Document:

prtk-ex107_15.htm

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.

 

DocuSign Envelope ID: 1D5A3E34-CCC5-466C-80BD-0FCCC34267BF

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 75 Park Plaza, 4th Floor, Boston, MA 02116 (“Paratek”) and CIPAN Companhia Industrial Produtora de Antibióticos, S.A., a corporation organized and existing under the laws of Portugal with an address at Rua da Estação, no42, 2600-726 Castanheira 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:

	
 
	
1.
	
Third Amendment to the Agreement. The Agreement is amended and modified as follows:

 

	
 
	
a.
	
The terms set forth on Exhibit A of this Third Amendment are hereby added as a new Exhibit F of the Agreement.
	
 

 

	
 
	
b.
	
The following provision is hereby added as the new Section 1.3:

 

	
 
	
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.”
	
 

 

	
 
	
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.

PARATEK PHARMACEUTICALS, INC.

 

 

By:/s/ Jason Burdette

Name:  Jason Burdette

Title:  SVP, Technical Operations

 

 

 

 

 

 

CIPAN COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIÓTICOS, S.A.

 

By:/s/ Daniel Rivero

Name:  Daniel Rivero

Title:  Industrial Director

 

 

 

 

 

 

DocuSign Envelope ID: 1D5A3E34-CCC5-466C-80BD-0FCCC34267BF

 

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 http://www.aquisition.gov; FAR and HHSAR clauses may be accessed at http://www.ecfr.gov. 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

	
 
	
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.

 

	
 
	
1.
	
EXCLUDED STATUS. Pursuant to FAR 52.209-6, Service Provider represents that, as of the date of the effective date of the Agreement, neither Service Provider or its subcontractor(s), nor any of Service Provider’s or its subcontractor’s respective principals, are debarred, suspended, or proposed for debarment by the U.S. Government. Service Provider must confirm this representation on the effective date of this Agreement if the effective date of this Agreement occurs after the date on which Service Provider executes this Agreement.
	
 

	
 
	
2.
	
PAYMENTS TO INFLUENCE CERTAIN FEDERAL TRANSACTIONS. Pursuant to FAR 52.203-11 and FAR 52.203-12, Service Provider hereby certifies to the best of its knowledge and belief that no Federal appropriated funds have been or will be paid to any person influencing or attempting to influence an officer or employee of any U.S. agency, a Member of Congress, an
	
 

 

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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.

	
 
	
3.
	
REPORTING EXECUTIVE COMPENSATION AND AWARD. Service Provider will provide PARATEK with any information necessary to satisfy PARATEK’s obligations under FAR 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018), including the information specified in FAR 52.204-10(d)(2) and, if applicable, the information set forth in FAR 52.204-10(d)(3). Any information provided pursuant to this provision will be publicly disclosed.
	
 

	
 
	
4.
	
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.
	
 

§§ 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.

	
 
	
5.
	
PROVISION OF INFORMATION TO THE U.S. GOVERNMENT. Service Provider acknowledges and agrees that information that Service Provider shares with PARATEK may be shared with the U.S. Government in connection with PARATEK’s performance of its agreement(s) with the U.S. Government. When appropriate, Service Provider may request that PARATEK provide specific information to the U.S. Government with restrictions on further disclosure of the information. PARATEK will not be responsible for any unauthorized use or disclosure of information by the U.S. Government or its agents or contractors.
	
 

	
 
	
6.
	
CONFIDENTIAL TREATMENT OF SENSITIVE INFORMATION. Notwithstanding any other provision in this Agreement, Service Provider will, to the extent permitted by law, guarantee strict confidentiality of sensitive/confidential information that is provided by PARATEK from the
	
 

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.

	
 
	
7.
	
FINANCIAL CONFLICTS OF INTEREST. The Service Provider shall comply with requirements set forth in 45 C.F.R. Part 94 regarding financial conflicts of interest. Unless otherwise agreed with PARATEK, the Service Provider and its agents and employees will follow PARATEK’s conflict of interest policy under 45 C.F.R. Part 94. If PARATEK and the Service Provider agree that the Service Provider and its agents and employees will follow the Service Provider’s conflict of interest policy under 45 C.F.R. Part 94, the Service Provider hereby certifies that its conflict of interest policy complies with 45 C.F.R. Part 94. The Service Provider will submit all required reports to PARATEK at least fifteen calendar days before each report is due to the U.S. Government. The Service Provider understands and agrees, and will ensure that its employees and
	
 

 

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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.

	
 
	
8.
	
PUBLICATIONS AND PRESS RELEASES. Service Provider must obtain PARATEK’s approval before publicly disclosing any publication or press release relating to this Agreement or Service Provider’s performance under this Agreement.
	
 

	
 
	
9.
	
U.S. GOVERNMENT REPORTING. No confidentiality provision included in this Agreement may be construed to prohibit or otherwise restrict Service Provider, as a subcontractor of PARATEK under a U.S. Government contract, from lawfully reporting waste, fraud, or abuse to a designated investigative or law enforcement representative of the federal department or agency authorized to receive such information under the procurement involving the applicable PARATEK agreement(s) with the U.S. Government.
	
 

	
 
	
10.
	
U.S. GOVERNMENT SITE VISITS, AUDITS, INSPECTIONS, AND COMMUNICATIONS. At the U.S. Government’s request, PARATEK and the U.S. Government together will have the right to conduct site visits, audits, and inspections at Service Provider’s facilities relating to PARATEK’s performance of this Agreement, including for the purpose of inventorying, with twenty-four hours’ advance notice or without notice with respect to time- sensitive or critical circumstances. If PARATEK or the U.S. Government identifies any issues during the visit, Service Provider will prepare a report describing the issues and identifying potential solutions. Service Provider will provide the report to PARATEK for review within seven business days of being notified of any issues. Once corrective action is taken in consultation with PARATEK, Service Provider will provide PARATEK with a follow-up report within seven business days.
	
 

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.

 

	
 
	
11.
	
PRIME CONTRACT AND QUALITY AGREEMENT. Service Provider will negotiate with PARATEK in good faith to make any revisions to this Agreement, including modifications to the cost or time required to complete work, that may be necessary based on future modifications to the applicable PARATEK agreement(s) with the U.S. Government or any quality agreement negotiated between PARATEK and the U.S. Government.
	
 

 

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12.
	
PRICING. Service Provider shall not under any circumstances bill PARATEK on an actual cost- plus-percentage-of-cost basis. Notwithstanding Service Provider’s standard pricing and billing practices, Service Provider shall also not charge PARATEK any premium for overtime. Service Provider shall ensure that no individual salary that exceeds the cap identified in HHSAR 352.231- 70 is charged to PARATEK or used by Service Provider to price services provided under this Agreement.
	
 

	
 
	
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
	
 

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:

	
 
	
a.
	
Service Provider shall notify PARATEK of the dispute as soon as practicable, but in no event more than six months after Service Provider knew or should have known of the facts giving rise to such a dispute. Service Provider shall provide in the notice a written justification for and evidence supporting its position in the dispute and certify that it has a good faith basis to take this position.
	
 

	
 
	
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
	
 

U.S. Government by submitting a sponsored claim to the relevant U.S. Government contracting officer(s).

	
 
	
c.
	
If Service Provider deems the contracting officer’s final decision in response to the sponsored claim to have an adverse effect on Service Provider’s position or rights, Service Provider and PARATEK will jointly determine in good faith whether to appeal the contracting officer’s final decision to the appropriate Board of Contract Appeals, the U.S. Court of Federal Claims, or any other forum that has jurisdiction over the contracting officer’s final decision. If Service Provider and PARATEK jointly agree to pursue such an appeal, Service Provider will be responsible for pursuing the appeal through PARATEK’s filings and will bear all expenses, including attorneys’ fees, arising from the appeal.
	
 

	
 
	
d.
	
PARATEK will transfer any amounts that it receives in a dispute with the U.S. Government to Service Provider to the extent that such amounts reflect recovery for any portion of a claim representing Service Provider’s damages. PARATEK’s payment of such amounts will constitute complete satisfaction of any liability that PARATEK may have to Service Provider under this Agreement in connection with such a claim. PARATEK will also have no liability to Service Provider in connection with a claim brought under this Section to the extent that the U.S. Government issues a final decision denying such a claim after the decision is no longer appealable. In addition, PARATEK will have no liability to Service Provider with respect to any dispute that Service Provider fails to timely raise under this Section, except to the extent that PARATEK expressly agrees in writing to waive an applicable timeline.
	
 

	
 
	
14.
	
NO SUPPORT OF TERRORISM. Service Provider acknowledges that U.S. executive orders and laws, including but not limited to Executive Order 13224 and Public Law 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of Service Provider to ensure compliance with these executive orders and laws. This clause must be included in all subcontracts under this Agreement.
	
 

 

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15.
	
SECURITY INCIDENTS. Service Provider will provide PARATEK with notice within eighteen hours of any security incident—including violation of Service Provider’s established security standards, compromise, intrusion, loss of or interference with security processes and procedures, and the loss or theft of PARATEK or U.S. Government property—relating to the work performed under this Agreement. Service Provider will investigate security incidents to determine their cause, the extent, loss or compromise of sensitive program information, and corrective actions taken to prevent future incidents. Service Provider will advise PARATEK of the steps taken to resolve the security incident, including to mitigate future vulnerabilities. The U.S. Government may direct that this Agreement be terminated in response to a severe security incident in which case PARATEK will be authorized to immediately terminate this Agreement and Service Provider will be solely entitled to receive an amount that it would be entitled to receive under FAR 52.249-2 if this Agreement were a prime contract with the U.S. Government.
	
 

	
 
	
16.
	
FOREIGN TRANSFERS.

	
 
	
a.
	
Definition.

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.

 

	
 
	
b.
	
Export Controls.

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.

 

	
 
	
c.
	
Transfer of Products and Associated Technical Data.

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.

 

	
 
	
d.
	
Lower Tier Agreements.

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.

82583935_1prtk-ex108_14.htm

Exhibit 10.8

 

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.

 

FOURTH AMENDMENT TO THE AMENDED AND RESTATED MANUFACTURING AND SERVICES AGREEMENT

This Fourth Amendment to the Amended and Restated Manufacturing and Services Agreement (the “Fourth Amendment”) is made as of December 16, 2020 (the “Effective Date”) by and between Paratek Pharmaceuticals, Inc., a Delaware corporation with a principal business address at 75 Park Plaza, 4th Floor, Boston, MA 02116 (“Paratek”) and CIPAN- Companhia Industrial Produtora de Antibióticos, S.A., a corporation organized and existing under the laws of Portugal with an address at Rua da Estação, no42, 2600-726 Castanheira 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, the Second Amendment, dated as of December 20, 2019, and the Third Amendment, dated as of July 28, 2020 (the “Agreement”);

WHEREAS, the Parties now desire to amend the Agreement as set forth in this Fourth Amendment;

NOW THEREFORE, the Parties agree as follows:

	
 
	
1.
	
Fourth Amendment to the Agreement. The Agreement is amended and modified as follows:

	
 
	
a.
	
Section 1.1.16 is hereby amended and restated in its entirety as follows:

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

	
 
	
b.
	
Section 1.1.30 is hereby amended and restated in its entirety as follows:

	
 
	
i.
	
“Initial Term” means the period commencing on the Original Effective Date and ending on [***].

	
 
	
c.
	
Section 1.1.42 is hereby amended and restated in its entirety as follows:

	
 
	
i.
	
[INTENTIONALLY LEFT BLANK].

	
 
	
d.
	
Section 1.1.54 is hereby amended and restated in its entirety as follows:

89154529_9

 

	
 
		

	
 
	
i.
	
“Paratek Improvement” means any Invention [***].

	
 
	
e.
	
Section 1.1.65 is hereby amended and restated in its entirety as follows:

	
 
	
i.
	
“Product” and “Products” have the meaning set forth in the recitals hereto. In addition, “Product” and “Products” will also include any other forms of Omadacycline that are requested by Paratek in writing pursuant to Section 8.1 (any such product, “New Omadacycline Product”).”

	
 
	
f.
	
Section 1.1.70 is hereby amended and restated in its entirety as follows:

	
 
	
i.
	
[***]

	
 
	
i.
	
[***]

	
 
	
ii.
	
[***]

	
 
	
iii.
	
[***]

	
 
	
g.
	
The following new definition shall be added to Section 1.1 in alphabetical order, and the numbering of the respective subsequent definitions shall be updated accordingly:

	
 
	
i.
	
[***]

	
 
	
ii.
	
“New Omadacycline Product” has the meaning set forth in Section 1.1.65.

	
 
	
h.
	
Section 2.1 is hereby amended and restated in its entirety as follows:

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

	
 
	
i.
	
Section 2.3 is hereby amended and restated in its entirety as follows:

	
 
	
i.
	
Orders.

2.3.1.  Paratek or a designee of Paratek may submit purchase orders for Products to CIPAN from time to time during the Term and at least [***] prior to the requested date of delivery. Each purchase order shall specify (a) the quantity of each Product ordered for 

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delivery; and (b) the delivery date for that order. CIPAN shall Manufacture and supply Products in accordance with this Agreement and each applicable purchase order. Within five (5) Business Days after receiving any purchase order from Paratek, CIPAN shall accept such purchase order in writing if it has been submitted and is otherwise in accordance with the terms and conditions of this Agreement and upon CIPAN’s acceptance of such purchase order, CIPAN shall provide Paratek with a Manufacturing schedule for the Products subject to such purchase order; provided that any failure by CIPAN to reject such a purchase order in the five (5) Business Day period following receipt shall be deemed an acceptance of such Purchase Order by CIPAN. Notwithstanding the foregoing, with respect to any of the [***] in the then most recent Firm Forecast Period, CIPAN may reject, by written notice to Paratek, any portion of any purchase order to the extent that fulfilling the entirety of such purchase order would cause the aggregate number of units of a Product supplied by CIPAN during such month to exceed [***] of the units of such Product forecast for such month in the applicable Rolling Forecast; provided, however, that CIPAN will use its reasonable efforts to, but shall not be obligated to, supply such Product in excess of such [***] quantity.

2.3.2.  Paratek may cancel any firm purchase order at any time as long as any cancellation of a purchase order placed for Product within the Firm Forecast Period for such Product occurs no later than [***] prior to the delivery date for such purchase order. If, at the time of Paratek’s cancellation of a firm purchase order:

(i)the Minocycline being used to fulfill such firm purchase order has been converted to 1020 Intermediate meeting the Specifications, Paratek will pay CIPAN [***] under such firm purchase order;

(ii)the 1020 Intermediate meeting the Specifications being used to fulfill such firm purchase order has been converted to 1040 Intermediate meeting the Specifications, Paratek will pay CIPAN [***] under such firm purchase order;

(iii)the 1040 Intermediate meeting the Specifications being used to fulfill such firm purchase order has been converted to Crude Omadacycline (Product), Paratek will pay CIPAN [***] under such firm purchase order; or

(iv)the Product for such firm purchase order has been approved for release by CIPAN’s quality assurance group in accordance with the Quality Agreement, Paratek will pay CIPAN [***] under such purchase order.

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For the avoidance of doubt, in no event shall Paratek be responsible for paying CIPAN more than the Supply Price under any cancelled purchase order.

	
 
	
j.
	
Section 5.2 is hereby amended and restated in its entirety as follows:

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

	
 
	
k.
	
Section 6.4.1 is hereby amended and restated in its entirety as follows:

	
 
	
i.
	
[***]

	
 
	
l.
	
The following provision is hereby added as the new Section 6.5:

	
 
	
i.
	
Use of New Facility Area for [***]. The Parties agree that CIPAN may use the New Facility Area to manufacture [***]; provided that (a) CIPAN has capacity for such manufacturing activities after fulfilling Paratek’s demand as estimated in the Rolling Forecasts and the Long Range Forecast, (b) Paratek has provided its prior written consent to such manufacturing activities, and (c) CIPAN reduces the Supply Price for each kilogram of Crude Omadacycline invoiced to Paratek by [***]. For purposes of determining whether CIPAN has capacity, the Parties agree that [***]. The [***] will apply starting in the [***] is produced in the New Facility Area and will continue until [***].

	
 
	
m.
	
The following sentence is hereby added to the end of Section 8.1:

	
 
	
i.
	
If Paratek elects to add any New Omadacycline Product as a Product under this Agreement, then Paratek will provide CIPAN written notice of the form of Omadacycline to be added as a Product. Promptly upon CIPAN’s receipt of such written notice, the Parties will negotiate in good faith the Supply Price for such New Omadacycline Product and will amend Exhibit A to include such pricing terms.

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n.
	
Exhibit A to the Agreement is hereby deleted in its entirety and replaced with Exhibit A attached to this Amendment.

	
 
	
2.
	
General Provisions. Unless specifically modified or changed by the terms of the Fourth 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 Fourth Amendment, on one hand, and the Agreement or Quality Agreement on the other hand, the terms and conditions of the Fourth Amendment shall control. This Fourth 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 Fourth 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 Fourth Amendment and all acts and transactions pursuant hereto and the rights 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.

 

 

89154529_9

 

 

 

IN WITNESS WHEREOF, each Party has caused this Fourth Amendment to be executed by its duly authorized representatives as of the Effective Date.

			
	
PARATEK PHARMACEUTICALS, INC.

	
By:
	
/s/ Jason Burdette

	
Name:
	
Jason Burdette

	
Title:
	
SVP, Technical Operations

 

			
	
CIPAN COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIÓTICOS, S.A.

	
By:
	
/s/ Daniel Rivero

	
Name:
	
Daniel Rivero

	
Title:
	
Industrial Director

 

 

 

89154529_9

 

 

 

EXHIBIT A

[***]

[***]

[***]

[***]

[***]

[***]

		
	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

 

[***]

		
	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

 

 

89154529_9

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