this Agreement, including Disputes related to termination of this Agreement under ARTICLE 14, all rights and obligations of the Parties will continue until such time as any Dispute has been resolved in accordance with the provisions of this ARTICLE 15.
15.3. Escalation . Any claim, Dispute, or controversy as to the breach, enforcement, interpretation or validity of this Agreement will be referr ed to the Executive Officers set forth in Section 3.2(f) for attempted resolution. In the event the Executive Officers are unable to resolve such Dispute within 30 days of such Dispute being referred to them, then, upon the written request of either Party to the other Party, the Dispute will be subject to arbitration in accordance with Section 15.4 .
(a) If the Parties fail to resolve the Dispute through escalation to the Executive Officers under Section 15.3 , and a Party desires to pursue resolution of the Dispute, the Dispute will be submitted by either Party for resolution in arbitration under the [* * *].
(b) There will be three arbitrators, the chairperson of whom will be appointed by the two party arbitrators. If, however, the aggregate award sought by the Parties is less than [* * *] and equitable relief is not sought, a single arbitrator will be chosen in accordance with the [* * *].
(c) The seat of arbitration will be [* * *] and the language of the proceedings will be English.
(d) The Parties agree that any award or decision made by the arbitral tribunal will be final and binding upon them and may be enforced in the same manner as a judgment or order of a court of competent jurisdiction. The arbitral tribunal will render its final award within nine months from the date on which the Request for Arbitration by one of the Parties wishing to have recourse to arbitration is received by the [* * *]. The arbitral tribunal will determine the dispute by applying the provisions of this Agreement and the governing law set forth in Section 16.5 .
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(e) By agreeing to arbitration, the Parties do not i ntend to deprive any court of its jurisdiction to issue, at the request of a Party, a pre-arbitral injunction, pre-arbitral attachment or other order to avoid irreparable harm, maintain the status quo, preserve the subject matter of the Dispute, or aid the arbitration proceedings and the enforcement of any award. Without prejudice to such provisional or interim remedies in aid of arbitration as may be available under the jurisdiction of a competent court, the arbitral tribunal will have full authority to g rant provisional or interim remedies and to award damages for the failure of any Party to the dispute to respect the arbitral tribunal ’ s order to that effect.
(f) EACH PARTY HERETO WAIVES: (I) ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY, AND (II) ANY CLAIM FOR ATTORNEY FEES, COSTS AND PREJUDGMENT INTEREST.
(g) Each Party will bear its own attorney’s fees, costs, and disbursements arising out of the arbitration, and will pay an equal share of the fees and costs of the administrator and the arbitrator; provided, however, that the arbitrator will be authorized to determine whether a Party is the prevailing party, and if so, to award to that prevailing party reimbursement for any or all of its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), and/or the fees and costs of the administrator and the arbitrator.
(h) Notwithstanding anything in this Section 15.4 , in the event of a Dispute with respect to the validity, scope, enforceability or ownership of any Patent or other intellectual property rights, and such Dispute is not resolved in accordance with Section 15.3 , such Dispute will not be submitted to an arbitration proceeding in accordance with this Section 15.4 , unless otherwise agreed by the Parties in writing, and instead, either Party may initiate litigation in a court of competent jurisdiction in any country in which such rights apply.
16.1. Force Majeure . Neither Party will be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, or other acts of God or any other deity, or acts, omissions or delays in acting by any Governmental Authority. The affected Party will notify the other Party of such force majeure circumstances as soon as reasonably practical, and will promptly undertake all reasonable efforts necessary to cure such force majeure circumstances.
16.2. Assignment . Neither Party may assign this Agreement to a Third Party without the other Party’s prior written consent (such consent not to be unreasonably withheld); except
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that (a) Paratek may mak e such an assignment without Zai ’ s consent to a successor to substantially all of the business of Paratek to which this Agreement relates (whether by merger, sale of stock, sale of assets or other transaction), (b) Zai may make such an assignment without P aratek ’ s consent to a successor to substantially all of the business of Zai (whether by merger, sale of stock, sale of assets or other transaction), and (c) either Party may assign this Agreement to an Affiliate without the other Party ’ s consent. This Agr eement will inure to the benefit of and be binding on the Parties ’ successors and permitted assigns. Any assignment or transfer in violation of this Section 16.2 will be null and void and wholly invalid, the assignee or transferee in any such assignment or transfer will acquire no rights whatsoever, and the non-assigning non-transferring Party will not recognize, nor will it be required to recogniz e, such assignment or transfer.
16.3. Severability . If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein will not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties will in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
16.4. Notices . All notices which are required or permitted hereunder will be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
If to Paratek:
Paratek Bermuda Ltd.
C/O Paratek Pharmaceuticals, Inc.
Address: 75 Park Plaza, 4 th Floor
Boston, MA 02116
[* * *]
with a copy to:
Ropes & Gray, LLP
Address: 36/F, Park Place, Nanjing Road West, Shanghai 200040, China
[* * *]
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Zai Lab (Shanghai) Co., Ltd.
Address: 1043 Halei Road, Building 8, Suite 502, Pudong, Shanghai, P.R. China, 201203
[* * *]
with a copy to:
Cooley LLP
Address: 3175 Hanover Street
Palo Alto, CA 94304 USA
[* * *]
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith . Any such notice will be deemed to have been given: (a) when delivered if personally delivered or sent by facsimile on a Business Day; (b) on the Business Day after dispatch if sent by nationally-recognized overnight courier; or (c) on the fifth Business Day following the date of mailing if sent by mail.
16.5. Governing Law . This Agreement will be governed by and construed in accordance with the laws of the State of New York, U.S. without reference to any rules of conflict of laws.
16.6. Entire Agreement; Amendments . The Agreement contains the entire understanding of the Parties with respect to the subject matter hereof. All express or implied agreements and understandings, either oral or written, with regard to the subject matter hereof (including the licenses granted hereunder) are superseded by the terms of this Agreement. Neither Party is relying on any representation, promise, nor warranty not expressly set forth in this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties hereto.
16.7. Headings . The captions to the several Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the Sections of this Agreement.
16.8. Independent Contractors . It is expressly agreed that Paratek and Zai will be independent contractors and that the relationship between the two Parties will not constitute a partnership, joint venture or agency. Neither Paratek nor Zai will have the authority to make any statements, representations or commitments of any kind, or to take any action, which will be binding on the other Party, without the prior written consent of the other Party.
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16.9. Waiver . The waiver by either Party of any right hereunder, or the failure of the other Party to perform, or a breach by the other Party, will not be deemed a waiver of any other right hereund er or of any other breach or failure by such other Party whether of a similar nature or otherwise.
16.10. Waiver of Rule of Construction . Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement will be construed against the drafting Party will not apply.
16.11. Construction . Except where the context expressly requires otherwise, (a) the use of any gender herein will be deemed to encompass references to either or both genders, and the use of the singular will be deemed to include the plural (and vice versa), (b) the words “include”, “includes” and “including” will be deemed to be foll owed by the phrase “without limitation”, (c) the word “will” will be construed to have the same meaning and effect as the word “shall”, (d) any definition of or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (e) any reference herein to any person will be construed to include the person’ s successors and assigns, (f) the words “herein”, “hereof” and “hereunder”, and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all refer ences herein to Sections, Schedules , or Exhibits will be construed to refer to Sections, Schedules or Exhibits of this Agreement, and references to this Agreement include all Schedules and Exhibits hereto, (h) the word “notice” means notice in writing (whe ther or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party, the Parties or any committee hereunder “agree”, “consent” or “appro ve” or the like will require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging), (j) references to any specific law, rule or regulation, or Section, section or other division thereof, will be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof, and (k) the term “or” will be interpreted in the inclusive sense commonly associated with the term “and/or” where applicable.
16.12. Counterparts . This Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. Each Party will be entitled to rely on the delivery of executed facsimile copies of counterpart execution pages of this Agreement and such facsimile copies will be legally effective to create a valid and binding agreement among the Parties.
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16.13. Language . This Agreement is in the English language only, which language will be controlling in all respects, and all versions hereof in any other language will be for accommodation only and will not be binding upon the Parties. All communications and notices to be made or given pursuant to this Agreement, and any dispute proceeding related to or arising hereunder, will be in the English language. If there is a discrepancy between any translation of this Agreement and this Agreement, this Agreement will prevail.
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IN WITNESS WHEREOF, the Parties intending to be bound have caused this License and Collaboration Agreement to be executed by their duly authorized representatives as of the Effective Date.
Paratek Bermuda Ltd. |
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Zai Lab (Shanghai) Co., Ltd. |
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/s/ William M. Haskel |
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/s/ Samantha Du |
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William M. Haskel |
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Samantha Du |
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Director |
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CEO |
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April 21, 2017 |
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April 21, 2017 |
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Schedule
1.23
Chemical Structure of the Compound
Omadacycline (OMC, PTK-796)
(4S,4aS,5aR,12aS)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-9-((neopentylamino)methyl)-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide
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Paratek Patents as of the Effective Date
Country |
M&E Ref. |
Paratek Ref. |
Type |
Application No. Publication No. |
Title |
Filing Date |
Patent No. |
Issue Date |
Expiration Date |
Status |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
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Material Sublicensees [* * *]
[* * *]
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Initial Development Plan
[* * *]
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Paratek Product Marks
Cntry |
Trademark |
Status |
App. No. |
Reg. No. |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
EXHIBIT 10.12
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Master Manufacturing Services Agreement
CONFIDENTIAL
Master Manufacturing Services Agreement
PARATEK PHARMACEUTICALS, INC.
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Master Manufacturing Services Agreement
ARTICLE 1 Structure of Agreement and Interpretation |
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1 |
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1.1 |
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Master Agreement. |
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1 |
1.2 |
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Product Agreements. |
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2 |
1.3 |
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Definitions. |
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2 |
1.4 |
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Currency. |
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7 |
1.5 |
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Sections and Headings. |
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7 |
1.6 |
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Singular Terms. |
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8 |
1.7 |
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Appendix 1, Schedules and Exhibits. |
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8 |
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ARTICLE 2 PATHEON'S MANUFACTURING services |
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9 |
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2.1 |
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Manufacturing Services. |
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9 |
2.2 |
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Active Material Yield. |
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11 |
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ARTICLE 3 CLIENT'S OBLIGATIONS |
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12 |
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3.1 |
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Payment. |
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12 |
3.2 |
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Active Materials and Qualification of Additional Sources of Supply. |
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12 |
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ARTICLE 4 [* * *] COMPONENT COSTS |
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13 |
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4.1 |
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First Year Pricing. |
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13 |
4.2 |
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Price Adjustments – Subsequent Years’ Pricing. |
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13 |
4.3 |
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[* * *] |
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14 |
4.4 |
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Price Adjustments – Current Year Pricing. |
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14 |
4.5 |
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[* * *] |
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14 |
4.6 |
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Multi-Country Packaging Requirements. |
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14 |
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ARTICLE 5 ORDERS, SHIPMENT, INVOICING, PAYMENT |
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14 |
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5.1 |
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Orders and Forecasts. |
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14 |
5.2 |
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Reliance by Patheon. |
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15 |
5.3 |
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[* * *]. |
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16 |
5.4 |
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Delivery and Shipping. |
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16 |
5.5 |
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Invoices and Payment. |
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16 |
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ARTICLE 6 PRODUCT CLAIMS AND RECALLS |
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16 |
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6.1 |
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Product Claims. |
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16 |
6.2 |
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Product Recalls and Returns. |
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17 |
6.3 |
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Patheon’s Responsibility for Defective and Recalled Products. |
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17 |
6.4 |
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Disposition of Defective or Recalled Products. |
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18 |
6.5 |
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Healthcare Provider or Patient Questions and Complaints. |
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18 |
6.6 |
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[* * *]. |
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18 |
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ARTICLE 7 CO-OPERATION |
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18 |
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7.1 |
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Quarterly Review. |
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18 |
7.2 |
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Governmental Agencies. |
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19 |
7.3 |
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Records and Accounting by Patheon. |
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19 |
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Master Manufacturing Services Agreement
- ii -
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Master Manufacturing Services Agreement
13.6 |
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No Waiver. |
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31 |
13.7 |
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Assignment and Subcontracting. |
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31 |
13.8 |
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Force Majeure. |
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31 |
13.9 |
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Additional Product. |
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32 |
13.10 |
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Notices. |
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32 |
13.11 |
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Severability. |
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32 |
13.12 |
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Entire Agreement. |
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32 |
13.13 |
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Other Terms. |
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33 |
13.14 |
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No Third Party Benefit or Right. |
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33 |
13.15 |
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Execution in Counterparts. |
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33 |
13.16 |
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Use of Client Name. |
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33 |
13.17 |
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Taxes. |
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33 |
13.18 |
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Governing Law. |
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33 |
13.19 |
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Further Assurances.. |
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34 |
13.20 |
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Supply and Quality Committee |
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34 |
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Master Manufacturing Services Agreement
MASTER MANUFACTURING SERVICES AGREEMENT
THIS MASTER MANUFACTURING SERVICES AGREEMENT (the “ Agreement ”) is made as of July 28, 2017 (the “ Effective Date ”)
B E T W E E N:
PATHEON
UK LIMITED
,
a corporation existing under the laws of England whose registered office is at Kingfisher Drive, Covingham, Swindon, SN3 5BZ, United Kingdom
(“ Patheon ”),
- and -
PARATEK PHARMACEUTICALS, INC.
,
a corporation existing under the laws of Delaware
of 4 th Floor, 75 Park Plaza,
Boston, MA 02116, USA
(“ Client ”, along with Patheon, the “ Parties ” and each, a “ Party ”).
THIS AGREEMENT WITNESSES THAT in consideration of the rights conferred and the obligations assumed herein, and for other good and valuable consideration (the receipt and sufficiency of which are acknowledged by each Party), and intending to be legally bound the Parties agree as follows:
ARTICLE 1
Structure of Agreement and Interpretation
This Agreement establishes the general terms and conditions under which Patheon or, subject to the terms of this Agreement, any Affiliate of Patheon as of the Effective Date may perform Manufacturing Services for Client or any Affiliate of Client, at the manufacturing site where Patheon or the relevant Affiliate of Patheon resides. This “master” form of agreement is intended to allow the Parties, or any of their Affiliates, to contract for the manufacture of multiple Products through Patheon’s global network of manufacturing sites through the issuance of site specific Product Agreements without having to re-negotiate the basic terms and conditions contained herein. [* * *] The Parties agree that a separate technology transfer agreement shall be agreed prior to such move within the Manufacturing Site, setting out the terms of the technology transfer. Product manufactured by Patheon in the PDS Area prior to the Effective Date may be released for commercial use on or after the Effective Date, and the terms of this Agreement (and not any prior agreement entered into between the Parties) shall apply to the release of the Product for commercial use and generally thereafter (including, without limitation, recall, insurance and liability and indemnities).
- 1 -
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Master Manufacturing Services Agreement
This Agreement is structured so that a Product Agreement may be entered into by the Parties for the manufacture of a particular Product or multiple Products at a Patheon manufacturing site. Each Product Agreement will be governed by the terms and conditions of this Agreement unless the Parties to the Product Agreement expressly modify the terms and conditions of this Agreement in the Product Agreement. Unless otherwise agreed by the Parties, each Product Agreement will be in the general form and contain the information set forth in Appendix 1 hereto.
The following terms will, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of these terms will have corresponding meanings:
“ Active Materials ”, “ Active Pharmaceutical Ingredients ” or “ API ” means the materials listed in a Product Agreement on Schedule D;
[* * *];
[* * *];
[* * *];
“ Affiliate ” means:
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(a) |
a business entity which owns, directly or indirectly, a controlling interest in a Party to this Agreement, by stock ownership or otherwise; or |
|
(b) |
a business entity which is controlled by a Party to this Agreement, either directly or indirectly, by stock ownership or otherwise; or |
|
(c) |
a business entity, the controlling interest of which is directly or indirectly common to the majority ownership of a Party to this Agreement; |
For this definition, “control” means the ownership of shares carrying at least a majority of the votes for the election of the directors of a corporation;
“ Annual Product Review Report ” means the annual product review report prepared by Patheon or an Affiliate of Patheon as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e);
“ Annual Report ” means the annual report to the FDA which is required to be prepared and filed by Client regarding the Product as described in Title 21 of the United States Code of Federal Regulations, Section 314.81(b)(2);
[* * *];
“ Applicable Laws ” means [* * *]
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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.
Master Manufacturing Services Agreement
“ Authority ” means any governmental or regulatory authority, department, body or agency or any court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal;
“ Bill Back Items ” means the expenses for all third party supplier fees for the purchase or use of columns, standards, tooling, non-standard pallets, PAPR or PPE suits (where applicable) and other project-specific items necessary for Patheon to perform the Manufacturing Services, and which are not included as Components;
“ Breach Notice ” has the meaning specified in Section 8.2(a);
“ Business Day ” means a day other than a Saturday, Sunday or a day that is a statutory holiday in (a) Boston, Massachusetts, (b) United Kingdom or (c) the jurisdiction where the relevant Manufacturing Site is located;
“ 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;
“ Capital Equipment Agreement ” means a separate agreement that the Parties may enter into that will address responsibility for the purchase of capital equipment and facility modifications that may be required to perform the Manufacturing Services under a particular Product Agreement;
“ cGMPs ” means, as applicable, current good manufacturing practices as described in:
|
(a) |
Parts 210 and 211 of Title 21 of the United States' Code of Federal Regulations; |
|
(b) |
EC Directive 2003/94/EC; and |
|
(c) |
Division 2 of Part C of the Food and Drug Regulations (Canada); |
together with the latest Health Canada, FDA and EMA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;
“ Client Intellectual Property ” means Intellectual Property [* * *];
“ Client Property ” has the meaning specified in Section 8.3(a)(vi);
“ Client Representatives ” has the meaning specified in Section 10.3(a);
“ Client-Supplied Components ” means those Components to be supplied by Client or that have been supplied by Client;
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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.
Master Manufacturing Services Agreement
“ Components ” means, collectively, all packaging components, raw materials, ingredients, and other materials (including labels, product inserts and other labelling for the Products) required to manufacture the Products in accordance with the Specifications, other than the Active Materials;
“ Confidential Information ” has the meaning specified in Section 11.1;
[* * *];
“ CTD ” has the meaning specified in Section 7.8(c);
“ Deficiencies ” have the meaning specified in Section 7.8(d);
“ Deficiency Notice ” has the meaning specified in Section 6.1(a);
“ Delivery Date ” means the date scheduled for shipment of Product under a Firm Order as set forth in Section 5.1(d);
“ Disclosing Party ” has the meaning specified in Section 11.1;
“ EMA ” means the European Medicines Agency;
“ FDA ” means the United States Food and Drug Administration;
“ Firm Orders ” have the meaning specified in Section 5.1(c);
“ Force Majeure Event ” has the meaning specified in Section 13.8;
“ Gross Negligence ” means [* * *];
;
“ GST ” has the meaning specified in Section 13.17(a)(iii);
“ Health Canada ” means the section of the Canadian Government known as Health Canada and includes, among other departments, the Therapeutic Products Directorate and the Health Products and Food Branch Inspectorate;
[* * *];
“ Initial Product Term ” has the meaning specified in Section 8.1;
“ Initial Term ” has the meaning specified in Section 8.1;
“ Intellectual Property ” includes, without limitation, rights in patents, patent applications, formulae, trademarks, trademark applications, trade-names, Inventions, copyrights, industrial designs, trade secrets, and know how;
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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.
Master Manufacturing Services Agreement
“ Invention ” means information about any innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which it is contained and whether or not patentable or copyrightable;
“ Inventory ” means all inventories of Components and work-in-process produced or held by Patheon for the manufacture of the Products but, for greater certainty, does not include the Active Materials;
“ Laws ” means all laws, statutes, ordinances, regulations, rules, by-laws, judgments, decrees or orders of any Authority;
“ Long Term Forecast ” has the meaning specified in Section 5.1(a);
“ Manufacturing Services ” means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Bill Back Items;
“ Manufacturing Site ” means the facility owned and operated by Patheon or an Affiliate of Patheon where the Manufacturing Services will be performed as identified in a Product Agreement;
“ Materials ” means all Components and Bill Back Items required to manufacture the Products in accordance with the Specifications, other than the Active Materials;
[* * *];
[* * *];
“ Obsolete Stock ” has the meaning specified in Section 5.2(b);
“ PAI ” has the meaning specified in Section 7.5;
[* * *];
“ Patheon Intellectual Property ” means Intellectual Property [* * *];
“ Patheon Representatives ” has the meaning specified in Section 10.4(a);
“ Price ” means the fees to be charged by Patheon for performing the Manufacturing Services, and includes the cost of Components (other than Client-Supplied Components), certain cost items as set forth in a Product Agreement on Schedule B, and annual stability testing fees as set forth in a Product Agreement on Schedule C;
“ Product(s) ” means the product(s) listed in a Product Agreement on Schedule 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.
Master Manufacturing Services Agreement
“ Product Agreement ” means the agreement between Patheon and Client issued under this Agreement in the form set forth in Appendix 1 (including Schedules A to D) under which Patheon will perform Manufacturing Services at a particular Manufacturing Site;
“ Product Claims ” have the meaning specified in Section 6.3(c);
“ Quality Agreement ” means the agreement between the Parties entering into a Product Agreement, or between the applicable Affiliate of Patheon and Client if the Manufacturing Services are subcontracted to such Affiliate by Patheon, that sets out the quality assurance standards and the Specifications for the Manufacturing Services to be performed by Patheon for Client;
“ Recall ” has the meaning specified in Section 6.2(a);
“ Recipient ” has the meaning specified in Section 11.1;
“ Regulatory Approval ” has the meaning specified in Section 7.8(a);
“ Regulatory Authority ” means the FDA, EMA, and Health Canada and any other foreign regulatory agencies competent to grant marketing approvals for pharmaceutical products including the Products in the Territory;
“ Remediation Period ” has the meaning specified in Section 8.2(a);
“ Representatives ” means a Party’s directors, officers, employees, advisers, agents, consultants, subcontractors, service partners, professional advisors, or representatives;
[* * *];
[* * *];
“ Specifications ” means the file, for each Product, which is given by Client to Patheon in accordance with the procedures listed in a Product Agreement on Schedule A and which contains documents relating to each Product, including, without limitation:
|
(a) |
specifications for Active Materials and Components; |
|
(b) |
manufacturing specifications, directions, and processes; |
|
(c) |
storage requirements; |
|
(d) |
all environmental, health and safety information for each Product including material safety data sheets; and |
|
(e) |
the finished Product specifications, packaging specifications and shipping requirements for each Product; |
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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.
Master Manufacturing Services Agreement
all as updated, amended and revised from time to time by Client in accordance with the terms of this Agreement;
“ Supply and Quality Committee ” has the meaning specified in Section 13.20;
[* * *];
[* * *];
[* * *];
“ Technical Dispute ” has the meaning specified in Section 12.2;
“ Term ” has the meaning specified in Section 8.1;
“ Territory ” means the geographic area described in a Product Agreement where Products manufactured by Patheon will be distributed by Client, as may be mutually extended by the Parties in writing from time to time (subject to agreement between the Parties on any revised costs of Manufacturing Services relating to provision of Manufacturing Services for the additional Territory or Territories);
“ Third Party Rights ” means the Intellectual Property of any third party;
“ VAT ” has the meaning specified in Section 13.17(d);
“ Year ” means in the first year of this Agreement or in the first year of a Product Agreement, the period from the Effective Date up to and including December 31 of the same calendar year, and thereafter will mean a calendar year;
[* * *]; and
[* * *].
Unless otherwise agreed in a Product Agreement, all monetary amounts expressed in this Agreement are in [* * *].
The division of this Agreement into Articles, Sections, Subsections, an Appendix, Schedules and Exhibits and the insertion of headings are for convenience of reference only and will not affect the interpretation of this Agreement. Unless otherwise indicated, any reference in this Agreement to a Section, Appendix, Schedule or Exhibit refers to the specified Section, Appendix, Schedule or Exhibit to this Agreement. In this Agreement, the terms " this Agreement ", " hereof ", " herein ", " hereunder " and similar expressions refer to this Agreement as a whole and not to any particular part, Section, Appendix, Schedule or Exhibit of this Agreement.
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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.
Master Manufacturing Services Agreement
Except as otherwise expressly stated or unless the context otherwise requires, all references to the singular will include the plural and vice versa.
1.7 Appendix 1, Schedules and Exhibits .
Appendix 1 (including the Schedules thereto) and the following Exhibits are attached to, incorporated in, and form part of this Agreement:
|
Appendix 1 |
-Form of Product Agreement (Including Schedules A to D) |
|
Exhibit A |
-Technical Dispute Resolution |
|
Exhibit B |
-Quarterly Active Materials Inventory Report |
|
Exhibit C |
- [* * *] |
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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.
Master Manufacturing Services Agreement
ARTICLE 2
PATHEON'S MANUFACTURING services
Patheon will perform the Manufacturing Services for the Territory for the Price specified in a Product Agreement in Schedules B and C to manufacture Products for Client. Schedule B to a Product Agreement sets forth a list of cost items that are included in the Price for Products; all cost items that are not included in the Price are subject to additional fees to be paid by Client. The fees set out in Schedules B and C to a Product Agreement may be amended as set forth in ARTICLE 4. Patheon may change the Manufacturing Site for the Products only with the prior written consent of Client, this consent not to be unreasonably withheld. In performing the Manufacturing Services, Patheon and Client agree that:
|
(a) |
Conversion of Active Materials and Components . Patheon will convert Active Materials and Components into Product. |
|
(d) |
Stability Testing . Patheon will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure[* * *]. Patheon will give Client all stability test data and results at Client’s request. |
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Master Manufacturing Services Agreement
|
(g) |
Bill Back Items . The Bill Back Items will be mutually agreed by the Parties and will be charged to Client at [* * *]. |
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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.
Master Manufacturing Services Agreement
|
(h) |
Validation Activities (if applicable) . Upon Client’s request, Patheon may assist in the development and approval of the validation protocols for analytical methods and manufacturing procedures (including packaging procedures) for the Products. The fees for this service are not included in the Price and will be set out separately in Schedule C to a Product Agreement. |
Quantity Received: The total quantity of Active Materials that complies with the Specifications and is received at the Manufacturing Site during the applicable period.
Quantity Dispensed: The total quantity of Active Materials dispensed at the Manufacturing Site during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Active Materials that complies with the Specifications held at the beginning of the applicable period, less the inventory of Active Materials that complies with the Specifications held at the end of the period. The Quantity Dispensed will only include Active Materials received and dispensed in commercial manufacturing of Products, including Active Materials lost in the warehouse prior to and during dispensing, and will not include any (i) Active Materials that must be retained by Patheon as samples, (ii) Active Materials contained in Product that must be retained as samples, (iii) Active Materials used in testing (if applicable), and (iv) Active Materials received or dispensed in technical transfer activities or development activities during the applicable period, including without limitation, any regulatory, stability, validation or test batches manufactured during the applicable period.
Quantity Converted: The total amount of Active Materials contained in the Products manufactured with the Quantity Dispensed (including any additional Products produced in accordance with Section 6.3(a) or 6.3(b)), delivered by Patheon, and not rejected, recalled or returned in accordance with Section 6.1 or 6.2 because of Patheon’s failure to perform the Manufacturing Services in accordance with Specifications, cGMPs, and Applicable Laws.
|
(b) |
[* * *] |
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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.
Master Manufacturing Services Agreement
|
(c) |
[* * *] |
|
(d) |
[* * *] |
|
(e) |
[* * *] |
ARTICLE 3
CLIENT'S OBLIGATIONS
Client will pay Patheon for performing the Manufacturing Services according to the Prices specified in Schedules B and C in a Product Agreement. These Prices may be subject to adjustment under other parts of this Agreement. Client will also pay Patheon for any Bill Back Items agreed upon by the Parties pursuant to Section 2.1(g).
3.2 Active Materials and Qualification of Additional Sources of Supply .
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Master Manufacturing Services Agreement
ARTICLE 4
[CONVERSION fees AND]
COMPONENT COSTS
The Price for the first Year will be listed in Schedules B and C in a Product Agreement and will be subject to the adjustments set forth in Sections 4.2 and 4.4. [* * *]
4.2 Price Adjustments – Subsequent Years’ Pricing .
After the first Year of the Product Agreement, Patheon may adjust the Price effective January 1 of each Year as follows:
|
(c) |
[* * *] |
|
(e) |
[* * *] |
|
(g) |
[* * * ] |
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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.
Master Manufacturing Services Agreement
4.4 Price Adjustments – Current Year Pricing .
During any Year, the Prices set out in Schedule B of a Product Agreement will be adjusted as follows:
|
(a) |
[* * *] |
4.6 Multi-Country Packaging Requirements .
If Client decides to have Patheon perform Manufacturing Services for the Product for countries outside the Territory, then Client will inform Patheon of the packaging requirements for each new country and Patheon will prepare a quotation for consideration by Client of any additional costs for Components (other than Client-Supplied Components) and the change-over fees for the Product destined for each new country. The agreed additional packaging requirements and related packaging costs and change over fees will be set out in a written amendment to the Product Agreement.
ARTICLE 5
ORDERS, SHIPMENT, INVOICING, PAYMENT
|
(c) |
Firm Orders . On a rolling basis during the term of the Product Agreement, Client will issue an updated [* * *] on or before [* * *]. This forecast will start on the first day of the next |
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Master Manufacturing Services Agreement
|
(e) |
Cancellation of a Firm Order . If Client cancels a Firm Order, [* * *]. |
|
(f) |
[* * *] |
|
(g) |
Controlled Substance Quota Requirements (if applicable) . Client will give Patheon the information set forth below for obtaining any required DEA or equivalent agency quotas needed to perform the Manufacturing Services. Patheon will be responsible for routine management of DEA quota information in accordance with DEA regulations. Patheon and Client will cooperate to communicate the information and to assist each other in DEA information requirements related to the Product as follows: [* * *]. |
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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.
Master Manufacturing Services Agreement
|
Components to meet Manufacturing Services requirements for longer periods if agreed to in writing by the Parties. Client will give Patheon written authorization to order Components for any launch quantities of Product requested by Client which will be considered a Firm Order when accepted by Patheon. |
|
(b) |
[* * *] |
|
(c) |
[* * *] |
5.3 [* * *]
Delivery of Products will be made [ * * *] unless otherwise agreed in a Product Agreement. Subject to Section 8.3(a)(vi), risk of loss or of damage to Products will [* * *]. Products will be transported in accordance with the Specifications.
Invoices will be sent by email to the email address given by Client to Patheon in writing. Invoices will be issued when the Product is released by Patheon. Patheon will also submit to Client, with each shipment of Products, a duplicate copy of the invoice covering the shipment. Patheon will also give Client an invoice covering any Inventory or Components which are to be purchased by Client under Section 5.2 of this Agreement. Each invoice will, to the extent applicable, identify Client’s Manufacturing Services purchase order number, Product numbers, names and quantities, unit price, freight charges, and the total amount to be paid by Client. Client will pay all invoices within [* * *]; provided that if any portion of an invoice is disputed, Client will pay Patheon for the undisputed amount and the Parties will use good faith efforts to reconcile the disputed amount as soon as practicable. Interest on undisputed past due amounts will accrue at [* * *].
ARTICLE 6
PRODUCT CLAIMS AND RECALLS
|
(b) |
Determination of Deficiency . Upon receipt of a Deficiency Notice, Patheon will have [* * *] to advise Client by notice in writing that it disagrees with the contents of the Deficiency |
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Master Manufacturing Services Agreement
|
Notice. If Client and Patheon fail to agree within [ * * *] after Patheon's notice to Client as to whether any Product identified in the Deficiency Notice was not manufactured in accordance with the Specifications, cGMPs, or Applicable Laws, the Parties will proceed as follows: [ * * *] . |
|
(c) |
Shortages and Price Disputes . Claims for shortages in the amount of Product shipped by Patheon or a Price dispute will be initially dealt with [* * *]. |
6.2 Product Recalls and Returns .
|
(b) |
Recalls . If (i) any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all cGMPs and Applicable Laws. |
|
(c) |
Product Returns . Client will have the responsibility for handling customer returns of the Product. Patheon will give Client any assistance that Client may reasonably require to handle the returns. |
6.3 Patheon’s Responsibility for Defective and Recalled Products .
|
(a) |
Defective Product . If Client rejects Product under Section 6.1 and the deficiency is determined to have arisen from [* * *] . |
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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.
Master Manufacturing Services Agreement
|
(c) |
[* * *] |
|
(d) |
[* * *] |
6.4 Disposition of Defective or Recalled Products .
Client will not dispose of any damaged, defective, returned, or Recalled Products for which it intends to assert a claim against Patheon without Patheon’s prior written authorization to do so. Alternatively, Patheon may instruct Client to return the Products to Patheon. [* * *]
6.5 Healthcare Provider or Patient Questions and Complaints .
Client will have the sole responsibility for responding to questions and complaints from its customers. Questions or complaints received by Patheon from Client's customers, healthcare providers or patients will be promptly referred to Client. Patheon will co-operate as reasonably required to allow Client to determine the cause of and resolve any questions and complaints. This assistance will include follow-up investigations, including testing. In addition, Patheon will give Client all agreed upon information that will enable Client to respond properly to questions or complaints about the Product as set forth in the Quality Agreement. [* * *]
6.6 [* * *]
Each Party will forthwith upon execution of this Agreement appoint one of its employees to be a relationship manager responsible for liaison between the Parties, which employee may be a member of the Supply and Quality Committee. The relationship managers will meet not less than once per Calendar Quarter, including at Supply and Quality Committee meetings, to review the current status of the business relationship and manage any issues that have arisen.
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Master Manufacturing Services Agreement
Subject to Section 7.8, each Party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting Regulatory Approval for the Products, regarding the Products if, in the opinion of that Party's counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a prohibition under one or more Applicable Laws against doing so, either Party will, where relevant, permit the other Party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency. Subject to Section 7.5 , Patheon will lead all communications relating to the Manufacturing Site and Client will lead all Product-specific communications. Each Party will keep the other informed as appropriate.
7.3 Records and Accounting by Patheon .
Patheon will keep records of the manufacture, testing, and shipping of the Products, and retain samples of the Products as are necessary to comply with manufacturing regulatory requirements applicable to Patheon, as well as to assist with resolving Product complaints and other similar investigations. Unless otherwise agreed to in the Quality Agreement, copies of the records and samples will be retained for [* * *], or longer if required by law or regulation, following which time Client will be contacted concerning the delivery and destruction of the documents and/or samples of Products. [* * *] Client is responsible for retaining samples of the Products necessary to comply with the legal/regulatory requirements applicable to Client.
Client may inspect Patheon reports and records relating to this Agreement, the Product Agreement or the Quality Agreement during normal business hours and with reasonable advance notice, but a Patheon representative must be present during the inspection.
Patheon will give Client reasonable access at agreed times to the areas of the Manufacturing Site in which the Products are manufactured, stored, handled, or shipped to permit Client to verify that the Manufacturing Services are being performed in accordance with the Specifications, cGMPs, and Applicable Laws. [ * * *] The right of access set forth in Section 7.4 and this Section 7.5 will not include a right to access or inspect Patheon’s financial records. [* * *]
7.6 Notification of Regulatory Inspections .
Each Party will notify the other within [* * *] of any inspections by any governmental agency at the Manufacturing Site specifically involving the Products. Patheon will also notify Client of receipt of any form 483s or warning letters or any other significant regulatory action which Patheon’s quality assurance group determines in good faith could impact the regulatory status or supply of the Products.
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Master Manufacturing Services Agreement
Upon request, Patheon will supply on an annual basis a copy of the Annual Product Review Report which includes all Product data in its control, including release test results, complaint test results, and all investigations (in manufacturing, testing, and storage), that Client reasonably requires in order to complete any filing under any applicable regulatory regime, including any Annual Report that Client is required to file with the FDA. Any additional data or report requested by Client beyond the scope of cGMPs and customary FDA requirements, including Continuous Process Verification data, will be subject to an additional reasonable fee to be agreed upon in good faith between Patheon and Client.
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Master Manufacturing Services Agreement
|
(h) |
No Patheon Responsibility . Subject to Section 7.8(e), Patheon will not assume any responsibility for the accuracy of any application for Regulatory Approval. [* * *] |
Patheon shall provide reasonable support and documentation to Client to enable Client to perform a technology transfer of the Product manufacturing process to a third party manufacturer who is to be a secondary source of supply. [* * *]
ARTICLE 8
TERM AND TERMINATION
This Agreement will become effective as of the Effective Date and will continue for [* * *] from the Effective Date (the " Initial Term "), unless terminated earlier by one of the Parties in accordance herewith. This Agreement will automatically renew after the Initial Term for successive terms of [* * *] each if there is a Product Agreement in effect, unless either Party gives written notice to the other Party of its intention to terminate this Agreement at least [ * * *] prior to the end of the then-current term, including the Initial Term (the Initial Term and any such renewal terms, collectively, the “ Term ”) . In any event, the legal terms and conditions of this Agreement will continue to govern any Product Agreement in effect as provided in Section 1.2. Each Product Agreement will have an initial term from the Effective Date of the Product Agreement until [* * *] (each, an “ Initial Product Term ”). Product Agreements will automatically renew after the Initial Product Term for successive terms of [* * *] each unless either Party gives written notice to the other Party of its intention to terminate the Product Agreement at least [* * *] prior to the end of the then-current term, including the Initial Product Term.
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Master Manufacturing Services Agreement
|
(b) |
Either Party at its sole option may immediately terminate this Agreement or a Product Agreement upon written notice, but without prior advance notice, to the other Party if: (i) the other Party is declared insolvent or bankrupt by a court of competent jurisdiction; (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by the other Party; or (iii) this Agreement or a Product Agreement is assigned by the other Party for the benefit of creditors. |
|
(e) |
[* * *] |
8.3 Obligations on Termination .
|
(a) |
If a Product Agreement is completed, expires, or is terminated in whole or in part for any reason, then: |
|
(i) |
[* * *] |
|
(ii) |
[* * *] |
|
(iii) |
[* * *] |
|
(iv) |
Patheon shall provide reasonable support and documentation to Client to enable Client to perform a technology transfer of the Product manufacturing process to a third party manufacturer. [* * *] |
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Master Manufacturing Services Agreement
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Patheon accurate monthly written updates on the duration of the extension, which cannot exceed [ * * *]; and |
ARTICLE 9
REPRESENTATIONS, WARRANTIES AND COVENANTS
Each Party covenants, represents and warrants that, as of the Effective Date it has the full right and authority to enter into this Agreement and that it is not aware of any impediment that would inhibit its ability to perform its obligations hereunder.
Client covenants, represents and warrants, that:
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(a) |
[* * *] |
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(b) |
[* * *] |
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(c) |
[* * *] |
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Master Manufacturing Services Agreement
Patheon covenants, represents, and warrants that:
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(a) |
it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, the Quality Agreement and Applicable Laws; |
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each Product at the time of delivery to Client shall (i) conform with Specifications, cGMPs and Applicable Laws, (ii) not be adulterated or misbranded within the meaning of the FD&C Act; |
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(c) |
it will allocate reasonably adequate resources to execute its obligations under this Agreement or any Product Agreement on the basis of Client’s reasonable forecasts; |
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(d) |
any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights; |
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(e) |
[* * *] |
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(f) |
it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); |
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Master Manufacturing Services Agreement
PATHEON MAKES NO WARRANTY OR CONDITION OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT. PATHEON MAKES NO WARRANTY OR CONDITION OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY WARRANTY OR CONDITION OF MERCHANTABILITY FOR THE PRODUCTS.
ARTICLE 10
REMEDIES AND INDEMNITIES
10.1 Consequential and Other Damages .
[* * *] neither Party will be liable to the other for (i) any (direct or indirect) loss of profits, of anticipated savings, of business, or goodwill or (ii) any costs or expenditures incurred to evaluate the viability of entering into this Agreement or to prepare for performance under this Agreement or (iii) for any other liability, damage, costs, penalty, or expense of any kind incurred by the other Party of an indirect or consequential nature, regardless of any notice of the possibility of these damages, in each case whether in contract, tort, negligence, breach of statutory duty, or otherwise.
10.2 Limitation of Liability .
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[* * *] |
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[* * *] |
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[* * *] |
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If a claim occurs, Client will: (a) promptly notify Patheon of the claim; (b) us e commercially reasonable efforts to mitigate the effects of the claim; (c) reasonably cooperate with Patheon in the defense of the claim; and (d) permit Patheon to control the defense and settlement of the claim, all at Patheon's cost and expense. But Patheon shall not be |
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Master Manufacturing Services Agreement
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permitted to settle the claim in a manner that imposes any financial liability or other obligation on the part of Client or requires an admission of liability, wrongdoing or fault or a waiver of rights, on the part of Client, without Client’s prior written consent. |
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If a claim occurs, Patheon will: (a) promptly notify Client of the claim; (b) use commercially reasonable efforts to mitigate the effects of the claim; (c) reasonably cooperate with Client in the defense of the claim; and (d) permit Client to control the defense and settlement of the claim, all at Client's cost and expense. But Client shall not be permitted to settle the claim in a manner that imposes any financial liability or other obligation on the part of Patheon or requires an admission of liability, wrongdoing or fault or a waiver of rights, on the part of Patheon, without Patheon’s prior written consent. |
10.5 Reasonable Allocation of Risk .
This Agreement (including, without limitation, this ARTICLE 10) is reasonable and creates a reasonable allocation of risk for the relative profits the Parties each expect to derive from the Products. Patheon assumes only a limited degree of risk arising from the manufacture, distribution, and use of the Products because Client has developed and holds the marketing approval for the Products, Client requires Patheon to manufacture and label the Products strictly in accordance with the Specifications, and Client, not Patheon, is best positioned to inform and advise potential users about the circumstances and manner of use of the Products.
11.1 Confidential Information .
“ Confidential Information ” means any information disclosed by the Disclosing Party to the Recipient (whether disclosed in oral, written, electronic or visual form) that is non-public, confidential or proprietary including, without limitation, information relating to the Disclosing Party’s patent and trademark applications, process designs, process models, drawings, plans, designs, data, databases and extracts therefrom, formulae, methods, know-how and other Intellectual Property, its clients or client
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Master Manufacturing Services Agreement
confidential information, finances, marketing, products and processes and all price quotations, manufacturing or professional services proposals, information relating to composition, proprietary technology, and all other information relating to manufacturing capabilities and operations. In addition, all analyses, compilations, studies, reports or other documents prepared by any Party's Representatives containing the Confidential Information will be considered Confidential Information. Samples or materials provided hereunder as well as any and all information derived from the approved analysis of the samples or materials will also constitute Confidential Information. For the purposes of this ARTICLE 11, a Party or its Representative receiving Confidential Information under this Agreement is a “ Recipient ”, and a Party or its Representative disclosing Confidential Information under this Agreement is the “ Disclosing Party ”.
11.2 Use of Confidential Information .
The Recipient will use the Confidential Information solely for the purpose of meeting its obligations under this Agreement. The Recipient will keep the Confidential Information strictly confidential and will not disclose the Confidential Information in any manner whatsoever, in whole or in part, other than to those of its Representatives who (i) have a need to know the Confidential Information for the purpose of this Agreement; (ii) have been advised of the confidential nature of the Confidential Information and (iii) have obligations of confidentiality and non-use to the Recipient no less restrictive than those of this Agreement. Recipient will protect the Confidential Information disclosed to it by using reasonable precautions to prevent the unauthorized disclosure, dissemination or use of the Confidential Information, which precautions will in no event be less than those exercised by Recipient with respect to its own confidential or proprietary Confidential Information of a similar nature.
The obligations of confidentiality will not apply to the extent that the information:
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is or becomes publicly known through no breach of this Agreement or fault of the Recipient or its Representatives; |
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is in the Recipient's possession at the time of disclosure by the Disclosing Party other than as a result of the Recipient's breach of any legal obligation; |
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is independently developed by the Recipient without use of or reference to the Disclosing Party's Confidential Information as evidenced by Recipient’s written records; or |
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is expressly authorized for release by the written authorization of the Disclosing Party. |
Any combination of information which comprises part of the Confidential Information are not exempt from the obligations of confidentiality merely because individual parts of that Confidential Information were publicly known, in the Recipient’s possession, or received by the Recipient, unless the combination itself was publicly known, in the Recipient’s possession, or received by the Recipient.
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Master Manufacturing Services Agreement
11.4 Photographs and Recordings .
Neither Party will take any photographs or videos of the other Party’s facilities, equipment or processes, nor use any other audio or visual recording equipment (such as camera phones) while at the other Party’s facilities, without that Party’s express written consent.
Notwithstanding any other provision of this Agreement, the Recipient may disclose Confidential Information of the Disclosing Party to the extent required, as advised by counsel, in response to a valid order of a court or other governmental body or as required by law, regulation or stock exchange rule. But the Recipient will advise the Disclosing Party in advance of the disclosure to the extent practicable and permissible by the order, law, regulation or stock exchange rule and any other Applicable Laws, will reasonably cooperate with the Disclosing Party, if required, in seeking an appropriate protective order or other remedy, and will otherwise continue to perform its obligations of confidentiality set out herein. If any public disclosure is required by law, the Parties will consult concerning the form of announcement prior to the public disclosure being made.
The Disclosing Party will use reasonable efforts to summarize in writing the content of any oral disclosure or other non-tangible disclosure of Confidential Information within [* * *] of the disclosure, but failure to provide this summary will not affect the nature of the Confidential Information disclosed if the Confidential Information was identified as confidential or proprietary when disclosed orally or in any other non-tangible form.
11.7 Return of Confidential Information .
Upon the written request of the Disclosing Party, the Recipient will promptly return the Confidential Information to the Disclosing Party or, if the Disclosing Party directs, destroy all Confidential Information disclosed in or reduced to tangible form including any copies thereof and any summaries, compilations, analyses or other notes derived from the Confidential Information except for one copy which may be maintained by the Recipient for its records. The retained copy will remain subject to all confidentiality provisions contained in this Agreement.
The Parties acknowledge that monetary damages may not be sufficient to remedy a breach by either Party of this ARTICLE 11 and agree that the non-breaching Party will be entitled to seek specific performance, injunctive and/or other equitable relief to prevent breaches of this ARTICLE 11 and to specifically enforce the provisions hereof in addition to any other remedies available at law or in equity. These remedies will not be the exclusive remedies for breach of this ARTICLE 11 but will be in addition to any and all other remedies available at law or in equity.
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Master Manufacturing Services Agreement
If any dispute arises out of this Agreement or any Product Agreement (other than a dispute under Section 6.1(b) or a Technical Dispute, as defined herein), the Parties will first try in good faith to resolve it in meetings of the Supply and Quality Committee. If the Supply and Quality Committee fails to resolve the matter within [ * * *], the dispute will immediately be referred to the Chief Operating Officer (or another officer as he/she may designate) of each Party who will meet and discuss as necessary to try to resolve the dispute amicably. Should the Parties fail to reach a resolution under this Section 12.1, the dispute will be referred to arbitration in accordance with Section 13.18.
12.2 Technical Dispute Resolution .
If a dispute arises (other than disputes under Section 12.1) between the Parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, or other activities under this Agreement (a “ Technical Dispute ”), the Parties will make all reasonable efforts to resolve the dispute by good faith negotiations in the Supply and Quality Committee. In that regard, the Supply and Quality Committee will, as soon as possible and in any event no later than [* * *] after a written request from either Party to the other, meet in good faith to resolve any Technical Dispute. If, despite this meeting, the Parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within [ * * *] of the written request, the Technical Dispute will, at the request of either Party, be referred for determination to an expert in accordance with Exhibit A. If the Parties cannot agree using good faith efforts that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certainty, the Parties agree that the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.
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Master Manufacturing Services Agreement
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(d) |
Each Party will be solely responsible for the costs of filing, prosecution, and maintenance of patents and patent applications on its own Inventions. |
Neither Party has, nor will it acquire, any interest in any of the other Party’s Intellectual Property unless otherwise expressly agreed to in writing. Neither Party will use any Intellectual Property of the other Party, except as specifically authorized by the other Party or as required for the performance of its obligations under this Agreement.
13.3 [* * *]
Each Party will maintain commercial general liability insurance, including blanket contractual liability insurance covering the obligations of that Party under this Agreement through the term of this Agreement and for a period of [* * *] thereafter. Patheon’s insurance policy will have policy limits of not less than [* * *]. If requested Patheon will give Client a certificate of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date, and the limits of liability. Such insurance certificate will further provide for a minimum of [* * *] written notice to the insured of a cancellation of, or material change in, the insurance.
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Master Manufacturing Services Agreement
13.5 Independent Contractors .
The Parties are independent contractors and this Agreement and any Product Agreement will not be construed to create between Patheon and Client any other relationship such as, by way of example only, that of employer-employee, principal agent, joint-venturer, co-partners, or any similar relationship, the existence of which is expressly denied by the Parties.
Neither Party's failure to require the other Party to comply with any provision of this Agreement or any Product Agreement will be deemed a waiver of the provision or any other provision of this Agreement or any Product Agreement, with the exception of Sections 6.1 and 8.2 of this Agreement.
13.7 Assignment and Subcontracting .
Neither Party will be liable for the failure to perform its obligations under this Agreement or any Product Agreement if the failure is caused by an event beyond that Party's reasonable control and without that Party’s fault or negligence (a " Force Majeure Event "). A Party claiming a right to excused performance under this Section 13.8 will immediately notify the other Party in writing of the extent of its inability to perform, which notice will specify the event beyond its reasonable control that prevents the performance. Neither Party will be entitled to rely on a Force Majeure Event to relieve it from an obligation to pay money (including any interest for delayed payment) which would otherwise be due and payable under this Agreement or any Product Agreement.
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Master Manufacturing Services Agreement
Additional Products may be added to, or existing Products deleted from, any Product Agreement by amendments to the Product Agreement including Schedules A, B, C, and D as applicable.
Unless otherwise agreed in a Product Agreement, any notice, approval, instruction or other written communication required or permitted hereunder will be sufficient if made or given to the other Party by personal delivery or confirmed receipt email or by sending the same by first class mail, postage prepaid to the respective addresses or electronic mail addresses set forth below:
If to Client:
Email addresses (any notice to be sent to both): [* * *]
If to Patheon:
Patheon UK Limited
Kingfisher Drive
Covingham
Swindon SN3 5BZ
United Kingdom
Attention: [* * *]
or to any other addresses or electronic mail addresses given to the other Party in accordance with the terms of this Section 13.10. Notices or written communications made or given by personal delivery, or electronic mail will be deemed to have been sufficiently made or given when sent (receipt acknowledged), or if mailed, five days after being deposited in the United States, Canada, or European Union mail, postage prepaid or upon receipt, whichever is sooner.
If any provision of this Agreement or any Product Agreement is determined by a court of competent jurisdiction to be invalid, illegal, or unenforceable in any respect, that determination will not impair or affect the validity, legality, or enforceability of the remaining provisions, because each provision is separate, severable, and distinct.
This Agreement, together with the applicable Product Agreement and the Quality Agreement, constitutes the full, complete, final and integrated agreement between the Parties relating to the subject matter hereof and supersedes all previous written or oral negotiations, commitments, agreements, transactions, or understandings concerning the subject matter hereof. Any modification,
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Master Manufacturing Services Agreement
amendment, or supplement to this Agreement or any Product Agreement must be in writing and signed by authorized representatives of both Parties. In case of conflict, the prevailing order of documents will be this Agreement, the Product Agreement, and the Quality Agreement.
No terms, provisions or conditions of any purchase order or other business form or written authorization used by Client or Patheon will have any effect on the rights, duties, or obligations of the Parties under or otherwise modify this Agreement or any Product Agreement, regardless of any failure of Client or Patheon to object to the terms, provisions, or conditions unless the document specifically refers to this Agreement or the applicable Product Agreement and is signed by both Parties.
13.14 No Third Party Benefit or Right .
For greater certainty, nothing in this Agreement or any Product Agreement will confer or be construed as conferring on any third party any benefit or the right to enforce any express or implied term of this Agreement or any Product Agreement.
13.15 Execution in Counterparts .
This Agreement and any Product Agreement may be executed in two or more counterparts, by original, facsimile or “pdf” signature, each of which will be deemed an original, but all of which together will constitute one and the same instrument.
Patheon will not make any use of Client’s name, trademarks or logo or any variations thereof, alone or with any other word or words (including in customer lists or related marketing and promotion material), without the prior written consent of Client, which consent will not be unreasonably withheld.
13.18 Governing Law .
This Agreement and any Product Agreement, unless otherwise agreed by the Parties in the Product Agreement and then only for the purposes of that Product Agreement, will be construed and enforced in accordance with the laws of [* * *], without regard to the conflict of laws principles thereof. All disputes arising out of or in connection with the present contract shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with said Rules. The seat of the arbitration shall be [* * *]. The UN Convention on Contracts for the International Sale of Goods will not apply to this Agreement.
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Master Manufacturing Services Agreement
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.
13.20 Supply and Quality Committee
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(d) |
Decision-Making . All of each Party’s representatives on the Supply and Quality Committee shall collectively have [* * *] with respect to decisions before the Supply and Quality Committee. 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. |
[Signature page to follow]
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Master Manufacturing Services Agreement
IN WITNESS WHEREOF, the duly authorized representatives of the Parties have executed this Agreement as of the Effective Date.
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PATHEON UK LIMITED |
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/s/ Andrew Robinson |
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Andrew Robinson |
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Director |
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7/28/17 |
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PARATEK PHARMACEUTICALS INC . |
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/s/ William M. Haskel |
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William M. Haskel |
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SVP, General Counsel and Corporate Secretary |
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7/28/17 |
[ Signature page to Master Manufacturing Services Agreement ]
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Master Manufacturing Services Agreement
APPENDIX 1
FORM OF PRODUCT AGREEMENT
(Includes Schedules A to D)
PRODUCT AGREEMENT
This Product Agreement (this “ Product Agreement ”) is issued under the Master Manufacturing Services Agreement dated July 28, 2017 between Patheon UK Limited and Paratek Pharmaceuticals Inc. (the “ Master Agreement ”), and is entered into [insert effective date] (the “ Effective Date ”), between Patheon UK Limited, a corporation existing under the laws of England [or applicable founding jurisdiction for Patheon Affiliate] , having a principal place of business at Kingfisher Drive, Covingham, Swindon, SN3 5BZ, England (“ Patheon ”) and Paratek Pharmaceuticals Inc. a corporation existing under the laws of Delaware, of 4 th Floor, 75 Park Plaza, Boston, MA 02116, USA (“ Client ”).
The terms and conditions of the Master Agreement are incorporated herein except to the extent this Product Agreement expressly references the specific provision in the Master Agreement to be modified by this Product Agreement. All capitalized terms that are used but not defined in this Product Agreement will have the respective meanings given to them in the Master Agreement.
The Schedules to this Product Agreement are incorporated into and will be construed in accordance with the terms of this Product Agreement.
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1. |
Product List and Specifications (See Schedule A attached hereto) |
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[* * *] Price (See Schedule B attached hereto) |
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Annual Stability Testing and Validation Activities (if applicable) (See Schedule C attached hereto) |
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Active Materials [* * *] (See Schedule D attached hereto) |
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[* * *] |
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Territory : (insert the description of the Territory here) |
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Manufacturing Site : (insert address of Patheon Manufacturing Site where the Manufacturing Services will be performed) |
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[* * *] |
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10. |
Initial Product Term: (per Section 8.1 of the Master Agreement) from the Effective Date until [* * *] |
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Master Manufacturing Services Agreement
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12. |
Other Modifications to the Master Agreement : (if applicable under Section 1.2 of the Master Agreement) |
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13. |
[* * *] |
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Master Manufacturing Services Agreement
IN WITNESS WHEREOF, the duly authorized representatives of the Parties have executed this Product Agreement as of the Effective Date set forth above.
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PARATEK PHARMACEUTICALS INC . |
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Master Manufacturing Services Agreement
SCHEDULE A
PRODUCT LIST AND SPECIFICATIONS
Product List
[insert product list]
Specifications
Prior to the start of commercial manufacturing of Product under this Agreement, Client will give Patheon the originally executed copies of the Specifications as approved by the applicable Regulatory Authority, which shall be appropriately referred to in the Quality Agreement. If the Specifications received are subsequently amended, then Client will give Patheon the revised and originally executed copies of the revised Specifications. Upon acceptance of the revised Specifications, Patheon will give Client a signed and dated receipt indicating Patheon’s acceptance of the revised Specifications.
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Master Manufacturing Services Agreement
SCHEDULE B
[* * *] PRICE
[Insert Price Table]
Manufacturing Assumptions :
Packaging Assumptions :
Testing Assumptions :
The following cost items are included in the Price for the Products :
[* * *]
The following cost items are not included in the Price for the Products :
[* * *]
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Master Manufacturing Services Agreement
SCHEDULE C
ANNUAL STABILITY TESTING [and VALIDATION ACTIVITIES (if applicable)]
Patheon and Client will agree in writing on any stability testing to be performed by Patheon on the Products. This agreement will specify the commercial and Product stability protocols applicable to the stability testing and the fees payable by Client for this testing including the Price for the Product withdrawn for the stability testing.
[NTD: Schedule C should clearly indicate when and/or under what conditions Patheon’s responsibility to perform stability testing will end]
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Master Manufacturing Services Agreement
SCHEDULE D
ACTIVE MATERIALS
Active Materials |
Supplier |
• |
• |
• |
• |
[* * *]
[End of Product Agreement]
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Master Manufacturing Services Agreement
EXHIBIT A
TECHNICAL DISPUTE RESOLUTION
Technical Disputes which cannot be resolved by negotiation as provided in Section 12.2 will be resolved in the following manner:
1. Appointment of Expert . Within [* * *] after a Party requests under Section 12.2 that an expert be appointed to resolve a Technical Dispute, the Parties will jointly appoint a mutually acceptable expert with experience and expertise in the subject matter of the dispute. If the Parties are unable to so agree within the [* * *] period, or if there is a disclosure of a conflict by an expert under Paragraph 2 hereof which results in the Parties not confirming the appointment of the expert, then an expert (willing to act in that capacity hereunder) will be appointed by an experienced arbitrator on the roster of the American Arbitration Association.
2. Conflicts of Interest . Any person appointed as an expert will be entitled to act and continue to act as an expert even if at the time of his appointment or at any time before he gives his determination, he has or may have some interest or duty which conflicts or may conflict with his appointment if before accepting the appointment (or as soon as practicable after he becomes aware of the conflict or potential conflict) he fully discloses the interest or duty and the Parties will, after the disclosure, have confirmed his appointment.
3. [* * *]
4. Procedure . Where an expert is appointed:
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Timing . The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the Parties and that he issues the authorizations to the Parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within [* * *] (or another date as the Parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof. |
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(c) |
Advisors . Each Party may appoint any counsel, consultants and advisors as it feels appropriate to assist the expert in his determination and so as to present their respective cases so that at all times the Parties will co-operate and seek to narrow and limit the issues to be determined. |
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(d) |
Appointment of New Expert . If within the time specified in Paragraph 4(a) above the expert will not have rendered a decision in accordance with his appointment, a new expert may (at the request of either Party) be appointed and the appointment of the existing expert will thereupon cease for the purposes of determining the matter at issue |
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.
Master Manufacturing Services Agreement
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between the Parties except if the existing expert renders his decision with full reasons prior to the appointment of the new expert, then this decision will have effect and the proposed appointment of the new expert will be withdrawn. |
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(e) |
Final and Binding . The determination of the expert will, except for fraud or manifest error, be final and binding upon the Parties. |
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(f) |
Costs . Each Party will bear its own costs for any matter referred to an expert hereunder and, in the absence of express provision in the Agreement to the contrary, the costs and expenses of the expert will be shared equally by the Parties. |
For greater certainty, the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further nothing in this Agreement (including this Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.
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.
Master Manufacturing Services Agreement
EXHIBIT B
QUARTERLY ACTIVE MATERIALS INVENTORY REPORT
PATHEON UK LIMITED |
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DATE: |
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[or applicable Patheon Affiliate] |
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Per: |
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Name: |
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Title: |
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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 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.
This Product Agreement (this “ Product Agreement ”) is issued under the Master Manufacturing Services Agreement dated July 28, 2017 between Patheon UK Limited and Paratek Pharmaceuticals Inc. (the “ Master Agreement ”), and is entered into as of July 28, 2017 (the “ Effective Date ”), between Patheon UK Limited, a corporation existing under the laws of England, having a principal place of business at Kingfisher Drive, Covingham, Swindon, SN3 5BZ, England (“ Patheon ”) and Paratek Pharmaceuticals Inc. a corporation existing under the laws of Delaware, of 4 th Floor, 75 Park Plaza, Boston, MA 02116, USA (“ Client ”).
The terms and conditions of the Master Agreement are incorporated herein except to the extent this Product Agreement expressly references the specific provision in the Master Agreement to be modified by this Product Agreement. All capitalized terms that are used but not defined in this Product Agreement will have the respective meanings given to them in the Master Agreement.
The Schedules to this Product Agreement are incorporated into and will be construed in accordance with the terms of this Product Agreement.
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14. |
Product List and Specifications (See Schedule A attached hereto). |
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[* * *] Price (See Schedule B attached hereto). |
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Annual Stability Testing (See Schedule C attached hereto). |
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17. |
Active Materials [* * *] (See Schedule D attached hereto). |
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18. |
[* * *] |
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19. |
Territory : [* * *] |
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20. |
Manufacturing Site : [* * *] |
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21. |
[* * *] |
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22. |
Currency : [* * *] |
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23. |
[* * *] |
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24. |
Initial Product Term: per Section 8.1 of the Master Agreement, from the Effective Date until [* * *] |
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25. |
Notices : As stated in Section 13.10 of the Master Agreement |
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26. |
Other Modifications to the Master Agreement : [* * *] |
[ Signature page to Product 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.
IN WITNESS WHEREOF, the duly authorized representatives of the Parties have executed this Product Agreement as of the Effective Date set forth above.
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PATHEON UK LIMITED |
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By: |
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/s/ Andrew Robinson |
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Name: |
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Andrew Robinson |
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Title: |
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Director |
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Date: |
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7/28/17 |
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PARATEK PHARMACEUTICALS INC . |
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By: |
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/s/ William M. Haskel |
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Name: |
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William M. Haskel |
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Title: |
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SVP, General Counsel and Corporate Secretary |
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Date: |
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7/28/17 |
[ Signature page to Product 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.
SCHEDULE A
PRODUCT LIST AND SPECIFICATIONS
Product List
Product |
Vial Size |
Fill Volume |
Lyo Cycle Duration |
Packaging Configuration |
PTK0796 lyophilized vials |
[* * *] |
[* * *] |
[* * *] |
[* * *] |
Specifications
Prior to the start of commercial manufacturing of Product under this Agreement, Client will give Patheon the originally executed copies of the Specifications as approved by the applicable Regulatory Authority, which shall be appropriately referred to in the Quality Agreement . If the Specifications received are subsequently amended, then Client will give Patheon the revised and originally executed copies of the revised Specifications. Upon acceptance of the revised Specifications, Patheon will give Client a signed and dated receipt indicating Patheon’s acceptance of the revised Specifications.
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.
SCHEDULE B
[* * *] PRICE
[* * *]
Manufacturing Assumptions :
[* * *]
Packaging Assumptions :
[* * *]
Testing Assumptions :
[* * *]
Cleaning Assumptions:
[* * *]
Supply Chain Assumptions:
[* * *]
The following cost items are included in the Price for the Products :
[* * *]
The following cost items are not included in the Price for the Products :
[* * *]
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.
SCHEDULE C
ANNUAL STABILITY TESTING
Patheon and Client will agree in writing on any stability testing to be performed by Patheon on the Products. The Quality Agreement will specify the commercial and Product stability protocols applicable to the stability testing and the fees payable by Client for this testing including the Price for the Product withdrawn for the stability testing.
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.
SCHEDULE D
ACTIVE MATERIALS
Active Materials |
Supplier |
ptk0796 |
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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: |
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(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; |
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(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; |
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(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 |
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(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): |
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(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 |
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(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. |
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/s/ MICHAEL F. BIGHAM |
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Michael F. Bigham |
Chief Executive Officer |
August 1, 2017 |
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: |
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(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; |
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(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; |
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(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 |
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(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): |
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(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 |
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(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. |
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/s/ DOUGLAS W. PAGAN |
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Douglas W. Pagán |
Chief Financial Officer |
August 1, 2017 |
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, 2017 (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, 2017.
/s/ MICHAEL F. BIGHAM |
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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, 2017 (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, 2017.
/s/ DOUGLAS W. PAGÁN |
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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.