VALIDATION AND MANUFACTURING AGREEMENT
Exhibit 10.3
Confidential Treatment Requested by Achaogen, Inc.
VALIDATION AND MANUFACTURING AGREEMENT
THIS AGREEMENT is made and entered into this 5th day of March, 2017 (the “Effective Date”), by and between Achaogen, Inc., a company with its principal place of business at 0000 Xxxxxxxxx Xxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, XX, XXX (“ACHAOGEN”) and Hovione Limited, a company with its principal place of business at Xxxxxxxx, Xxxxxxxxxxx, Xxxx, Xxxxxx Xxxx, Xxxxxxx (“HOVIONE”). ACHAOGEN and HOVIONE may also hereinafter be referred to individually as a “Party” or collectively as the “Parties”.
WHEREAS, HOVIONE has expertise, available facilities, and experience related to the development, synthesis, formulation, testing, and production of active pharmaceutical ingredients, has both pilot plant and commercial scale facilities to manufacture same, and has been interested in providing such development and manufacturing services to ACHAOGEN; and
WHEREAS, ACHAOGEN wishes to engage the services of HOVIONE in a phased program whereby HOVIONE would carry out a Validation Program to confirm, validate and scale up ACHAOGEN technology to manufacture the active pharmaceutical ingredient “Plazomicin”, followed by certain post-submission development activities, and the manufacture of commercial quantities of the active pharmaceutical ingredient using the validated technology on a commercial scale in HOVIONE’s facility; and
WHEREAS, ACHAOGEN receives Federal funding from BARDA (as defined herein) in support of ACHAOGEN’s discovery and development of Plazomicin pursuant to the Prime Contract (as defined herein).
NOW, THEREFORE, in consideration of the acknowledgements, confirmations, representations, warranties, and covenants contained herein, ACHAOGEN and HOVIONE hereby agree as follows:
The following terms (in addition to such other terms as are specifically defined within the Agreement), whether used in the singular or plural, shall have the meanings assigned to them below for purposes of this Agreement:
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
owns, or directly or indirectly controls, at least fifty percent (50%) of the voting stock of the other corporation; or (ii) in the absence of the ownership of at least fifty percent (50%) of the voting stock of a corporation, or in the case of a non-corporate entity, it has the power to direct the direction of the management and policies of such corporation or non-corporate entity, as applicable. |
1.3 |
“Agreement” shall mean this Validation and Manufacturing Agreement, incorporating all appendices, schedules, and exhibits, as may be amended from time to time. |
1.6 |
“Approval” shall mean the first approval of the Product from the Facility for commercial sale by FDA or the EMA. |
1.10 |
“Batch Records” shall mean the final executed batch production and control records for each Batch of the Product Manufactured under this Agreement in accordance with 21 CFR § 211.188. |
1.12 |
“Calendar Year” shall mean the twelve (12) month period commencing on January 1 and ending on December 31 of each year during the Term. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
1.16 |
“Commercially Reasonable” and “Commercially Reasonable Efforts” shall mean the level of diligence and/or efforts and commitment of resources consistent with the past practice of similarly situated pharmaceutical manufacturers with respect to comparable pharmaceutical products. |
1.23 |
“Facility” shall means the Manufacturing facility of HOVIONE at a location specified in Section 2.9 (each of which is also referred to in this Agreement as a “Site”), or such other Manufacturing facility of HOVIONE as prior approved in writing by ACHAOGEN. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
1.25 |
“FDA Approval” means regulatory approval by the FDA to market and sell a final product containing the Product in the United States of America. |
1.26 |
“FDCA” shall mean the United States Federal Food, Drug and Cosmetic Act, including all regulations, guidelines, and guidances arising thereunder, as any of the same may be amended from time to time. |
1.27 |
“Governmental Authority” shall mean any national, multinational, regional, state, or local regulatory agency in the United States, the European Union, or any other country in the Territory. |
1.28 |
“Governmental Project” shall have the meaning set forth in Section 20.1. |
1.29 |
“Improvements” means all discoveries, inventions, developments, modifications, innovations, updates, enhancements, or improvements to Technology (whether or not protectable under patent, trademark, copyright, or similar laws) that are conceived, discovered, invented, developed, created, made, or reduced to practice in the performance of the Parties’ obligations under this Agreement. |
1.33 |
“Prime Contract” means Contract No. HHSO 100201000046C between ACHAOGEN and BARDA (as modified). |
1.34 |
“Process” shall mean the series of operations needed to convert the Starting Materials to the Product, including the testing thereof. |
1.36 |
“Product” shall means any active pharmaceutical ingredient Plazomicin [***] to be Manufactured by HOVIONE for ACHAOGEN under this Agreement. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
1.39 |
“Quality Agreement” shall have the meaning set forth in Section 2.5 hereof and be attached hereto as Exhibit 3 hereof. |
1.42 |
“Services” shall mean the activities to be undertaken by HOVIONE related to the Manufacture of the Product hereunder pursuant to this Agreement and an applicable Work Plan. |
1.43 |
“Specifications” shall mean the specifications for the Product as set forth in Exhibit 2 (as may be amended from time to time by written agreement of the Parties). |
1.45 |
“Successful Completion” in regard to the Validation Program shall mean ACHAOGEN’s acceptance of [***] Batches capable of being used for a submission of a marketing authorization as described in Section 4.2. |
1.46 |
“Supply Failure” shall have the meaning set forth in Section 8.3 hereof. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
1.50 |
“Validation Batches” shall mean a series of [***] Batches capable of being used for a submission of a marketing authorization as described in Section 4.2.2.2. |
1.52 |
“Work Plan” shall mean an individual contract agreed to by the Parties and executed under this Agreement that references this Agreement as containing the governing terms and conditions, to conduct additional Services related to the Manufacturing of Product. |
ARTICLE 2
PERFORMANCE OF SERVICES
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Confidential Treatment Requested by Achaogen, Inc.
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2.4.1 |
HOVIONE shall be responsible for, at its own expense, filing and maintaining all necessary regulatory approvals to operate the Facility as a cGMP Manufacturing site for the Product. |
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2.4.3 |
Except as provided in Section 2.4.1, ACHAOGEN shall be responsible for filing and for maintaining all necessary regulatory approvals for the Product. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
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2.4.7 |
HOVIONE shall [***] any reasonable request by ACHAOGEN, [***], for feasible changes in the Specifications, Manufacturing Process, materials, and any change in analytical testing methods requested by ACHAOGEN, the FDA, or any other applicable Regulatory Authority. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
use of an alternate subcontractor within [***] from the date on which such HOVIONE approved subcontractor is placed on ‘Official Action Indicated’ status by FDA or a substantially similar status by FDA or another Regulatory Authority. |
ARTICLE 3
DEVELOPMENT TEAM AND SUPPLY COMMITTEE
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
3.3 |
Costs. Each Party shall be responsible for its own costs in respect of travel and accommodation expenses in attending meetings of the Development Project Team and Supply Committee. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
4.4 |
Audits. ACHAOGEN and/or its designee(s) shall be allowed, [***] and during normal business hours, to audit HOVIONE’s records [***] that are directly related to the Validation Program. |
4.5 |
Milestone Payment. With respect to the Manufacture of Product at the [***] pursuant to this Agreement, ACHAOGEN shall pay HOVIONE a one-time non-refundable and non-creditable milestone payments, payable as follows: [***] payable to HOVIONE if, without any compromise in quality or standards, there is a Successful Completion of the Product Validation Program by no later than [***]. Such completion shall be evidence by delivery of the Final Validation Report and the payment will be made within [***] of ACHAOGEN’s acceptance of such report. The Parties agree and acknowledge that there may be factors beyond either Party’s control that prevent them from reaching this milestone. Provided that there is not a Successful Completion of the Validation Program by [***], no milestone shall be owed under this Agreement. |
ARTICLE 5
COMMERCIAL MANUFACTURE AND SUPPLY OF THE PRODUCT
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Confidential Treatment Requested by Achaogen, Inc.
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5.2.1 |
Prior to First FDA Approval. No later than [***] prior to the anticipated date on which ACHAOGEN will require its first delivery of Product under this Agreement, ACHAOGEN shall provide HOVIONE with a non-binding forecast of its estimated requirements for Product for the first [***] of sales, broken down on a [***] basis. Every [***] thereafter but only prior to the first FDA Approval date of Plazomicin, ACHAOGEN shall provide HOVIONE with an updated non-binding forecast of its estimated requirements of Product for the first [***] of sales, broken down on a [***] basis. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
5.6 |
The Parties agree that time is of the essence with respect to Manufacturing under the Agreement. Accordingly, should any condition arise in the course of this Agreement that is reasonably likely to delay Manufacturing or a Delivery Date, including but not limited to, disruption with suppliers, regulatory issues, or failure of any Batch, HOVIONE shall notify ACHAOGEN of such condition as soon as reasonably practicable. Similarly, should any ACHAOGEN responsibility be delayed in such a way to disrupt HOVIONE’s obligations under this Agreement, ACHAOGEN shall notify HOVIONE of such condition as soon as reasonably practicable. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
And
ARTICLE 6
MATERIALS AND EQUIPMENT
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Confidential Treatment Requested by Achaogen, Inc.
Materials as required by this Agreement in preparation for the Manufacture of Product hereunder, HOVIONE shall [***]. HOVIONE shall [***]. If at any time, [***]. |
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6.1.4 |
[***]. HOVIONE shall hold and maintain a minimum of [***]. [***] will be based on [***]. HOVIONE shall rotate the [***] with each new Manufacturing Batch. |
6.2 |
HOVIONE-Sourced Materials. HOVIONE shall [***] plan, manage and procure all materials necessary for the Manufacturing of the Product [***]. HOVIONE shall ensure |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
that all such materials are purchased from qualified or specified manufacturers. HOVIONE shall obtain a certificate of analysis or equivalent with each lot of materials purchased. HOVIONE will store all materials in a secure location under appropriate conditions. For the avoidance of doubt, [***] shall not [***]. |
6.4 |
HOVIONE Supplier Contracts. HOVIONE shall take all steps necessary to execute the contracts with its suppliers to ensure that HOVIONE can purchase the necessary quantities of Project Specific Raw Materials and Starting Materials in a timely manner to Manufacture the Product in the quantities required by Section 5.4., the terms of such contracts shall be known to ACHAOGEN. ACHAOGEN assures that should HOVIONE [***] ACHAOGEN shall [***]. |
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6.5.2 |
Should the scale-up to [***] batches and/or the technology transfer to [***] require additional equipment not reasonably predicted by HOVIONE’s current |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
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6.5.4 |
If the [***] ACHAOGEN’s manufacturing program, the Parties will negotiate in good faith to [***]. |
ARTICLE 7
OWNERSHIP AND TECHNOLOGY TRANSFER
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
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be provided during regular business hours for HOVIONE and ACHAOGEN shall [***]. |
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7.4.5 |
Nothing contained in 7.4 shall be construed as HOVIONE providing any assurance of success of the technology transfer to a third-party. Hovione only assures that it shall provide all API and API process information available resulting from the development and validation work performed for ACHAOGEN, provided however that nothing in this Agreement shall prevent ACHAOGEN from having access to information directly related to the Product, which is necessary for a Regulatory Authority to approve a second source of Product. |
ARTICLE 8
EXCLUSIVITY BY HOVIONE
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
8.3 |
Supply Failure. A “Supply Failure” means (i) any notification from HOVIONE of an anticipated Product shortage or inability to fill [***] or more of a Purchase Order in either case for a period of [***] or more from the agreed upon Delivery Date; (ii) a Force Majeure Event or [***] that meets the Manufacturing Standards in accordance with this Agreement for a period of [***] or more from the agreed upon delivery date; or (iii) the occurrence on [***] or more occasions within a [***] period of a [***]. Notwithstanding any rights or obligations in the Agreement, should there be a Supply Failure and such failure is not due to the actions of ACHAOGEN, then (i) ACHAOGEN is permitted to [***] supply of Product from other sources even if such supply would otherwise be contrary to the terms of this Agreement, including but not limited to Section 5.1; and (ii) ACHAOGEN is excused from for any Minimum Annual Commitment for the remainder of the Term. |
ARTICLE 9
WARRANTIES; SPECIFICATIONS
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Confidential Treatment Requested by Achaogen, Inc.
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provides HOVIONE with no less than [***] prior written notice of any such change in the shelf life of the Product. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
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by FDA pursuant to Section 306 of the FDCA, 21 U.S.C. § 335a (“Debarred Entity”); or (c) the subject of an FDA debarment investigation or proceeding (or similar proceeding of another regulatory agency); and HOVIONE will not retain or employ any personnel, and will not knowingly use the services of any contractor or consultant, who is debarred by the FDA or who is the subject of an FDA debarment investigation or proceeding (or similar sanction or investigation by another regulatory agency) in connection with performing any Manufacturing or Services. HOVIONE has no knowledge of any circumstances which may affect the accuracy of the foregoing representation, including, without limitation, any FDA investigations of, or debarment proceedings against, HOVIONE or any person or entity performing services or rendering assistance which is in any way related to activities taken pursuant to this Agreement. HOVIONE shall notify ACHAOGEN in writing as soon as possible if HOVIONE, at any time during the Term, becomes aware of any such circumstances. |
9.4 |
ACHAOGEN Warranties. ACHAOGEN represents and warrants that: |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
9.6 |
ACHAOGEN as Party. The Parties acknowledge and agree that, in entering into this Agreement, ACHAOGEN (a) is making and providing only those acknowledgments, confirmations, representations, and warranties explicitly stated in this Agreement as made and provided by ACHAOGEN; (b) is not, and shall not be deemed as, making or providing any other acknowledgments, confirmations, representations, or warranties or undertaking covenants of any kind; and (c) is not, and shall not be deemed, in any way responsible or liable for (or jointly responsible or liable for), or the guarantor of, the acknowledgements, confirmations, representations, warranties, or covenants of ACHAOGEN in this Agreement. |
ARTICLE 10
PRICE AND TERMS FOR THE COMMERCIAL PRODUCT
10.1 |
Price. The initial price for commercial Product supplied by HOVIONE to ACHAOGEN during the Term of this Agreement (excluding the Product from the validation Batches) is |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
set forth in Exhibit 7. The price for the Product from the Validation Batches shall be included in the appropriate Work Plan. |
10.4 |
Invoices. The invoices for the fees under this Agreement shall be marked with the following information: |
Purchase Order Number __________;
“Manufacturing/Services performed under this Validation and Manufacturing Agreement and associated with the Work Plan:
HOVIONE shall invoice ACHAOGEN for Product upon the earlier to occur of (i) shipment of such Product, (ii) within [***] after Batch Release/Disposition by ACHAOGEN, or (iii) within [***] of HOVIONE’s Batch Release (as evidenced by the date of HOVIONE’s certificate of analysis), (iv) upon ACHAOGEN’s request. HOVIONE will submit its invoices for Manufacturing, Services, products, and expenses to ACHAOGEN by regular mail or by email as noted below:
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
10.6 |
Reimbursement of Costs and Expenses. For any provision in this Agreement requiring ACHAOGEN to reimburse HOVIONE for its actual costs or expenses, including but not limited to [***], HOVIONE agrees to [***] such amounts and to [***] any proposals by ACHAOGEN to reduce such amounts. |
10.7 |
Currency: Currency Conversion. All payments to be made under this Agreement shall be made in US Dollars. The Parties agree to [***]. If and hen the [***] hereunder, HOVIONE shall notify ACHAOGEN in writing and such [***] (with such [***]). |
10.8 |
Taxes. Any use, sales, excise or value added tax, duty, custom, inspection or testing fee, or any other tax, fee or charge of any nature whatsoever imposed by any governmental authority on or measured by the transaction between HOVIONE and ACHAOGEN (other than HOVIONE’s income tax), will be paid by ACHAOGEN in addition to the prices quoted or invoiced by HOVIONE. In the event HOVIONE is required to pay any such tax, fee, or charge, ACHAOGEN will reimburse HOVIONE for such payment, or in lieu of such payment, ACHAOGEN will provide HOVIONE at the time the order is submitted an exemption certificate or other document acceptable to the authority imposing the tax, fee or charge. |
10.9 |
Import and Export. Without limiting the generality of any other provisions of this Agreement, and in addition to any other amounts due to HOVIONE under his Agreement, ACHAOGEN will be responsible for [***]. If applicable, HOVIONE will provide customary export documentation, as specified by ACHAOGEN in writing or by separate delivery and shipment documentation instructions, together with each shipment of Product (or such other deliverables). HOVIONE shall also provide ACHAOGEN with all relevant shipping information (e.g., carrier, shipment details, scheduled arrival date, quantity) prior to or coincident with shipping any Product (or such other deliverables) under this Agreement. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
ARTICLE 11
MANUFACTURING AUDITS
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
purposes of this provision, shall be [***] for the Annual MA and [***] for the Event MA) and shall last no longer than [***]. During a Manufacturing Audit, upon ACHAOGEN’s request, HOVIONE shall make available for review and photocopying such documents as ACHAOGEN and its auditors may reasonably request provided they relate to the Product and its Manufacture by HOVIONE. |
12.4 |
Bankruptcy; Insolvency. Either Party may terminate this Agreement upon: (a) the entry of a decree or order for relief by a court having jurisdiction in the premises in respect of |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
such Party in an involuntary case under the U.S. Federal Bankruptcy Code, as now constituted or hereafter amended, or any other applicable federal or state insolvency or other similar law and the continuance of any such decree or order unstayed and in effect for a period of sixty (60) consecutive days; or (b) filing by such Party of a petition for relief under the U.S. Federal Bankruptcy Code, as now constituted or hereafter amended, or any other applicable federal or state insolvency or similar law. |
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(a) |
[***]; |
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(b) |
any outstanding, unpaid invoices issued by HOVIONE; |
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(c) |
[***]; |
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(d) |
[***]; and |
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(f) |
an amount equal to the sum of (i) the [***] in which the termination occurs, plus (ii) the [***] that would otherwise have been owed for the [***]; provided however, in the event this Agreement is terminated by ACHAOGEN pursuant to Section 12.2(a) (No FDA approval), the amount otherwise owed under this subsection (f) shall be [***]. |
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(g) |
For the avoidance of doubt, the amounts set forth in subsection 12.6(e) shall not be owed by ACHAOGEN in the event of a termination of this Agreement by ACHAOGEN pursuant Section 12.3 (HOVIONE breach), or Section 12.4 (HOVIONE bankruptcy). |
ARTICLE 13
CONTROL SAMPLE; CLAIMS OF NON-CONFORMANCE
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Confidential Treatment Requested by Achaogen, Inc.
Such control sample must be from, and representative of, the lot of the Product actually shipped. |
ARTICLE 14
RECALLS; CMC DOCUMENTATION
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
be recalled or otherwise withdrawn from any country in the Territory; or (c) a court of competent jurisdiction orders such a recall or withdrawal (either (b) or (c) together, an “Order”), the Parties shall take all appropriate corrective actions reasonably requested by the other Party or any Regulatory Authority. To the extent such recall or withdrawal results from HOVIONE’s: (i) [***], including but not limited to [***]; (ii) the [***]; or (iii) [***], then HOVIONE shall be responsible for: (x) its [***]; (y) [***] for such recall or withdrawal; and (z) [***]. If ACHAOGEN believes that the recall results from any reason defined in (i), (ii), and/or (iii) above, then ACHAOGEN and its Affiliates may proceed with such recall [***] (subject to the following sentence) and will hold a [***] to ensure the [***]. If HOVIONE agrees, or a final determination is made in an arbitration, that the recall results from any reason defined in (i), (ii), and/or (iii) above, then HOVIONE shall be responsible for its and ACHAOGEN’s expenses as set forth above; provided that HOVIONE’s aggregate liability to ACHAOGEN under this Section 14.1 for any recall shall be [***]. If the recall results from any other reason, [***]. For purposes of this Agreement, [***] of such recall or withdrawal shall be [***]. The Parties each have the right to audit such recall costs. ACHAOGEN shall be responsible for coordinating any and all such recall or withdrawal activities with the Regulatory Authorities, its customers, or otherwise. |
ARTICLE 15
INDEMNIFICATION; INSURANCE
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Confidential Treatment Requested by Achaogen, Inc.
foregoing, ACHAOGEN shall have no such indemnity obligation to the extent that such third party claims are based on, arise out of, or are caused by: (x) the gross negligence or willful misconduct of HOVIONE or its Affiliates (or their respective directors, officers, employees, agents, contractors, successors, and assigns); (y) any breach of any representation or warranty made by HOVIONE in this Agreement; or (z) any failure by HOVIONE to perform any covenant, agreement, or undertaking on the part of HOVIONE contained in this Agreement. |
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(a) |
Excess products liability with a combined single limit in an amount of not less than U.S. [***] per occurrence and U.S. [***] in the aggregate during |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
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(d) |
employer’s liability with a limit of liability in an amount of not less than the statutory limits. |
ACHAOGEN agrees to furnish within [***] after execution of this Agreement, and upon each policy renewal thereafter, and upon written request of HOVIONE, a certificate of insurance or self-insurance evidencing that such insurance is in effect. ACHAOGEN will provide HOVIONE [***] prior written notice of cancellation, non-renewal, or material change in the insurance required by this Agreement.
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
this Agreement; or (b) the amount of consideration actually paid by ACHAOGEN to HOVIONE under this Agreement in the [***] period immediately preceding the date of the Claim. |
ARTICLE 16
CONFIDENTIALITY; XXXXXXX XXXXXXX
16.1 |
Definition. “Confidential Information” means any scientific, technical, trade, or business information which is disclosed by one Party (“Disclosing Party”) to the other (“Receiving Party”) and which is treated by the Disclosing Party as confidential or proprietary. Confidential Information does not include information that (a) is in possession of the Receiving Party at the time of disclosure, as reasonably demonstrated by written records and without obligation of confidentiality; (b) is part of the public domain at the time of the Receiving Party’s public disclosure through no fault of the Receiving Party; (c) is received by the Receiving Party from a third party who has no obligation of confidentiality to the Disclosing Party; or (d) is developed independently by the Receiving Party without use of, reference to, or reliance upon the Disclosing Party’s Confidential Information. The Disclosing Party will, to the extent practical, use reasonable efforts to label or identify as confidential, at the time of disclosure all such Confidential Information that is disclosed in writing or other tangible form. Confidential Information of HOVIONE includes, but is not limited to, HOVIONE’s Background Intellectual Property, HOVIONE’s Technology, and HOVIONE’s Improvements, whether or not labeled confidential. Confidential Information of ACHAOGEN includes, but is not limited to, ACHAOGEN’s Background Intellectual Property, ACHAOGEN’s Technology, and Refinements, whether or not labeled confidential. This Agreement shall be Confidential Information of both Parties. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
reasonably cooperate with the Disclosing Party in its efforts to seek such a protective order. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
omissions, or delays do not arise from such Party’s breach of this Agreement), and labor disputes (a “Force Majeure Event”). Such excuse shall continue as long as the Force Majeure Event continues. Upon cessation of such Force Majeure Event, such Party shall promptly resume performance hereunder. |
ARTICLE 18
MUTUAL REPRESENTATIONS
18.1 |
Each Party hereby represents, warrants and covenants to the other Party as follows throughout the Term of this Agreement: |
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18.1.1 |
Organization. It is duly organized, validly existing and in good standing under the laws of the jurisdiction of incorporation or organization. Such Party has the requisite legal and corporate power and authority to conduct its business as presently being conducted, and as proposed to be conducted by it, and is duly qualified to do business in those jurisdictions where its ownership of property or the conduct of its business requires. |
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18.1.2 |
Authority. It has all requisite legal and corporate power and authority to enter into this Agreement and to perform the services contemplated hereunder. All corporate actions on the part of such Party, the boards of directors or managers, or similar governing body of such Party and the equity holders of such Party necessary for: (a) the authorization, execution, delivery, and performance by such Party of this Agreement; and (b) the consummation of the transactions contemplated hereby, have been duly taken. |
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18.1.3 |
Binding Obligation. This Agreement is a legally valid and binding obligation of such Party, enforceable against such Party in accordance with its terms. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
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18.1.5 |
Consents and Approvals. All material consents, approvals, qualifications, orders or authorizations of, filings with, or notices to any Governmental Authority or any other person required in connection with such Party’s execution, delivery, or performance of: (a) this Agreement; and (b) the consummation of any other transaction contemplated on the part of such Party hereby, have been obtained, made or given. |
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18.1.6 |
No Violation of Law; Permits. Such Party is not in violation of any law or regulation (nor is such Party aware of any violation of any law or regulation by any other person), which violation could reasonably be expected to adversely affect such Party’s performance of its obligations hereunder or the ability of the other Party to realize the intended benefits to such other Party under this Agreement, and, except as otherwise contemplated hereby, such Party holds each of the licenses, permits, approvals, or authorizations necessary with respect to its current business and operations (and its rights and obligations contemplated hereby) in compliance with all laws and regulations. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
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against any Party that exceed the limits set forth in Section 15.5, to the extent applicable. |
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(g) |
A final award shall be issued no later than [***] from the date the claimant Party files its demand for arbitration. |
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(j) |
During the continuance of any arbitration proceeding, the Parties shall continue to perform their respective obligations under this Agreement to the greatest extent practicable. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
20.4 |
All BARDA requirements applicable to HOVIONE as contained in this Agreement shall only be applicable for so long as ACHAOGEN has ongoing obligations to BARDA. ACHAOGEN agrees to notify HOVIONE as soon as reasonably practicable for any BARDA requirements that are no longer applicable after commercial launch of the Product. |
21.1 |
Independent Contractors. The relationship between ACHAOGEN and HOVIONE is that of independent contractors and nothing herein shall be deemed to constitute the relationship of partners, joint ventures, nor of principal and agent between ACHAOGEN and HOVIONE. Neither Party shall have an express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any third party. |
21.2 |
Cooperation with Collaboration Partner. HOVIONE acknowledges that ACHAOGEN may have a collaboration partner in conjunction with certain sales of Product outside the United States. HOVIONE agrees to cooperate with such partner as required in matters relating to supply for and regulatory compliance in jurisdictions outside the United States. ACHAOGEN shall [***]. |
21.3 |
Performance by Affiliates. The Parties agree that either Party’s rights or obligations hereunder may be exercised or performed by one or more of that Party’s Affiliates; provided that the Party shall remain liable for the performance of any such obligations by any of its Affiliates. |
21.4 |
Assignment. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
21.5 |
Continuing Obligations. Termination, assignment or expiration of this Agreement shall not relieve either Party from full performance of any obligations incurred prior thereto. |
21.6 |
Waiver. Neither Party’s waiver of any breach or failure to enforce any of the terms and conditions of this Agreement, at any time, shall in anyway affect, limit, or waive such Party’s right thereafter to enforce and compel strict compliance with every term and condition of this Agreement. |
21.7 |
Survival. Expiration or termination of this Agreement for any reason shall not relieve either Party of any obligation accruing prior to such expiration or termination, or of any rights and obligations of the Parties that by their terms survive termination or expiration of this Agreement, including, without limitation, Sections 2.7, 8.1, 12.6 and ARTICLE 7 (Ownership and Technology Transfer), ARTICLE 9 (Warranties; Specifications), ARTICLE 11 (Audits), ARTICLE 14 (Recalls; CMC Documentation); ARTICLE 15 (Indemnification; Insurance), ARTICLE 16 (Confidentiality; Xxxxxxx Xxxxxxx), ARTICLE 19 (Dispute Resolution), ARTICLE 20 (BARDA Requirements), and this ARTICLE 21 (Miscellaneous). |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
or association of countries, such words, sentences, paragraphs, clauses, or combination shall be inoperative in such country or community or association of countries and the remainder of this Agreement shall remain binding upon the Parties, so long as enforcement of the remainder does not violate the Parties’ overall intentions in this transaction. |
21.9 |
Headings and Construction. The headings in this Agreement are for convenience of reference only and shall not affect its interpretation. Both Parties participated equally in the formation of this Agreement, and the language of this Agreement shall not be presumptively construed against either Party |
21.10 |
Exhibits. All exhibits referred to herein form an integral part of this Agreement and are incorporated into this Agreement by such reference. |
21.11 |
Notices. All notices required to be given under this Agreement shall be in writing and shall be delivered personally or sent by: (i) registered or certified mail, return receipt requested; (ii) a nationally-recognized courier service guaranteeing next-day delivery, charges prepaid; or (iii) electronically (with the original sent within [***] by either of the two foregoing manners), and shall be deemed to have been given when delivered if delivered personally, by mail or by courier, or electronically, as the case may be. Any such notices shall be addressed to the receiving Party at such Party’s address set forth below, or at such other address as may from time to time be furnished by similar notice by either Party. |
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If to ACHAOGEN: |
Achaogen, Inc. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
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Email: [***] |
21.12 |
Counterparts. This Agreement and any amendment or supplement hereto may be executed in any number of counterparts, and any Party hereto may execute any such counterpart, each of which when executed and delivered shall be deemed to be an original and all of which counterparts taken together shall constitute but one and the same instrument. The execution of this Agreement and any such amendment or supplement by any Party hereto will not become effective until counterparts hereof have been executed by both Parties hereto. |
21.14 |
Governing Law. The validity, interpretation and performance of this Agreement shall be governed and construed in accordance with the laws of the State of New York, without regard to the conflicts of law provisions thereof. The Parties agree that the provisions of the United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement, and are hereby expressly excluded. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
THE REST OF THIS PAGE IS INTENTIONALLY LEFT BLANK
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized representatives as of the Effective Date.
By: /s/ Xxxxx Xxxx Title: COO Date: 3/9/17 |
By: /s/ Xxx Xxxxxx Title: Chief Executive Date: Zurich, 6th March 2017 |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Sample Validation Program Work Plan
Work Plan No. C-XX
This Work Plan No. C-[#] (the “Work Plan”), dated _______________ (the “Effective Date”), is by and between Achaogen, Inc., a company with its principal place of business at 7000 Xxxxxxxxx Xxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, XX, XXX (“ACHAOGEN”) and Hovione Limited, a company with its principal place of business at Loxxxxxx, Xxxxxxxxxxx, Xxxx, Xxxxxx Xxxx, Xxxxxxx (“HOVIONE”), and upon execution by both Parties, shall be incorporated into the Validation and Manufacturing Agreement between ACHAOGEN and HOVIONE dated _____ November, 2016 (the “Manufacturing Agreement”). Capitalized terms used in this Order shall have the meanings ascribed to them in the Agreement.
ACHAOGEN hereby engages HOVIONE to provide Services as follows:
1. |
Work Plan. This agreement constitutes a “Work Plan” under the Manufacturing Agreement, and this Work Plan and the Services contemplated herein are subject to the terms and provisions of the Manufacturing Agreement. |
2. |
Services and Payment of Fees and Expenses. The specific services contemplated by this Work Plan (the “Services”) and the related payment terms and obligations are set forth on the following attachments, which are incorporated herein by reference: |
SCOPE OF WORKAttachment 1
PROJECT BUDGETAttachment 2
PAYMENT SCHEDULEAttachment 3
3. |
Delivery Date. HOVIONE shall [***] deliver to ACHAOGEN [description of the deliverable] by not later than [delivery date(s) or schedule of delivery dates] and a final report by not later than [delivery date(s) or schedule of delivery dates. |
4. |
Price. As consideration for HOVIONE conducting the Services described in this Order, ACHAOGEN shall pay to HOVIONE an amount not to exceed [Insert written amount; include shipping and taxes, if applicable] US dollars ($ numerical amount]) |
[Insert payment schedule if not [***].]
5. |
Term. The term of this Work Plan shall commence on the Effective Date and shall continue until the Services described in Attachment 1 are completed, unless this Work Plan is terminated in accordance with the following terms: |
Exhibit 1-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
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b. |
In no event shall ACHAOGEN be liable for lost or anticipated profits, unabsorbed indirect costs or overhead, or for any sum in excess of the total Work Plan price. |
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c. |
In the event of a material breach of this Work Plan by either Party, the other Party may terminate this Agreement immediately if the material breach is not cured within thirty (30) days’ written notice. |
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d. |
In the event of termination of any Work Plan, ACHAOGEN will compensate HOVIONE for all Services performed thereunder, [***] under this subsection. |
If the Manufacturing Agreement is terminated or expires, but this Work Plan is not terminated or completed, then the terms of the Manufacturing Agreement shall continue to apply to this Work Plan until the Work Plan is either terminated or completed.
6. |
Project Contacts. |
The primary contact at ACHAOGEN will be [name, title], [email], [phone].
The primary contact at HOVIONE will be [name, title], [email], [phone].
7. |
Government Projects. Pursuant to ARTICLE 20 of the Manufacturing Agreement, this Work Plan is/is not a “Government Project”. |
8. |
Entire Agreement. This Work Plan, along with the Attachments and the Manufacturing Agreement, constitute the full understanding of the Parties and a complete and exclusive statement of the terms of the Parties’ agreement with respect to the subject matter herein. |
9. |
Amendments. No modification, amendment, or waiver of this Work Plan shall be effective unless in writing and duly executed and delivered by each party to the other. |
Following the full execution of this Order, any change to the price must be agreed to in writing by the parties. [***]
Exhibit 1-2
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized representatives as of the Effective Date.
ACHAOGEN, INC. By: Title: Date: |
HOVIONE LIMITED By: Title: Date: |
Exhibit 1-3
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Exhibit 2-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
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Confidential Treatment Requested by Achaogen, Inc.
To Be Subsequently Attached
No Later Than March 31, 2017
QUALITY AGREEMENT
between
HOVIONE [***] (hereafter HOVIONE")
and
ACHAOGEN,INC,
located at 7000 Xxxxxxxxx Xxxxx. #000, Xxxxx Xxx Xxxxxxxxx, XX 00000, Xxxxxx Xxxxxx xf
America (hereafter “ACHAOGEN”)
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
1 of 40 |
Exhibit 3-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
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Confidential Treatment Requested by Achaogen, Inc.
[***]
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
2 of 40 |
Exhibit 3-2
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
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Confidential Treatment Requested by Achaogen, Inc.
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Introduction/Purpose/Scope |
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Introduction |
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Purpose |
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Scope of the Agreement |
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Product Covered by the Quality Agreement |
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Applicable Laws |
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Term of Agreement |
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Definitions and Abbreviations |
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Roles and Responsibilities |
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Training |
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Facilities |
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Manufacturing Equipment |
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HAPIs |
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Qualification / Validation |
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Batch Manufacturing |
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Stability |
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Controlled Documents |
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Change Control |
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Annual Product Quality Review |
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Subcontracting |
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Access to Manufacturing Facilities |
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Resolution of Quality Issues |
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General Requirements |
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HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
3 of 40 |
Exhibit 3-3
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
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Confidential Treatment Requested by Achaogen, Inc.
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Specifications |
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Analytical methods |
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Reference standards |
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Raw materials |
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Starting Materials |
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Process Validation Program |
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Undesirable contaminants |
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Deviations / OOS (incl. stability) |
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Reference (Product) and Retention of samples (final Product) |
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Storage and Distribution |
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Certificate of Analysis |
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Product Release |
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Reprocessing |
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Reworking |
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4.15. |
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Packaging |
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Labelling |
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Product Rejection |
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Laboratory Control |
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Complaints and Recalls |
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Complaints |
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Recall |
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Compliance and Regulatory Requirements |
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Applicable GMP Standard |
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Regulatory documents |
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Audits and Inspections |
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HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
4 of 40 |
Exhibit 3-4
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
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Confidential Treatment Requested by Achaogen, Inc.
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ACHAOGEN’s Right to Audit |
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7.2. |
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Authority Inspections |
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8. |
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Miscellaneous Provisions |
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Assignment |
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Related agreements |
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Confidentiality |
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Choice of Law |
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Debarment Certification |
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BARDA Requirements |
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Entire Agreement |
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28 |
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Amendments and Supplements |
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28 |
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9. |
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Contacts |
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10. |
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List of Appendices |
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29 |
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
5 of 40 |
Exhibit 3-5
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
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Confidential Treatment Requested by Achaogen, Inc.
Introduction
ACHAOGEN and HOVIONE are Parties to this Quality Agreement (the “Quality Agreement”). The Quality Agreement covers the validation, manufacturing, analytical testing, stability, packaging and supply of the Drug Substance (as defined below), as well as certain regulatory activities for Drug Substance.
Purpose
The purpose of this Quality Agreement is to define the roles and responsibilities of each Party under the Validation and Manufacturing Agreement, between ACHAOGEN and Hovione International Limited, an Affiliate of HOVIONE, still under discussion (the “Manufacturing Agreement”). This Quality Agreement will also define the required technical quality arrangements between HOVIONE and ACHAOGEN for managing the quality systems.
The purpose of this agreement is to establish the Quality Agreement, required by Section 2.4 of the Manufacturing Agreement, regarding the validation, manufacturing, testing, packaging and supply of the drug substance (DS), Plazomicin [***]. This agreement outlines the responsibilities of HOVIONE and ACHAOGEN with respect to the quality of the aforementioned OS and the interface between the parties.
Scope of the Agreement
The scope of this Quality Agreement is to cover the essential quality requirements pertinent to the manufacture of Drug Substance intended to be used as the registration / validation batches, and Drug Substance for commercial production. It includes all aspects of process development, manufacturing, analytical testing, storage, release, stability and regulatory activities. This agreement delineates the responsibilities and the channels of communication between the Parties.
Product Covered by the Quality Agreement
This Quality Agreement covers the following Product
Product: Plazomlcin [***]
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
6 of 40 |
Exhibit 3-6
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
HOVIONE shall manufacture Product and control Product quality in compliance with the technical information provided by ACHAOGEN and in compliance with Applicable Laws.
Term of Agreement
This Quality Agreement shall become effective and binding upon the date of the final approval signature and shall remain in effect until two (2) years after the last delivery of Product by HOVIONE to ACHAOGEN under the Manufacturing Agreement, unless the Parties specifically agree in writing an extension of the Quality Agreement.
2. |
Definitions and Abbreviations |
Capitalized terms used but not defined herein are used as defined in the Manufacturing Agreement. The following terms (in addition to such other terms as are specifically defined within the Quality Agreement), whether used in the singular or plural, shall have the meanings assigned to them below for purposes of this Agreement:
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- |
Drug substance (DS): Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient. |
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HOVIONE’s Quality System: The Quality System for management of facilities, personnel and procedures, including current SOPs. |
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- |
Intermediate Drug Substance (IDS): A material produced during steps of the processing of an Active Pharmaceutical Ingredient (API) or Drug Substance that undergoes further molecular change or purification before it becomes an API. May or may not be isolated. |
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Major/Critical Change: A change to a validated system or process that has the potential to impact Product quality. Additionally, any change that has the potential to impact the regulatory filing. |
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
7 of 40 |
Exhibit 3-7
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
|
- |
Out-of-specification (OOS) result: any test result that does not conform to the current specification limit. |
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Raw materials (RM): A general term used to denote starting materials, reagents, excipients, solvents and primary and secondary packaging material intended for use in the production of any DS or DP. |
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Specifications: The analytical release criteria defined in the technical agreement by which the Product will be accepted by ACHAOGEN. |
3. |
Roles and Responsibilities |
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3.1. |
Training |
HOVIONE shall insure that all personnel engaging in the manufacture, testing, processing, packing, or storage of the Product have the required education, training, and experience or any combination thereof, to perform the assigned functions. All training relative to a specific task will be completed prior to the initiation of the task. Training will be conducted with sufficient frequency meeting cGMP requirements applicable to the position and function. Training records shall be readily available for review and audits.
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3.2. |
Facilities |
Facilities shall be properly maintained, including general cleanliness, maintenance and monitoring of water and environmental control systems (as appropriate) per cGMP requirements. HOVIONE shall perform qualification/validation (revalidation requirements), monitoring, calibration and maintenance (preventative and repair) for all plant utility systems, including but not limited to purified water, HVAC, clean steam and process compressed air, and QC equipment. Such work to be conducted within the established timeframes appropriate to the significance of the system and the equipment.
HOVIONE will follow its Facility and manufacturing processes, which are designed and operated to minimize risk of contamination (general), microbial contamination, cross-over contamination (between products) and/or carry-over contamination (between batches of the Product). This includes robust cleaning
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
8 of 40 |
Exhibit 3-8
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
methods for manufacturing equipment, line/room clearance procedures and change-over (between product campaign) procedures. Product shall be manufactured in a GMP manufacturing area.
The product will be manufactured, packaged, labeled, tested, and stored, if agreed upon, at the HOVIONE’s Facility covered by this Quality Agreement. HOVIONE shall not use third parties or other sites for the manufacturing, packaging, labeling, testing and storage of the Product without prior written agreement by ACHAOGEN.
ACHAOGEN must be notified in advance of any modifications to the Facility that directly impact the Product or the Product’s regulatory filings. Modifications that impact the Product’s regulatory filings must be pre-approved by ACHAOGEN.
|
3.3. |
Manufacturing Equipment |
All equipment used for the manufacture of Product shall be qualified before use. For all manufacturing, testing, packaging, storage, equipment and facilities, HOVIONE shall operate per written, approved procedures such as equipment qualification/validation, preventative maintenance, instrument calibration, cleaning, and revalidation requirements.
HOVIONE shall perform cleaning verification for manufacturing equipment used for Product manufacturing. For non-dedicated equipment, this shall include potential impact from other products using the same equipment.
All equipment used for the manufacture of the Product shall undergo equipment cleaning per HOVIONE’s Standard Operating Procedures ("SOPs") and requirements and be verified clean by HOVIONE as meeting the required specifications for residual active ingredient and residual cleaning agent before use.
HOVIONE shall be responsible for completing and maintaining records of equipment usage, calibration, qualification and cleaning.
HOVIONE shall notify ACHAOGEN of any Major/Critical Changes or modifications to equipment that directly impact the Product quality and obtain ACHAOGEN’s approval before the equipment is used to Manufacture the Product.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
9 of 40 |
Exhibit 3-9
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
HOVIONE shall not conduct production and handling of highly sensitizing materials (such as penicillins, cytotoxics or cephalosporins) in the equipment being used for the manufacturing of Product. Manufacturing of such materials in the same building being used for the Product is permitted only if performed in a closed and dedicated system.
For any other type of materials manufactured by HOVIONE in the same facilities as used for Product, validated inactivation and/or cleaning procedures and appropriate containment shall be in place.
|
3.5. |
Qualification / Validation |
HOVIONE shall insure that equipment qualification, process validation, analytical methods validation and validation of computerized systems, if applicable, are in place and covered by change control. Validation documentation related to the process and/or analytical method validation shall be reviewed and approved by ACHAOGEN. On request, ACHAOGEN will get copies or summaries from the validation reports, as applicable.
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3.6. |
Batch Manufacturing |
All Master Batch Records ("MBR") will be created by HOVIONE, and submitted to ACHAOGEN Technical, Regulatory Affairs (RA) and QA representatives for review and approval. Once approved by both HOVIONE and ACHAOGEN, HOVIONE Manufacturing and QA will submit the MBR to Document Control for approval, issuance and security.
In the event of a deviation that directly impacts product quality during processing, ACHAOGEN Technical and QA Representative shall be notified to ACHAOGEN within [***] and an investigation is to be initiated. Review and approvals of deviation reports are required from both HOVIONE and ACHAOGEN Technical and QA.
Executed batch records ("EBR") shall be reviewed by manufacturing and approved by HOVIONE and ACHAOGEN QA to determine completeness and compliance with all established, approved written procedures and specifications.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
10 of 40 |
Exhibit 3-10
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages if established in MBR) or the failure of a batch to meet any of its specifications shall be thoroughly investigated, and the documentation will become part of the EBR.
HOVIONE will complete the analytical release testing and review of the records and related documents within [***] of the completion of production date. A copy of the HOVIONE reviewed production record and lot-specific analytical results will be sent to ACHAOGEN after HOVIONE review is complete. The final supplied production record should contain copies of the following documents:
|
• |
HOVIONE-reviewed and approved EBR and all supporting documentation (raw material and packaging materials CoA, environment monitoring records, etc.); |
|
• |
Deviation or investigation reports related to the lot as required; |
|
• |
Release Certificate of Analysis reviewed by HOVIONE QA, including raw data as requested. |
|
3.7. |
Stability |
HOVIONE is responsible for performing stability studies for the product as per ICH guidelines and ACHAOGEN requirements, approved stability protocols and as per internal procedures.
HOVIONE is responsible for assigning re-evaluation dates to the Product or extending the retest date of the Product and for determining suitable storage and shipping conditions, based upon stability studies and ACHAOGEN approval.
HOVIONE is responsible for generating stability protocols, methods and specifications.
HOVIONE and ACHAOGEN is responsible for approving stability protocols, stability reports, methods and specifications in a timely manner.
HOVIONE will upon request or at least [***] provide updated data from the stability program to ACHAOGEN.
HOVIONE will inform ACHAOGEN if there are any adverse trends that could impact on current retest date.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
11 of 40 |
Exhibit 3-11
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
Stability Protocol: The material will be placed on stability only after the stability protocol for that lot of the Product has been signed and approved by HOVIONE and ACHAOGEN. The number of Batches to be placed on stability will required discussion between Hovione and ACHAOGEN.
Stability Testing & Report: Hovione will conduct the stability testing as per the approved stability protocol and current approved test methods for the lot. After HOVIONE review of the stability results is complete, a copy of the analytical results summary and the updated stability table summarizing all the stability results for that lot with HOVIONE review signatures will be sent to ACHAOGEN Technical and QA Representatives for review and approval. Once the stability study is completed, a final stability report will be prepared by HOVIONE and sent to ACHAOGEN for review and approval.
Deviation/OOS/Other Investigation: In the event of any stability incident, HOVIONE shall communicate issue and proposed actions to ACHAOGEN within [***] of confirmation. HOVIONE shall conduct the investigation per HOVIONE’s SOP and report results to ACHAOGEN as soon as investigation is complete, but not to exceed [***] from confirmation, unless otherwise mutually agreed to.
|
3.8. |
Controlled Documents |
All documents used in the production of the Product, from the receiving of raw material to the releasing of the Product are considered controlled documents. Controlled documents consist of the following: receiving documents, test methods, including in-process methods, SOPs, specifications, including in-process specifications, production records, batch records, testing data/records, product reports and protocols, stability protocols and stability reports, and all product support documents. These shall be under revision control (as appropriate) and shall be filed in such a manner as to be traceable. Current SOPs and test methods will be readily accessible to production personnel or QC chemists.
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3.9. |
Change Control |
HOVIONE shall have a documented and effective change control system in place. HOVIONE shall provide advanced notification to ACHAOGEN of any changes to the process, specifications and analytical methods (drug product, API/drug substance, intermediates and Project Specific Raw Materials), storage, labelling,
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
12 of 40 |
Exhibit 3-12
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
primary packaging, stability protocols and equipment, which may have an impact on the quality of the Product, and/or on any regulatory applications related to the Product to allow ACHAOGEN to assess the impact of the change(s) for approval prior to implementation.
Principles:
|
☐ |
Product produced by the new process shall not be accepted unless the process change has first been reviewed and approved by ACHAOGEN. |
|
☐ |
Change requests shall be supported by appropriate technical documents to support the change and to confirm that technical performance has not been altered. |
|
☐ |
Modifications relating to Product Specifications shall only take place by mutual consent between the Parties. |
|
☐ |
For those changes required to comply with Applicable Laws and Regulatory Authority requirements, HOVIONE shall promptly notify ACHAOGEN of such requirements after HOVIONE becomes aware of the need for such change. |
|
☐ |
ACHAOGEN shall assess any change request received from HOVIONE in a timely manner. Unless there are justified scientific and/or compliance reasons to reject the change request, ACHAOGEN shall not unreasonably withhold its approval of the request. |
|
☐ |
ACHAOGEN is responsible for the submission of all necessary change notifications to all Regulatory Authorities in full compliance with the applicable regulations, respectively. |
|
☐ |
ACHAOGEN will inform HOVIONE of the receipt of the necessary acknowledgement of the validity of the regulatory notification and, depending on the type of change, the acceptance or approval of the change by the competent authorities. |
|
☐ |
ACHAOGEN will notify HOVIONE of any changes to the manufacturing process and/or components supplied by ACHAOGEN used for the manufacturing of the product. |
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
13 of 40 |
Exhibit 3-13
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
|
☐ |
ACHAOGEN will provide to HOVIONE copies of the relevant sections of the INDs or NDAs or other regulatory filings and changes thereof. |
|
☐ |
ACHAOGEN shall provide advanced notification to HOVIONE of any changes to the process, specifications and analytical methods, storage, labelling, primary packaging, stability protocols, which may have an impact on HOVIONE Quality System and/or on any regulatory applications related to the Product to allow HOVIONE to assess the impact of the change upon the product supplied or its Quality System. |
|
3.10. |
Retention of records/documentation |
HOVIONE will store the original master batch records, the executed batch records, and all other original documentation that is related to the manufacture of Product and that is required to be maintained under cGMP, protected from destruction and unauthorized access, for the time period outlined below:
|
☐ |
DS with retest date: for [***] after the batch is completely distributed by HOVIONE; |
HOVIONE will retain the original records related to the manufacture of the Product for the entire term of the Manufacturing Agreement. The documentation shall be kept for a minimum of [***] after the Batch is completed. ACHAOGEN will be notified prior to the destruction of any documents to determine disposition of documents at the end of the specified storage period. Upon termination of the Manufacturing Agreement, HOVIONE will provide upon request ACHAOGEN with the original manufacturing records. For the archiving of data, media, diskettes, etc., the original media and backup copies shall be kept in a separate location protected against damage, destruction, and or disposal during the required time of storage. Data media shall be readable for the entire period that the documentation is retained, and will be compliant with 21 CFR §11, as applicable.
HOVIONE will keep the latest version of test methods and/or Specifications and will invalidate the previous, superseded versions.
|
3.11. |
Annual Product Quality Review |
HOVIONE shall conduct [***] Product Quality Review ("PQR.) for the Product, per the requirements of the applicable guidelines as defined in Section 6.1 and any
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
14 of 40 |
Exhibit 3-14
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
additional requirements mutually agreed between the Parties. HOVIONE shall present the findings from its annual PQR to ACHAOGEN in a clear format, which makes it possible to identify quality problems, deviations and trends and/or to substantiate consistent quality of the Product.
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3.12. |
Subcontracting |
HOVIONE will use its established cGMP systems for evaluation, approval and maintenance of all subcontracted services with a cGMP impact on the Product manufactured.
HOVIONE shall not subcontract to a third party any of the work entrusted to them under this Quality Agreement without ACHAOGEN’s prior written approval in accordance with Section 2.9 of the Manufacturing Agreement. If such an agreement is given, HOVIONE shall nonetheless remain fully responsible for the quality of the materials or services provided by subcontractors and for all commitments as agreed upon with this Quality Agreement. This must be assured through quality agreements with the respective subcontractors and technical delivery specifications.
A list of currently approved subcontractors related to the manufacture of the product is provided in Appendix C. In case that HOVIONE would like to use a new subcontractor, this list will be updated and will be review and approved by ACHAOGEN. Any change in subcontracting shall follow the established change control procedure.
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3.13. |
Access to Manufacturing Facilities |
HOVIONE shall have appropriate control procedures in place to ensure that only authorized personnel have access to HOVIONE’s manufacturing facilities.
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3.14. |
Resolution of Quality Issues |
Representatives from both ACHAOGEN and HOVIONE Quality Assurance (QA) departments will be involved in decision-making and resolution of quality issues. All action items and resolutions shall be documented in writing. Any dispute between the Parties arising from or with respect to this Agreement shall be resolved through the Dispute Resolution provisions of the Manufacturing Agreement.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
15 of 40 |
Exhibit 3-15
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
|
4.1. |
Specifications |
Specifications for the Product are detailed In Appendix B.
All raw materials, starting materials, intermediates, Product packaging materials must be tested and released per approved specifications.
No changes in any Specifications for starting materials, intermediates, or API, starting material sources, Product-specific analytical methods, production records, or any other changes that would affect ACHAOGEN’s current regulatory filings shall be made without prior written approval of ACHAOGEN via the formal change control system (See Section 3.9).
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4.2. |
Analytical methods |
Analytical methods used for testing the product: Compendial analytical methods’ suitability shall be established and documented under actual conditions of use and all others shall be validated prior to use.
Any Major/Critical Changes to these analytical methods shall be approved by ACHAOGEN via a formal change control system (See Section 3.9).
|
4.3. |
Reference standards |
All reference standards shall be stored in accordance with the HOVIONE’s recommended storage conditions and used within the assigned expiry or retest date.
HOVIONE or ACHAOGEN is responsible for the purchase and certification of the reference standards.
(In case, HOVIONE is responsible) HOVIONE shall provide to ACHAOGEN reasonable quantities of any non-compendial or not commercially available reference standards necessary to perform the tests included in the Specifications.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
16 of 40 |
Exhibit 3-16
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
(In case, ACHAOGEN is responsible) ACHAOGEN shall provide to HOVIONE reasonable quantities of any non-compendial or not commercially available reference standards necessary to perform the tests included in the Specifications.
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4.4. |
Raw materials |
HOVIONE shall be responsible for the purchase, storage, handling, sampling, testing and approval or rejection of materials used in manufacturing the Product pursuant to this agreement, except for any material supplied by ACHAOGEN.
HOVIONE shall have in place a vendor qualification program to evaluate the suppliers of critical materials. HOVIONE shall only purchase materials from qualified suppliers. As part of the PQR, HOVIONE shall provide a list of changes in vendors HOVIONE is using to purchase materials and any changes the existing vendors make to the material they are sourcing.
HOVIONE shall utilize approved material inspection plans and testing procedures. The results of this inspection and testing shall be in accordance with specifications filed by ACHAOGEN.
HOVIONE shall inspect and/or test all materials on a batch-by-batch basis.
Raw materials supplied by qualified vendors and those supplied by ACHAOGEN can be subject to reduced testing but a minimum ID testing (or visual examination in case of hazardous or highly toxic raw materials) needs to be performed for each delivery and each lot.
HOVIONE shall store and handle materials used in manufacturing the Product pursuant to this Agreement under appropriate conditions, consistent with cGMPs, all applicable laws, rules and regulations, and industry standards. ACHAOGEN shall inform HOVIONE on the storage conditions of any material supplied to HOVIONE.
HOVIONE shall have all necessary and appropriate controls in place to prevent cross contamination of the raw materials and intermediates used in the manufacture of the Product from other chemicals stored, used, or manufactured by HOVIONE.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
17 of 40 |
Exhibit 3-17
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
When materials are supplied by ACHAOGEN, HOVIONE shall receive sufficient amount of material to manufacture the quantities of batches ordered. ACHAOGEN warrants that any material supplied to HOVIONE shall comply with the agreed specifications. A Certificate of Analysis and a MSDS shall be submitted to HOVIONE and shall accompany each shipment. The specification in force for the ACHAOGEN-supplied material is attached as Appendix B. ACHAOGEN shall be responsible for the maintenance and storage of appropriate retain samples of any material supplied to HOVIONE.
If HOVIONE believes that any shipment received of ACHAOGEN-supplied material does not meet specification, HOVIONE shall notify ACHAOGEN in writing, including a detailed explanation of the non-conformity. ACHAOGEN shall investigate such alleged non-conformity and, if agrees, such material is not conforming and ACHAOGEN will replace it or the Product will be manufactured at the sole risk of ACHAOGEN. If ACHAOGEN disagrees, it shall be notified to HOVIONE in writing. Consequently, the manufacturing of the Product will be at the sole risk of ACHAOGEN. HOVIONE shall not be responsible for materials defects or not meeting specifications.
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4.5. |
Starting Materials |
The regulatory starting materials of the manufacturing process are [***].
|
4.6. |
Process Validation Program |
Program Activities: ACHAOGEN acknowledges and confirms that it has provided or will provide HOVIONE with the most current technical package for the manufacture of the Product, including process, analytical methods, and testing. HOVIONE shall keep and is keeping accurate and detailed records regarding its activities performed in respect of the Validation Program consistent with its internal policies and procedures.
Process Validation: HOVIONE shall conduct the following process validation activities as part of the Validation Program, including:
Validation Master Plan: HOVIONE and ACHAOGEN acknowledge that they will agree, in writing, on a validation master plan for the Process Validation activities to be conducted by HOVIONE (the "Validation Master Plan") and the
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
18 of 40 |
Exhibit 3-18
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
process validation shall not commence until the Validation Master Plan has been approved by both ACHAOGEN and HOVIONE.
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4.7. |
Undesirable contaminants |
HOVIONE shall upon request provide to ACHAOGEN a BSE/TSE certificate for the Product in accordance with the current EMA/410/01 Note for Guidance. The certificate shall indicate if the Product is (are) of human or animal origin, and if materials of human or animal origin are used during the manufacturing process of the Product. An updated BSE/TSE certificate must be issued if the previous statement changes after any change to the manufacturing process which involves new raw materials or for raw materials that have been sourced from a different supplier.
Any contaminants found in the routine analysis will be investigated as per the procedure in place. HOVIONE shall inform ACHAOGEN if there is any investigation as soon as detected and that could impact on product quality.
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4.8. |
Deviations / OOS (incl. stability) |
HOVIONE must have a formal procedure for handling deviations as well as non-conforming laboratory test results (OOS results) that is in accordance with cGMP.
HOVIONE shall notify ACHAOGEN promptly (target: [***] after any Critical Deviation or OOS confirmation, excluding stability results) in the event of any Critical Deviation(s) that can potentially affect the integrity of the Product.
For all confirmed OOS stability test results that indicate that the product has failed to remain within specifications, HOVIONE shall notify ACHAOGEN promptly ([***] after stability OOS confirmation) and provide the stability data. ACHAOGEN may participate in any investigation concerning the OOS results and may need to inform Regulatory Authority. HOVIONE shall implement any agreed corrective and/or preventive actions arising out of the completed investigation report to avoid the reoccurrence of similar issues in the future.
In all cases, HOVIONE shall investigate any confirmed OOS result and forward a copy of the completed investigation report to ACHAOGEN within a reasonable period of time.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
19 of 40 |
Exhibit 3-19
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
All Product related deviations and OOS shall be reviewed and approved by ACHAOGEN.
Unplanned Deviations
The following procedure for notification and approval will be followed for any unplanned deviation that may have an impact on the quality of the product during the manufacturing, storage or testing of starting materials, intermediates or the Products:
If an ACHAOGEN representative is present on site, HOVIONE will promptly communicate the deviation and proposed corrective action to the representative verbally.
If an ACHAOGEN representative is not present on site, HOVIONE will communicate verbally via telephone or by email to [***] (as a first choice) the deviation and proposed corrective action to ACHAOGEN Technical Representative within [***] or as soon as possible.
OOS Results
HOVIONE shall verbally communicate (via e-mail to [***]) the OOS and proposed actions to ACHAOGEN within [***] and [***] or as soon as possible of confirmation of the OOS. HOVIONE shall conduct the investigation as per their internal OOS procedure and report the results to ACHAOGEN as soon as the investigation is complete, but not to exceed [***] from date of confirmation of OOS, unless otherwise mutually agreed to.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
20 of 40 |
Exhibit 3-20
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
HOVIONE shall store product reference samples to perform at least [***] full specification analyses, in containers that are equivalent to or more protective than the commercial packaging. Samples are to be retained for the time period outlined below:
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☐ |
General Starting Materials at least for [***] after the batch release by HOVIONE (other than water, compressed gases, cleaning solvents and highly volatile compounds) if their stability allows; |
|
☐ |
API/Drug Substance Starting Material at least for [***] after the expiration date of the last batch of the drug substance; |
|
☐ |
Product with retest date: for [***] after the Batch is completely distributed by HOVIONE; |
HOVIONE shall store final Product retention sample, representative from the Batch for identification purpose. The quantity of retention samples shall allow at least [***] full specification analyses.
HOVIONE shall make Product retention samples available to ACHAOGEN promptly upon ACHAOGEN’s justified request.
The samples shall be stored in a controlled manner until further authorization by ACHAOGEN. HOVIONE shall notify ACHAOGEN prior to destroying retain samples.
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4.10. |
Storage and Distribution |
HOVIONE shall make commercially reasonable efforts to exclude, during packaging, storage, and shipping of the Product, the possibility of deterioration, contamination, or mix-ups with any other material.
Per shipment HOVIONE shall provide an up-to-date MSDS to ACHAOGEN, and a certificate of analysis.
This agreement does not absolve HOVIONE from complying with any legal requirements in relation to the transportation of the product.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
21 of 40 |
Exhibit 3-21
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
A Certificate of Analysis is required for each Batch of Product shipped on behalf of ACHAOGEN.
The Certificate of Analysis shall be produced by a computer system which provides a degree of control equivalent to that given by a signature. The Certificate of Analysis states that the batch is suitable for release, and it shall include- as a minimum:
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☐ |
HOVIONE name, address and telephone number, |
|
☐ |
Product name and grade (if applicable), |
|
☐ |
HOVIONE batch/lot number, |
|
☐ |
Reference to the Specification (approved current version), |
|
☐ |
Test parameters and corresponding specification requirements, |
|
☐ |
Test results (numerical, where applicable) for each chemical, physical or microbiological test performed, |
|
☐ |
Date of manufacture, retest date and release date of the Product (if applicable). |
|
☐ |
A statement that the batch was: |
|
o |
analyzed in accordance with the tests listed in the Certificate of Analysis and conforms to the latest HOVIONE specification; |
|
o |
produced in accordance with the current Good Manufacturing Practices. |
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4.12. |
Product Release |
HOVIONE will perform initial review of EBR and lot-specific related documents. Review and approval by HOVIONE QA must include closure/resolution of all associated deviations and/or out-of-specification (OOS) related to the batch. Once HOVIONE QA has approved the production documentation, the documentation will be forwarded to ACHAOGEN.
HOVIONE Quality Assurance Director/delegate or Qualified Person (depending if it is a Drug Substance or Drug Product and the HOVIONE site local law) has the responsibility to release the Product for disposition by ACHAOGEN.
HOVIONE shall not ship any Product to any destination, as identified by ACHAOGEN, until the product is dispositioned by ACHAOGEN for shipment,
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
22 of 40 |
Exhibit 3-22
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
unless prior written approval has been received from ACHAOGEN to perform such a shipment under quarantine.
Unless otherwise authorized by ACHAOGEN, HOVIONE shall not deliver to any destination any product under quarantine conditions.
HOVIONE shall be responsible for the issuance of a product Certificate of Analysis per batch (see also Section 11.2).
HOVIONE shall answer all inquiries for the batch quality as promptly as possible; and make the complete batch documentation available to ACHAOGEN upon its and/or a Regulatory Authority’s request.
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4.13. |
Reprocessing |
Reprocessing shall be performed per the current regulatory dossier, if applicable, and reported to ACHAOGEN. Reasons for reprocessing shall be investigated, and the results shall be communicated to ACHAOGEN.
Reprocessed Batches shall be reported and agreed with ACHAOGEN.
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4.14. |
Reworking |
Reworking is only possible after approval by ACHAOGEN. Any reworking process shall be validated. Additional stability tests and analytical testing of reworked Batches may be required.
Reworked Batches shall be reported and approved by ACHAOGEN. Reworking process could be part of the experience through process development.
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4.15. |
Packaging |
The following shall apply to the packaging of the final product:
The specifications for packaging materials including tamper evident seals must be in accordance with the regulatory documentation related to the product.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
23 of 40 |
Exhibit 3-23
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
HOVIONE shall comply with the requirements related to labelling:
|
☐ |
Master of shipping label shall be approved by ACHAOGEN |
|
☐ |
Labelling operations shall be conducted to prevent mix ups, |
|
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Labels shall be checked for accuracy before application. |
The shipping label may include additional information (e.g., ACHAOGEN material code); details may be defined in the supply agreement if required by ACHAOGEN.
This agreement does not absolve HOVIONE from complying with any legal requirements in relation to the transportation of the product.
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4.17. |
Product Rejection |
If there is any issue which likely to cause rejection of the Product, ACHAOGEN shall communicate to HOVIONE as soon as possible, but in any case, within [***] of release of the Product from HOVIONE to ACHAOGEN.
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4.18. |
Laboratory Control |
|
• |
General: Any specifications, standards, sampling plans, test procedures, validation protocols, reports or other laboratory control mechanisms, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, should be prepared and approved by HOVIONE. |
|
• |
Laboratory Equipment: All laboratory equipment used to perform cGMP operations should be calibrated/qualified and maintained in a controlled state by HOVIONE. |
|
• |
Reference Standards: See Section 4.3. |
|
• |
Specifications: See Section 4.1. |
5. |
Complaints and Recalls |
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
24 of 40 |
Exhibit 3-24
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
All complaints related to the Product reported, regardless of source (e.g., consumers, doctors, pharmacists, sales representatives) shall be handled by ACHAOGEN. If a complaint relates to the activities or processes carried out or controlled by HOVIONE, ACHAOGEN shall communicate the complaints to HOVIONE.
HOVIONE shall be responsible for recording and Investigating all quality-related complaints on the Product and will maintain the complete complaint database and complaint files, as per internal procedures.
HOVIONE shall complete their investigation and respond to ACHAOGEN in writing to all complaints within [***] of receipt.
A formal written report on the complaint detailing identifiable root causes and corrective and preventive actions where applicable shall be prepared by HOVIONE and sent to ACHAOGEN.
In case the investigation could not be finalized within [***], HOVIONE shall provide an interim report to ACHAOGEN. HOVIONE is responsible for implementing a corrective and/or preventive action plan to correct any deficiencies identified during an investigation.
ACHAOGEN shall make relevant information and samples of the affected product available to assist HOVIONE investigation.
HOVIONE shall provide complaint files for ACHAOGEN product to ACHAOGEN within [***], if they are required during a Regulatory Authority inspection.
|
5.2. |
Recall |
If HOVIONE believes that a recall of the product may be necessary or appropriate, HOVIONE shall immediately, i.e. within [***], notify ACHAOGEN. The Parties will take joint decisions on the disposition of the Product or user information, where required.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
25 of 40 |
Exhibit 3-25
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
ACHAOGEN is responsible for the final decision and the coordination of any recalls or field alert activities.
HOVIONE shall provide any information required by ACHAOGEN relating to recall or field alert activities within [***] of the request, if such information is readily available at HOVIONE.
HOVIONE shall not initiate any notifications to health authorities concerning a (potential) nonconformance without the prior agreement of ACHAOGEN.
HOVIONE shall collaborate, if needed, in any recall of a defective Batch of Product.
HOVIONE and ACHAOGEN shall immediately inform each other of any recall actions concerning the Product. Relevant contact persons are listed in Quality contacts.
6. |
Compliance and Regulatory Requirements |
|
6.1. |
Applicable GMP Standard |
HOVIONE shall manufacture the Product in compliance with current Good Manufacturing Practices of all applicable health authorities including without limitation, the FDA applicable rules, regulations, guides and guidance, such as 21 CFR Parts 11, 210-211, the EU GMP Guide Part I and/or Part II and respective guidance documents and ICH respective guidance including but not limited to ICH Q7 and legislation of other countries, as applicable.
|
6.2. |
Regulatory documents |
ACHAOGEN shall be responsible for preparation of registration documents related to Product and submission of such registration documents to any Regulatory Authority, including maintaining such submissions (hereafter altogether called ‘Regulatory Submissions’).
Upon request by, and in mutual consultation with ACHAOGEN, HOVIONE shall be responsible for preparation of documentation on manufacture of Product as required for the Regulatory Submissions of ACHAOGEN, limited to HOVIONE’s activities under this agreement.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
26 of 40 |
Exhibit 3-26
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
ACHAOGEN shall provide portions of Regulatory Submissions, related to Product and HOVIONE’s activities performed under this agreement, to HOVIONE for review and written consent, prior to submission to any Regulatory Authority.
HOVIONE shall review and comment to ACHAOGEN on such portions of Regulatory Submissions, within [***] from receipt or other period previously agreed by the Parties.
ACHAOGEN shall, upon submission to any Regulatory Authority, provide HOVIONE with current copies of portions of Regulatory Submissions, including amendments and supplements thereto, related to the Product and HOVIONE’s activities performed under this Quality Agreement.
HOVIONE shall provide, in mutually agreed timelines, all other information related to the product that ACHAOGEN may reasonably request for its Regulatory Submissions, including any data for annual reports (e.g. annual stability reports for the product.
When a change is known to require, or has the potential to require a Regulatory Submission, ACHAOGEN will develop a joint strategy to secure the appropriate regulatory approval prior to implementation of the change at HOVIONE and ACHAOGEN. For change control see Section II.3 of Manufacturing Agreement.
7. |
Audits and Inspections |
|
7.1. |
ACCHAOGEN’s Right to Audit |
Routine GMP audit: In accordance with Article 11 of the Manufacturing Agreement, HOVIONE shall allow ACHAOGEN’s representatives including but not limited to third party audit companies under the scope of audit sharing programs (e.g. Rx-360, API Institute), to carry out the routine GMP audit. [***] during the routine GMP audit, HOVIONE shall permit ACHAOGEN all reasonable access to the manufacturing, packaging, warehousing and laboratory areas related to the manufacture of the Product including pertinent documentation.
The results of the audit and the observation(s) shall be sent to HOVIONE by means of a written report. HOVIONE will ensure a satisfactory follow up to the observations made during the audit performed by the ACHAOGEN within [***]
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
27 of 40 |
Exhibit 3-27
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
after receipt of the report, and take corrective/preventive actions designed to address non-conformities with the applicable guidelines and mutually agreed upon by the Parties. All other observations shall be evaluated and actions may be defined and implemented if considered that they bring added value to HOVIONE Quality System.
The frequency of the routine GMP audit shall depend upon the results of the audit and the quality performance of HOVIONE. In the absence of any Major/Critical Changes or Critical Deviations being found by ACHAOGEN’s audits or reported by HOVIONE, the frequency shall be not more than [***] targeting every [***].
For-Cause Audit: In accordance with Section 11.3 of the Manufacturing Agreement, HOVIONE shall permit ACHAOGEN and its representatives to perform a for-cause audit for certain causes including whenever any Major/Critical Changes or /Critical Deviations have been identified. HOVIONE shall permit all reasonable access to the plant area and to all data and documents related to the product with the objective to understand the root cause and to define corrective and/or preventive actions with the collaboration of the ACHAOGEN. HOVIONE shall work with any permitted subcontractors to ensure that the appropriate agreements are in place to allow ACHAOGEN to participate in any for-cause audit related to the subcontractor’s performance, if so required.
Person-In-Plant: HOVIONE shall permit ACHAOGEN to have manufacturing, technical and/or quality representatives present during the Product’s manufacturing and processing operations. ACHAOGEN shall provide prior notification of their intention to witness the production. No more than [***] ACHAOGEN representatives will be permitted to be present in the manufacturing area, and only [***] in the actual processing room. ACHAOGEN representatives in the plant shall adhere to HOVIONE quality and safety procedures. HOVIONE shall also provide a key contact person at their facility to communicate the production and product quality related issues during the production.
|
7.2. |
Authority Inspections |
In accordance with Section 11.1 of the Manufacturing Agreement, HOVIONE shall notify ACHAOGEN of regulatory inspections that relate to the Product. During the Pre-Approval Inspection (PAI), not more than [***] representatives from ACHAOGEN may be on-site for consultation purposes only (direct
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
28 of 40 |
Exhibit 3-28
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
interaction with Regulatory Agency personnel is the sole responsibility of HOVIONE).
HOVIONE shall release any records required to be made available to the inspecting or inquiring authority by law or regulation, but shall not release any ACHAOGEN’s Confidential Information not required by law to be provided for inspection or copying without specific written consent of ACHAOGEN.
Each party shall promptly notify the other of any information or notice it receives or becomes aware of, including without limitation, any threatened or pending action by the FDA or other regulatory authority, concerning the safety or efficacy of the API. ACHAOGEN will notify HOVIONE of any regulatory actions on the APIor ACHAOGEN that may impact HOVIONE.
HOVIONE shall reasonably assist ACHAOGEN in its efforts to secure and maintain government regulatory filings for the Product and shall participate as is reasonably necessary in resolving the concerns of FDA or other regulatory authority arising with respect to HOVIONE’s manufacture of the Product for ACHAOGEN.
8. |
Miscellaneous Provisions |
|
8.1. |
Assignment |
Neither Party shall have the right to assign any or all its rights or obligations under this Quality Agreement without the other Party’s prior written consent, which consent shall not unreasonably be withheld. The foregoing notwithstanding, prior written consent shall not be required (i) in case of an assignment of rights or obligations to an Affiliate of the assignor (optional extension: provided that the assignor procures that any such Affiliate assigns such rights back to the assignor immediately before ceasing to be an Affiliate of the assignor), or (ii) in connection with a merger, consolidation, or a sale of all or substantially all of party’s assets to a third Party, except if such merger, consolidation or sale is with a competitor of the other Party.
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8.2. |
Related agreements |
In the event of a conflict between any of the provisions of the Manufacturing Agreement and the Quality Agreement with respect to quality-related activities, including compliance with cGMP, the provisions of the Quality Agreement shall
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
29 of 40 |
Exhibit 3-29
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
control. In the event of a conflict between any of the provisions of the Manufacturing Agreement and the Quality Agreement with respect to any commercial or other matters, including the allocation of risk, liability, and financial responsibility, the provisions of the Manufacturing Agreement shall control.
|
8.3. |
Confidentiality |
All communications and documentation exchanged between the Parties, including the terms of this Agreement, shall be considered proprietary and confidential, and its use is subject to the terms and conditions of the Manufacturing Agreement.
Each Party may share with the other Party and Affiliates copies of confidential documents to facilitate their mutual understanding and in support of the development and quality activities under this Quality Agreement. Neither Party shall use the other Party’s Confidential Information in support of regulatory filings without the express written consent of the other Party.
|
8.4. |
Choice of Law |
The Parties agree that this Quality Agreement shall be governed by and construed in accordance with the law applicable to the Manufacturing Agreement.
|
8.5. |
Debarment Certification |
Neither HOVIONE nor any of its officers or employees, nor any other person, consultant or contractor used by HOVIONE to perform Manufacturing or Services under this Quality Agreement is: (a) an individual who has been debarred by the FDA pursuant to section 306 of the FDCA, 21 U.S.C. § 335a ("Debarred Individual"), (b) a corporation, partnership or association that has been debarred by FDA pursuant to section 306 of the FDCA, 21 U.S.C. § 335 a ("Debarred Entity"), or (c) the subject of an FDA debarment investigation or proceeding (or similar proceeding of another regulatory agency); and HOVIONE will not retain or employ any personnel, and will not knowingly use the services of any contractor or consultant, who is debarred by the FDA or who is the subject of an FDA debarment investigation or proceeding (or similar sanction or investigation by another regulatory agency) in connection with performing any Manufacturing or Services. HOVIONE has no knowledge of any circumstances which may affect the accuracy of the foregoing representation, including, without
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
30 of 40 |
Exhibit 3-30
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
limitation, any FDA investigations of, or debarment proceedings against, HOVIONE or any person or entity performing services or rendering assistance which is in any way related to activities taken pursuant to this Agreement. HOVIONE shall notify ACHAOGEN in writing as soon as possible if HOVIONE, at any time during the Term, becomes aware of any such circumstances.
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8.6. |
BARDA Requirements |
For certain Services, including those covered by this Quality Agreement, ACHAOGEN may engage HOVIONE as a subcontractor to certain projects under the Prime Contract by mutual execution of a Work Plan. Any Work Plan under which HOVIONE is acting as a subcontractor shall be a "Government Project", and such Government Projects will be expressly identified as such within the applicable Work Plan.
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8.7. |
Entire Agreement |
This Quality Agreement and the Manufacturing Agreement constitute the entire agreement between the Parties with respect to the subject matter hereof, and supersedes all other prior agreements, understandings, warranties, or any other representation between the Parties with respect thereto. If there is a conflict between the terms of this Quality Agreement and the Manufacturing Agreement, the terms of the Manufacturing Agreement shall govern on all matters except quality, in which cases this Quality Agreement shall govern.
|
8.8. |
Amendments and Supplements |
Any amendment or supplement to this Quality Agreement shall be documented and approved in writing by both Parties.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
31 of 40 |
Exhibit 3-31
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
HOVIONE
[***]
ACHAOGEN
[***]
10.List of Appendices
Appendix A – Responsibility Matrix
Appendix B – Product specification
Appendix C – Subcontractors list
Appendix D – Quality Agreement change control record
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
32 of 40 |
Exhibit 3-32
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
Responsibility Matrix
[***]
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
33 of 40 |
Exhibit 3-33
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
1 – When material is supplied by ACHAOGEN
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
34 of 40 |
Exhibit 3-34
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
35 of 40 |
Exhibit 3-35
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
[***]
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
36 of 40 |
Exhibit 3-36
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
Product Specification (Current Spec Doc. [***])
Test Name |
Specification |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
Informative tests |
|
[***] |
[***] |
[***] |
[***] |
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
37 of 40 |
Exhibit 3-37
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
[***]
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
38 of 40 |
Exhibit 3-38
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
Subcontractors list
Service(s) Provided |
Company name and address |
|
|
Storage of Stability Samples |
[***]
|
|
|
Determination of elemental impurities, By ICP-MS-Final Product Release |
[***] |
Signatories
[***]
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
39 of 40 |
Exhibit 3-39
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
|
Confidential Treatment Requested by Achaogen, Inc.
Change Control
Revision no.
|
Reason
|
Effective date
|
000
|
First execution of this Agreement.
|
|
|
|
|
|
|
|
|
|
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Signatories
[***]
HQ.QSD.MA711.4.EN – [***] – Contract Manufacturing Prepared based on APIC version [***] HOVIONE/ACHAOGEN – version 00 – [***] |
40 of 40 |
Exhibit 3-40
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Exhibit 4-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Project Specific Raw Materials
[***]
[***]
Long lead time raw material:
|
• |
[***] |
The Project Specific Raw Materials in Exhibit 5 are included in Raw Materials.
Exhibit 5-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
[***]
[***]
Exhibit 6-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Pricing and Production Performance
AND MINIMUM ANNUAL COMMITMENT
[***]
validation campaign based on the average process performance. Accordingly, all amounts are subject to change pending confirmation following completion of the Validation Process campaigns.
All forecasting and ordering lead-times set out in the Agreement shall take production performance into consideration [***]. For clarity a delivery date in a purchase orders shall be defined as [***]
[***]
Exhibit 7-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
TABLE OF WORK PLANS
[***]
Exhibit 8-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Program Work PLAN - WORK Plan No. C-1
[***]
Work Plan No. C-01
Version [***]
[***]
Reference: [***]
This Work Plan No. C-01 (the “Work Plan”), dated [***] (the “Order Date”), is by and between [***] Hovione Limited, (“Hovione”) and Achaogen, Inc., a Delaware corporation, having a principle place of business at 0000 Xxxxxxxxx Xxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000, U.S.A. ("Customer"), and upon execution by both parties, shall be incorporated into the Validation and Manufacturing Agreement between Customer and Hovione Limited with an effective date of [***] (the “Agreement”). Customer, [***] and Hovione Limited hereby acknowledge and agree to all terms in both this Work Plan and the Agreement. Capitalized terms used in this Work Plan shall have the meanings ascribed to them in the Agreement.
1. |
Background: |
This Work Plan is based on Hovione’s historical experience with the Plazomicin [***] program and on detailed discussions between the Customer and Hovione’s project teams. All information and content herein reflects information known at the time of the Order Date.
The Validation Program for Customer’s proprietary compound Plazomicin [***] (the “Product”) will occur at Hovione’s Loures site in Portugal (the “Facility”). Assuming that all process optimization and PAR/NOR activities are completed in a timely manner, the anticipated start date for the Validation Program of the Product will be [***] with completion of the Manufacture of the Validation Program anticipated for [***]. Since [***], [***]. For sake of clarity, the [***] are covered under separate Work Plans executed under the Master Services Agreement between Customer and Hovione International Limited with an effective date of [***], amended on [***] and on [***] (collectively, the “MSA”), and are not included herein.
Achaogen-Hovione Validation and Manufacturing Agreement |
1 |
Work Plan [***]] |
CONFIDENTIAL |
Exhibit 9-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
The scale of the Validation Program in this Work Plan is anticipated to be [***] per Batch.
This Work Plan does not include any [***]. If such work is requested, it will be covered in a separate Work Plan(s).
2. |
Tasks: |
This Work Plan covers the Product Validation Program to be run in the projected equipment train [***] at the Facility. The reserved equipment train during the below- listed timeslot will be used to perform the Validation Program of the Product. It is anticipated that this Validation Program will consist of [***] engineering batch followed by [***] validation batches [***]. It is anticipated that all [***] batches will target the same batch size. It is also anticipated that a Demo run of the [***] step will be run at [***] to [***], prior to conducting the engineering batch’s [***] step. At the time that this Work Plan is issued, the projected batch size is confirmed to target [***]. The total targeted output for this validation campaign is [***].
3. |
Timeline: |
Hovione confirms that the Product Validation Program would start in [***] (subject to PO issuance). The deadline for delivery of the Final Validation Report (the “Final Deliverable”) to Customer is [***] (the “Deadline”). Any changes to the timeline shall be made in writing signed by both Parties.
At the time this Work Plan was prepared, the following is anticipated:
|
• |
It will take approximately [***] to execute the demonstration/engineering batch [***] and approximately [***] to execute the [***] validation batches [***]. |
|
• |
Following completion of manufacture, QC/QA release testing is expected to take [***] weeks. |
|
• |
Campaign report writing (PVR, CVR) is expected to take at least [***] weeks after the batches are completed. |
|
• |
Upon execution of this Work Plan, Hovione will reserve a minimum of a [***] of production time for Customer’s validation campaign of [***]. |
Achaogen-Hovione Validation and Manufacturing Agreement |
2 |
Work Plan [***]] |
CONFIDENTIAL |
Exhibit 9-2
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Hovione shall prepare the following deliverables for Customer under this Work Plan (collectively the “Deliverables”).
|
• |
[***] Demonstration batch of [***] of [***], based on an input of [***] (previously manufactured at Hovione) under GMP Commercial conditions (suitable for Validation and Commercial supply) |
|
• |
[***] Engineering batch of [***], based on an input of [***], produced under GMP Commercial conditions (suitable for Validation and Commercial supply) |
|
• |
[***] Process Validation batches of [***], based on an input of [***] per batch, produced under GMP Commercial conditions (suitable for Validation and Commercial supply) |
|
• |
Testing of the [***] batches including a CoA for each batch and the completed batch records in the release package |
|
• |
VMP (Validation Master Plan), [***] PVPs (Process Validation Protocols), [***] PVRs (Process Validation Reports), [***] CVPs (Cleaning Validation Protocols), CVR (Cleaning Validation Reports), FVR (Final Validation Report) |
|
• |
Master Batch Production Records |
|
• |
Completed Batch Production Records |
|
• |
Campaign summary report |
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5. |
Compensation and Payment Terms |
|
5.1 |
Labor & Equipment |
In consideration of these Services performed by Hovione, Achaogen shall pay Hovione [***] for the Tasks outlined in Section 2 and the Deliverables set forth in Section 4 (the “Service Fees”).
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5.2 |
Reports and Deliverables |
All Deliverables are included in the Service Fees above.
|
5.3 |
Project Specific Materials |
Project Specific Materials are raw materials and reagents (including solvents) used in the conduct of the tasks described in Section 2 and that
Achaogen-Hovione Validation and Manufacturing Agreement |
3 |
Work Plan [***]] |
CONFIDENTIAL |
Exhibit 9-3
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Hovione must procure specifically in the course of the project to conduct the Services.
The total cost of Project Specific Materials described in this Work Plan shall not exceed [***] where a maximum of [***] is for the procurement of [***], where a maximum of [***] is for the procurement of [***] of the [***] and a maximum of [***] for procurement of [***].
Hovione will not use Project Specific Materials on any other project. Project Specific Materials may be shipped to Achaogen at Achaogen’s written request and expense.
General Chemicals, Materials, and Supplies constitute items such as [***] which are used routinely in all operations and widely across projects at Hovione. The total cost for General Chemicals, Materials and Supplies is approximately [***].
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5.4 |
Shipping |
[***]. Hovione will use a dedicated shipping account provided by Achaogen for these charges. Compounds will be shipped by [***] unless otherwise requested by Achaogen. Hovione estimates that the shipping costs inclusive of customs, shipping and packing materials will not exceed [***]. [***].
All materials shipped by Hovione on behalf of Achaogen will follow [***].
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5.5 |
Travel Costs |
The fee above does not account for nor does it include any travel costs. Customer will only reimburse Hovione for reasonable out-of-pocket expenses actually incurred in connection with the Services that are approved in writing in advance by Customer and supported by receipts and documentation. All out-of-pocket expenses shall be invoiced to Customer without xxxx-up.
Achaogen-Hovione Validation and Manufacturing Agreement |
4 |
Work Plan [***]] |
CONFIDENTIAL |
Exhibit 9-4
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Not applicable at the time of Work Plan issuance. If Other Costs need to be incurred, these will be discussed and agreed in writing by both the Customer and Hovione prior to their expenditure.
|
5.7 |
Invoices |
Payment will be made according to the terms of the Agreement, and as outlined below.
|
5.7.1 |
Milestones: Hovione will invoice Achaogen according to the following payment milestone schedule: |
|
5.7.1.1. |
[***] of this Work Plan and issuance of the PO, Hovione will issue an invoice for [***]. |
|
5.7.1.2. |
[***] Master Batch Records for Achaogen’s review, Hovione will issue an invoice for [***]. |
|
5.7.1.3. |
[***] of the Validation Master Plan (VMP) and Process Validation Protocols (PVP) for [***], Hovione will issue an invoice for [***]. |
|
5.7.1.4. |
[***] of the [***] of [***], Hovione will issue an invoice for [***]. |
|
5.7.1.5. |
[***] of the [***] of [***], Hovione will issue an invoice for [***]. |
|
5.7.1.6. |
[***] of the [***] of [***], Hovione will issue an invoice for [***]. |
|
5.7.1.7. |
[***] of the [***] of [***], Hovione will issue an invoice for [***]. |
|
5.7.1.8. |
[***] of the [***] of [***] to [***], Hovione will issue an invoice for [***]. |
|
5.7.1.9. |
[***] of the [***] of [***] to [***], Hovione will issue an invoice for [***]. |
Achaogen-Hovione Validation and Manufacturing Agreement |
5 |
Work Plan [***]] |
CONFIDENTIAL |
Exhibit 9-5
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
|
5.7.1.11. |
[***] of the [***] of [***] to [***], Hovione will issue an invoice for [***]. |
|
5.7.1.12. |
[***] of the [***] of [***] to [***], Hovione will issue an invoice for [***]. |
|
5.7.1.13. |
[***] of the [***] of [***] to [***], Hovione will issue an invoice for [***]. |
|
5.7.1.14. |
[***] of the [***] of [***] to [***], Hovione will issue an invoice for [***]. |
|
5.7.1.15. |
[***] of the [***] of [***] to [***], Hovione will issue an invoice for [***]. |
|
5.7.1.16. |
[***] of the [***] of [***] to [***], Hovione will issue an invoice for [***]. |
|
5.7.1.17. |
[***] of the [***] of [***] to [***], Hovione will issue an invoice for [***]. |
|
5.7.1.18. |
[***] of the [***] of [***] to [***], Hovione will issue an invoice for [***]. |
|
5.7.1.19. |
[***] of the [***] of [***] to [***], Hovione will issue an invoice for [***]. |
|
5.7.1.20. |
[***] of the [***] of [***] to [***], Hovione will issue an invoice for [***]. |
|
5.7.1.21. |
[***] of the [***], Hovione will issue an invoice for [***]. |
|
5.7.1.22. |
[***] of the [***], Hovione will issue an invoice for [***]. |
|
5.7.1.23. |
[***] of the [***], Hovione will issue an invoice for [***]. |
|
5.7.1.24. |
[***] of the [***], Hovione will issue an invoice for [***]. |
Achaogen-Hovione Validation and Manufacturing Agreement |
6 |
Work Plan [***]] |
CONFIDENTIAL |
Exhibit 9-6
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
|
5.7.1.26. |
[***] of the [***], Hovione will issue an invoice for [***]. |
|
5.7.1.27. |
[***] of the [***], Hovione will issue an invoice for [***]. |
|
5.7.1.28. |
[***] of the [***], Hovione will issue an invoice for [***]. |
|
5.7.1.29. |
[***] of the [***], Hovione will issue an invoice for [***]. |
|
5.7.1.30. |
[***] of the [***], Hovione will issue an invoice for [***]. |
|
5.7.1.31. |
[***] of the [***], Hovione will issue an invoice for [***]. |
5.7.2 Project Specific Materials and Shipping. Hovione will issue invoices for reimbursement of Project Specific Material and shipping costs as these costs are incurred.
|
5.7.2.1. |
[***] of this Work Plan, Hovione has purchased [***] of Project Specific Materials. |
|
5.7.2.2. |
In reference to the [***], Hovione has purchased [***]. |
|
5.7.2.3. |
In reference to [***], Hovione has purchased [***]. |
|
5.7.2.4. |
In reference to [***], Hovione has purchased [***]. |
|
5.7.2.4. |
[***], Hovione will invoice Achaogen the remaining budget for Project Specific Materials, which will not exceed [***], without Achaogen’s prior written consent. |
|
5.7.2.5 |
[***], Hovione will invoice Achaogen up to [***] for shipping costs incurred during the campaign. |
5.7.3. Invoice Markings. All invoices for payments to be made to Hovione for services under this Exhibit shall be marked with:
|
5.7.3.1. |
the following unique Purchase Order number: . |
|
5.7.3.2. |
the statement “Work Plan C-01 entitled, [***].” |
Achaogen-Hovione Validation and Manufacturing Agreement |
7 |
Work Plan [***]] |
CONFIDENTIAL |
Exhibit 9-7
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
The ceiling price for the services covered under this Work Plan C-01 is [***] of which no more than [***] shall be for services (6.1), [***] for the final report (6.2), [***] for General and Project-Specific Materials (6.3), and [***] for shipping costs (6.4). Achaogen shall not be obligated to pay Hovione any amount in excess of this ceiling price, unless and until an additional agreement that raises this price has been negotiated and signed by both Parties.
Under Work Plan [***], Customer has paid Hovione a reservation fee of [***]. The monies paid under Work Plan [***] have been applied to the ceiling price in this Work Plan C-01 (in particular they have covered the cost of the General and Project-Specific Materials (6.3) in the amount of [***]. The total invoiceable amount under this Work Plan is [***].
|
7. |
Government Sponsored Project: |
Pursuant to Article 20 of the Manufacturing Agreement, this Work Plan is a “Government Project”.
8. |
Commercial Contact: |
Project Management Contact: |
|
Hovione: |
Hovione: |
|
[***] |
[***] |
|
Tel: [***] |
Tel: [***] |
|
[***] |
[***] |
|
|
|
|
Achaogen: |
Achaogen |
|
[***] |
[***] |
|
Tel: [***] |
Tel: [***] |
|
[***] |
[***] |
|
9. |
Term: |
|
9.1 |
The term of this Work Plan shall commence on the Order Date and shall continue until the Services described in Section 2 are completed, unless this Work Plan is terminated in accordance with the following terms: |
|
(a) |
Upon termination of a Work Plan under Section 3(a), Hovione will immediately: (i) cease work under the Work Plan; (ii) prepare and submit to Customer an itemization of all completed and partially |
Achaogen-Hovione Validation and Manufacturing Agreement |
8 |
Work Plan [***]] |
CONFIDENTIAL |
Exhibit 9-8
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
|
completed deliverables and Services; (iii) deliver to Customer any and all work completed under the Work Plan up to the date of termination at the agreed upon prices; and (iv) deliver upon request any work in process. |
|
(b) |
In no event shall Customer be liable for lost or anticipated profits, unabsorbed indirect costs or overhead, or for any sum in excess of the total Work Plan price. |
|
(c) |
In the event of a material breach of this Work Plan by either Party, the other Party may terminate this Agreement immediately if the material breach is not cured within thirty (30) days’ written notice. |
|
(d) |
In the event of termination of any Work Plan, Customer will compensate Hovione for all Services performed thereunder, as well as [***], provided Hovione [***]. |
|
9.2 |
If the Agreement is terminated or expires, but this Work Plan is not terminated or completed, then the terms of the Agreement shall continue to apply to this Work Plan until the Work Plan is either terminated or completed. |
|
9.3 |
If this Work Plan is cancelled after [***] and before the planned start date of the Validation Campaign, Customer will compensate Hovione with [***] of the total value of this Work Plan [***]. |
|
9.4 |
If this Work Plan is cancelled after the start of the Validation Campaign, a cancellation fee of [***] of the total value of this Work Plan [***] plus [***] of the Work Plan value for each started and completed batches. |
|
10. |
Miscellaneous: |
|
10.1 |
Each Party represents that it has full power and authority to enter into this Work Plan. |
|
10.2 |
This Work Plan, together with the Agreement, sets forth the entire understanding among the Parties with respect to the subject matter of this Work Plan. This Work Plan supersedes all previous oral or written agreements and understandings on this subject matter between the Parties or their respective Affiliates. |
Achaogen-Hovione Validation and Manufacturing Agreement |
9 |
Work Plan [***]] |
CONFIDENTIAL |
Exhibit 9-9
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
ORDER PREPARED BY: |
||
Hovione Inter Limited |
||
Name: |
|
[***] |
Title: |
|
[***] |
Date: |
|
[***] |
ORDER AGREED TO AND ACCEPTED BY:
Achaogen, Inc. |
|
Hovione Limited |
||||
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By: |
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/s/ [***] |
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By: |
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/s/ [***] |
Name: |
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[***] |
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Name: |
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[***] |
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Title: |
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[***] |
|
Title: |
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[***] |
Date: |
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[***] |
|
Date: |
|
[***] |
Achaogen-Hovione Validation and Manufacturing Agreement |
10 |
Work Plan [***]] |
CONFIDENTIAL |
Exhibit 9-10
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Program Work PLAN - WORK Plan No. C-2
[***]
(TO BE AGREED TO SEPARATELY)
Exhibit 10-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requestred with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Program Work PLAN - WORK Plan No. C-3
[***]
Work Plan No. C-03
Version [***]
[***]
Reference: [***]
This Work Plan No. C-03 (the “Work Plan”), dated [***] (the “Order Date”), is by and between [***] Hovione Limited, (“Hovione”) and Achaogen, Inc., a Delaware corporation, having a principle place of business at 0000 Xxxxxxxxx Xxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000, X.X.X. (“Customer”), and upon execution by both parties, shall be incorporated into the Validation and Manufacturing Agreement between Customer and Hovione Limited with an effective date of [***] (the “Agreement”). Customer, [***] and Hovione Limited hereby acknowledge and agree to all terms in both this Work Plan and the Agreement. Capitalized terms used in this Work Plan shall have the meanings ascribed to them in the Agreement.
1. |
Background: |
This Work Plan is based on Hovione’s historical experience with the Plazomicin [***] program and on detailed discussions between the Customer and Hovione’s project teams. All information and content herein reflects information known at the time of the Order Date.
In order to meet Customer’s commercial demand for [***] and produce API in larger batch sizes, Customer and Hovione recommend [***]
The current [***] process has been developed and dimensioned to produce batches of [***] of final product. This [***]. The current forecast requires a significant increase in the batch scale and consequently it is necessary to further scale-up [***]. The current [***]. Using current process yields and the known properties of a [***]. The following [***] are expected for various batch sizes (Table 1.)
Achaogen-Hovione Validation and Manufacturing Agreement |
1 |
Work Plan #[***] |
CONFIDENTIAL |
Exhibit 11-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
[***] |
|
|
|
||||
[***] |
|
|
|
||||
[***] |
|
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||||
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[***] |
[***] |
[***] |
[***] |
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[***] |
[***] |
[***] |
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[***] |
[***] |
[***] |
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[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
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[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
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[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
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[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
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[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
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[***] |
[***] |
[***] |
[***] |
The most [***]) is estimated to take [***] and utilizes at least [***]. The following workplan is directed to [***] as well as other steps in the [***].
This Work Plan does not include the [***]. At the moment, the costs included in this Work Plan cover the various stages of [***]. Though it is expected that the chemistry and engineering teams from the Customer and Hovione will meet to provide a list of user requirements for a [***]. If a [***], a separate Work Plan will be prepared [***]. The following activities will have to be carried out [***]:
[***]
2. |
Tasks: |
This Work Plan covers the tasks listed below. These tasks cover the various stages of column [***].
[***]
[***]
[***]
Achaogen-Hovione Validation and Manufacturing Agreement |
2 |
Work Plan #[***] |
CONFIDENTIAL |
Exhibit 11-2
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
[***]
[***]
|
• |
[***] |
|
• |
[***] |
|
• |
[***] |
Note:
These changes could [***] The [***] It is expected that [***] The [***]
[***]
[***] Note: if the [***]
[***]
|
• |
[***] |
[***]
[***]
|
• |
[***] |
|
• |
[***] |
|
• |
[***] |
|
• |
[***] |
[***]
[***]
|
• |
[***] |
Achaogen-Hovione Validation and Manufacturing Agreement |
3 |
Work Plan #[***] |
CONFIDENTIAL |
Exhibit 11-3
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
[***]
|
• |
[***] |
|
o |
[***] |
|
o |
[***] |
3. |
Timeline: |
Hovione anticipates that the implementation of activities outlined in Section 2 above will take:
|
• |
[***] |
|
• |
[***] |
|
• |
[***] |
|
• |
[***] |
During this time, [***]
4. |
Deliverables: |
Hovione shall prepare the following deliverables for Customer under this Work Plan (collectively the “Deliverables”).
|
4.1 |
Meetings and Project Oversight |
Hovione will provide effective project monitoring and oversight to ensure work is proceeding diligently and that all assigned Hovione staff are conducting the work on the project as directed by Customer. Project timelines will be reviewed on a [***] basis during the regular team teleconferences. An additional project oversight teleconference will be held every [***] during which timelines, budgets and resource allocation will be reviewed and discussed.
Project meetings will occur [***] by teleconference. Leaders of the project from both Achaogen and Hovione will be required to attend these [***] status meetings, and other members will make reasonable efforts to attend, as needed. Hovione will send (electronically) [***] reports to Customer at least [***] prior to the [***] status meetings detailing progress on the project. Hovione will reasonably tailor the [***] reports as directed by Customer as needed. On a [***]
Achaogen-Hovione Validation and Manufacturing Agreement |
4 |
Work Plan #[***] |
CONFIDENTIAL |
Exhibit 11-4
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
basis, the reports will include the tracking of resources and project budget. These updates will be discussed during the [***] teleconference between both Parties.
|
4.2 |
Final Report |
Hovione shall provide a comprehensive Final Report in writing to Customer approximately [***] after the completion of the Tasks. This Report (as an electronic Adobe acrobat file) shall consist of a written, comprehensive description of the development results and calculations including relevant analytical data.
|
4.3 |
Other Project Data and Information |
At Customer’s request, Hovione shall provide any data or information generated in the course of performing the Tasks, including but not limited to, analytical data, meeting notes, photographs, drawings, and designs, regardless of the media containing the information. Hovione shall provide all information or data pertaining to a Customer request using commercially reasonable efforts within a commercially reasonable timeframe.
5. |
Compensation and Payment Terms |
|
5.1 |
Labor & Equipment |
In consideration of these services performed by Hovione, Customer shall pay Hovione at a rate of [***] based on [***]. This rate includes General Chemicals, Materials, and Supplies, and hazardous waste disposal, as well as routine use of general dedicated instrumentation and [***]. The total estimated cost of labor for the scope of work outlined in this Work Plan is [***].
|
5.2 |
Reports and Deliverables |
In consideration for the provision of the final report (4.2), Customer shall pay Hovione a fixed fee of [***].
|
5.3 |
Project Specific Materials |
Project Specific Materials are raw materials and reagents (including solvents) used in the conduct of the tasks described in Section 2 and that Hovione must procure specifically in the course of the project to conduct the Services. The cost for Project Specific Materials is estimated to total [***].
Achaogen-Hovione Validation and Manufacturing Agreement |
5 |
Work Plan #[***] |
CONFIDENTIAL |
Exhibit 11-5
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
General Chemicals, Materials, and Supplies constitute items such as [***] which are used routinely in all operations and widely across projects at Hovione.
Customer will [***]. All Project Specific Materials will be ordered by Hovione from commercial sources.
Hovione will not use Project Specific Materials on any other project. Project Specific Materials may be shipped to Customer at Customer’s written request and expense.
|
5.4 |
Shipping |
[***]. Hovione will use a dedicated shipping account provided by Customer for these charges. Compounds will be shipped by [***] unless otherwise requested by Customer.
Each billing period, Hovione will provide an itemized list of shipping costs being charged, in addition to copies of all associated invoices.
|
5.5 |
Travel Costs |
The fee above does not account for nor does it include any travel costs. Customer will only reimburse Hovione for reasonable out-of-pocket expenses actually incurred in connection with the Services that are approved in writing in advance by Customer and supported by receipts and documentation. All out-of-pocket expenses shall be invoiced to Customer without xxxx-up.
|
5.6 |
Other Costs |
Not applicable at the time of Work Plan issuance. If Other Costs need to be incurred, these will be discussed and agreed in writing by both the Customer and Hovione prior to their expenditure.
Achaogen-Hovione Validation and Manufacturing Agreement |
6 |
Work Plan #[***] |
CONFIDENTIAL |
Exhibit 11-6
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Payment will be made according to the terms of the Agreement, and as outlined below.
|
5.7.1 |
Milestones: Hovione will invoice Customer according to the following payment milestone schedule: |
|
5.7.1.1 |
[***], Hovione will invoice Customer [***] for execution of Stage 1 (Task 1). |
|
5.7.1.2 |
[***], Hovione will invoice Customer [***]. |
|
5.7.1.3 |
[***], Hovione will invoice Customer [***]. |
|
5.7.1.4 |
[***], Hovione will invoice Customer [***]. |
|
5.7.1.5 |
[***], Hovione will invoice Customer [***]. |
|
5.7.1.6 |
Hovione will invoice [***]. |
|
5.7.2 |
Invoice Markings. All invoices for payments to be made to Hovione for services under this Exhibit shall be marked with: |
|
5.7.2.1. |
the following unique Purchase Order number: ___________________. |
|
5.7.2.2. |
the statement “Work Plan #C-03 entitled, [***].” |
6. |
Ceiling Price: |
The ceiling price for the services covered under this Work Plan [***] is [***] of which no more than [***] shall be for services (Section 2), [***] for the Final Report (4.2) and [***] for Project Specific Materials (5.3). Customer shall not be obligated to pay Hovione any amount in excess of this ceiling price, unless and until an additional agreement that raises this price has been negotiated and signed by both Parties.
7. |
Government Sponsored Project: |
Pursuant to Article 20 of the Manufacturing Agreement, this Work Plan is a “Government Project”.
Achaogen-Hovione Validation and Manufacturing Agreement |
7 |
Work Plan #[***] |
CONFIDENTIAL |
Exhibit 11-7
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
8. |
Commercial Contact: |
|
Project Management Contact: |
|
Hovione: |
|
Hovione: |
|
[***] |
|
[***] |
|
Tel: [***] |
|
Tel: [***] |
|
[***] |
|
[***] |
|
Achaogen: |
|
Achaogen |
|
[***] |
|
[***] |
|
Tel: [***] |
|
Tel: [***] |
|
[***] |
|
[***] |
9. |
Term: |
|
9.1 |
If this Work Plan is cancelled greater than or equal to [***] prior to the planned start of the campaign, Customer will compensate Hovione with [***] of the total value of this Work Plan [***]. |
|
9.2 |
If this Work Plan is cancelled after the start of activities in Section 2, a cancellation fee of [***] of the total value of this Work Plan [***] plus pro-rata per time worked over total estimated time for the balance of [***] of the Work Plan ([***] pro-rated for every [***] or part thereof worked). |
|
9.3 |
If the Agreement is terminated or expires, but this Work Plan is not terminated or completed, then the terms of the Agreement shall continue to apply to this Work Plan until the Work Plan is either terminated or completed. |
10. |
Miscellaneous: |
|
10.1 |
Each party represents that it has full power and authority to enter into this Work Plan. |
|
10.2 |
This Work Plan, together with the Agreement, sets forth the entire understanding among the parties with respect to the subject matter of this Work Plan. This Work Plan supersedes all previous oral or written agreements and understandings on this subject matter between the Parties or their respective Affiliates. |
Achaogen-Hovione Validation and Manufacturing Agreement |
8 |
Work Plan #[***] |
CONFIDENTIAL |
Exhibit 11-8
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
ORDER PREPARED BY: |
||
Hovione Limited |
||
Name: |
|
[***] |
Title: |
|
[***] |
Date: |
|
[***] |
ORDER AGREED TO AND ACCEPTED BY:
Achaogen, Inc. |
|
Hovione Limited |
||||
|
|
|
|
|
|
|
By: |
|
/s/ [***] |
|
By: |
|
/s/ [***] |
Name: |
|
[***] |
|
Name: |
|
[***] |
|
|
|
|
|
||
Title: |
|
[***] |
|
Title: |
|
[***] |
Date: |
|
[***] |
|
Date: |
|
[***] |
Achaogen-Hovione Validation and Manufacturing Agreement |
9 |
Work Plan #[***] |
CONFIDENTIAL |
Exhibit 11-9
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Program Work PLAN - WORK Plan No. C-4
[***]
Work Plan No. C-04
Version [***]
[***]
Reference: [***]
This Work Plan No. C-04 (the “Work Plan”), dated [***] (the “Order Date”), is by and between Hovione Limited, having a place of business at Xxxxxxxx, Xxxxxxxxxxx, Xxxx, Xxxxxx Xxxx, Xxxxxxx (“Hovione”) and Achaogen, Inc., a Delaware corporation, having a principle place of business at 0000 Xxxxxxxxx Xxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000, X.X.X. (“Customer”), and upon execution by both parties, shall be incorporated into the Validation and Manufacturing Agreement between Customer and Hovione Limited with an effective date of [***] (the “Agreement”). Customer and Hovione Limited hereby acknowledge and agree to all terms in both this Work Plan and the Agreement. Capitalized terms used in this Work Plan shall have the meanings ascribed to them in the Agreement.
1. |
Background: |
In order to meet Customer’s commercial demand for [***] and [***], Hovione recommends [***]
This purpose of this Work Plan is to confirm that both Parties will discuss and agree in good faith on a Work Plan that will cover [***].
This Work Plan does not include [***]. The [***] is covered in a separate Work Plan.
2. |
Tasks: |
In order to ensure that the Facility is ready in time to support the [***], the Parties will discuss and agree in good faith on a Work Plan which covers the specific tasks and business terms for the engineering and qualification activities at the Facility by [***].
In order to ensure that the [***] is available and qualified to support the Manufacture of Plazomicin outlined in Work Plan [***] and Work Plan [***], the Parties will discuss and agree in good faith on a Work Plan which covers the [***] by [***].
Achaogen-Hovione Validation and Manufacturing Agreement |
1 |
Work Plan #C-[***] |
CONFIDENTIAL |
Exhibit 12-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Work Plan to support [***] at Facility: due [***]. Work Plan to support purification scale-up and qualification activities: due [***]
4. |
Deliverables: |
Work Plans to support [***]
Work Plan to support [***]
5. |
Compensation and Payment Terms |
|
5.1 |
Labor & Equipment |
Not applicable for this Work Plan.
|
5.2 |
Reports and Deliverables |
Work Plan for [***]
Work Plan for [***]
|
5.3 |
Project Specific Materials |
Not applicable for this Work Plan.
|
5.4 |
Shipping |
Not applicable for this Work Plan.
|
5.5 |
Travel Costs |
Not applicable for this Work Plan.
|
5.6 |
Other Costs |
Not applicable for this Work Plan.
|
5.7 |
Invoices |
Not applicable for this Work Plan.
Achaogen-Hovione Validation and Manufacturing Agreement |
2 |
Work Plan #C-[***] |
CONFIDENTIAL |
Exhibit 12-2
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Not applicable for this Work Plan.
7. |
Government Sponsored Project: |
Pursuant to Article 20 of the Manufacturing Agreement, this Work Plan is a “Government Project”.
8. |
|
Commercial Contact: Hovione: |
|
Project Management Contact: Hovione: |
|
|
[***] |
|
[***] |
|
|
Tel: [***] |
|
Tel: [***] |
|
|
[***] |
|
[***] |
|
|
|
|
|
|
|
Achaogen: [***] Tel: [***] [***] |
|
Achaogen [***] Tel: [***] [***] |
9.Term:
|
9.1 |
If the Agreement is terminated or expires, but this Work Plan is not terminated or completed, then the terms of the Agreement shall continue to apply to this Work Plan until the Work Plan is either terminated or completed. |
10.Miscellaneous:
|
10.1 |
Each party represents that it has full power and authority to enter into this Work Plan. |
|
10.2 |
This Work Plan, together with the Agreement, sets forth the entire understanding among the parties with respect to the subject matter of this Work Plan. This Work Plan supersedes all previous oral or written agreements and understandings on this subject matter between the parties or their respective Affiliates. |
Achaogen-Hovione Validation and Manufacturing Agreement |
3 |
Work Plan #C-[***] |
CONFIDENTIAL |
Exhibit 12-3
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
|
electronic exchange of this Work Plan, or of any counterpart, shall be deemed the equivalent of an original. |
ORDER PREPARED BY: |
||
Hovione Limited |
||
Name: |
|
[***] |
Title: |
|
[***] |
Date: |
|
[***] |
ORDER AGREED TO AND ACCEPTED BY:
Achaogen, Inc. |
|
Hovione Limited |
||||
|
|
|
|
|
|
|
By: |
|
/s/ [***] |
|
By: |
|
/s/ [***] |
Name: |
|
[***] |
|
Name: |
|
[***] |
|
|
|
|
|
||
Title: |
|
[***] |
|
Title: |
|
[***] |
Date: |
|
[***] |
|
Date: |
|
[***] |
Achaogen-Hovione Validation and Manufacturing Agreement |
4 |
Work Plan #C-[***] |
CONFIDENTIAL |
Exhibit 12-4
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Program Work PLAN - WORK Plan No. C-5
[***]
Work Plan No. C-05
Version [***]
[***]
Reference: [***]
This Work Plan No. C-05 (the “Work Plan”), dated [***] (the “Order Date”), is by and between Hovione Limited, having a place of business at Xxxxxxxx, Xxxxxxxxxxx, Xxxx, Xxxxxx Xxxx, Xxxxxxx (“Hovione”) and Achaogen, Inc., a Delaware corporation, having a principle place of business at 0000 Xxxxxxxxx Xxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000, U.S.A. ("Customer"), and upon execution by both parties, shall be incorporated into the Validation and Manufacturing Agreement between Customer and Hovione Limited with an effective date of [***] (the “Agreement”). Customer and Hovione Limited hereby acknowledge and agree to all terms in both this Work Plan and the Agreement. Capitalized terms used in this Work Plan shall have the meanings ascribed to them in the Agreement.
1. |
Background: |
This Work Plan is based on Hovione’s historical experience with the Plazomicin [***] program and on discussions between the Customer and Hovione. All information and content herein reflects information known at the time of the Order Date.
The [***] for Customer’s proprietary compound Plazomicin [***] (the “Product”) will occur at [***] with the [***] at [***], individually referred to as the “Facility” and collectively referred to as the “Facilities.” This is covered in Work Plan [***].
This Work Plan will cover the Manufacture of one [***] referenced above. It will cover the manufacture of [***] covered in Work Plan [***]. The [***]
This Work Plan does not include any [***]. If such work is requested, it will be covered in a separate Work Plan(s).
Achaogen-Hovione Validation and Manufacturing Agreement |
1 |
Work Plan [***] |
CONFIDENTIAL |
Exhibit 13-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
This Work Plan covers the [***]. The batch will be produced in the [***] in [***]. It is anticipated that batch [***]. It is anticipated that [***] will occur at [***].
3. |
Timeline: |
Hovione confirms that the [***] would commence in [***]. The Manufacture of this batch is anticipated to be completed by [***]. Any changes to the timeline shall be made in writing and signed by both Parties.
At the time this Work Plan was prepared, the following is anticipated:
|
• |
[***] |
|
• |
[***] |
4. |
Deliverables: |
Hovione shall prepare the following deliverables for Customer under this Work Plan (collectively the “Deliverables”).
|
• |
[***] |
|
• |
Master Batch Production Records |
|
• |
Completed Batch Production Records |
|
• |
Campaign summary report |
5. |
Compensation and Payment Terms |
|
5.1 |
Labor & Equipment |
In consideration of these Services performed by Hovione, Customer shall pay Hovione [***] for the Tasks outlined in Section 2 and the Deliverables set forth in Section 4 (the “Service Fees”).
|
5.2 |
Reports and Deliverables |
All Deliverables are included in the Service Fees above.
Achaogen-Hovione Validation and Manufacturing Agreement |
2 |
Work Plan [***] |
CONFIDENTIAL |
Exhibit 13-2
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Project Specific Materials are raw materials and reagents (including solvents) used in the conduct of the tasks described in Section 2 and that Hovione must procure specifically in the course of the project to conduct the Services.
The total cost of Project Specific Materials described in this Work Plan shall not exceed [***] where a maximum of [***] is for the procurement of [***] and a maximum of [***] for procurement of [***]. The [***] has been purchased under a separate Work Plan.
Hovione will not use Project Specific Materials on any other project. Project Specific Materials may be shipped to Customer at Customer’s written request and expense.
General Chemicals, Materials, and Supplies constitute items such as [***] which are used routinely in all operations and widely across projects at Hovione. The total cost for General Chemicals, Materials and Supplies is approximately [***].
|
5.4 |
Shipping |
[***]. Hovione will use a dedicated shipping account provided by Customer for these charges. Compounds will be shipped by [***] unless otherwise requested by Customer. Hovione estimates that the shipping costs inclusive of customs, shipping and packing materials will not exceed [***]. [***].
All materials shipped by Hovione on behalf of Customer will follow [***].
|
5.5 |
Travel Costs |
The fee above does not account for nor does it include any travel costs. Customer will only reimburse Hovione for reasonable out-of-pocket expenses actually incurred in connection with the Services that are approved in writing in advance by Customer and supported by receipts and documentation. All out-of-pocket expenses shall be invoiced to Customer without xxxx-up.
|
5.6 |
Other Costs |
Not applicable at the time of Work Plan issuance. If Other Costs need to be incurred, these will be discussed and agreed in writing by both the Customer and Hovione prior to their expenditure.
Achaogen-Hovione Validation and Manufacturing Agreement |
3 |
Work Plan [***] |
CONFIDENTIAL |
Exhibit 13-3
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Payment will be made according to the terms of the Agreement, and as outlined below.
|
5.7.1 |
Milestones: Hovione will invoice Customer according to the following payment milestone schedule: |
|
5.7.1.1. |
[***] and issuance of the PO, Hovione will issue an invoice for [***] for the purchase of Project Specific Materials, General Chemicals, Materials and Supplies and the reservation of capacity and resources. |
|
5.7.1.2. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.3. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.4. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.5. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.6. |
[***], Hovione will invoice Customer up to [***]. |
|
5.7.2. |
Invoice Markings. All invoices for payments to be made to Hovione for services under this Exhibit shall be marked with: |
|
5.7.2.1. |
the following unique Purchase Order number: . |
|
5.7.2.2. |
the statement “Work Plan #C-05 entitled, [***].” |
6. |
Ceiling Price |
The ceiling price for the services covered under this Work Plan C-05 is [***] of which no more than [***] shall be for services (6.1), [***] for the final report (6.2), [***] for General and Project-Specific Materials (6.3), and [***] for shipping costs (6.4). Customer shall not be obligated to pay Hovione any amount in excess of this ceiling price, unless and until an additional agreement that raises this price has been negotiated and signed by both Parties.
Achaogen-Hovione Validation and Manufacturing Agreement |
4 |
Work Plan [***] |
CONFIDENTIAL |
Exhibit 13-4
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Pursuant to Article 20 of the Manufacturing Agreement, this Work Plan is a “Government Project”.
8. |
|
Commercial Contact: Hovione: |
|
Project Management Contact: Hovione: |
|
|
[***] |
|
[***] |
|
|
Tel: [***] |
|
Tel: [***] |
|
|
[***] |
|
[***] |
|
|
|
|
|
|
|
Achaogen: [***] Tel: [***] [***] |
|
Achaogen [***] Tel: [***] [***] |
9. |
Term: |
|
9.1 |
If this Work Plan is cancelled greater than or equal to [***] prior to the planned start of the campaign, Customer will compensate Hovione with [***] of the total value of this Work Plan [***]. |
|
9.2 |
If this Work Plan is cancelled less than [***] prior to the planned start of the campaign, Customer will compensate Hovione with [***] of the total value of this Work Plan [***]. |
|
9.3 |
If this Work Plan is cancelled after the start of the campaign, Customer will compensate Hovione with a cancellation fee of [***] of the total value of this Work Plan. |
|
9.4 |
If the Agreement is terminated or expires, but this Work Plan is not terminated or completed, then the terms of the Agreement shall continue to apply to this Work Plan until the Work Plan is either terminated or completed. |
10. |
Miscellaneous: |
|
10.1 |
Each party represents that it has full power and authority to enter into this Work Plan. |
Achaogen-Hovione Validation and Manufacturing Agreement |
5 |
Work Plan [***] |
CONFIDENTIAL |
Exhibit 13-5
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
|
10.3 |
This Work Plan may be executed in counterparts, each of which, when executed and delivered, shall be deemed to be an original, and all of which, when joined, shall together constitute one and the same agreement. Any photocopy or electronic exchange of this Work Plan, or of any counterpart, shall be deemed the equivalent of an original. |
ORDER PREPARED BY: |
||
Hovione Limited |
||
Name: |
|
[***] |
Title: |
|
[***] |
Date: |
|
[***] |
ORDER AGREED TO AND ACCEPTED BY:
Achaogen, Inc. |
|
Hovione Limited |
||||
|
|
|
|
|
|
|
By: |
|
/s/ [***] |
|
By: |
|
/s/ [***] |
Name: |
|
[***] |
|
Name: |
|
[***] |
|
|
|
|
|
||
Title: |
|
[***] |
|
Title: |
|
[***] |
Date: |
|
[***] |
|
Date: |
|
[***] |
Achaogen-Hovione Validation and Manufacturing Agreement |
6 |
Work Plan [***] |
CONFIDENTIAL |
Exhibit 13-6
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Program Work PLAN - WORK Plan No. C-6
[***]
Work Plan No. C-06
Version [***]
[***]
Reference: [***]
This Work Plan No. C-06 (the “Work Plan”), dated [***] (the “Order Date”), is by and between Hovione Limited, having a place of business at Xxxxxxxx, Xxxxxxxxxxx, Xxxx, Xxxxxx Xxxx, Xxxxxxx (“Hovione”) and Achaogen, Inc., a Delaware corporation, having a principle place of business at 0000 Xxxxxxxxx Xxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000, U.S.A. ("Customer"), and upon execution by both parties, shall be incorporated into the Validation and Manufacturing Agreement between Customer and Hovione Limited with an effective date of [***] (the “Agreement”). Customer and Hovione Limited hereby acknowledge and agree to all terms in both this Work Plan and the Agreement. Capitalized terms used in this Work Plan shall have the meanings ascribed to them in the Agreement.
1. |
Background: |
This Work Plan is based on Hovione’s historical experience with the Plazomicin [***] program and on discussions between the Customer and Hovione. All information and content herein reflects information known at the time of the Order Date.
The [***] for Customer’s proprietary compound [***] (the “Product”) will occur at [***], individually referred to as the “Facility” and collectively referred to as the “Facilities.” Assuming that all [***] are completed in a timely manner, the anticipated timing for the [***] of the Product will be [***]. Additional process development such as [***] will be covered under a separate Work Plan and is anticipated to be [***].
This Work Plan does not include any [***]. If such work is requested, it will be covered in a separate Work Plan(s).
Achaogen-Hovione Validation and Manufacturing Agreement |
1 |
Work Plan C-[***] |
CONFIDENTIAL |
Exhibit 14-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
This Work Plan covers the Validation Program to be run in the [***]. It is anticipated that [***]. It is anticipated that this campaign will consist of [***]
3. |
Timeline: |
Hovione confirms that the [***] would commence in [***]. The deadline for delivery of the [***] (the “Final Deliverable”) to Customer is [***] following [***] (the “Deadline”). The Manufacturing campaign is anticipated to be completed by [***]. Any changes to the timeline shall be made in writing and signed by both Parties.
At the time this Work Plan was prepared, the following is anticipated:
|
• |
[***] |
|
• |
[***] |
|
• |
[***] |
|
• |
[***] |
4. |
Deliverables: |
Hovione shall prepare the following deliverables for Customer under this Work Plan (collectively the “Deliverables”).
|
• |
[***] |
|
• |
[***] |
|
• |
[***] |
|
• |
[***] |
|
• |
Master Batch Production Records |
|
• |
Completed Batch Production Records |
|
• |
Campaign summary report |
5. |
Compensation and Payment Terms |
|
5.1 |
Labor & Equipment |
In consideration of these Services performed by Hovione, Customer shall pay Hovione [***] for the Tasks outlined in Section 2 and the Deliverables set forth in Section 4 (the “Service Fees”).
Achaogen-Hovione Validation and Manufacturing Agreement |
2 |
Work Plan C-[***] |
CONFIDENTIAL |
Exhibit 14-2
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
All Deliverables are included in the Service Fees above.
|
5.3 |
Project Specific Materials |
Project Specific Materials are raw materials and reagents (including solvents) used in the conduct of the tasks described in Section 2 and that Hovione must procure specifically in the course of the project to conduct the Services.
The total cost of Project Specific Materials described in this Work Plan shall not exceed [***] where a maximum of [***] is for the procurement of [***] and a maximum of [***]. The [***] has been purchased under a separate Work Plan.
Hovione will not use Project Specific Materials on any other project. Project Specific Materials may be shipped to Customer at Customer’s written request and expense.
General Chemicals, Materials, and Supplies constitute items such as [***] which are used routinely in all operations and widely across projects at Hovione. The total cost for General Chemicals, Materials and Supplies is approximately [***].
|
5.4 |
Shipping |
[***]. Hovione will use a dedicated shipping account provided by Customer for these charges. Compounds will be shipped by [***] unless otherwise requested by Customer. Hovione estimates that the shipping costs inclusive of customs, shipping and packing materials will not exceed [***]. [***].
All materials shipped by Hovione on behalf of Customer will follow [***]
|
5.5 |
Travel Costs |
The fee above does not account for nor does it include any travel costs. Customer will only reimburse Hovione for reasonable out-of-pocket expenses actually incurred in connection with the Services that are approved in writing in advance by Customer and supported by receipts and documentation. All out-of-pocket expenses shall be invoiced to Customer without xxxx-up.
Achaogen-Hovione Validation and Manufacturing Agreement |
3 |
Work Plan C-[***] |
CONFIDENTIAL |
Exhibit 14-3
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
Not applicable at the time of Work Plan issuance. If Other Costs need to be incurred, these will be discussed and agreed in writing by both the Customer and Hovione prior to their expenditure.
|
5.7 |
Invoices |
Payment will be made according to the terms of the Agreement, and as outlined below.
|
5.7.1 |
Milestones: Hovione will invoice Customer according to the following payment milestone schedule: |
|
5.7.1.1. |
[***], Hovione will issue an invoice for [***] for the purchase of Project Specific Materials, General Chemicals, Materials and Supplies and the reservation of capacity and resources. |
|
5.7.1.2. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.3. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.4. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.5. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.6. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.7. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.8. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.9. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.10. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.11. |
Upon issuance of the [***], Hovione will issue an invoice for [***]. |
|
5.7.1.12. |
[***], Hovione will issue an invoice for [***]. |
Achaogen-Hovione Validation and Manufacturing Agreement |
4 |
Work Plan C-[***] |
CONFIDENTIAL |
Exhibit 14-4
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
|
5.7.1.14. |
[***], Hovione will issue an invoice for [***]. |
|
5.7.1.15. |
[***], Hovione will invoice Customer up to [***] for shipping costs incurred during the campaign. |
5.7.2.Invoice Markings. All invoices for payments to be made to Hovione for services under this Exhibit shall be marked with:
|
5.7.2.1. |
the following unique Purchase Order number: . |
|
5.7.2.2. |
the statement “Work Plan #C-06 entitled, [***].” |
6. |
Ceiling Price |
The ceiling price for the services covered under this Work Plan C-06 is [***] of which no more than [***] shall be for services (6.1), [***] for the final report (6.2), [***] for General and Project-Specific Materials (6.3), and [***] for shipping costs (6.4). Customer shall not be obligated to pay Hovione any amount in excess of this ceiling price, unless and until an additional agreement that raises this price has been negotiated and signed by both Parties.
7. |
Government Sponsored Project: |
Pursuant to Article 20 of the Manufacturing Agreement, this Work Plan is a “Government Project”.
8. |
|
Commercial Contact: Hovione: |
|
Project Management Contact: Hovione: |
|
|
[***] |
|
[***] |
|
|
Tel: [***] |
|
Tel: [***] |
|
|
[***] |
|
[***] |
|
|
|
|
|
|
|
Achaogen: [***] Tel: [***] [***] |
|
Achaogen [***] Tel: [***] [***] |
Achaogen-Hovione Validation and Manufacturing Agreement |
5 |
Work Plan C-[***] |
CONFIDENTIAL |
Exhibit 14-5
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
|
9.1 |
If this Work Plan is cancelled greater than or equal to [***] prior to the planned start of the campaign, Customer will compensate Hovione with [***] of the total value of this Work Plan [***]. |
|
9.2 |
If this Work Plan is cancelled less than [***] prior to the planned start of the campaign, Customer will compensate Hovione with [***] of the total value of this Work Plan [***]. |
|
9.3 |
If this Work Plan is cancelled after the start of the campaign, a cancellation fee of [***] of the total value of this Work Plan [***] of the Work Plan value for each started and completed batches [***]. |
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9.4 |
If the Agreement is terminated or expires, but this Work Plan is not terminated or completed, then the terms of the Agreement shall continue to apply to this Work Plan until the Work Plan is either terminated or completed. |
10. |
Miscellaneous: |
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10.1 |
Each party represents that it has full power and authority to enter into this Work Plan. |
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10.2 |
This Work Plan, together with the Agreement, sets forth the entire understanding among the parties with respect to the subject matter of this Work Plan. This Work Plan supersedes all previous oral or written agreements and understandings on this subject matter between the parties or their respective Affiliates. |
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10.3 |
This Work Plan may be executed in counterparts, each of which, when executed and delivered, shall be deemed to be an original, and all of which, when joined, shall together constitute one and the same agreement. Any photocopy or electronic exchange of this Work Plan, or of any counterpart, shall be deemed the equivalent of an original. |
Achaogen-Hovione Validation and Manufacturing Agreement |
6 |
Work Plan C-[***] |
CONFIDENTIAL |
Exhibit 14-6
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Achaogen
Plazomicin
[***]
[***]
ORDER PREPARED BY: |
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Hovione Limited |
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Name: |
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[***] |
Title: |
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Date: |
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[***] |
ORDER AGREED TO AND ACCEPTED BY:
Achaogen, Inc. |
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Hovione Limited |
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By: |
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/s/ [***] |
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By: |
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/s/ [***] |
Name: |
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[***] |
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Name: |
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[***] |
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Title: |
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Title: |
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Date: |
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Achaogen-Hovione Validation and Manufacturing Agreement |
7 |
Work Plan C-[***] |
CONFIDENTIAL |
Exhibit 14-7
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Project Time-Line that describes the planned scheduling of the activities and tasks by Hovione from the effective date of this agreement ti^ªll up to and including [***]
Exhibit 15-1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requestred with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Government Contract Clauses
1. |
The Terms and Conditions explicated in this Appendix are applicable to the Service Provider for all Government Projects conducted by HOVIONE on behalf of ACHAOGEN. |
2. |
Referenced Clauses. The following provisions are incorporated by reference and have the same force and effect as if set forth in full text. Clauses listed in this Section that are incorporated by reference have the same force and effect as if they were given in full text. References are to the Federal Acquisition Regulation (FAR) and to the Defense Federal Acquisition Regulation Supplement (DFARS). Full text is available at xxxx://xxxxxxx.xxxx.xx.xxx/. For purposes of this Agreement, the term “contract” shall mean this Agreement; the term “Contractor” shall mean HOVIONE; the term “prime contractor” shall mean ACHAOGEN; and the terms “Government” and “Contracting Officer” shall mean ACHAOGEN or the United States Government depending on the context in which the term is used. |
Clause |
Date |
Title |
FAR 52.203-5 |
Sep-06 |
Covenant Against Contingent Fees (Over $100,000) |
FAR 52.203-6 |
Sep-06 |
Restrictions on Subcontractor Sales to the Government (Over $100,000) |
FAR 52.203-7 |
Jul-95 |
Anti-Kickback Procedures (Over $100,000) |
FAR 52.215-2 |
Mar-09 |
Audit and Records-Negotiation (Over $100,000) Insert “and Achaogen” after “Contracting Officer” and “Comptroller General of the United States”. |
FAR 52.215-12 |
Oct-97 |
Subcontractor Cost or Pricing Data (Over $650,000) |
FAR 52.215-21 |
Oct-97 |
Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data-Modifications. Substitute “Achaogen” for “Contracting Officer” throughout this clause. |
FAR 52.219-8 |
May-04 |
Utilization of Small Business Concerns (Over $100,000) |
FAR 52.222-35 |
Sept-06 |
Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Over $100,000) |
FAR 52.222-37 |
Sep-06 |
Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Over $100,000) |
FAR 52.222-50 |
Feb-09 |
Combating Trafficking in Persons Substitute “Achaogen” for “Contracting Officer” throughout this clause. In paragraph I, insert “and Achaogen” after “Government”. |
FAR 52.225-13 |
Jun-08 |
Restrictions on Certain Foreign Purchases |
FAR 52.227-1 |
Dec-07 |
Authorization and Consent, Alternate I (Apr 1984) (Over $100,000) |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
Clause |
Date |
Title |
Dec-07 |
Notice and Assistance Regarding Patent and Copyright Infringement (Over $100,000) |
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FAR 52.227-11 |
Dec-07 |
Patent Rights – Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph I is modified to include the requirements in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual |
FAR 52.230-3 |
Aug-96 |
Disclosure and Consistency of Cost Accounting Practices, with the exception of clause (b). |
FAR 52.230-6 |
Mar-08 |
Administration of Cost Accounting Standards |
FAR 52.244-6 |
Jun-10 |
Subcontracts for Commercial Items |
FAR 52.247-64 |
Feb-06 |
Preference for Privately Owned U.S.-Flag Commercial Vessels |
FAR 52.247.67 |
Feb-06 |
Submission of Transportation Documents for Audit |
FAR 252.203-7001 |
Dec-04 |
Prohibition on Persons Convicted of Fraud or Other Defense-Contract-Related Felonies |
FAR 252.204.7000 |
Dec-91 |
Disclosure of Information |
FAR 252.227.7013 |
Nov-95 |
Rights to Technical Data-Noncommercial Items |
FAR 252.227.7016 |
Jun-95 |
Rights in Bid or Proposal Information |
FAR 252.227.7037 |
Sep-99 |
Validation of Restrictive Markings on Technical Data |
FAR 252.247.7023 |
May-02 |
Transportation of Supplies by Sea |
FAR 252.247.7024 |
Mar-00 |
Notification of Transportation of Supplies by Sea |
3. |
Referenced Clauses for Lower Tier Contracts. Notwithstanding any other language in this Agreement, including any clauses incorporated by reference, HOVIONE agrees as a subcontractor to a Federal prime contract to incorporate only the following Government Contract Clauses, as applicable, with all subcontracts HOVIONE negotiates in association with the services materials provided to ACHAOGEN as an aspect of a Government Project. |
Clause |
Date |
Title |
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FAR 52.230-6 |
Mar-08 |
Administration of Cost Accounting Standards |
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FAR 52.244-6 |
Sep-06 |
Subcontracts for Commercial Items |
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FAR 52.247-64 |
Feb-06 |
Preference for Privately Owned U.S.-Flag Commercial Vessels |
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FAR 52.247.67 |
Feb-06 |
Submission of Transportation Documents for Audit |
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FAR 252.203-7001 |
Dec-04 |
Prohibition on Persons Convicted of Fraud or Other Defense-Contract-Related Felonies |
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FAR 252.204.7000 |
Dec-91 |
Disclosure of Information |
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FAR 252.227.7013 |
Sep-99 |
Validation of Restrictive Markings on Technical Data |
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FAR 252.227.7016 |
Nov-05 |
Subcontracts for Commercial Items and Commercial Components |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
5. |
Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Reference: FAR 52.203-11). As a condition of this Agreement, HOVIONE certifies that: |
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5.1 |
no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence in the extension, continuation, renewal, amendment, or modification of any Federal contract, grant, loan, or cooperative agreement; |
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5.2 |
for any funds other than Federally appropriated funds, HOVIONE shall complete and submit, with its offer, OMB standard form LLL, “Disclosure of Lobbying Activities”, for transmittal to the Contracting Officer; and |
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5.3 |
HOVIONE will include the language of this certification in all subcontracts, at any tier, negotiated in association with the services and materials provided to ACHAOGEN under this Agreement, and require that all recipients of subcontract awards in excess of $100,000 certify and, if required, disclose accordingly. |
6. |
Government Right to Inspection of Research and Development (Reference: FAR 52.246-8). |
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6.1 |
HOVIONE recognizes that the Government has the right to inspect and test all work called for by this Agreement, to the extent practicable at all places and times, including the period of performance, and in any event before its termination. The Government may also inspect the plant or plants of the contractor or its subcontractors engaged in Prime Contract performance. The Government shall perform inspections and tests in a manner that will not unduly delay the work. |
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6.2 |
If the Government performs any inspection or test on its premises, HOVIONE shall furnish all reasonable facilities and assistance for the safe and convenient performance of these duties. |
7. |
Registration in the Central Contractor Registration (“CCR”) Database (Reference: FAR 52.204-7). |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
|
7.1 |
HOVIONE shall be registered in the CCR database prior to signing, during performance, and through final payment of this Agreement |
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7.2 |
HOVIONE will include this requirement in all subcontracts, at any tier, negotiated in association with the services and materials provided to ACHAOGEN under this Agreement, and require that all recipients of subcontract awards in excess of $100,000 register accordingly. |
8. |
Government Interface. |
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8.1 |
As the Government is not in privity with HOVIONE, HOVIONE employees may not interface with any Government employee without advance consent from ACHAOGEN. |
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8.2 |
If ACHAOGEN allows HOVIONE or HOVIONE employees access to Government employees, HOVIONE is not authorized to accept Government instruction on behalf of ACHAOGEN. HOVIONE is not authorized to make offers, commitments, or otherwise negotiate with the government on ACHAOGEN’s behalf or its own behalf in its capacity as a subcontractor to ACHAOGEN. In case of occurrence of any such offense, HOVIONE shall |
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8.2.1 |
suggest to the Government representative that ACHAOGEN be involved in all such discussions, and |
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8.2.2 |
immediately report to ACHAOGEN any attempt by Government personnel to provide such instruction or conduct such negotiations. |
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8.3 |
If HOVIONE interfaces with the Government, HOVIONE’s regular reports to list all data exchanged and shall summarize all significant technical discussions with the Government personnel during the reporting period. |
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8.4 |
Under no circumstances shall HOVIONE initiate contact with ACHAOGEN’s Procuring Contracting Officer (“PCO”), Administrative Contracting Officer (“ACO”), Contracting Officer’s Representative (“COR”), or their respective support staff, with respect to any matters pertaining to this agreement or the Prime Contract, without the advance consent of ACHAOGEN. |
9. |
Disputes. |
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9.1 |
Disputes Involving the Prime Contract and/or the Government: |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.
Confidential Treatment Requested by Achaogen, Inc.
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affects ACHAOGEN’s interests, ACHAOGEN will promptly notify HOVIONE and, at its option, as permitted by the terms of the Prime Contract, follow one of the following procedures: |
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9.1.1.1 |
ACHAOGEN will prosecute, defend, or appeal all claims to the extent of ACHAOGEN’s interest. HOVIONE will assist ACHAOGEN in every reasonable manner, including but not limited to furnishing all documents, statements, witnesses as may be in its employ, and other pertinent information, as required by ACHAOGEN. |
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9.1.1.2 |
ACHAOGEN will authorize HOVIONE to prosecute, defend, or appeal in ACHAOGEN’s name, to the extent of HOVIONE’s interest. ACHAOGEN will assist HOVIONE in every reasonable manner, including but not limited to furnishing all relevant documents, statements, witnesses as may be in its employ, and other pertinent information as deemed necessary. |
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9.1.2 |
Effect of Decisions. |
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9.1.2.1 |
All preliminary and final decisions and judgments issued by the Government or a court pursuant to claims or appeals within the scope of paragraph 9.1.1 of this Section shall be binding upon HOVIONE to the extent binding on ACHAOGEN, whether or not HOVIONE was a party to the prosecution, defense, or appeal. |
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9.1.2.2 |
If, as the result of any decision or judgment which is binding upon ACHAOGEN and HOVIONE, ACHAOGEN is unable to obtain reimbursement from the Government under the Prime Contract for, or is required to refund or credit to the government any amount with respect to any item of cost or fee for which ACHAOGEN has reimbursed HOVIONE, HOVIONE shall, on demand, promptly repay such amount to ACHAOGEN. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions.