OPTION AND LICENSE AGREEMENT
EXECUTION VERSION
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and is the type that the registrant treats as private or confidential.
between
and
TAKEDA PHARMACEUTICALS, USA, INC.
Dated as of May 11, 2024
TABLE OF CONTENTS
i
| | |
ii
| | |
iii
| | |
Schedules
Schedule 1.18Amyloid Precursor Protein Sequences
Schedule 1.39CMC Development Plan
Schedule 1.40CMC Readiness Elements
Schedule 1.58Data Package
Schedule 1.68Development Plan
Schedule 1.138Other Licensed Patents
Schedule 1.148Phase 3 Process Elements
Schedule 1.157Product Patents
[***][***]
Schedule 3.3.3Clean Team Agreement
Schedule 3.4Permitted Subcontractors
Schedule 3.5.1FDA Question
Schedule 6.1.2 Pre-Option Effective Date Materials
Schedule 6.1.4Supply Terms
Schedule 10.7Press Release
Schedule 10.10Standard Contractual Clauses
Schedule 11.2.2Existing Agreements
Schedule 11.2.8Existing Inventions Funded by Governmental Authority
Schedule 11.2.14Existing Third Party Obligations of ACI
iv
This Option and License Agreement (the “Agreement”) is made and entered into as of May 11, 2024 (the “Effective Date”) by and between AC Immune SA, a Swiss company (“ACI”) and Takeda Pharmaceuticals, USA, Inc., a corporation organized under the laws of the State of Delaware (“Takeda”). ACI and Takeda are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
Recitals
WHEREAS, ACI owns and controls certain intellectual property rights with respect to the Licensed Compounds (as defined herein) and Licensed Products (as defined herein) in the Territory (as defined herein); and
WHEREAS, ACI wishes to grant to Takeda, and Xxxxxx wishes to take, an exclusive option to obtain an exclusive license under such intellectual property rights to develop, manufacture and commercialize Licensed Compounds and Licensed Products in the Territory, in each case, in accordance with the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
1
2
3
4
5
6
7
8
9
10
11
12
Notwithstanding the foregoing, amounts received or invoiced by Takeda or its Affiliates or its or their Sublicensees for the sale of such Licensed Product among Takeda or its Affiliates or its or their Sublicensees for resale will not be included in the computation of Net Sales hereunder; [***] For clarity, a particular deduction may only be accounted for once in the calculation of Net Sales. [***]
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 8.9.
[***]
[***]
[***]
[***]
[***]
13
14
15
16
17
18
19
20
21
provided that, in each case ((i) and (ii)), neither Party shall exercise its final decision-making authority in a manner that is reasonably likely to cause the other Party to violate Applicable Law.
22
In participating in the JDT, and in exercising their rights under this Article 2, all representatives of both Parties shall consider reasonably and in good faith all input received from the other Party.
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
POST-OPTION DEVELOPMENT, REGULATORY AND COMMERCIALIZATION ACTIVITIES
38
39
40
41
42
[***]
For clarity, Development Milestone Event No. 2 shall not apply, and Development Milestone Payment No. 2 shall not be due, if the Option Effective Date occurs and Takeda assumes control of the Phase 1b/2 Trial in accordance with Section 7.2.2 prior to achievement of Development Milestone Event No. 2.
Each Development Milestone Payment in this Section 8.3 shall be payable only upon the first achievement of the corresponding Development Milestone Event and no amounts shall be due for subsequent or repeated achievements of such Development Milestone Event, whether for the same or a different Licensed Product. If Development Milestone Event No. 4 is achieved and Development Milestone Event No. 3 has not been previously paid to ACI, then such unpaid Development Milestone Event No. 3 will be deemed achieved and the corresponding Development Milestone Payment shall be payable in addition to and concurrently with Development Milestone Event No. 4. If Development Milestone Event No. 5, Development Milestone Event No. 6 or Development Milestone Event No. 7 is achieved and Development Milestone Event No. 3 or Development Milestone Event No. 4 has not been previously paid to ACI, then such unpaid Development Milestone Event No. 3 or Development Milestone Event No. 4, as applicable, will be deemed achieved and the corresponding Development Milestone Payment shall be payable in addition to and concurrently with Development Milestone Event No. 5, Development Milestone Event No. 6 or Development Milestone Event No. 7, as applicable. The maximum aggregate [***] for the full amount of the corresponding Development Milestone Payment, which amount shall be payable [***] after the receipt by Takeda of a valid invoice.
Each Commercial Milestone Payment in this Section 8.4 shall be payable only upon the first achievement of the corresponding Commercial Milestone Event and no amounts shall be due for subsequent or repeated achievements of such Commercial Milestone Event in any given or subsequent Fiscal Year, whether for the same or a different Licensed Product. The maximum aggregate amount payable by Takeda pursuant to this Section 8.4 is [***]
In the event that any of the Commercial Milestone Events set forth in this Section 8.4 occurs and any of the preceding Commercial Milestone Events set forth in this Section 8.4 have not occurred, then each such skipped Commercial Milestone Payment shall become due and payable concurrently with the Commercial Milestone Payment for the Commercial Milestone Event with respect to which payment is due.
Following the end of a Fiscal Year in which a given Commercial Milestone Event was achieved, Takeda will send ACI written notice that such Commercial Milestone Event is achieved under this
43
Section 8.4, within [***] following the end of such Fiscal Year. Following receipt of such notice, ACI shall submit an invoice promptly, but no more than [***] after receipt of such notice, to Takeda for the full amount of the corresponding Commercial Milestone Payment, which amount shall be payable [***] after the receipt of a valid invoice.
[***]
44
45
For the purposes of this Section 8.10, “ACI” and “Takeda” include any assignees under Section 14.3 of such respective Party.
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
Specific aspects or details of Confidential Information shall not become exempt from the obligations set forth in this Article 10 merely because the Confidential Information is embraced by more general information included in the exceptions set forth in this Section 10.2. Further, any combination of Confidential Information shall not become exempt from the obligations herein merely because individual elements of such Confidential Information are included in the exceptions set forth in this Section 10.2, unless the combination and its principles fall within one or more of such exceptions.
61
62
63
64
65
66
67
68
69
provided that, in each case, any update in a Data Package Updated Disclosure Schedule or a Bring Down Updated Disclosure Schedule (as applicable) shall not be deemed to amend or supplement the Initial Disclosure Schedule as it exists as of the Effective Date or Data Package Updated Disclosure Schedule as it exists as of the Data Package Bring Down Date or prior to such amendment for any purposes hereunder, including for the purposes of the indemnification provisions under Section 12.2 (and therefore shall not cure any prior failure to disclose). For all representations and warranties for which ACI does not provide an updated schedule pursuant to clause (a) of Section 11.3.1 or clause (x) of Section 11.3.2 (as applicable), or if ACI fails to provide any updated schedules or such statement in clause (b) of Section 11.3.1 or clause (y) Section 11.3.2 (as applicable) within the time periods set forth in each such Section, ACI shall be deemed to have made the representations and warranties in Section 11.2 to Takeda as of the Data Package Bring Down Date and the Option Effective Date (as applicable) without additional qualification. For the avoidance of doubt, an exception made by ACI in a Data Package Updated Disclosure Schedule or a Bring Down Updated Disclosure Schedule (as applicable) shall not cure a deficiency in the Initial Disclosure Schedule or Data Package Updated Disclosure Schedule (as applicable). ACI acknowledges and agrees that any disclosure made in a Data Package Updated Disclosure Schedule or a Bring Down Updated Disclosure Schedule (as applicable) cannot cure a breach of any covenant or obligation of ACI hereunder, including Section 11.5, and no disclosure made in a Data Package Updated Disclosure Schedule or a Bring Down Updated Disclosure Schedule (as applicable) that relates to or reflects any such breach by ACI shall be deemed to qualify any representation or warranty hereunder.
70
71
72
73
74
All insurances maintained by a Party as required hereunder will be provided by a company having a financial rating of not less than A-Viii in the most current edition of Best’s Key Rating Guide. Upon request by a Party, each Party shall provide to the requesting Party evidence of its insurance coverage. Each Party will provide a minimum of [***] notice of any cancellation, with no replacement policy, to the other Party. The insurance policies shall be under an occurrence form, but if only a claims-made form is available to a Party, then such Party shall continue to maintain such insurance after the expiration or termination of this Agreement in its entirety for a period of [***] the foregoing, Takeda may self-insure in whole or in part the insurance requirements described above.
75
It is understood that termination pursuant to this Section 13.2.1 shall be a remedy of last resort and may be invoked only in the case where the breach cannot be reasonably remedied by the payment of money damages.
76
77
78
79
80
If this Agreement is terminated with respect to one (1) or more Licensed Products or one (1) or more countries but not in its entirety, then following such termination, the foregoing provisions of this Agreement set forth in Section 13.8.1 shall remain in effect with respect to the terminated Licensed Product(s) in the terminated country(ies) (to the extent they would survive and apply in the event this Agreement is terminated in its entirety or as otherwise necessary for any of Takeda and its Affiliates and its and their Sublicensees to exercise their rights for the other Licensed Products or other countries) and all provisions not surviving in accordance with the foregoing shall terminate upon termination of this Agreement and be of no further force and effect with respect to the terminated Licensed Product(s) for the terminated country(ies) (and for the avoidance of doubt all provisions of this Agreement shall remain in effect with respect to all non-terminated Licensed Products and non-terminated countries).
81
provided that, in each case in which this Agreement is assigned in its entirety to an Affiliate or Third Party, the assigning Party shall provide written notice to the other Party within [***] such assignment. Any permitted successor of a Party or any permitted assignee of all of a Party’s rights under this Agreement that has also assumed all of such Party’s obligations hereunder in writing shall, upon any such succession or assignment and assumption, be deemed to be a party to this
82
Agreement as though named herein in substitution for the assigning Party, whereupon the assigning Party shall cease to be a party to this Agreement and shall cease to have any rights or obligations under this Agreement; [***]
All validly assigned rights of a Party shall inure to the benefit of and be enforceable by, and all validly delegated obligations of such Party shall be binding on and be enforceable against, the permitted successors and assigns of such Party. Any attempted assignment or delegation in violation of this Section 14.3 shall be void and of no effect ab initio.
83
84
If to Takeda, to:
Takeda Pharmaceuticals, USA, Inc.
00 Xxxxxx Xxxxxx
Lexington, MA 02421
Attention: Regional General Counsel
[***]
with a copy (which shall not constitute notice) to:
Takeda Pharmaceutical Company Limited
1-1 Doshomachi 4-chomeChuo-ku, Osaka
540-8645, Japan
Attention: Head of Center for External Innovation
[***]
If to ACI, to:
EPFL Innovation Park, Building B
CH-1015 Lausanne, Switzerland
[***]
[***]
with a copy (which shall not constitute notice) to:
EPFL Innovation Park, Building B
CH-1015 Lausanne, Switzerland
Attention: General Counsel, Legal Department
85
86
[SIGNATURE PAGE FOLLOWS.]
87
THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the Effective Date.
TAKEDA PHARMACEUTICALS, USA, INC. | |
By: Name: Title: | By: Name: Title: |
|
By: Name: Title: |
[Signature Page to Option and License Agreement]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
| | |
[***]
| | |
[***]
| | |
[***]
| | |
[***]
| | |
[***]
![Graphic](https://www.sec.gov/Archives/edgar/data/1651625/000155837024010944/aciu-20240630xex10d1001.jpg)
![Graphic](https://www.sec.gov/Archives/edgar/data/1651625/000155837024010944/aciu-20240630xex10d1002.jpg)
Schedule 10.7
Press Release
![Graphic](https://www.sec.gov/Archives/edgar/data/1651625/000155837024010944/aciu-20240630xex10d1003.jpg)
News Release
AC Immune and Takeda Sign Exclusive Option and License Agreement for Active Immunotherapy Targeting Amyloid Beta for Alzheimer’s Disease
OSAKA, Japan, CAMBRIDGE, Massachusetts, and LAUSANNE, Switzerland, May 13, 2024 – Takeda (TSE:4502/NYSE:TAK) and AC Immune SA (NASDAQ: ACIU) today announced an exclusive, worldwide option and license agreement for AC Immune’s active immunotherapies targeting toxic forms of amyloid beta (Abeta), including ACI-24.060 for the treatment of Alzheimer’s disease.
ACI-24.060 is an anti-Abeta active immunotherapy candidate designed to induce a robust antibody response against the toxic forms of Abeta believed to drive plaque formation and Alzheimer’s disease progression. By inducing plaque clearance and efficiently inhibiting plaque formation in the brain, ACI-24.060 has the potential to delay or slow Alzheimer’s disease progression. ACI-24.060 is being investigated in the ongoing XXXXX randomized, double-blind, placebo-controlled Phase 1b/2 trial to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of the investigational immunotherapy in subjects with prodromal Alzheimer’s disease and in adults with Down syndrome.
“As pioneers in the field of active immunotherapy, we are developing an innovative approach that could change the treatment paradigm for Alzheimer’s disease and address the multifaceted burden that patients and the broader community face. We believe the maximum impact of ACI-24.060 can best be realized by partnering with Xxxxxx at this critical juncture in its development, which will help us move rapidly into Phase 3,” said Xx. Xxxxxx Xxxxxxx, CEO of AC Immune. “This agreement allows us to leverage the developmental expertise, strategic vision and financial capacity of an accomplished organization that has demonstrated its ability to execute the type of comprehensive global program required for Phase 3 trials in Alzheimer’s disease while allowing us to focus on completing Phase 1b/2 development and accelerating our efforts to replicate this success with enhanced funding for our early-stage pipeline.”
AC Immune will be responsible for completing the XXXXX trial. Following option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialization.
“At Takeda, we are committed to tackling some of society’s most debilitating illnesses, including Alzheimer’s disease. We are excited to partner with AC Immune on this ground-breaking treatment
| | |
approach, which leverages novel technology with the potential to offer patients a treatment with differentiated efficacy, safety and ease of administration,” said Xxxxx Xxxxxx, X.Xx., B.M., X.Xx, MRCP, Head, Neuroscience Therapeutic Area Unit and Head, Global Development at Takeda. “Combining AC Immune’s deep experience with active immunotherapy approaches with Xxxxxx’s expertise in neuroscience drug development and commercialization, we have an incredible opportunity to deliver real impact to the Alzheimer’s community.”
Under the terms of the agreement, AC Immune will receive an upfront payment of $100 million and be eligible to receive an option exercise fee and additional potential development, commercial and sales-based milestones of up to approximately $2.1 billion if all related milestones are achieved over the course of the agreement. Upon commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales.
Further details related to the agreement are available in the Form 6-K filed today by AC Immune with the U.S. Securities and Exchange Commission (SEC). The effectiveness of Takeda’s license following option exercise is subject to the termination or expiration of any applicable waiting periods under the Xxxx-Xxxxx-Xxxxxx Act.
Conference Call and Webcast Information
AC Immune management will host a conference call and webcast today at 8:30 a.m. ET to provide a brief overview of the agreement.
Monday, May 13 at 8:30 a.m. ET
Participants wishing to ask questions or to join the event via phone may call the following numbers 10 – 15 minutes before conference start:
United States | x0 (0) 000 000 00 00 |
Switzerland / Europe | x00 (0) 00 000 00 00 |
United Kingdom | x00 (0) 000 000 00 00 |
Other international numbers available | HERE |
Webcast:
xxxxx://xxxxx.xxxxxxxxxx.xxx/xxxxxxxxxx/xxxxxxx.xxxx?xxxxxxxxxxXxxXXxxx
Please note that there is a function to type in your questions via webcast.
| | |
A live and archived webcast will also be accessible in the Investors section of the Company's website at xxxxx://xxx.xxxxxxxx.xxx/.
About ACI-24.060
This product is AC Immune’s anti-Abeta active immunotherapy candidate. The XXXXX randomized, double-blind, placebo-controlled Phase 1b/2 trial of ACI-24.060 for treatment of Alzheimer’s disease (AD) continues fully blinded (NCT05462106). Enrolled patients are required to have a diagnosis of prodromal AD: MCI due to AD according to the National Institute on Aging Alzheimer’s Association (NIA-AA) criteria, and a PET scan at screening must be consistent with the presence of amyloid pathology. Patients will be randomized to one of several doses of ACI-24.060 or placebo. Following multiple data safety monitoring board (DSMB) reviews, no safety concerns have been raised to date, consistent with previous results. Immunogenicity of the immunotherapy is very encouraging with clear evidence of anti-Abeta antibody responses against toxic Abeta species observed in the blinded data. The six-month Abeta positron emission tomography (PET) imaging results are expected in Q2 2024, and the 12-month Abeta PET data are expected in Q4 2024.
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit xxx.xxxxxx.xxx.
About AC Immune SA
AC Immune SA is a clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer’s disease, Xxxxxxxxx’x disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features sixteen therapeutic and diagnostic programs, five of which are currently in Phase 2 clinical trials and one of which is in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5 billion in potential milestone payments.
SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO and RU.
The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.
AC Immune Investor and Media Contacts:
SVP, Investor Relations & Corporate
Communications
Xxxx Xxxxxxxx, Ph.D., MBA AC Immune
Phone: x00 00 000 00 00
| | |
xxxx.xxxxxxxx@xxxxxxxx.xxx
U.S. Investors
Xxxxx Xxxxx, Ph.D.
LifeSci Advisors
Phone: x0 000 000 0000
xxxxxx@xxxxxxxxxxxxxxx.xxx
U.S. and International Media
Xxxxx Xxxxxx, Cohesion Bureau
Phone: x00 00 000 0000
xxxxx.xxxxxx@xxxxxxxxxxxxxx.xxx
Takeda Media Contacts:
Japanese Media
Xxxx Xxxxxxxx
xxxx.xxxxxxxx@xxxxxx.xxx
x00 00-0000-0000
U.S. and International Media
Xxxxx Xxxxx
xxxxx.xxxxx@xxxxxx.xxx
x0 000-000-0000
Takeda Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
Takeda Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Xxxxxx’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation,
| | |
forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Xxxxxx’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: xxxxx://xxx.xxxxxx.xxx/xxxxxxxxx/xxx-xxxxxxx-xxx-xxxxxxxx-xxxxxxx/ or at xxx.xxx.xxx. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
AC Immune Forward Looking Statements
This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward- looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.
###
| | |
Schedule 10.10
Standard Contractual Clauses
Module 1: Controller to Controller Transfers
Takeda has entered into the Option and License Agreement (“Agreement”) with AC Immune SA (“Company”), under which the Parties will share Personal Data for the purpose of effectuating the rights granted within the Agreement.
The Parties agree that if a Party will store, have access to or otherwise process Personal Data of individuals residing in the European Economic Area (“EEA”), United Kingdom (“UK”) or Switzerland from any location other than (i) the “Safe Cluster” which comprises: countries in the EEA or adequate countries (Andorra, Argentina, Canada (commercial organisations), Faroe Islands, Guernsey, Israel, Isle of Man, Japan, Jersey, New Zealand, Republic of Korea, Switzerland, the UK, Uruguay, or as otherwise provided by the European Commission (at xxxxx://xx.xxxxxx.xx/xxxx/xxx/xxx-xxxxx/xxxx-xxxxxxxxxx/xxxxxxxxxxxxx-xxxxxxxxx-xxxx-xxxxxxxxxx/xxxxxxxx-xxxxxxxxx_xx)) and (ii) specifically for transfers from the UK or Switzerland, any additional countries identified as adequate by the UK or Swiss authorities, then the Parties will comply with the terms set forth in this Module 1 of the European Commission Standard Contractual Clauses (“SCCs”) under which each Party acts as a controller of the EEA, UK or Swiss Personal Data. In the event of a conflict between the SCCs and the Agreement, the SCCs shall prevail.
UK and Swiss transfers. For any storage, access to or processing of Personal Data of individuals residing in the UK or Switzerland, the following amendments to the SCCs shall apply:
| | |
STANDARD CONTRACTUAL CLAUSES
Purpose and scope
(a) | The purpose of these standard contractual clauses is to ensure compliance with the requirements of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) for the transfer of personal data to a third country. |
(b) | The Parties: |
(i) | the natural or legal person(s), public authority/ies, agency/ies or other body/ies (hereinafter “entity/ies”) transferring the personal data, as listed in Annex I.A. (hereinafter each “data exporter”), and |
(ii) | the entity/ies in a third country receiving the personal data from the data exporter, directly or indirectly via another entity also Party to these Clauses, as listed in Annex I.A. (hereinafter each “data importer”) |
have agreed to these standard contractual clauses (hereinafter: “Clauses”).
(c) | These Clauses apply with respect to the transfer of personal data as specified in Annex I.B. |
(d) | The Appendix to these Clauses containing the Annexes referred to therein forms an integral part of these Clauses. |
Effect and invariability of the Clauses
(a) | These Clauses set out appropriate safeguards, including enforceable data subject rights and effective legal remedies, pursuant to Article 46(1) and Article 46 (2)(c) of Regulation (EU) 2016/679 and, with respect to data transfers from controllers to processors and/or processors to processors, standard contractual clauses pursuant to Article 28(7) of Regulation (EU) 2016/679, provided they are not modified, except to select the appropriate Module(s) or to add or update information in the Appendix. This does not prevent the Parties from including the standard contractual clauses laid down in these Clauses in a wider contract and/or to add other clauses or additional safeguards, provided that they do not contradict, directly or indirectly, these Clauses or prejudice the fundamental rights or freedoms of data subjects. |
(b) | These Clauses are without prejudice to obligations to which the data exporter is subject by virtue of Regulation (EU) 2016/679. |
| | |
Third-party beneficiaries
(a) | Data subjects may invoke and enforce these Clauses, as third-party beneficiaries, against the data exporter and/or data importer, with the following exceptions: |
(i) | Clause 1, Xxxxxx 2, Xxxxxx 3, Xxxxxx 6, Xxxxxx 7; |
(ii) | Clause 8 - Clause 8.5(e) and Clause 8.9(b); |
(iii) | Clause 12 - Clause 12(a) and (d); |
(iv) | Clause 13; |
(v) | Clause 15.1(c), (d) and (e); |
(vi) | Clause 16(e); |
(vii) | Clause 18 - Clause 18(a) and (b). |
(b) | Paragraph (a) is without prejudice to rights of data subjects under Regulation (EU) 2016/679. |
Interpretation
(a) | Where these Clauses use terms that are defined in Regulation (EU) 2016/679, those terms shall have the same meaning as in that Regulation. |
(b) | These Clauses shall be read and interpreted in the light of the provisions of Regulation (EU) 2016/679. |
(c) | These Clauses shall not be interpreted in a way that conflicts with rights and obligations provided for in Regulation (EU) 2016/679. |
Hierarchy
In the event of a contradiction between these Clauses and the provisions of related agreements between the Parties, existing at the time these Clauses are agreed or entered into thereafter, these Clauses shall prevail.
| | |
Description of the transfer(s)
The details of the transfer(s), and in particular the categories of personal data that are transferred and the purpose(s) for which they are transferred, are specified in Annex I.B.
Docking clause
(a) | An entity that is not a Party to these Clauses may, with the agreement of the Parties, accede to these Clauses at any time, either as a data exporter or as a data importer, by completing the Appendix and signing Annex I.A. |
(b) | Once it has completed the Appendix and signed Annex I.A, the acceding entity shall become a Party to these Clauses and have the rights and obligations of a data exporter or data importer in accordance with its designation in Annex I.A. |
(c) | The acceding entity shall have no rights or obligations arising under these Clauses from the period prior to becoming a Party. |
Data protection safeguards
The data exporter warrants that it has used reasonable efforts to determine that the data importer is able, through the implementation of appropriate technical and organisational measures, to satisfy its obligations under these Clauses.
8.1 | Purpose limitation |
1. | The data importer shall process the personal data only for the specific purpose(s) of the transfer, as set out in Annex I. B. It may only process the personal data for another purpose: |
(i) | where it has obtained the data subject’s prior consent; |
(ii) | where necessary for the establishment, exercise or defence of legal claims in the context of specific administrative, regulatory or judicial proceedings; or |
(iii) | where necessary in order to protect the vital interests of the data subject or of another natural person. |
| | |
8.2 | Transparency |
(a) | In order to enable data subjects to effectively exercise their rights pursuant to Clause 10, the data importer shall inform them, either directly or through the data exporter: |
(i) | of its identity and contact details; |
(ii) | of the categories of personal data processed; |
(iii) | of the right to obtain a copy of these Clauses; |
(iv) | where it intends to onward transfer the personal data to any third party/ies, of the recipient or categories of recipients (as appropriate with a view to providing meaningful information), the purpose of such onward transfer and the ground therefore pursuant to Clause 8.7. |
(b) | Paragraph (a) shall not apply where the data subject already has the information, including when such information has already been provided by the data exporter, or providing the information proves impossible or would involve a disproportionate effort for the data importer. In the latter case, the data importer shall, to the extent possible, make the information publicly available. |
(c) | On request, the Parties shall make a copy of these Clauses, including the Appendix as completed by them, available to the data subject free of charge. To the extent necessary to protect business secrets or other confidential information, including personal data, the Parties may redact part of the text of the Appendix prior to sharing a copy, but shall provide a meaningful summary where the data subject would otherwise not be able to understand its content or exercise his/her rights. On request, the Parties shall provide the data subject with the reasons for the redactions, to the extent possible without revealing the redacted information. |
(d) | Paragraphs (a) to (c) are without prejudice to the obligations of the data exporter under Articles 13 and 14 of Regulation (EU) 2016/679. |
8.3 | Accuracy and data minimisation |
(a) | Each Party shall ensure that the personal data is accurate and, where necessary, kept up to date. The data importer shall take every reasonable step to ensure that personal data that |
| | |
is inaccurate, having regard to the purpose(s) of processing, is erased or rectified without delay. |
(b) | If one of the Parties becomes aware that the personal data it has transferred or received is inaccurate, or has become outdated, it shall inform the other Party without undue delay. |
(c) | The data importer shall ensure that the personal data is adequate, relevant and limited to what is necessary in relation to the purpose(s) of processing. |
8.4 | Storage limitation |
The data importer shall retain the personal data for no longer than necessary for the purpose(s) for which it is processed. It shall put in place appropriate technical or organisational measures to ensure compliance with this obligation, including erasure or anonymisation of the data and all back-ups at the end of the retention period.
8.5 | Security of processing |
(a) | The data importer and, during transmission, also the data exporter shall implement appropriate technical and organisational measures to ensure the security of the personal data, including protection against a breach of security leading to accidental or unlawful destruction, loss, alteration, unauthorised disclosure or access (hereinafter “personal data breach”). In assessing the appropriate level of security, they shall take due account of the state of the art, the costs of implementation, the nature, scope, context and purpose(s) of processing and the risks involved in the processing for the data subject. The Parties shall in particular consider having recourse to encryption or pseudonymisation, including during transmission, where the purpose of processing can be fulfilled in that manner. |
(b) | The Parties have agreed on the technical and organisational measures set out in Xxxxx XX. The data importer shall carry out regular checks to ensure that these measures continue to provide an appropriate level of security. |
(c) | The data importer shall ensure that persons authorised to process the personal data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality. |
(d) | In the event of a personal data breach concerning personal data processed by the data importer under these Clauses, the data importer shall take appropriate measures to address the personal data breach, including measures to mitigate its possible adverse effects. |
(e) | In case of a personal data breach that is likely to result in a risk to the rights and freedoms of natural persons, the data importer shall without undue delay notify both the data exporter and the competent supervisory authority pursuant to Clause 13. Such notification shall contain i) a description of the nature of the breach (including, where possible, categories and approximate number of data subjects and personal data records concerned), ii) its likely consequences, iii) the measures taken or proposed to address the breach, and iv) the details of a contact point from whom more information can be |
| | |
obtained. To the extent it is not possible for the data importer to provide all the information at the same time, it may do so in phases without undue further delay. |
(f) | In case of a personal data breach that is likely to result in a high risk to the rights and freedoms of natural persons, the data importer shall also notify without undue delay the data subjects concerned of the personal data breach and its nature, if necessary in cooperation with the data exporter, together with the information referred to in paragraph (e), points ii) to iv), unless the data importer has implemented measures to significantly reduce the risk to the rights or freedoms of natural persons, or notification would involve disproportionate efforts. In the latter case, the data importer shall instead issue a public communication or take a similar measure to inform the public of the personal data breach. |
(g) | The data importer shall document all relevant facts relating to the personal data breach, including its effects and any remedial action taken, and keep a record thereof. |
8.6 | Sensitive data |
Where the transfer involves personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, genetic data, or biometric data for the purpose of uniquely identifying a natural person, data concerning health or a person’s sex life or sexual orientation, or data relating to criminal convictions or offences (hereinafter “sensitive data”), the data importer shall apply specific restrictions and/or additional safeguards adapted to the specific nature of the data and the risks involved. This may include restricting the personnel permitted to access the personal data, additional security measures (such as pseudonymisation) and/or additional restrictions with respect to further disclosure.
8.7 | Onward transfers |
The data importer shall not disclose the personal data to a third party located outside the European Union (in the same country as the data importer or in another third country, hereinafter “onward transfer”) unless the third party is or agrees to be bound by these Clauses, under the appropriate Module. Otherwise, an onward transfer by the data importer may only take place if:
(i) | it is to a country benefitting from an adequacy decision pursuant to Article 45 of Regulation (EU) 2016/679 that covers the onward transfer; |
(ii) | the third party otherwise ensures appropriate safeguards pursuant to Articles 46 or 47 of Regulation (EU) 2016/679 with respect to the processing in question; |
(iii) | the third party enters into a binding instrument with the data importer ensuring the same level of data protection as under these Clauses, and the data importer provides a copy of these safeguards to the data exporter; |
(iv) | it is necessary for the establishment, exercise or defence of legal claims in the context of specific administrative, regulatory or judicial proceedings; |
| | |
(v) | it is necessary in order to protect the vital interests of the data subject or of another natural person; or |
(vi) | where none of the other conditions apply, the data importer has obtained the explicit consent of the data subject for an onward transfer in a specific situation, after having informed him/her of its purpose(s), the identity of the recipient and the possible risks of such transfer to him/her due to the lack of appropriate data protection safeguards. In this case, the data importer shall inform the data exporter and, at the request of the latter, shall transmit to it a copy of the information provided to the data subject. |
Any onward transfer is subject to compliance by the data importer with all the other safeguards under these Clauses, in particular purpose limitation.
8.8 | Processing under the authority of the data importer |
The data importer shall ensure that any person acting under its authority, including a processor, processes the data only on its instructions.
8.9 | Documentation and compliance |
(a) | Each Party shall be able to demonstrate compliance with its obligations under these Clauses. In particular, the data importer shall keep appropriate documentation of the processing activities carried out under its responsibility. |
(b) | The data importer shall make such documentation available to the competent supervisory authority on request. |
Use of sub-processors
(a) | Intentionally omitted. |
Data subject rights
(a) | The data importer, where relevant with the assistance of the data exporter, shall deal with any enquiries and requests it receives from a data subject relating to the processing of his/her personal data and the exercise of his/her rights under these Clauses without undue delay and at the latest within one month of the receipt of the enquiry or request. The data importer shall take appropriate measures to facilitate such enquiries, requests and the exercise of data subject rights. Any information provided to the data subject shall be in an intelligible and easily accessible form, using clear and plain language. |
(b) | In particular, upon request by the data subject the data importer shall, free of charge: |
| | |
(i) | provide confirmation to the data subject as to whether personal data concerning him/her is being processed and, where this is the case, a copy of the data relating to him/her and the information in Annex I; if personal data has been or will be onward transferred, provide information on recipients or categories of recipients (as appropriate with a view to providing meaningful information) to which the personal data has been or will be onward transferred, the purpose of such onward transfers and their ground pursuant to Clause 8.7; and provide information on the right to lodge a complaint with a supervisory authority in accordance with Clause 12(c)(i); |
(ii) | rectify inaccurate or incomplete data concerning the data subject; |
(iii) | erase personal data concerning the data subject if such data is being or has been processed in violation of any of these Clauses ensuring third-party beneficiary rights, or if the data subject withdraws the consent on which the processing is based. |
(c) | Where the data importer processes the personal data for direct marketing purposes, it shall cease processing for such purposes if the data subject objects to it. |
(d) | The data importer shall not make a decision based solely on the automated processing of the personal data transferred (hereinafter “automated decision”), which would produce legal effects concerning the data subject or similarly significantly affect him/her, unless with the explicit consent of the data subject or if authorised to do so under the laws of the country of destination, provided that such laws lays down suitable measures to safeguard the data subject’s rights and legitimate interests. In this case, the data importer shall, where necessary in cooperation with the data exporter: |
(i) | inform the data subject about the envisaged automated decision, the envisaged consequences and the logic involved; and |
(ii) | implement suitable safeguards, at least by enabling the data subject to contest the decision, express his/her point of view and obtain review by a human being. |
(e) | Where requests from a data subject are excessive, in particular because of their repetitive character, the data importer may either charge a reasonable fee taking into account the administrative costs of granting the request or refuse to act on the request. |
(f) | The data importer may refuse a data subject’s request if such refusal is allowed under the laws of the country of destination and is necessary and proportionate in a democratic society to protect one of the objectives listed in Article 23(1) of Regulation (EU) 2016/679. |
(g) | If the data importer intends to refuse a data subject’s request, it shall inform the data subject of the reasons for the refusal and the possibility of lodging a complaint with the competent supervisory authority and/or seeking judicial redress. |
| | |
Redress
(a) | The data importer shall inform data subjects in a transparent and easily accessible format, through individual notice or on its website, of a contact point authorised to handle complaints. It shall deal promptly with any complaints it receives from a data subject. |
(b) | In case of a dispute between a data subject and one of the Parties as regards compliance with these Clauses, that Party shall use its best efforts to resolve the issue amicably in a timely fashion. The Parties shall keep each other informed about such disputes and, where appropriate, cooperate in resolving them. |
(c) | Where the data subject invokes a third-party beneficiary right pursuant to Clause 3, the data importer shall accept the decision of the data subject to: |
(i) | lodge a complaint with the supervisory authority in the Member State of his/her habitual residence or place of work, or the competent supervisory authority pursuant to Clause 13; |
(ii) | refer the dispute to the competent courts within the meaning of Clause 18. |
(d) | The Parties accept that the data subject may be represented by a not-for-profit body, organisation or association under the conditions set out in Article 80(1) of Regulation (EU) 2016/679. |
(e) | The data importer shall abide by a decision that is binding under the applicable EU or Member State law. |
(f) | The data importer agrees that the choice made by the data subject will not prejudice his/her substantive and procedural rights to seek remedies in accordance with applicable laws. |
Liability
(a) | Each Party shall be liable to the other Party/ies for any damages it causes the other Party/ies by any breach of these Clauses. |
(b) | Each Party shall be liable to the data subject, and the data subject shall be entitled to receive compensation, for any material or non-material damages that the Party causes the data subject by breaching the third-party beneficiary rights under these Clauses. This is without prejudice to the liability of the data exporter under Regulation (EU) 2016/679. |
(c) | Where more than one Party is responsible for any damage caused to the data subject as a result of a breach of these Clauses, all responsible Parties shall be jointly and severally liable and the data subject is entitled to bring an action in court against any of these Parties. |
| | |
(d) | The Parties agree that if one Party is held liable under paragraph (c), it shall be entitled to claim back from the other Party/ies that part of the compensation corresponding to its/their responsibility for the damage. |
(e) | The data importer may not invoke the conduct of a processor or sub-processor to avoid its own liability. |
Supervision
(a) | [[Where the data exporter is established in an EU Member State:] The supervisory authority with responsibility for ensuring compliance by the data exporter with Regulation (EU) 2016/679 as regards the data transfer, as indicated in Annex I.C, shall act as competent supervisory authority. |
[Where the data exporter is not established in an EU Member State, but falls within the territorial scope of application of Regulation (EU) 2016/679 in accordance with its Article 3(2) and has appointed a representative pursuant to Article 27(1) of Regulation (EU) 2016/679:] The supervisory authority of the Member State in which the representative within the meaning of Article 27(1) of Regulation (EU) 2016/679 is established, as indicated in Annex I.C, shall act as competent supervisory authority.
[Where the data exporter is not established in an EU Member State, but falls within the territorial scope of application of Regulation (EU) 2016/679 in accordance with its Article 3(2) without however having to appoint a representative pursuant to Article 27(2) of Regulation (EU) 2016/679:] The supervisory authority of one of the Member States in which the data subjects whose personal data is transferred under these Clauses in relation to the offering of goods or services to them, or whose behaviour is monitored, are located, as indicated in Annex I.C, shall act as competent supervisory authority.]
(b) | The data importer agrees to submit itself to the jurisdiction of and cooperate with the competent supervisory authority in any procedures aimed at ensuring compliance with these Clauses. In particular, the data importer agrees to respond to enquiries, submit to audits and comply with the measures adopted by the supervisory authority, including remedial and compensatory measures. It shall provide the supervisory authority with written confirmation that the necessary actions have been taken. |
| | |
Local laws and practices affecting compliance with the Clauses
(a) | The Parties warrant that they have no reason to believe that the laws and practices in the third country of destination applicable to the processing of the personal data by the data importer, including any requirements to disclose personal data or measures authorising access by public authorities, prevent the data importer from fulfilling its obligations under these Clauses. This is based on the understanding that laws and practices that respect the essence of the fundamental rights and freedoms and do not exceed what is necessary and proportionate in a democratic society to safeguard one of the objectives listed in Article 23(1) of Regulation (EU) 2016/679, are not in contradiction with these Clauses. |
(b) | The Parties declare that in providing the warranty in paragraph (a), they have taken due account in particular of the following elements: |
(i) | the specific circumstances of the transfer, including the length of the processing chain, the number of actors involved and the transmission channels used; intended onward transfers; the type of recipient; the purpose of processing; the categories and format of the transferred personal data; the economic sector in which the transfer occurs; the storage location of the data transferred; |
(ii) | the laws and practices of the third country of destination – including those requiring the disclosure of data to public authorities or authorising access by such authorities – relevant in light of the specific circumstances of the transfer, and the applicable limitations and safeguards; |
(iii) | any relevant contractual, technical or organisational safeguards put in place to supplement the safeguards under these Clauses, including measures applied during transmission and to the processing of the personal data in the country of destination. |
(c) | The data importer warrants that, in carrying out the assessment under paragraph (b), it has made its best efforts to provide the data exporter with relevant information and agrees that it will continue to cooperate with the data exporter in ensuring compliance with these Clauses. |
(d) | The Parties agree to document the assessment under paragraph (b) and make it available to the competent supervisory authority on request. |
(e) | The data importer agrees to notify the data exporter promptly if, after having agreed to these Clauses and for the duration of the contract, it has reason to believe that it is or has become subject to laws or practices not in line with the requirements under paragraph (a), including following a change in the laws of the third country or a measure (such as a |
| | |
disclosure request) indicating an application of such laws in practice that is not in line with the requirements in paragraph (a). |
(f) | Following a notification pursuant to paragraph (e), or if the data exporter otherwise has reason to believe that the data importer can no longer fulfil its obligations under these Clauses, the data exporter shall promptly identify appropriate measures (e.g. technical or organisational measures to ensure security and confidentiality) to be adopted by the data exporter and/or data importer to address the situation. The data exporter shall suspend the data transfer if it considers that no appropriate safeguards for such transfer can be ensured, or if instructed by the competent supervisory authority to do so. In this case, the data exporter shall be entitled to terminate the contract, insofar as it concerns the processing of personal data under these Clauses. If the contract involves more than two Parties, the data exporter may exercise this right to termination only with respect to the relevant Party, unless the Parties have agreed otherwise. Where the contract is terminated pursuant to this Clause, Clause 16(d) and (e) shall apply. |
Obligations of the data importer in case of access by public authorities
15.1 | Notification |
(a) | The data importer agrees to notify the data exporter and, where possible, the data subject promptly (if necessary with the help of the data exporter) if it: |
(i) | receives a legally binding request from a public authority, including judicial authorities, under the laws of the country of destination for the disclosure of personal data transferred pursuant to these Clauses; such notification shall include information about the personal data requested, the requesting authority, the legal basis for the request and the response provided; or |
(ii) | becomes aware of any direct access by public authorities to personal data transferred pursuant to these Clauses in accordance with the laws of the country of destination; such notification shall include all information available to the importer. |
(b) | If the data importer is prohibited from notifying the data exporter and/or the data subject under the laws of the country of destination, the data importer agrees to use its best efforts to obtain a waiver of the prohibition, with a view to communicating as much information as possible, as soon as possible. The data importer agrees to document its best efforts in order to be able to demonstrate them on request of the data exporter. |
(c) | Where permissible under the laws of the country of destination, the data importer agrees to provide the data exporter, at regular intervals for the duration of the contract, with as much relevant information as possible on the requests received (in particular, number of requests, type of data requested, requesting authority/ies, whether requests have been challenged and the outcome of such challenges, etc.). |
| | |
(d) | The data importer agrees to preserve the information pursuant to paragraphs (a) to (c) for the duration of the contract and make it available to the competent supervisory authority on request. |
(e) | Paragraphs (a) to (c) are without prejudice to the obligation of the data importer pursuant to Clause 14(e) and Clause 16 to inform the data exporter promptly where it is unable to comply with these Clauses. |
15.2 | Review of legality and data minimisation |
(a) | The data importer agrees to review the legality of the request for disclosure, in particular whether it remains within the powers granted to the requesting public authority, and to challenge the request if, after careful assessment, it concludes that there are reasonable grounds to consider that the request is unlawful under the laws of the country of destination, applicable obligations under international law and principles of international comity. The data importer shall, under the same conditions, pursue possibilities of appeal. When challenging a request, the data importer shall seek interim measures with a view to suspending the effects of the request until the competent judicial authority has decided on its merits. It shall not disclose the personal data requested until required to do so under the applicable procedural rules. These requirements are without prejudice to the obligations of the data importer under Clause 14(e). |
(b) | The data importer agrees to document its legal assessment and any challenge to the request for disclosure and, to the extent permissible under the laws of the country of destination, make the documentation available to the data exporter. It shall also make it available to the competent supervisory authority on request. |
(c) | The data importer agrees to provide the minimum amount of information permissible when responding to a request for disclosure, based on a reasonable interpretation of the request. |
Non-compliance with the Clauses and termination
(a) | The data importer shall promptly inform the data exporter if it is unable to comply with these Clauses, for whatever reason. |
(b) | In the event that the data importer is in breach of these Clauses or unable to comply with these Clauses, the data exporter shall suspend the transfer of personal data to the data importer until compliance is again ensured or the contract is terminated. This is without prejudice to Clause 14(f). |
(c) | The data exporter shall be entitled to terminate the contract, insofar as it concerns the processing of personal data under these Clauses, where: |
| | |
(i) | the data exporter has suspended the transfer of personal data to the data importer pursuant to paragraph (b) and compliance with these Clauses is not restored within a reasonable time and in any event within one month of suspension; |
(ii) | the data importer is in substantial or persistent breach of these Clauses; or |
(iii) | the data importer fails to comply with a binding decision of a competent court or supervisory authority regarding its obligations under these Clauses. |
In these cases, it shall inform the competent supervisory authority of such non-compliance. Where the contract involves more than two Parties, the data exporter may exercise this right to termination only with respect to the relevant Party, unless the Parties have agreed otherwise.
(d) | Personal data that has been transferred prior to the termination of the contract pursuant to paragraph (c) shall at the choice of the data exporter immediately be returned to the data exporter or deleted in its entirety. The same shall apply to any copies of the data. The data importer shall certify the deletion of the data to the data exporter. Until the data is deleted or returned, the data importer shall continue to ensure compliance with these Clauses. In case of local laws applicable to the data importer that prohibit the return or deletion of the transferred personal data, the data importer warrants that it will continue to ensure compliance with these Clauses and will only process the data to the extent and for as long as required under that local law. |
(e) | Either Party may revoke its agreement to be bound by these Clauses where (i) the European Commission adopts a decision pursuant to Article 45(3) of Regulation (EU) 2016/679 that covers the transfer of personal data to which these Clauses apply; or (ii) Regulation (EU) 2016/679 becomes part of the legal framework of the country to which the personal data is transferred. This is without prejudice to other obligations applying to the processing in question under Regulation (EU) 2016/679. |
Governing law
These Clauses shall be governed by the law of one of the EU Member States, provided such law allows for third-party beneficiary rights. The Parties agree that this shall be the law of Ireland.
Choice of forum and jurisdiction
(a) | Any dispute arising from these Clauses shall be resolved by the courts of an EU Member State. |
(b) | The Parties agree that those shall be the courts of Ireland. |
| | |
(c) | A data subject may also bring legal proceedings against the data exporter and/or data importer before the courts of the Member State in which he/she has his/her habitual residence. |
(d) | The Parties agree to submit themselves to the jurisdiction of such courts. |
| | |
[***]
| | |
[***]
| | |
ANNEX III to Module I
UK Addendum to the
EU Commission Standard Contractual Clauses
EU Commission Standard Contractual Clauses
This Addendum has been issued by the Information Commissioner for Parties making Restricted Transfers. The Information Commissioner considers that it provides Appropriate Safeguards for Restricted Transfers when it is entered into as a legally binding contract.
Part 1: Tables
Table 1: Parties
Start Date | The date of this Agreement. |
The Parties | |
Parties’ details | The details of the data exporter and the data importer can be found in Annex 1.A. of the attached EU SCCs. |
Key Contact | Key Contact information of the data exporter and the data importer can be found in Annex 1.A. of the attached EU SCCs. |
Table 2: Selected SCCs, Modules and Selected Clauses
Addendum EU SCCS | ☒ | The version of the Approved EU SCCs which this Addendum is appended to including the Appendix Information. | ||||||
OR | ||||||||
☐ | the Approved EU SCCs, including the Appendix Information and with only the following modules, clauses or optional provisions of the Approved EU SCCs brought into effect for the purposes of this Addendum: | |||||||
| Module | Module in operation | Clause 7 (Docking Clause) | Clause 11 (Option) | Clause 9a (Prior Authorisation or General Authorisation) | Clause 9a (Time Period) | Is personal data received from the Importer combined with personal data collected by the Exporter? | |
1 | | | | | | |
| | |
| 2 | | | | | | | |
3 | | | | | | | ||
4 | | | | | | |
Table 3: Appendix Information
“Appendix Information” means the information which must be provided for the selected modules as set out in the Appendix of the Approved EU SCCs (other than the Parties), and which for this Addendum is set out in the Annexes to the Approved EU SCCs which this Addendum is appended to.
Table 4: Ending this Addendum when the Approved Addendum Changes
Ending this Addendum when the Approved Addendum changes | Which Parties may end this Addendum as set out in Section 19: | |
☒ | Importer | |
☒ | Exporter | |
☐ | neither Party |
Part 2: Mandatory Clauses
Entering into this Addendum
1. | Each Party agrees to be bound by the terms and conditions set out in this Addendum, in exchange for the other Party also agreeing to be bound by this Addendum. |
2. | Although Annex 1A and Clause 7 of the Approved EU SCCs require signature by the Parties, for the purpose of making Restricted Transfers, the Parties may enter into this Addendum in any way that makes them legally binding on the Parties and allows data subjects to enforce their rights as set out in this Addendum. Entering into this Addendum will have the same effect as signing the Approved EU SCCs and any part of the Approved EU SCCs. |
Interpretation of this Addendum
3. | Where this Addendum uses terms that are defined in the Approved EU SCCs those terms shall have the same meaning as in the Approved EU SCCs. In addition, the following terms have the following meanings: |
Term | Meaning |
Addendum | This International Data Transfer Addendum which is made up of this Addendum incorporating the Addendum EU SCCs. |
| | |
Addendum EU SCCs | The version(s) of the Approved EU SCCs which this Addendum is appended to, as set out in Table 2, including the Appendix Information. |
Appendix Information | As set out in Table 3. |
Appropriate Safeguards | The standard of protection over the personal data and of data subjects’ rights, which is required by UK Data Protection Laws when you are making a Restricted Transfer relying on standard data protection clauses under Article 46(2)(d) UK GDPR. |
Approved Addendum | The template Addendum issued by the ICO and laid before Parliament in accordance with s119A of the Data Protection Act 2018 on 2 February 2022, as it is revised under Section 18. |
Approved EU SCCs | The Standard Contractual Clauses set out in the Annex of Commission Implementing Decision (EU) 2021/914 of 4 June 2021. |
ICO | The Information Commissioner. |
Restricted Transfer | A transfer which is covered by Chapter V of the UK GDPR. |
UK | The United Kingdom of Great Britain and Northern Ireland. |
UK Data | All laws relating to data protection, the processing of personal data, privacy and/or electronic communications in force from time to time in the UK, including the UK GDPR and the Data Protection Act 2018. |
UK GDPR | As defined in section 3 of the Data Protection Act 2018. |
4. | This Addendum must always be interpreted in a manner that is consistent with UK Data Protection Laws and so that it fulfils the Parties’ obligation to provide the Appropriate Safeguards. |
5. | If the provisions included in the Addendum EU SCCs amend the Approved SCCs in any way which is not permitted under the Approved EU SCCs or the Approved Addendum, such amendment(s) will not be incorporated in this Addendum and the equivalent provision of the Approved EU SCCs will take their place. |
6. | If there is any inconsistency or conflict between UK Data Protection Laws and this Addendum, UK Data Protection Laws applies. |
7. | If the meaning of this Addendum is unclear or there is more than one meaning, the meaning which most closely aligns with UK Data Protection Laws applies. |
8. | Any references to legislation (or specific provisions of legislation) means that legislation (or specific provision) as it may change over time. This includes where that legislation (or specific provision) has been consolidated, re- enacted and/or replaced after this Addendum has been entered into. |
| | |
Hierarchy
9. | Although Clause 5 of the Approved EU SCCs sets out that the Approved EU SCCs prevail over all related agreements between the parties, the parties agree that, for Restricted Transfers, the hierarchy in Section 10 will prevail. |
10. | Where there is any inconsistency or conflict between the Approved Addendum and the Addendum EU SCCs (as applicable), the Approved Addendum overrides the Addendum EU SCCs, except where (and in so far as) the inconsistent or conflicting terms of the Addendum EU SCCs provides greater protection for data subjects, in which case those terms will override the Approved Addendum. |
11. | Where this Addendum incorporates Addendum EU SCCs which have been entered into to protect transfers subject to the General Data Protection Regulation (EU) 2016/679 then the Parties acknowledge that nothing in this Addendum impacts those Addendum EU SCCs. |
Incorporation of and changes to the EU SCCs
12. | This Addendum incorporates the Addendum EU SCCs which are amended to the extent necessary so that: |
a. | together they operate for data transfers made by the data exporter to the data importer, to the extent that UK Data Protection Laws apply to the data exporter’s processing when making that data transfer, and they provide Appropriate Safeguards for those data transfers; |
b. | Sections 9 to 11 override Clause 5 (Hierarchy) of the Addendum EU SCCs; and |
c. | this Addendum (including the Addendum EU SCCs incorporated into it) is (1) governed by the laws of England and Wales and (2) any dispute arising from it is resolved by the courts of England and Wales, in each case unless the laws and/or courts of Scotland or Northern Ireland have been expressly selected by the Parties. |
13. | Unless the Parties have agreed alternative amendments which meet the requirements of Section 12, the provisions of Section 15 will apply. |
14. | No amendments to the Approved EU SCCs other than to meet the requirements of Section 12 may be made. |
15. | The following amendments to the Addendum EU SCCs (for the purpose of Section 12) are made: |
a. | References to the “Clauses” means this Addendum, incorporating the Addendum EU SCCs; |
b. | In Clause 2, delete the words: |
“and, with respect to data transfers from controllers to processors and/or processors to processors, standard contractual clauses pursuant to Article 28(7) of Regulation (EU) 2016/679”;
c. | Clause 6 (Description of the transfer(s)) is replaced with: |
“The details of the transfers(s) and in particular the categories of personal data that are transferred and
| | |
the purpose(s) for which they are transferred are those specified in Annex I.B where UK Data Protection Laws apply to the data exporter’s processing when making that transfer.”;
d. | Clause 8.7(i) of Module 1 is replaced with: |
“it is to a country benefitting from adequacy regulations pursuant to Section 17A of the UK GDPR that covers the onward transfer”;
e. | Clause 8.8(i) of Modules 2 and 3 is replaced with: |
“the onward transfer is to a country benefitting from adequacy regulations pursuant to Section 17A of the UK GDPR that covers the onward transfer;”
f. | References to “Regulation (EU) 2016/679”, “Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation)”and “that Regulation” are all replaced by “UK Data Protection Laws”. References to specific Article(s) of “Regulation (EU) 2016/679” are replaced with the equivalent Article or Section of UK Data Protection Laws; |
g. | References to Regulation (EU) 2018/1725 are removed; |
h. | References to the “European Union”, “Union”, “EU”, “EU Member State”, “Member State” and “EU or Member State” are all replaced with the “UK”; |
i. | The reference to “Clause 12(c)(i)” at Clause 10(b)(i) of Module one, is replaced with “Clause 11(c)(i)”; |
j. | Clause 13(a) and Part C of Annex I are not used; |
k. | The “competent supervisory authority” and “supervisory authority” are both replaced with the “Information Commissioner”; |
l. | In Clause 16(e), subsection (i) is replaced with: |
“the Secretary of State makes regulations pursuant to Section 17A of the Data Protection Act 2018 that cover the transfer of personal data to which these clauses apply;”;
m. | Clause 17 is replaced with: |
“These Clauses are governed by the laws of England and Wales.”;
n. | Clause 18 is replaced with: |
“Any dispute arising from these Clauses shall be resolved by the courts of England and Wales. A data subject may also bring legal proceedings against the data exporter and/or data importer before the courts of any country in the UK. The Parties agree to submit themselves to the jurisdiction of such courts.”; and
o. | The footnotes to the Approved EU SCCs do not form part of the Addendum, except for footnotes 8, 9, 10 and 11. |
| | |
Amendments to this Addendum
16. | The Parties may agree to change Clauses 17 and/or 18 of the Addendum EU SCCs to refer to the laws and/or courts of Scotland or Northern Ireland. |
17. | If the Parties wish to change the format of the information included in Part 1: Tables of the Approved Addendum, they may do so by agreeing to the change in writing, provided that the change does not reduce the Appropriate Safeguards. |
18. | From time to time, the ICO may issue a revised Approved Addendum which: |
a. | makes reasonable and proportionate changes to the Approved Addendum, including correcting errors in the Approved Addendum; and/or |
b. | reflects changes to UK Data Protection Laws; |
The revised Approved Addendum will specify the start date from which the changes to the Approved Addendum are effective and whether the Parties need to review this Addendum including the Appendix Information. This Addendum is automatically amended as set out in the revised Approved Addendum from the start date specified.
19. | If the ICO issues a revised Approved Addendum under Section 18, if any Party selected in Table 4 “Ending the Addendum when the Approved Addendum changes”, will as a direct result of the changes in the Approved Addendum have a substantial, disproportionate and demonstrable increase in: |
a. | its direct costs of performing its obligations under the Addendum; and/or |
b. | its risk under the Addendum, |
and in either case it has first taken reasonable steps to reduce those costs or risks so that it is not substantial and disproportionate, then that Party may end this Addendum at the end of a reasonable notice period, by providing written notice for that period to the other Party before the start date of the revised Approved Addendum.
20. | The Parties do not need the consent of any third party to make changes to this Addendum, but any changes must be made in accordance with its terms. |
| | |
[***]
| | |
[***]
| | |
[***]