CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Exhibit 10.7
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
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THIRD AMENDMENT TO THE AMENDED AND RESTATED MANUFACTURING AND SERVICES AGREEMENT
This Third Amendment to the Amended and Restated Manufacturing and Services Agreement (the “Third Amendment”) is made as of July 28, 2020 (the “Effective Date”) by and between Paratek Pharmaceuticals, Inc., a Delaware corporation with a principal business address at 00 Xxxx Xxxxx, 0xx Xxxxx, Xxxxxx, XX 00000 (“Paratek”) and CIPAN Companhia Industrial Produtora de Antibióticos, S.A., a corporation organized and existing under the laws of Portugal with an address at Xxx xx Xxxxxxx, xx00, 0000-000 Xxxxxxxxxxx do Ribatejo, Portugal (“CIPAN” and together with Paratek, the “Parties”). Capitalized terms used, but not otherwise defined, herein shall have the meanings set forth in the Agreement.
WHEREAS, Paratek and CIPAN are parties to that certain Amended and Restated Manufacturing and Services Agreement, dated April 18, 2018, as amended by the First Amendment, dated as of February 18, 2019, and the Second Amendment, dated as of December 20, 2019 (the “Agreement”);
WHEREAS, the Parties now desire to amend the Agreement as set forth in this Third Amendment;
NOW THEREFORE, the Parties agree as follows:
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1. |
Third Amendment to the Agreement. The Agreement is amended and modified as follows: |
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a. |
The terms set forth on Exhibit A of this Third Amendment are hereby added as a new Exhibit F of the Agreement. |
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b. |
The following provision is hereby added as the new Section 1.3: |
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i. |
“1.3 Appendix Terms. Notwithstanding anything to the contrary in the Agreement, the Parties acknowledge and agree to comply with any covenants set forth in Exhibit F. The Parties further acknowledge and agree that any representations and warranties set forth in Exhibit F are true and correct as of the Effective Date (as defined therein) of the Third Amendment. The provisions in Exhibit F will control over other provisions in this Agreement to the extent of any conflict.” |
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2. |
General Provisions. Unless specifically modified or changed by the terms of the Third Amendment, all terms and conditions of the Agreement and the Quality Agreement, between the Parties, dated as of November 2, 2016 (as may be amended from time to time, “Quality Agreement”) shall remain in full force and effect and shall apply fully as described and set forth in the Agreement and Quality Agreement, respectively. In the event of any express conflict or inconsistency between the Third Amendment, on one hand, and the Agreement or Quality Agreement on the other hand, the terms and conditions of the Third Amendment shall control. This Third Amendment, the Quality Agreement and the Agreement constitute the entire understanding among the parties regarding subject matters contained therein and herein and supersede all prior negotiations, commitments, agreements and understandings among them on such subject matters. This Third Amendment may be executed in any number of counterparts, either by original or facsimile counterpart, each such counterpart shall be deemed to be an original instrument, and all such counterparts together shall constitute but one agreement. This Third Amendment and all acts and transactions pursuant hereto and the rights |
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and obligations of the parties hereto shall be governed, construed and interpreted in accordance with the law of the [***], without regard to the conflict of laws principles thereof.
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IN WITNESS WHEREOF, each Party has caused this Third Amendment to be executed by its duly authorized representatives as of the Effective Date.
By:/s/ Xxxxx Xxxxxxxx
Name: Xxxxx Xxxxxxxx
Title: SVP, Technical Operations
CIPAN COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIÓTICOS, S.A.
By:/s/ Xxxxxx Xxxxxx
Name: Xxxxxx Xxxxxx
Title: Industrial Director
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EXHIBIT A
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EXHIBIT F
U.S. GOVERNMENT REQUIREMENTS FOR COMMERCIAL SUBCONTRACTS UNDER PARATEK U.S. GOVERNMENT CONTRACTS
This Agreement is a commercial-item subcontract under one or more prime contracts between PARATEK and the U.S. Government. As a result, this Agreement between PARATEK and Service Provider is subject to the following Federal Acquisition Regulation (“FAR”) and Health and Human Services Acquisition Regulation (“HHSAR”) clauses, to the extent applicable, which are hereby incorporated into this Agreement by reference with the force and effect as though set forth in full text herein. The full text of FAR clauses may be accessed electronically at xxxx://xxx.xxxxxxxxxx.xxx; FAR and HHSAR clauses may be accessed at xxxx://xxx.xxxx.xxx. The additional clauses included in full text below are also incorporated by reference into this Agreement.
Unless otherwise noted with respect to a particular clause, the following changes in terminology will apply to each clause, regardless of capitalization, when consistent with a reasonable interpretation of the clause, which properly expresses the relationship between PARATEK and Service Provider.
The term “government” or “USG” means “PARATEK.”
The term “contractor” or “offeror” means “Service Provider.” The term “contract” or “grant” means “this Agreement.”
The term “contracting officer” or “contracting officer’s representative” means “authorized PARATEK representative.”
The term “subcontract” means “lower-tier agreement under this Agreement.”
FAR CLAUSE |
TITLE |
52.203-12 |
Limitation on Payments to Influence Certain Federal Transactions (Oct 2010) |
52.203-13 |
Contractor Code of Business Ethics and Conduct (Oct 2015) [references to “Government” and “Contracting Officer” remain unchanged] |
52.203-19 |
Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) [references to “Government” remain unchanged] |
52.204-21 |
Basic Safeguarding of Covered Contractor Information Systems (Jun 2016) [references to the “Government” remain unchanged] |
52.204-23 |
Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) [references to “Government” and “Contracting Officer” remain unchanged; Service Provider will timely provide PARATEK with a copy of any notice that Service Provider provides to the Government under this clause] |
52.204-25 |
Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2019) [references to “Government” and “Contracting Officer” remain unchanged; Service Provider will timely provide PARATEK with a copy of any notice that Service Provider provides to the Government under this clause] |
52.209-6 |
Protecting the Government Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) |
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FAR CLAUSE |
TITLE |
52.219-8 |
Utilization of Small Business Concerns (Nov 2016 & Oct 2018) [Service Provider is required to flow down this clause to lower-tier subcontractors if the value of this Agreement exceeds $700,000] |
52.222-21 |
Prohibition on Segregated Facilities (Apr 2015) |
52.222-26 |
Equal Opportunity (Sept 2016) |
52.222-35 |
Equal Opportunity for Veterans (Oct 2015) |
52.222-36 |
Equal Opportunity for Workers with Disabilities (Jul 2014) |
52.222-37 |
Employment Reports on Veterans (Feb 2016) [Service Provider and PARATEK will abide by the requirements of 41 C.F.R. § 61-300.10 as amended from time to time] |
52.222-40 |
Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) |
52.222-50 |
Combating Trafficking in Persons (Jan 2019) [PARATEK may take appropriate action against Service Provider, including termination of this Agreement, for violation of paragraph (b); if a certification is required under paragraph (h)(5), the Contractor will submit the certification at FAR 52.222-56 before award and during performance of the Agreement] |
52.222-54 |
Employment Eligibility Verification (Oct 2015) |
52.224-3 |
Privacy Training (Jan 2017) |
52.227-11 |
Patent Rights—Ownership by the Contractor (May 2014) [references to “Government” and “Contracting Officer” remain unchanged; paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i) through (iv); the frequency of reporting in FAR 27.303(b)(2)(i) is annual; to the extent that this Agreement specifies different intellectual property rights as between Service Provider and PARATEK, the Agreement will control subject to any rights provided to the U.S. Government under the applicable PARATEK contract(s) with the U.S. Government] |
52.227-14 |
Rights in Data—General (May 2014), Alt II (Dec 2007) [Limited Rights Notice; paragraph (a) 75A50120C00001 (unless another number is identified by PARATEK); Service Provider will provide data or analyses generated with Agreement funding upon PARATEK’s request at no additional cost; to the extent that this Agreement specifies different intellectual property rights as between Service Provider and PARATEK, the Agreement will control subject to any rights provided to the U.S. Government under the applicable PARATEK contract(s) with the U.S. Government] |
52.227-16 |
Additional Data Requirements (Jun 1987) |
52.232-40 |
Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) |
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FAR CLAUSE |
TITLE |
52.243-1 |
Changes – Fixed Price (Aug 1987), Alt V (Apr 1984) [the value of any disputed adjustment will be determined by a good faith subcontractor claim submitted by PARATEK to the U.S. Government under the Disputes clause of the applicable PARATEK contract(s) with the U.S. Government] |
52.243-6 |
Change Order Accounting (Apr 1984) [the value of any disputed adjustment will be determined by a good faith subcontractor claim submitted by PARATEK to the U.S. Government under the Disputes clause of the applicable PARATEK contract(s) with the U.S. Government] |
52.243-7 |
Notification of Changes (Apr 1984) [timing for prompt notice and contracting officer response to be determined by the U.S. Government; any disputed adjustment will be determined by a good faith subcontractor claim submitted by PARATEK to the U.S. Government under the Disputes clause of the applicable PARATEK contract(s) with the U.S. Government] |
52.244-6 |
Subcontracts for Commercial Items (Jan & Aug 2019) |
52.245-1 |
Government Property (Jan 2017) [references to “Government” remain unchanged; Service Provider will, with respect to Government property, comply with the U.S. Department of Health and Human Services publication titled “Contractor’s Guide for Control of Government Property”] |
52.246-2 |
Inspection of Supplies—Fixed Price (Aug 1996) [references to the “Government” and the “Contracting Officer” refer to both PARATEK and the U.S. Government, as well as their respective representatives] |
52.246-4 |
Inspection of Services—Fixed Price (Aug 1996) [references to the “Government” and the “Contracting Officer” refer to both PARATEK and the U.S. Government, as well as their respective representatives] |
52.246-5 |
Inspection of Services—Cost-Reimbursement (Apr 1984) [references to the “Government” and the “Contracting Officer” refer to both PARATEK and the U.S. Government, as well as their respective representatives] |
52.246-8 |
Inspection of Research and Development—Cost-Reimbursement (May 2001) [references to the “Government” and the “Contracting Officer” refer to both PARATEK and the U.S. Government, as well as their respective representatives] |
52.246-9 |
Inspection of Research and Development (Short Form) (Apr 1984) [references to the “Government” and the “Contracting Officer” refer to both PARATEK and the U.S. Government, as well as their respective representatives] |
52.246-16 |
Responsibility for Supplies (Apr 1984) |
52.247-64 |
Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) |
52.249-2 |
Termination for Convenience of the Government (Fixed-Price) (Apr 2012) [paragraph (d) does not apply; the time period for submitting a termination settlement proposal under paragraph (e) will be 6 months; the time period for submitting a request for equitable adjustment under paragraph (j) will be 45 days; |
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FAR CLAUSE |
TITLE |
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any appeal through paragraph (j) will be made through a good faith subcontractor claim submitted by PARATEK under the Disputes clause of the applicable PARATEK contract(s) with the U.S. Government] |
52.249-8 |
Default (Fixed-Price Supply and Service) (Apr 1984) |
52.249-9 |
Default (Fixed-Price Research and Development (Apr 1984) |
HHSAR CLAUSE |
TITLE |
352.203-70 |
Anti-Lobbying (Dec 2015) |
352.222-70 |
Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) |
352.223-70 |
Safety and Health (Dec 2015) |
352.224-70 |
Privacy Act (Dec 2015) |
352.227-70 |
Publications and Publicity (Dec 2015) |
352.231-70 |
Salary Rate Limitation (Dec 2015) |
352.233-71 |
Litigation and Claims (Dec 2015) [references to the “Government” and the “Contracting Officer” remain unchanged] |
352.270-5b |
Care of Live Vertebrate Animals |
352.270-6 |
Restriction on Use of Human Subjects [if applicable, Service Provider will maintain a Federalwide Assurance through the U.S. Department of Health and Human Services Office of Human Research Protections] |
Additional Clauses Included in Full Text
The following additional clauses are included in this Agreement in full text, unless otherwise indicated below. The interpretive guidelines set forth above do not apply to each of the clauses included below.
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officer or employee of Congress, or an employee of a Member of Congress on its behalf in connection with the awarding of this Agreement. Service Provider will provide PARATEK with a completed copy of OMB Standard Form LLL, Disclosure of Lobbying Activities, if any registrants under the Lobbying Disclosure Act of 1995 have made lobbying contact on behalf of Service Provider with respect to this Agreement.
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NON-DISCRIMINATION AND OTHER LABOR REQUIREMENTS. Service Provider, if and to the extent applicable to it, and PARATEK will abide by the requirements of 41 C.F.R. |
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§§ 60-1.4, 60-1.7, 60-1.35(c), 60-300.5(a), 60-741.5(a), and 29 C.F.R. part 471, Appendix A to
Subpart A, as updated from time to time. Among other requirements, these regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity, or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
U.S. Government during performance of the Agreement, including without limitation details about locations associated with the U.S. Government’s Strategic National Stockpile. PARATEK will identify such information to Service Provider upon disclosure. Service Provider may only disclose confidential/sensitive information, in whole or in part, with PARATEK’s express prior written consent. Whenever Service Provider is unsure as to the status of information shared under this Agreement, Service Provider will seek and follow written guidance from PARATEK.
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agents understand and agree, that all information submitted pursuant to this provision may be disclosed to the U.S. Government. This provision only applies if the Agreement involves research, including, without limitation, nonclinical research.
To the extent permitted by law, Service Provider will also provide PARATEK with notice within eighteen hours of any arrival of U.S. Government personnel to conduct site visits or audits at Service Provider’s facility that could cover work performed under this Agreement. Service Provider will also provide PARATEK with a plan for addressing any areas of non-conformance with regulatory requirements identified in such a site visit or audit, as well as a complete copy of any Form 483 provided to Service Provider by the U.S. Food and Drug Administration in connection with such a site visit or audit. Service Provider will permit U.S. Government representatives identified by PARATEK to be present at the final debrief associated with such a site visit or audit.
Service Provider will provide its standard operating procedures relating to performance of this Agreement directly to the U.S. Government upon the U.S. Government’s request. Service Provider will also, to the extent permitted by law, provide PARATEK with copies of any correspondence between Service Provider and the U.S. Food and Drug Administration relating to performance under this Agreement within eighteen hours of receipt.
Service Provider will provide PARATEK with monthly inventory reports identifying products under its control using a template to be provided by PARATEK.
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13. |
U.S. GOVERNMENT DISPUTES. Any dispute between Service Provider and PARATEK arising from the U.S. Government’s actions under the applicable PARATEK agreement(s) with the |
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U.S. Government, and for which PARATEK has recourse against the U.S. Government, will be resolved as follows notwithstanding any other dispute provisions in this Agreement:
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b. |
Upon receiving a timely and complete notice from Service Provider, PARATEK will pursue relief under the Disputes clause in the applicable PARATEK agreement(s) with the |
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U.S. Government by submitting a sponsored claim to the relevant U.S. Government contracting officer(s).
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FOREIGN FIRM OR INSTITUTION: A firm or institution organized or existing under the laws of a country other than the United States, its territories, or possessions. The term includes, for purposes of this Agreement, any agency or instrumentality of a foreign government; and firms, institutions, or business organizations which are owned or substantially controlled by foreign governments, firms, institutions, or individuals.
Service Provider agrees to comply with all applicable laws regarding export controls and not to export any products or associated technical data covered by this Agreement to any
U.S. embargoed countries.
Service Provider shall provide notice to PARATEK within two business days of a proposed transfer of control of products or associated technical data covered by this Agreement to a Foreign Firm or Institution. Service Provider shall not complete such a transfer without the express prior written consent of PARATEK. PARATEK may terminate this agreement for default in the event that such a transfer takes place without PARATEK’s consent.
Service Provider shall include this Section, suitably modified to identify the parties, in all subcontracts or lower-tier agreements under this Agreement, regardless of tier.
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