Exhibit 10.25
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) THE TYPE THAT THE REGISTRANT TREATS A PRIVATE OR CONFIDENTIAL.
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Commercial Master Service Agreement
Between
Ultragenyx Pharmaceutical Inc.
60 Leveroni Court
Novato, CA 94949 USA
(Herein known as “UGX”)
And
BSP Pharmaceuticals S.p.A.
via Appia km 65,561 04013 Latina Scalo (LT), Italy
(Herein known as “BSP”)
Hereinafter referred to individually as a “Party” and together as the “Parties”
This Commercial Master Service Agreement (“AGREEMENT”) is made as of the 22ndday of February, 2021 (“EFFECTIVE DATE”), by and between UGX (on behalf of itself and its Affiliates and subsidiaries), and BSP.
Preamble
Whereas, UGX is a company engaged in the pharmaceutical field focusing on development of rare disease therapies and has obtained regulatory approval to market certain medicinal products based on active pharmaceutical ingredients;
Whereas, BSP is a contract development and manufacturing organization focused on innovative products and has the know-how, expertise, capability, experience and the infrastructure necessary to manufacture certain DRUG PRODUCTS subject to and in accordance with the terms hereof;
Whereas,UGX wishes to establish a contractual relationship with BSP for the development, manufacturing, supply, RELEASE and store DRUG PRODUCTS for UGX as set forth in the respective sections of this AGREEMENT;
NOW THEREFORE, in consideration of the foregoing, both PARTIES agree to work in a partnership model and are committed to establish the appropriate level of trust and transparency. Each PARTY hereto has a duty of good faith and fair dealing in connection with its performance under this AGREEMENT. Each PARTY shall perform its obligations under this AGREEMENT in a diligent, legal, ethical and professional manner so as to advance the purposes and intend of this AGREEMENT.
Hereby agree as follows:
1. Definition 5
2. Scope of the Agreement 10
3. BSP `s Responsabilities 11
4. UGX Responsibilities 12
5. Governance Model 12
6. FOC MATERIALS 15
7. PURCHASED MATERIALS. EQUIPMENT 17
8. Forecast 18
9. Delivery of DRUG PRODUCT 20
10. DRUG PRODUCT ACCEPTANCE AND REJECTION 21
11. Price. Invoice and Payment 23
12. Records. Audits and Inspections 25
13. Intellectual Property 26
14. Indemnification 27
15. General Representation and Warranties 29
16. Limitation of Liability 31
17. Insurance 31
18. Confidential Information 32
19. Force Majeure 33
20. Term and Termination 34
21. Decommissioning 36
22. EFFECTS OF TERMINATION 36
23. Miscellaneous 38
Appendix I 41
Product Schedule 41
Appendix II 45
Compliance 45
Appendix III 47
QUALITY AND TECHNICAL AGREEMENT (QTA) 47
Appendix I
| Product Schedule |
Appendix II
| Compliance |
Appendix III | QUALITY AND TECHNICAL AGREEMENT (QTA) |
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10.7.1. If UGX is the Party responsible for such NON-CONFORMING BATCH, then UGX shall:
(i) pay for the NON-CONFORMING BATCH and such replacement DRUG PRODUCT on the [***] and at the [***]; and
(ii) bear the disposition costs of the NON-CONFORMING BATCH; and
(iii) have BSP MANUFACTURE the replacement DRUG PRODUCT, provided that UGX shall supply BSP with the sufficient quantity of FOC MATERIALS necessary to replace such NON-CONFORMING BATCH, at [***] costs and expenses.
10.7.2. Subject to Section 16, if BSP is the Party responsible for such NON-CONFORMING BATCH and UGX is willing to be supplied with a replacement DRUG PRODUCT BATCH, then, as sole remedies,
(a) to the extent UGX paid BSP for such NON-CONFORMING BATCH, BSP shall provide such a replacement BATCH of DRUG PRODUCT [***], or
(b) to the extent UGX did not pay BSP for such NON-CONFORMING DRUG PRODUCT, then UGX shall pay only for such a replacement DRUG PRODUCT BATCH on the [***] and at the [***] as for the [***], provided that
(c) in either case, UGX shall provide BSP with the sufficient quantity of FOC MATERIALS necessary to replace under (a) and (b) of this Section 10.7.2 such NON-CONFORMING BATCH, at [***] costs and expenses and BSP shall return or destroy, at [***] costs, the NON-CONFORMING BATCH as determined by UGX in its sole discretion.
(d) should UGX have (i) not opted for the replacement of NON –CONFORMING BATCH and (ii) [***] for such [***], [***] will [***] (or [***]if [***] under Section [***]) equal to [***], excluding [***]].With respect to [[***], [***]may [***] provided by [***] and, in the absence of [***] or[***] or in the event that the [***],[***] shall [***] the [***], excluding [***], within [***] CALENDAR DAYS after [***].
With respect to each Party, the indemnification obligations set forth in this Section 14.1 shall not apply to the extent that the LOSSES are the result of (i) a material breach of this AGREEMENT (including a breach of any representation, warranty or covenant) by the other Party, or (ii) the [***] of the other Party’s INDEMNITEES, or (iii) for which the other Party is obligated to [***] as set forth in Sections [***], [***] and [***] below].
IN WITNESS WHEREOF, this Agreement is executed as of the Effective Date on behalf of the parties by their duly authorized representatives.
Ultragenyx Pharmaceutical Inc. | BSP Pharmaceuticals S.p.A. | |
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Dennis Huang | Aldo Braca | |
Chief Technical Operations Officer | President and CEO |
10-Mar-2021 | 10-Mar-2021 |