Exhibit 10.18
[***] = 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.
Commercial Supply Agreement
Triheptanoin Ultrapure
Between
Ultragenyx Pharmaceutical Inc.
60 Leveroni Court Novato, CA 94949 USA
(Herein known as UGX)
And
IOI Oleo GmbH Herrengraben 31
20459 Hamburg, Germany (Herein known as IOI)
Hereinafter referred to individually as a “Party” and together as the “Parties”
1
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, IOI is a supplier of oleochemical specialties for a large number of pharmaceutical and industrial applications, including the development and manufacturing of drug substance.
Whereas, given IOI’s know-how, expertise, capability, experience and infrastructure, Ultragenyx entrusted IOI with, and IOI accepted, the manufacturing, packing, releasing of Ultragenyx’s Triheptanoin Ultrapure Drug Substance (the PRODUCT) in accordance with the terms and conditions of the Supply Agreement between CREMER OLEO GmbH & Co KG as legal predecessor of IOI and Ultragenyx Pharmaceutical Inc. of November 19th 2012 (“INITIAL AGREEMENT”);
Whereas, as the PARTIES have determined the INITIAL AGREEMENT to be terminated and replaced with a modified agreement to better regulate their collaboration in particular, but not limited to, the evolving regulatory status of PRODUCT across the world, both PARTIES have expressed their intention to better regulate respective duties and obligations in relation to the manufacturing of Ultragenyx’s Triheptanoin Ultrapure Drug Substance;
Whereas, each Party herewith expresses once again its commitment to (i) work in a partnership model, (ii) always apply the appropriate level of trust and transparency, (iii) respect a duty of good faith and fair dealing in connection with its performance under this AGREEMENT, (iv) perform its obligations under this AGREEMENT in a diligent, legal, ethical and professional manner so as to advance the purposes and intent of this AGREEMENT.
Now, Therefore, in consideration of the mutual agreements and covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:
2
Contents
1. DEFINITION | 5 |
2. SCOPE OF THE AGREEMENT | 7 |
3. IOI`S RESPONSIBILITIES | 8 |
4. UGX RESPONSIBILITIES | 9 |
5. GOVERNANCE MODEL | 9 |
6. RECORDS, AUDITS AND INSPECTIONS | 11 |
7. INTELLECTUAL PROPERTY | 10 |
8. DEFECTIVE PRODUCT | 12 |
9. INDEMNIFICATION FOR THIRD-PARTY CLAIMS | 13 |
10. LIMITATION OF LIABILITIES | 14 |
11. INSURANCE | 15 |
12. FORCE MAJEURE | 15 |
13. TERM AND TERMINATION | 15 |
14. MISCELLANEOUS | 15 |
APPENDIX I (COMMERCIAL TERMS) | 20 |
APPENDIX II (COMPLIANCE) | 23 |
APPENDIX III (PRICES AND FEES) | 25 |
APPENDIX IV (QUALITY AND TECHNICAL AGREEMENT) | 19 |
3
|
|
APPENDIX V (PRODUCT SPECIFICATION) | 22 |
APPENDIX VI (RAW MATERIAL SPECIFICATIONS) | 24 |
APPENDIX VII (CDA) | 29 |
APPENDIX VIII (THIRD PARTY LABORATORIES) | 30 |
4
AGREEMENT means this Commercial Supply AGREEMENT.
ADDITIONAL SERVICE means any service provided by IOI and agreed by both PARTIES, except all activities involved in MANUFACTURE and TECHNICAL RELEASES of PRODUCT. Additional services are subject to individual OFFERS. They are defined in Appendix I.
AFFILIATE shall mean with respect to a Party, any person, corporation, company, partnership or other entity that controls, is controlled by, or is under common control with that Party. For the purpose of this definition, “control” shall mean direct ownership of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interest in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby the entity or person controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity, or the ability to cause the direction of the management or policies of a corporation or other entity.
BUSINESS DAY shall mean each day of the week on which a Party`s offices are open for business (usually any day except Saturday, Sunday and legal holidays).
CALENDAR QUARTER shall mean the respective periods of 3 (three) consecutive CALENDAR MONTHs ending March 31st, June 30th, September 30th and December 31st.
CALENDAR MONTH shall mean any of the 12 (twelve) CALENDAR MONTHs of a CALENDAR YEAR.
CALENDAR YEAR shall mean a period of 12 (twelve) consecutive months corresponding to a calendar year commencing on the first days of January.
CONFIDENTIAL INFORMATION shall have the meaning as provided in Appendix 7.
DELIVERY DATE means the point in time set out in the confirmed FORECAST at which PRODUCT is delivered to UGX under the applicable Incoterm®.
EQUIPMENT means any equipment system to support the manufacturing and/or packaging of UGX`s PRODUCT.
EXECUTIVE LEADERSHIP shall mean for the purpose of this AGREEMENT the [***] of UGX and the [***] of IOI respectively (or whoever is on these roles ad interim).
FACILITY shall mean the IOI manufacturing site located in [***] adequate to MANUFACTURE the PRODUCT by means of validated processing equipment and manufacturing processes for the PRODUCT, trained and competent personnel with relevant knowledge and experience.
FINAL RELEASE shall mean PRODUCT quality release by UGX or UGX`s delegate as per QTA.
5
FORCE MAJEURE shall have the meaning as provided in Section 12.
FORECAST shall have the meaning as provided in Appendix I.
cGMP means those practices related to the manufacture of medicinal products for human use laid down in international guidelines and regulations such as the GMP rules of the World Health Organization, the United States Code of Federal Regulations (Title 21, Parts 210), and the European Union Guide to Good Manufacturing Practice (Eudralex Volume 4). Current Good Manufacturing Practice (cGMP) is the applicable term in the United States. For the purpose of this AGREEMENT, the terms GMP and cGMP are equivalent.
HIDDEN DEFECT means a defect of PRODUCT already present at the time of delivery but not detectable at the time of the inspection.
IMPROVEMENT means technical and business process optimization that is beneficial for the manufacturing process, product quality, financial aspect or supply of PRODUCT.
INTELLECTUAL PROPERTY RIGHTS or IP RIGHTS means rights in or arising from patents, patent applications (including all utility and design patents and patent applications), inventions, trademarks, service marks, trade names, internet domain names, rights in designs, rights in get-up and trade dress, goodwill and the right to sue for passing off or unfair competition, copyrights, (including all computer applications, programs and other software, including without limitation operating software, network software, firmware, middleware, and design software rights in computer software and databases), database rights, industrial property rights, moral rights of authors, rights to use and protect the confidentiality of, confidential information (including know-how and trade secrets), utility models, any common law rights arising from use of the foregoing, all rights of use, renewal, continuations, divisions, extensions and the like relating to the foregoing, and other intellectual property rights, in each case whether registered or unregistered and including any applications and rights to apply for the grant of any such rights and all rights and forms of protection having an equivalent or similar effect anywhere in the world.
JOINT WORKING TEAM shall mean the team selected by the STEERING COMMITTEE in accordance with the criteria set out under Section 5 of this AGREEMENT.
MANUFACTURE or MANUFACTURING means compounding, filling and processing, production, testing and packaging of material by IOI to obtain PRODUCT in accordance with the SPECIFICATION under cGMP conditions.
MATERIAL CHANGE IN CONTROL or BUSINESS MODEL shall mean any of the following: (i) the sale or disposition of all or substantially all of the assets of a Party to a THIRD-PARTY, (ii) the acquisition by a THIRD-PARTY, of more than 50% of a Party’s outstanding shares of voting capital stock (e.g. capital stock entitled to vote generally for the election of directors), or (iii) the merger or consolidation of a Party with or into another corporation. References in this definition to a THIRD-PARTY shall exclude AFFILIATES.
OFFER shall mean IOI`s quotation containing the details of the proposed ADDITIONAL SERVICES subject to UGX`s binding order.
6
ON-TIME DELIVERY shall mean PRODUCT released by both Parties and ready to be picked up under the applicable INCOTERM® in accordance with the applicable FORECAST.
PRODUCT shall mean Triheptanoin Ultrapure, a Drug Substance as specified in Appendix 5 to this agreement and solely used in pharmaceutical applications.
PURCHASE ORDER shall mean a firm order placed and issued by UGX with a corresponding PURCHASE ORDER number to IOI reflecting forecasted DELIVERY DATE within the binding forecast period.
QUALITY AND TECHNICAL AGREEMENT (QTA) shall be drafted substantially in the same form as Appendix IV.
QUARANTINE SHIPMENT means a shipment of PRODUCT before the quality release by IOI in accordance with the QTA.
SERVICES means all activities related to MANUFACTURING of PRODUCT as described in this AGREEMENT and includes all activities involved in MANUFACTURING of PRODUCT and according to the quality standards set forth in the QTA including costs of in-process control, quality assurance, Continuous Process Verification, Product Quality Review, quality control and release, storage of raw materials, sharing raw analytical/process data, providing relevant documentation and THIRD-PARTY MATERIAL procured by IOI, disposal of waste.
SPECIFICATION means the PRODUCT specification [***], as amended from time to time by mutual agreement between the Parties, and as defined in IOI’s quality system attached as Appendix V to this AGREEMENT and THIRD PARTY MATERIAL specifications for [***] as defined in Appendix VI.
STEERING COMMITTEE shall mean the committee selected by the Parties in accordance with the criteria set out under Section 5 of this AGREEMENT.
TECHNICAL RELEASE shall mean the release of PRODUCT by IOI and UGX in accordance with the QTA.
THIRD-PARTY means any person other than UGX, IOI and their respective AFFILIATES.
THIRD-PARTY MATERIAL means all material procured by IOI for the MANUFACTURING of the PRODUCT.
7
shall be discussed and agreed in good faith by the PARTIES. It is understood by the PARTIES that: (i) [***] shall be [***] by UGX to [***], provided IOI’s [***]are [***] to [***]; and (ii) in no event [***].
UGX shall purchase the PRODUCT exclusively from IOI.
Appendix I | Commercial Terms |
Appendix II | Compliance |
Appendix III | Prices and Fees |
Appendix IV | QUALITY AND TECHNICAL AGREEMENT (QTA) |
Appendix V | PRODUCT SPECIFICATION |
Appndix VI | RAW MATERIAL SPECIFICATIONS |
Appendix VII | CDA |
Appendix VIII | THIRD-PARTY laboratories |
8
9
10
the RECORDS, to the extent they are [***] and do not [***]. In such a circumstance, each Party will [***] on the RECORDS containing [***].
11
inform UGX of any proposed written response by IOI to any such REGULATORY AUTHORITY as far as it relates to MANUFACTURE of PRODUCT and (iii) provide UGX with copies of all documentation as far as it relates to MANUFACTURE of PRODUCT within the terms provided in the QTA. UGX will have the opportunity to review and provide input to the response to IOI as promptly as practicable and in accordance with the QTA.
12
13
14
Neither Party is liable to the other Party for failure or delay in performing its obligations to the extent and for so long as such failure or delay results from causes that were not reasonably foreseeable at the time of signing the AGREEMENT, are beyond the reasonable control of such Party, including but not limited to fires, earthquakes, floods, embargoes, wars, acts of war (whether war is declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts or other labor disturbances, acts of God or other acts, omissions, pandemics or delays in acting by any administrative authority (each, a “Force Majeure”), and the effects of which cannot be avoided or overcome by such Party. In the event of the occurrence of Force Majeure, the Party affected must notify the other Party promptly of the Force Majeure event and its anticipated duration, and each Party will use its [***] to mitigate the adverse consequences.
15
16
of such Party to which this AGREEMENT relates, whether in a merger, consolidation, reorganization, acquisition, sale or otherwise. Notwithstanding anything to the contrary contained herein, in the event of an assignment to an AFFILIATE pursuant to this Section 14.4, the assigning Party consents, acknowledges, covenants and guarantees that it shall remain jointly and severally liable, along with the assignee, to the non-assigning Party for all the obligations contained herein. This AGREEMENT shall be binding on the successors and permitted assigns of the assigning Party, and the name of a Party appearing herein shall be deemed to include the name(s) of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this AGREEMENT. Any assignment or attempted assignment by either Party in violation of this Section 14.4, shall be null and void and of no legal effect.
17
IN WITNESS WHEREOF, this AGREEMENT is executed as of the AGREEMENT Effective Date on behalf of the parties by their duly authorized representatives.
Ultragenyx Pharmaceutical Inc. |
| IOI Oleo GmbH |
|
|
|
By: /s/ Siegfried Hackl |
| /s/ Rene Fresen |
Siegfried Hackl |
| Rene Fresen |
Printed Name |
| Printed Name |
SVP Product Supply |
| Chief Marketing Officer |
Title |
| Title |
31-Mai-2023 |
| 15-June-2023 |
Date |
| Date |
Ultragenyx Pharmaceutical Inc. |
| IOI Oleo GmbH |
|
|
|
By: /s/ Dennis Huang |
| /s/ Mark Tuchen |
Dennis Huang |
| Mark Tuchen |
Printed Name |
| Printed Name |
Chief Technical Ops Officer |
| Chief Financial Officer |
Title |
| Title |
06-June-2023 |
| 19-June-2023 |
Date |
| Date |
18
Appendix I
Commercial Terms
19
UGX assumes all risks, responsibilities and costs associated with a QUARANTINED SHIPMENT, unless the reason for the non-compliance of the PRODUCT is caused by IOI.
20
All costs concerning [***]. In such a case, [***] of receipt of invoice and documentation of such amounts. As soon as possible, UGX will inform IOI about any administrative requirement applicable to IOI in force in any country where UGX is marketing commercial PRODUCT.
Upon request by UGX, IOI will perform ADDITIONAL SERVICES, as long as [***]. If [***], the [***]. These additional services might be but are not limited to:
IOI will [***] ADDITIONAL SERVICE to UGX by written OFFER referring to this AGREEMENT. Upon agreement between the Parties about such OFFER, IOI will provide the ADDITIONAL SERVICES as described in the respective OFFER.
21
Appendix II
Compliance
To the extent applicable, IOI shall inform itself of and comply with applicable anti-corruption legislation, including legislation enacted pursuant to the 1997 OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions (the “OECD Convention”), and the Foreign Corrupt Practices Act of 1977, as amended (15 U.S.C. §§78dd-1, et. seq.) (the “FCPA”). If applicable to the MANUFACTURE, SERVICES and ADDITIONAL SERVICES provided hereunder, IOI declares that it understands the provisions of the OECD Convention and the FCPA and agrees not to breach any such legislation or to cause UGX to breach any such legislation. IOI further agrees that, if applicable, it will educate its personnel and contractors engaged in MANUFACTURE, providing SERVICES and ADDITIONAL SERVICES to UGX hereunder in relation to such legislation. IOI agrees it has not, and covenants that it will not, in connection with the conduct of its business activities, promise, authorize, ratify or offer to make, or take any act in furtherance of any payment, contribution, gift, reimbursement or other transfer of anything of value, or any solicitation, directly or indirectly: (i) to any individual including government officials; or (ii) to an intermediary for payment to any individual including government officials; or (iii) to any political party for the purpose or effect of public or commercial bribery, acceptance of or acquiescence in extortion, kickbacks or other unlawful, illegal or improper means. IOI has not, nor to the knowledge of IOI, have any of the IOI’s directors, officers, agents, stockholders or employees acting on behalf of IOI made any false or artificial entries on any of its books or records for any reason. IOI also represents, but only to the best of their knowledge, that, except as disclosed to UGX in writing, it will collaborate with UGX to the best of its ability to represent on a CALENDAR YEAR basis whether neither it nor any of its officers, directors, shareholders or beneficial owners is (i) an officer or employee of a government or any department, agency or instrumentality thereof (including a government-owned or controlled commercial enterprise), (ii) an officer or employee of a public international organization, (iii) a person who acts in any official capacity for or on behalf of any government or department, agency, instrumentality or public international organization, or (iv) a political party official or candidate for political office (each, a “GOVERNMENT OFFICIAL”). IOI will immediately disclose to UGX any current or future affiliation or association between itself and any GOVERNMENT OFFICIAL as long as it becomes aware of that.
Each Party shall collect, use, retain and disclose any personal data provided or belonging to the other Party in a fair, transparent and secure way in accordance to any Applicable Law. Each Party shall (i) use the other Party personal data only under such Party’s instructions in writing and not use it for any purpose other than the performance of this AGREEMENT; (ii) ensure that effective organisational and security measures (both technological and physical) are applied to all personal data of the other Party to ensure the privacy of affected individuals; (iii) appoint a representative who is accountable for data privacy and security; (iv) ensure information is protected and kept secure at all times from unauthorised use, damage, disclosure, diversion or removal, whether through accident, improper act or breach of trust; (v) ensure employees who will have access to the other Party’s personal data are appropriately trained in their responsibilities around processing and protecting the personal data.
22
The documentation of any and all business transactions must be complete, transparent, and in compliance with the statutory provisions as well as with any provisions and processes.
IOI respects the dignity of every human being and is committed to compliance with and the protection of human rights.
IOI does not tolerate any kind of child labor as well as any exploitation of children and adolescents. The minimum age for admission to employment must not be under the age for the fulfillment of compulsory education and in no case under 15 (fifteen) years.
IOI disapproves of any form of forced labor.
IOI creates a working atmosphere characterized by respectful cooperation and to strictly oppose any kind of discrimination on grounds of race or ethnic origin, gender, religion or philosophy of life, disability, age, or sexual identity.
IOI undertakes to operate in a safe and responsible manner with respect to the environment and health of employees, customers and the communities where they operate.
IOI will not compromise environmental, health or safety values for other interests; value human life above all else and manage risks accordingly.
IOI pursues and continually improves an EHS system and processes to achieve an EHS incident-free environment.
IOI agrees to always comply with applicable laws and set standards for suppliers.
23
Appendix III Prices and Fees
[***]
24
Appendix IV
QUALITY AND TECHNICAL AGREEMENT (QTA)
The current version of the QTA executed separately by the Parties.
25
Appendix V
PRODUCT SPECIFICATION
The current version of [***]
26
Appendix VI
RAW MATERIAL SPECIFICATIONS
[***]
27
Appendix VII
[***]
28
Appendix VIII
THIRD PARTY laboratories
THIRD-PARTY labs are, but are not limited to:
[***]
29