Document:

Exhibit 10.1

 

Dated 2 April 2014

(as amended and restated on 23 April 2014 and again on 28 May 2014)

 

 

TIGENIX NV

 

and

 

SWEDISH ORPHAN BIOVITRUM AB (publ)

 

 

DISTRIBUTION AGREEMENT

 

 

DISTRIBUTION AGREEMENT

 

Between:

 

TiGenix NV, a company incorporated under the laws of Belgium, with registered office at Romeinse straat 12 bus 2, 3001 Leuven, Belgium, registered with the register of legal entities of Leuven under number 0471.340.123, hereinafter referred to as “TiGenix”;

 

and

 

Swedish Orphan Biovitrum AB (publ), a company incorporated under the laws of Sweden, with registered office at SE-112 76 Stockholm, registered under number 556038-9321, hereinafter referred to as “Sobi”;

 

Whereas:

 

(A)                            TiGenix is engaged in the development, manufacturing and distribution of regenerative medicinal products for the treatment of damaged and osteoarthritic joints, inflammatory and autoimmune conditions;

 

(B)                            TiGenix has developed a medicinal product, ChondroCelect, as defined below, 10000 cells/μl, an implantation suspension intended for repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults;

 

(C)                            The active substance of ChondroCelect consists of characterised viable autologous chondrocytes (cartilage-forming cells) expanded ex vivo expressing specific marker proteins, a cell-based medicinal product;

 

(D)                            The chondrocytes are taken from a small biopsy of healthy cartilage from the patient at the hospital to be transported in an appropriate biopsy-kit to the Manufacturing Facility, where they are expanded, thereafter transported by an approved carrier back to the hospital in an Implantation-kit and then re-implanted during surgery with the aim to repair cartilage defects by the formation of durable cartilage;

 

(E)                             ChondroCelect has been approved by a Marketing Authorization in the EU. As part of the Marketing Authorization for ChondroCelect, a risk management system was required including an educational programme and a controlled distribution system. ChondroCelect must be administered by appropriately qualified health professionals and is restricted to hospital use only;

 

(F)                              Sobi has the expertise to register and distribute medicinal products in the Territory, as defined below;

 

(G)                            Sobi has an interest in acting as TiGenix’ exclusive distributor of ChondroCelect in the Territory, based on the terms and conditions agreed in this agreement (hereinafter together with the schedules referred to as the “Agreement”).

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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The Parties agree as follows:

 

1                                      Definitions

 

1.1                            For purposes of this Agreement, the following terms shall have the following meaning, both in plural and in singular:

 

1.1.1                   “Affiliates” means any Person directly or indirectly controlled by, controlling or under common control with, a Party, but only for so long as such control shall continue. For purposes of this definition, “control” (including, with correlative meanings, “controlled by”, “controlling” and “under common control with”) shall be presumed to exist with respect to a Person in the event of the possession, direct or indirect, of (i) the power to direct or cause the direction of the management and policies of such Person (whether through ownership of securities, by contract or otherwise), or (ii) at least fifty percent (50%) of the voting securities or other comparable equity interests. For the avoidance of doubt, neither of the Parties shall be deemed to be an “Affiliate” of the other;

 

1.1.2                   “Agreement” has the meaning as set out in recital (G);

 

1.1.3                   “Assigned Agreements” means the agreements listed in Schedule 6;

 

1.1.4                   “Assigned Hospitals” means Hospitals that have consented to the assignment to Sobi as of the Closing Date;

 

1.1.5                   “ATMP” means an advanced therapy medicinal product, as defined under European Parliament and Council Regulation 1394/2007, or, where applicable, the equivalent in the Territory of an advanced therapy medicinal product as defined under European Parliament and Council Regulation 1394/2007;

 

1.1.6                   “Biopsy” or “Procurement” means the extraction of Knee Cartilage, being the process by which the Knee Cartilage becomes available;

 

1.1.7                   “Biopsy-kit” means TiGenix’ biopsy-kit described in the User Manual;

 

1.1.8                   “cGMP” means current Good Manufacturing Practices as promulgated in EU Commission Directive 2003/94/EC (EU cGMP Guidelines), EU Commission Directive 2001/20/EC (Clinical Trials), EU Regulation EC 1394/2007 (Advanced Therapy medicinal Products (ATmP)), EU Directive 2001/83/EC (Medicinal Products for Human Use), and national implementation of the foregoing, and applicable International Conference on Harmonisation guidelines as well as any applicable regulatory guidelines issued by Government Competent Authorities in particular relevant guidance on good manufacturing practices contained in Volume 4 of the Rules Governing Medicinal Products in the European Union and the national implementations of these rules.

 

1.1.9                   “ChondroCelect” or “Product” means a cell-based medicinal product, consisting of characterized viable autologous cartilage cells (initially taken from a healthy region of a Patient’s articular knee cartilage), expanded ex vivo (outside the body) expressing specific

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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marker proteins, and finally re-implanted during surgery. ChondroCelect was approved by Marketing Authorization no EU/1/09/563/001 dated 5 October 2009;

 

1.1.10            “ChondroCelect Personal Data” means Personal Data processed by Sobi on behalf of TiGenix (i) in the framework of the ChondroCelect Process (including but not limited to personally identifiable information regarding Patients, Healthcare Providers and Surgeons processed in the framework of the ChondroCelect Process) or (ii) in connection with the Product (including but not limited to personally identifiable information processed in the framework of pharmacovigilance, such as for the global safety database for the Product, and personally identifiable information processed for traceability purposes); in respect of personally identifiable information regarding Patients, Sobi should only receive the Unique Code and coded Patient data (whereby “coded Patient data” means data that do not allow Sobi to identify the Patient concerned without intervention of the Hospital which holds the key to the Unique Code); for the avoidance of doubt, both the Unique Code and coded Patient data constitute ChondroCelect Personal Data to which clause 22.2 shall apply.

 

1.1.11            “ChondroCelect Process” has the meaning as set out in clause 5 and is further detailed in Schedule 4;

 

1.1.12            “ChondroCelect Specifications” means the ChondroCelect specifications set out in the applicable Marketing Authorization;

 

1.1.13            “ChondroCelect Training” means the training of healthcare providers and surgeons provided by Sobi (after accreditation by TiGenix) (or prior to the Closing Date, by TiGenix) pursuant to the training material provided and/or approved by TiGenix;

 

1.1.14            “Claim” has the meaning as set out in clause 19.1;

 

1.1.15            “Closing Date” means June 1, 2014;

 

1.1.16            “Commencement Date” means April 2, 2014;

 

1.1.17            “Confidential Material” has the meaning as set out in clause 17.2;

 

1.1.18            “Control” means, when used in reference to intellectual property, other intangible property, or materials, that a Party owns or has a license or sublicense to such intellectual property, other intangible property or materials, and has the ability to grant a license or sublicense or other right to use such intellectual property, other intangible property or materials, as applicable, as provided for herein, without (i) requiring the consent of a Third Party or (ii) violating the terms of any agreement or other arrangement with any Third Party;

 

1.1.19            “Data Controller” has the meaning as set out in clause 22.1;

 

1.1.20            “Data Processor” has the meaning as set out in clause 22.1;

 

1.1.21            “Data Subject” has the meaning as set out in clause 22.1;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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1.1.22            “Default” means (i) a breach, default or violation, (ii) the occurrence of an event that with or without the passage of time or the giving of notice, or both, would constitute a breach, default or violation or cause an Encumbrance to arise, or (iii) with respect to any Contract, the occurrence of an event that with or without the passage of time or the giving of notice, or both, would give rise to a right of termination, modification, renegotiation, acceleration, cancellation, or a right to receive damages or a payment of penalties;

 

1.1.23            “Designated Laboratory” means the laboratory designated by TiGenix.

 

1.1.24            “Disclosing Party” has the meaning as set out in clause 17.1.1;

 

1.1.25            “Encumbrance” means any claim, mortgage, pledge, assessment, security interest, option, deed of trust, lease, lien, levy, restriction on transferability, defect in title, charge or other encumbrance of any kind, whether voluntarily incurred or arising by operation of Law or any conditional sale or title retention agreement or other agreement to give any of the foregoing in the future. For avoidance of doubt, Encumbrances shall not include licenses;

 

1.1.26            “Excluded Liabilities” has the meaning as set out in clause 12.2;

 

1.1.27            “Governmental Authority” means any multinational, federal, state, local, municipal or other governmental authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal), in each case, having jurisdiction over the applicable subject matter;

 

1.1.28            “Healthcare Provider” means a healthcare provider working at a Hospital who has followed the ChondroCelect Training, as evidenced by a training record signed by the trainer(s) and the healthcare provider and whose training is still valid;

 

1.1.29            “Hospital” means a hospital in the Territory ordering ChondroCelect from Sobi pursuant to a Hospital Agreement or pursuant to an Assigned Agreement;

 

1.1.30            “Hospital Agreement” means the agreements entered into by Sobi with the Hospitals in accordance with clause 10.3.2, excluding the Assigned Agreements;

 

1.1.31            “Hospital Agreement Requirements” has the meaning as set out in clause 10.3.2;

 

1.1.32            “Implantation” means the surgical procedure for implanting ChondroCelect in the knee;

 

1.1.33            “Implantation-kit” means TiGenix’ implantation-kit described in the User Manual;

 

1.1.34            “Indemnification Claim Notice” has the meaning as set out in clause 19.8.1;

 

1.1.35            “Indemnified Party” has the meaning as set out in clause 19.8.1;

 

1.1.36            “Indemnifying Party” has the meaning as set out in clause 19.8.1;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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1.1.37            “Indemnitee(s)” has the meaning as set out in clause 19.8.1;

 

1.1.38            “Indication” means the repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults;

 

1.1.39            “Informed Consent Form” means the consent form to be filled out and signed by the Patient, a template of which is included in the User Manual and which may be modified from time to time by TiGenix or Sobi if so required by laws, regulations or necessary permits, such as for example in the event of a process change;

 

1.1.40            “IPR” means Patents, copyrights, software rights, registered and unregistered design rights, trade marks, trade and business names, trade secrets, know-how, database rights, domain names, other intellectual property rights and all other similar or corresponding proprietary rights (whether registered or unregistered) and all applications for and rights to apply for the same, anywhere in the world;

 

1.1.41            “Knee Cartilage” means the cartilage extracted from the knee of a Patient using the Biopsy-kit;

 

1.1.42            “Laboratory Testing” means the laboratory tests to be performed by the Designated Laboratory;

 

1.1.43            “Liabilities” means any liability, indebtedness, obligation, claim, loss, damage, deficiency, penalty, cost, expense, guarantee or commitment, including any liability for taxes;

 

1.1.44            “License for Pharmaceutical Wholesale Distribution” means a valid license for the wholesale distribution of pharmaceuticals in the Territory;

 

1.1.45            “Losses” has the meaning as set out in clause 19.1;

 

1.1.46            “Manufacturing Facility” means the cGMP manufacturing facility, approved by the Regulatory Authority for manufacturing of the Product, at which the Product is manufactured;

 

1.1.47            “Marketing Authorization” means the approval of a Regulatory Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction (but shall not include any pricing approvals);

 

1.1.48            “Minimum Binding Volumes” has the meaning as set out in Schedule 2a;

 

1.1.49            “Minimum Sales” has the meaning as set out in clause 13.2.1;

 

1.1.50            “Net Sales” means the sales proceeds invoiced by Sobi, its Affiliates, and its sub-licensees in respect of sales to any Third Party of the Products less: (i) rebates granted in connection with reimbursement agreements with local, regional or national health authorities; (ii) discounts (e.g. trade discounts/cash discounts/quantity discounts) with a limit of 10% of the gross sales proceeds invoiced by Sobi; (iii) sales, value-added, excise

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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taxes, tariffs and duties directly related to the sale of the Product, to the extent actually borne by Sobi without reimbursement from any Third Party (but not including taxes assessed against the income derived from such sale); (iv) goods returned (e.g. rejections, defects, recalls, returns) with a limit of 10% of the gross sales invoiced by Sobi and only to the extent that the Product was initially invoiced by Sobi and therefore included in the “sales proceeds”; (v) transportation costs; (vi) the cost for assembly of both the Biopsy-kit and the Implantation-kit; and (vii) [***].

 

1.1.51            “Non-Assigned Hospitals” means hospitals listed in Schedule 6 that have not yet consented to the assignment to Sobi as of the Closing Date;

 

1.1.52            “Notified Product” has the meaning as set out in clause 6.1;

 

1.1.53            “Order” has the meaning as set out in clause 4.1 of Schedule 4;

 

1.1.54            “Party” means TiGenix or Sobi, jointly referred to as the “Parties”;

 

1.1.55            “Patents” means patents and patent applications and all substitutions, divisions, continuations, continuations-in-part, any patent issued with respect to any such patent applications, any reissue, re-examination, utility models or designs, renewal or extension (including any supplementary protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all counterparts thereof in any country;

 

1.1.56            “Patient” means a person admitted at a Hospital for treatment with ChondroCelect;

 

1.1.57            “Person” means a corporation, limited or general partnership, limited liability company, joint venture, trust, unincorporated association, governmental body, authority, bureau or agency, any other entity or body, or an individual;

 

1.1.58            “Personal Data” has the meaning as set out in clause 22.1;

 

1.1.59            “Procurement” shall have the same meaning as Biopsy;

 

1.1.60            “Product” shall have the same meaning as ChondroCelect;

 

1.1.61            “Receiving Party” has the meaning as set out in clause 17.1;

 

1.1.62            “Regulatory Approvals” means all necessary approvals (including Marketing Authorization, pricing approvals, import permits, and, in each case any supplements and amendments thereto), licenses, registrations or authorizations of any Governmental Authority, necessary for the development, manufacture, distribution, use, promotion and sale of the Product in a given country or regulatory jurisdiction;

 

1.1.63            “Regulatory Authority” means, in a particular country or regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or regulatory jurisdiction, including, without limiting the foregoing, the European

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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Medicines Agency, the European Commission and relevant national medicines regulatory authorities;

 

1.1.64            “Results” means the results, including any data, information, creative ideas, inventions, know-how, discoveries, developments, whether patentable or not, discovered, conceived or reduced to practice during and in connection with ChondroCelect and its application by a Hospital;

 

1.1.65            “SAE” and “SAR” have the meaning provided in the applicable local legislation, where applicable implementing the European Directive and/or local directive on SAEs (Serious Adverse Events) and SARs (Serious Adverse Reactions);

 

1.1.66            “Sobi Background IPR” has the meaning as set out in clause 15.1.1;

 

1.1.67            “SOP” means a standard operating procedure described in the User Manual. TiGenix shall inform Sobi of any proposed amendments to existing SOP’s or the introduction of any proposed new SOP’s in advance and shall give Sobi the opportunity to review and provide comments on the proposed amendments or new SOPs and TiGenix shall take into account any reasonable comments. Changes to an SOP which are required by applicable laws and regulations (including the date as of which such changes shall be applicable) are in TiGenix sole discretion to include. Changes to an SOP which are not required by applicable law or regulations (including the date as of which such changes shall be applicable)require Sobi’s prior approval, such approval not to be unreasonably withheld. If Sobi’s prior approval is required, Sobi shall review the proposed amendments or new SOPs and provide comments to TiGenix within ten (10) working days from receipt. If no changes are required to be made to the proposed amendments or new SOPs, Sobi shall give approval within ten (10) working days from receipt. In the event changes are required to be made to the proposed amendments or new SOPs, TiGenix shall provide Sobi with revised documents, which Sobi will subsequently review as soon as practicably possible and in any case within ten (10) working days from receipt of the revised documents. This is repeated until Sobi has no more comments on the proposed amendments or new SOPs, after which Sobi shall give approval within five (5) working days from receipt of the last revised documents. In no event shall any proposed amendments or new SOPs be considered approved without the explicit written approval of Sobi. In the event any change to an SOP has a material effect on Sobi, the Parties shall negotiate the consequences of such change in good faith;

 

1.1.68            “Surgeon” means a surgeon working at a Hospital who has successfully completed the ChondroCelect Training, who has obtained the related certificate from Sobi (or prior to the Closing Date, from TiGenix) signed by the trainer(s) and the surgeon and whose certificate is still valid;

 

1.1.69            “Technology” means any Confidential Material, IPR (excluding domain names) and Patent in and to the Product and in and to the ChondroCelect Process, that is (i) Controlled by TiGenix (or its Affiliates) as of the Closing Date, or (ii) that comes under the Control of TiGenix during the term of the Agreement;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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1.1.70            “Territory” means, subject to clause 2.5, the current members of the European Union (excluding Finland), Switzerland, Norway, Russia, Turkey and other countries located in Europe (as defined by the Council of Europe), Iran, Iraq, Saudi Arabia, Yemen, Syria, UAB (United Arab Emirates), Israel, Jordan, Palestine, Lebanon, Oman, Kuwait, Qatar, Bahrain, Egypt, Algeria, Libya, Morocco, Sudan, Tunisia and Western Sahara. Sobi has an option to include [***] in the Territory according to clause 2.3;

 

1.1.71            “Third Party” means any Person other than the Parties or their respective Affiliates;

 

1.1.72            “Tissue Establishment” means the entity that, where legally required, will hold the Tissue Establishment License in the relevant part of the Territory for the donation, procurement, import, export, testing and release of primary material for the production of an ATMP;

 

1.1.73            “Tissue Establishment License” means, where legally required, a license in the relevant part of the Territory for the donation, procurement, import, export, testing and release of primary material for the production of an ATMP;

 

1.1.74            “Transitional Phase” means the period between Commencement Date and Closing Date;

 

1.1.75            “Trade Marks” means any registered and unregistered trade marks in the Territory that are (i) Controlled by TiGenix (or its Affiliates) as of the Closing Date, or (ii) that comes under the Control of TiGenix during the term of the Agreement, in each case of (i) or (ii) which is related to the Product and/or the Process in the Territory, except for TiGenix’ corporate, trade or domain names;

 

1.1.76            “Uncapped Hospital Agreement” has the meaning set out in clause 19.5;

 

1.1.77            “Unique Code” has the meaning as set out in clause 8.2;

 

1.1.78            “User Manual” means the manual attached as Schedule 1, which is used as a reference guide for the ChondroCelect Process and which is provided to Sobi by TiGenix. TiGenix shall inform Sobi of any proposed amendments to the User Manual in advance and shall give Sobi the opportunity to review and provide comments on the proposed amendments and TiGenix shall take into account any reasonable comments. Changes to the User Manual which are required by applicable laws and regulations (including the date as of which such changes shall be applicable) are in TiGenix sole discretion to include. Changes to the User Manual which are not required by applicable law or regulations (including the date as of which such changes shall be applicable) require Sobi’s prior approval, such approval not to be unreasonably withheld. If Sobi’s prior approval is required, Sobi shall review the proposed amendments to the User Manual and provide comments to TiGenix within ten (10) working days from receipt. If no changes are required to be made to the proposed amendments to the User Manual, Sobi shall give approval within ten (10) working days from receipt. In the event changes are required to be made to the proposed amendments to the User Manual, TiGenix shall provide Sobi with revised documents, which Sobi will subsequently review as soon as practicably possible and in any case within ten (10) working days from receipt of the revised documents. This is repeated until Sobi has no more comments on the proposed amendments to the User Manual, after which Sobi shall give approval within five (5)

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

8

 

 

working days from receipt of the last revised documents. In no event shall any proposed amendments to the User Manual be considered approved without the explicit written approval of Sobi. In the event any change to the User Manual has a material effect on Sobi, the Parties shall negotiate the consequences of such change in good faith;

 

1.1.79            “Works” has the meaning as set out in clause 15.2.2.

 

2                                      Appointment and Scope

 

2.1                            TiGenix hereby grants to Sobi, including Affiliates, and Sobi, including Affiliates, hereby accepts, the exclusive (subject to clause 3) right to sell, distribute, market, promote and file for pricing and reimbursement of the ChondroCelect Process and the Product (upon the terms and conditions as set out in clause 5) in the Territory, solely for the treatment of the Indication.

 

2.2                            In addition to Sobi’s right to sub-contract rights under the Hospital Agreements, Sobi shall have the right, on the terms and conditions of this Agreement, to sublicense or subcontract to Third Parties the performance of sales, marketing, promotion and filing for pricing and reimbursement in such countries of the Territory where Sobi does not act through its own Affiliates. Any such sublicense or subcontract shall (a) be subject to TiGenix’ prior written approval of the identity of the sublicensee, and (b) be subject to an appropriate written agreement that imposes on any such sublicensee or subcontractor all applicable terms, conditions and obligations under this Agreement, including the reporting, audit, inspection and confidentiality provisions hereunder, and (c) contain a provision prohibiting such sublicensee or subcontractor from further sublicensing and subcontracting and (d) not in any way diminish, reduce or eliminate any of Sobi’s obligations under this Agreement. For the avoidance of doubt, Sobi will remain directly responsible for the acts of its sublicensees and subcontractors, including for all amounts owed to TiGenix under this Agreement.

 

2.3                            Sobi shall not be entitled to actively sell ChondroCelect outside the Territory. The Parties may in the future agree to expand the Territory by mutual agreement. Provided Sobi has the necessary Regulatory Approvals in accordance with clause 10.1.1, Sobi shall have the right to include [***] in the Territory by providing written notice to TiGenix, in which case clause 2.6 shall apply.

 

2.4                            Outside of the scope of this Agreement, Sobi has the intention to evaluate and potentially offer employment to certain commercial staff of TiGenix, who have been working with the Product at TiGenix prior to the Commencement Date of this Agreement, on an individual basis, and TiGenix has no objections against Sobi doing so. In case (i) Sobi would decide not to offer employment to certain commercial staff of TiGenix as listed in Schedule 3bis (or offer employment but not effectively enter into an employment agreement with such commercial staff), (ii) such commercial staff would be dismissed by TiGenix, and (iii) Sobi would nevertheless hire such staff within 12 (twelve) months after the Closing Date, Sobi shall reimburse TiGenix for the costs of said dismissal.

 

2.5                            Sobi acknowledges that TiGenix is bound by an existing distribution agreement for certain parts of the Middle East and Northern Africa (Saudi Arabia, UAE, Kuwait, Bahrain, Qatar, Oman, Lebanon, Jordan, Syria, Iraq, Iran and Egypt). TiGenix undertakes to use commercially reasonable efforts to terminate this existing agreement as soon as possible after the Commencement Date. Until termination of the existing agreement will be effective, the Territory

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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will not include said parts of the Middle East and Northern Africa. Upon termination of said existing agreement, the Territory will include said parts of the Middle East and Northern Africa.

 

2.6                            [***].

 

3                                      Non-Compete - Conflicts of interest

 

3.1                            During the term of this Agreement, and for a period of 24 (twenty-four) months after termination of this Agreement (unless applicable law provides a shorter maximum term, in which case such shorter maximum term shall apply), Sobi shall not, whether directly or indirectly, (i) actively or inactively develop or market in the Territory any cell-based therapies for the treatment of cartilage lesions in the knee without TiGenix’ prior written approval, or (ii) actively develop or sell the Products outside the Territory.

 

4                                      Prices, Royalties, Costs and Payment thereof

 

4.1                            Price

 

4.1.1                   Sobi will procure the Product from TiGenix for a price in accordance with a table of volume dependent prices as set forth in Schedule 2a.

 

4.1.2                   In addition, Sobi will also pay for:

 

(i)                                  the Biopsy-kits that are in consignment stock at the Hospitals on the Closing Date as listed in Schedule 2e,

 

(ii)                               the materials used in/for and the assembly of the Biopsy-kits,

 

(iii)                            the materials used in/for and the assembly of the Implantation-kits, and

 

(iv)                           all costs of transportation in relation to the Product (including transportation of Biopsy-kits, Biopsies and Implantation-kits),

 

as set forth in Schedule 2a.

 

4.1.3                   TiGenix will issue one or more invoices to Sobi, on a monthly basis, on the last day of each month:

 

(i)                                  for all Biopsy-kits ordered by Sobi and shipped to a Hospital during that month (including the cost of the materials used in/for the Biopsy-kit, and the cost for the assembly of the Biopsy-kit) (including for Biopsy-kits that were shipped to a Hospital in replacement of expired or discarded Biopsy-kits), as set out in Schedule 2a;

 

(ii)                               for all Products shipped to a Hospital during that month (including the cost of the materials used in/for the Implantation-kit, and the cost for the assembly of the Implantation-kit), as set out in Schedule 2a; and

 

(iii)                            for all transportation costs made during the last month (Biopsy-kits, Biopsies, Implantation-kits) and for which TiGenix has already received the corresponding invoice from the transportation company; invoices which are not timely received

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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from a transportation company to include them in the monthly invoice from TiGenix to Sobi, will be added to the next monthly invoice.

 

4.2                            Royalties

 

4.2.1                   For as long as this Agreement is in force, and as a consideration for the rights granted to Sobi under it, TiGenix shall also obtain a royalty on Net Sales from Products in the Territory, as per the following royalty rate:

 

The royalty rate shall be 22% (twenty two percent) on Net Sales for the first full 12 months, and thereafter 20% (twenty percent) on Net Sales.

 

4.2.2                   Sales and royalties shall be calculated in Euros by use of the exchange rate ECB EXR on the invoice date. The transfer or sale of Products by Sobi to an Affiliate shall not be considered a sale for the purpose of calculating the royalties.

 

4.2.3                   The royalties shall be paid monthly. At the end of each calendar month, Sobi shall send a financial report over the calculation of such calendar month’s Net Sales to TiGenix, who shall subsequently issue the related invoice. Payment of the royalties shall be made by Sobi to TiGenix within sixty (60) days from the end of each calendar month.

 

4.3                            Costs

 

4.3.1                   Sobi will reimburse TiGenix for:

 

(i)                                  costs related to the regulatory activities required to fulfil the obligations towards EMA to maintain the Marketing Authorization (excluding the EMA annual fee which shall be borne by TiGenix), including the costs for the ongoing registry studies in Belgium and the Netherlands, up to a cap of [***] EUR ([***] euros) in total for the ongoing registry study in Belgium (protocol number TGX001-2011), up to a cap of [***] EUR ([***] euros) in total for the ongoing registry study in the Netherlands (where data relating to ChondroCelect are obtained via the surgeon who coordinates the Dutch national register) and up to a cap of [***] EUR ([***] euros) per year for all other regulatory activities.

 

The payment of the registry studies cost will be made during the years 2014—2018 in accordance with clause 4.3.2(i), based on the quarterly indicative estimates set out in Schedule 2a;

 

(ii)                               costs related to the holding by TiGenix of the Belgian Tissue Establishment License (“production establishment license”), for [***] EUR ([***] euros) per year,

 

(iii)                            costs related to central pharmacovigilance activities up to a cap of [***] EUR ([***] euros) per year;

 

(iv)                           costs related to customer support for Belgium and the Netherlands and the management of the logistical co-ordination provided by TiGenix for [***] ([***] ) FTE’s, up to a cap of [***] EUR ([***] euros), such amount as the case may be increased due to indexation pursuant to Belgian law.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

11

 

Parties acknowledge that the total capacity (number of batches) that can be managed by [***] FTEs will depend on the number of batches for which full customer support will be provided (in Belgium and the Netherlands) plus the number of batches for which only logistical co-ordination will be provided, as well as on the distribution of the batches throughout the year (even vs. uneven/peak distribution during the year).

 

Parties shall regularly monitor whether [***] FTEs are sufficient to manage the effective requirements (both in view of the mix of batches requiring full customer support and the batches requiring only logistical co-ordination, as well as in view of the even vs. uneven distribution of the bathes throughout the year) and shall meet to discuss in good faith when either Party is of the opinion that additional resources are needed to provide the required customer support and/or logistical co-ordination. If such resources are deemed best delivered in the form on an employee, the employee will be hired by TiGenix but the costs of the employee should be reimbursed by Sobi to TiGenix as from the hiring of such additional employee (it being understood that the cap of [***] EUR will not apply to such additional employee).

 

Parties agree to meet 12 months following the Closing Date to review the set up of the customer support and the logistical co-ordination.

 

4.3.2                   TiGenix will invoice the reimbursement of the costs in clause 4.3.1 to Sobi as follows:

 

(i)                                  in respect of the costs listed in clauses 4.3.1(i) and 4.3.1(iii): on a monthly basis, based on real costs and/or invoices received by TiGenix from third parties,

 

(ii)                               in respect of the cost listed in clause 4.3.1(ii): on a quarterly basis, with the fixed annual fee split evenly over the year, and

 

(iii)                            in respect of the cost listed in clause 4.3.1(iv): on a monthly basis, with the fixed annual fee split evenly over the year.

 

4.3.3                   For the avoidance of doubt, other than according to 4.3.1(i) and (ii), each Party will bear the costs related to the renewal/upholding of such Regulatory Approvals and other licenses which it must hold pursuant to this Agreement for which it is responsible in accordance with Schedule 3 (Responsibilities) without reimbursement from the other Party.

 

4.3.4                   If the costs listed in clause 4.3.1 would increase due to an increase in volume of Products sold to Sobi under this Agreement, Parties will discuss in good faith how to handle the increased costs.

 

4.4                            Payment

 

4.4.1                   Except as otherwise specified in this Agreement, payment of TiGenix invoices shall be made in full, in euro, net of bank charges, within 30 (thirty) days of the date of the invoice.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

12

 

4.4.2                   All taxes or other levies imposed in the Territory directly or indirectly in connection with sales of ChondroCelect and payments to TiGenix under this Agreement shall be borne by Sobi.

 

4.4.3                   TiGenix may decide to refuse new Orders if prior invoices are not paid in full by Sobi within 30 (thirty) days from due date.

 

4.4.4                   In case Sobi fails to settle its invoices on the due date, these will automatically, and without there being a need for TiGenix to issue a notice in this respect, bear an interest at a rate of (i) 1% (one percent) per month, or (ii) the highest possible interest rate permitted under applicable law, whichever is the lowest.

 

4.5                            Records and Inspection

 

4.5.1                   Each Party, their Affiliates, subcontractors or sublicensees, shall keep full and accurate records and books of account with respect to all elements that determine the Net Sales, the price (clause 4.1) and costs (clause 4.3), in sufficient detail to permit computation of the royalties and other amounts payable by Sobi to TiGenix hereunder.

 

4.5.2                   Each Party has the right, at any time during the term of this Agreement and for a period of two years thereafter, at its expense, to have inspected by a certified accounting firm as such Party may designate, the other Party’s records and books of account with respect to all elements that determine the Net Sales, the price (clause 4.1) or costs (clause 4.3) during reasonable business hours , so as to verify compliance by the other Party with the terms and conditions of this Agreement.

 

4.5.3                   In the event any report of royalties or other amounts payable submitted or stated to the other Party hereunder is determined in the course of any inspection to be inaccurate in any material respect prejudicial to either TiGenix or Sobi, the owing Party shall pay or refund any such royalties due or other amounts payable with interest according to clause 4.4.4 hereof and, if applicable, shall reimburse the other Party for the costs of such inspection under clause 4.5.2.

 

4.5.4                   Each Party shall render all necessary assistance and cooperation to facilitate such inspection and shall make available to the other Party’s representatives all records and books of account with respect to all elements that determine the Net Sales, the price (clause 4.1) and costs (clause 4.3) and shall instruct its employees to act accordingly.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

13

 

4.6                            No further payments

 

4.6.1                   Except as herein specifically set forth, neither Party shall be obliged to reimburse the other Party for any services or assistance, the other Party’s performance of its obligations hereunder, use of resources, or any other costs, fees or similar.

 

5                                      The ChondroCelect Process

 

5.1                            The ChondroCelect Process consists of the following steps/procedure, which are set out in more detail in Schedule 3 and Schedule 4:

 

5.1.1                   Transportation of the Biopsy-kit from the Manufacturing Facility to the Hospital, under a valid Tissue Establishment License if and where such license is legally required, by a validated carrier (more details set out below under clause 2 of Schedule 4);

 

5.1.2                   Donation and Procurement of Knee Cartilage from a Patient by a Surgeon at the Hospital (more details set out below under clause 3 of Schedule 4);

 

5.1.3                   Collection of the Knee Cartilage and blood samples in the Biopsy-kit, under a valid Tissue Establishment License if and where such license is legally required (more details set out below under clause 3 of Schedule 4);

 

5.1.4                   Ordering of the Product (more details set out below under clause 4 of Schedule 4);

 

5.1.5                   Transportation of the Knee Cartilage and the blood samples in the Biopsy-kit from the Hospital to the Manufacturing Facility, under a valid Tissue Establishment License if and where such license is legally required, by a validated carrier (more details set out below under clause 4 of Schedule 4);

 

5.1.6                   Donor testing by the Designated Laboratory, under a valid Tissue Establishment License if and where such license is legally required (more details set out below under clause 5 of Schedule 4);

 

5.1.7                   Acceptance and release of the Knee Cartilage by the relevant Tissue Establishment for processing to ChondroCelect (more details set out below under clause 5 of Schedule 4);

 

5.1.8                   Processing by the manufacturer at the Manufacturing Facility of the Knee Cartilage to ChondroCelect (more details set out below under clause 6 of Schedule 4);

 

5.1.9                   Release of the Product for sale by the Marketing Authorisation holders’ qualified person responsible for batch certification and release in accordance with the Marketing Authorisation;

 

5.1.10            Transportation of ChondroCelect in an Implantation-kit from the Manufacturing Facility to the Hospital, by a validated carrier (more details set out below under clause 7 of Schedule 4); and

 

5.1.11            Autologous Implantation of ChondroCelect in the Patient at the Hospital by a Surgeon.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

14

 

6                                      Product Specification Compliance

 

6.1                            If Sobi or the Hospital has reasonable cause to believe that a particular ChondroCelect batch (the “Notified Product”) is deficient (i.e., is suspected not to meet quality or safety requirements), Sobi must notify TiGenix thereof in accordance with clause 9.2 upon becoming aware of this presumed deficiency and document the reasons for the suspected deficiency. TiGenix shall be entitled to request to examine the ChondroCelect batch concerned, if appropriate.

 

6.2                            If the Parties fail to agree whether the Notified Product(s) is/are deficient, the Parties shall mutually select an independent expert, who will be subject to confidentiality obligations at least as stringent as the ones included in this Agreement, to evaluate whether the Notified Product(s) has/have been appropriately released according to Eudralex Volume 4, annex 16. During this evaluation and in the conclusion, the independent expert shall not disclose any Confidential Material of TiGenix that was not already disclosed to Sobi in the framework of this Agreement. The evaluation of the independent expert shall be binding on the Parties.

 

6.3                            If it is determined by TiGenix or by the independent expert in accordance with clause 6.2 that the ChondroCelect batch concerned was effectively deficient at the time of delivery of the Product to the Hospital, then TiGenix will at Sobi’s discretion, either:

 

6.3.1                   replace the Notified Product and reimburse all costs directly related to the Notified Product borne by Sobi, or

 

6.3.2                   allow a full credit to Sobi in respect of the Notified Product and all costs directly related to the Notified Product borne by Sobi.

 

6.4                            If Sobi has reasonable cause to believe that a systematic and consistent breach of cGMP guidelines occurs during manufacturing, Sobi must notify TiGenix thereof upon becoming aware of this presumed systematic and consistent breach of cGMP guidelines, and document the reasons for the suspected breach. If the Parties fail to agree on this presumed breach, the Parties shall mutually select an independent expert, who will be subject to confidentiality obligations at least as stringent as the ones included in this Agreement, to evaluate the existence and extent of this presumed breach. During this evaluation and in the conclusion, the independent expert shall not disclose any Confidential Material of TiGenix that was not already disclosed to Sobi in the framework of this Agreement. The evaluation of the independent expert shall be binding on the Parties. If a breach has been determined by the independent expert, both Parties shall discuss implementation of corrective actions and TiGenix shall ensure implementation of such corrective actions within a time as agreed by the Parties.

 

7                                      Adverse event reporting

 

7.1                            Sobi shall inform TiGenix about all safety information which comes to its attention within three (3) calendar days from first awareness. TiGenix shall maintain the global safety database for the Product. TiGenix shall maintain the pharmacovigilance system for the Product according to European legislation, including the establishment of a European qualified person for pharmacovigilance. TiGenix shall be responsible for all regulatory reporting in the EU. Sobi shall be responsible for regulatory reporting in countries in the Territory outside the EU. In addition to the aforementioned, the Parties shall enter into a separate pharmacovigilance agreement, setting

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

15

 

out the Parties’ further mutual obligations in respect of pharmacovigilance, in accordance with applicable laws, rules and regulations.

 

8                                      Traceability

 

8.1                            Sobi shall, and shall in the Hospital Agreements oblige the Hospitals to, comply with all applicable laws and regulations relating to the traceability of the Knee Cartilage and ChondroCelect for the time it is under Sobi’s or the Hospital’s control and that the applicable SOP on traceability is complied with.

 

8.2                            TiGenix shall set up a unique coding system, based on a unique lot number (recorded on the Biopsy-kit) combined with the Patient number and Patient initials (the “Unique Code”). TiGenix shall through the Unique Code have traceability on which unique lot has been sent to which Hospital.

 

8.3                            Sobi shall, and shall in the Hospital Agreements oblige the Hospitals to, each for the part of the information under their control, establish and maintain a system of traceability that contains sufficient detail to allow linking of each ChondroCelect to the Patient who received it and vice versa, and can at all times be linked to the Unique Code which refers to the Knee Cartilage (as indicated on the Biopsy-kit) and the medicinal product resulting from it. The Unique Code shall be the only code communicated to TiGenix at any given time.

 

8.4                            Sobi shall, and shall in the Hospital Agreements oblige the Hospitals to, each for the part of the information under their control, ensure that at least the following information can be retrieved by using the Unique Code: (i) the Patient’s relevant personal data, (ii) the institution where the tissue material was retrieved, (iii) the date and time of the retrieval of the tissue material, (iv) the characteristics of the tissue material, (v) the purpose for which the tissue material may be used (i.e. treatment of the Patient with ChondroCelect), (vi) the necessary instructions for storage and use, (vii) adverse events if any, (viii) substances and materials used for transport, if arranged by the Hospital according to requirements under applicable law, (ix) the batch number, (x) the provider of the tissue material and (xi) the name and address of the institution to which the tissue material was delivered (i.e. TiGenix). In this respect, Sobi should only receive the Unique Code and coded Patient data (whereby “coded Patient data” means data that do not allow Sobi to identify the Patient concerned without intervention of the Hospital which holds the key to the Unique Code). Any other personally identifiable information regarding Patients should be communicated directly between the Hospital and TiGenix (for purposes of which Sobi shall include appropriate provisions in the Hospital Agreements).

 

8.5                            Sobi shall in the Hospital Agreements oblige the Hospital to keep the key for decoding the data of the Patient, including at least (i) donor identification, (ii) age and sex, (iii) signed Informed Consent Form and (iv) copy of the Laboratory Test results, for a period of 30 (thirty) years after clinical use.

 

8.6                            Sobi undertakes, and shall in the Hospital Agreements oblige the Hospitals to undertake, unless required by law not to communicate to any Third Party any data identifying the Patient other than the Unique Code and to process any Patient data pursuant to the applicable law.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

16

 

9                                      ChondroCelect Recall and Complaints

 

9.1                            Each Party shall inform the other immediately by telephone (immediately confirmed in writing) in the event of any circumstances giving rise to a possible or actual recall of any ChondroCelect in the Territory, in accordance with the applicable SOP.

 

9.2                            Sobi shall report to TiGenix any product complaints related to the Product and keep a list hereof. Sobi shall report the Product complaints to TiGenix as soon as possible but no later than 2 (two) working days after becoming aware of such Product complaints using the applicable complaint form.

 

9.3                            TiGenix has the right (irrespective of any power granted by law to the Regulatory Authority or any other authority in the Territory) on the grounds of public health and safety to recall any ChondroCelect at any time, and Sobi shall promptly carry out such a recall requested by TiGenix.

 

9.4                            Sobi shall cooperate with TiGenix for the purpose of effecting any recall of ChondroCelect, which in TiGenix’ opinion is necessary.

 

9.5                            Sobi shall inform the local authorities about any Product defects after information received from TiGenix in conformity with the local administrative regulations.

 

9.6                            TiGenix shall bear all costs and expenses of a recall, save for such recalls in the Territory resulting from the negligence or breach of this Agreement by Sobi. For the purposes of this Agreement, costs and expenses of a recall include the expenses of notification and destruction or return of the ChondroCelect recalled.

 

10                               Sobi’s additional duties and obligations

 

10.1                     Regulatory and Procedures

 

10.1.1            Sobi shall be the holder of and maintain (i) a Tissue Establishment License, if and where legally required in the Territory, (ii) a License for Pharmaceutical Wholesale Distribution; and (iii) any other Regulatory Approvals, including corresponding analysis, licenses or other permits, required to perform its obligations under this Agreement in the Territory and comply with all related local legislation.

 

10.1.2            The Parties recognize that the national requirements for Tissue Establishment Licenses (including import/export of Knee Cartilage and Biopsy-kits) may be different and when determining which Party between Sobi and TiGenix might be obliged to hold a Tissue Establishment License, this will be determined based on the Parties’ respective obligations under this Agreement. Notwithstanding the aforementioned, the decision to obtain any new Tissue Establishment License after the Commencement Date shall be the sole decision of each Party. In the event a Tissue Establishment License is necessary in a country in the Territory and the Party who, after the Commencement Date and based on the Parties’ respective obligations under this Agreement, should obtain the Tissue Establishment License decides not to obtain it, then Products will not be sold in such country.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

17

 

10.1.3            The Parties recognize that certain countries in the Territory may require import or export licenses for the Product.. If a country requires a license for import or export in a country in the Territory, Parties shall determine which Party between Sobi and TiGenix should hold such license based on the Parties’ respective obligations under this Agreement. Notwithstanding the aforementioned, the decision to obtain any such license shall be the sole decision of each Party. In the event a license for import or export is necessary in a country in the Territory and the Party who, based on the Parties’ respective obligations under this Agreement, should obtain the license decides not to obtain such license (and no Third Party will hold it), then Products will not be sold in such country.

 

10.1.4            Sobi acknowledges that the Product is currently only registered in the EU. TiGenix shall decide in its sole discretion if, when and where it wishes to register the Product outside the EU.

 

10.1.5            Outside of the EU, but within the Territory, Sobi is allowed to sell the Product in compliance with applicable laws and all of Sobi’s obligations under this Agreement, to the extent this does not require registration of the Product by TiGenix outside of the EU.

 

10.1.6            In addition to the above, if Sobi wishes that TiGenix registers the Product in any country outside the EU where TiGenix has not yet registered the Product, the Parties will meet to discuss the matter in good faith. For the avoidance of doubt, TiGenix shall be under no obligation to register the Product in any country outside the EU.

 

10.1.7            Sobi shall collaborate with TiGenix and provide to TiGenix as soon as reasonably possible upon a request thereto by TiGenix any information and/or documentation that TiGenix may require from Sobi in order to comply with the Belgian production establishment legislation. This includes (without being limited to):

 

(i)                                  Information regarding Hospitals, training of Sobi personnel, Surgeons and Healthcare Providers (more in particular: confirmation of all training delivered to Hospitals and list of trained Surgeons), donor selection, informed consent, storage conditions of Biopsy-kits and Biopsies, etc.

 

(ii)                               Information regarding traceability, quality and confidentiality of data management, etc.

 

10.1.8            Sobi shall comply with TiGenix’ logistics and documentation systems, as included in the applicable SOPs and the User Manual, and in the Hospital Agreements oblige the Hospitals that any Hospitals involved in the administration of ChondroCelect to patients also implement the currently valid SOP’s, including but not limited to the SOP’s on Procurement, Biopsy and Traceability (as attached as Schedule 4).

 

10.1.9            Sobi shall ensure that, or in the Hospital Agreements oblige the Hospitals to ensure that, as applicable, all requirements necessary for TiGenix to start with the processing of the Knee Cartilage, as set out in the relevant SOPs, are fulfilled, including, but not limited to:

 

(i)                                  the confirmation that the Informed Consent Form was signed by the Patient prior to the Biopsy; and

 

(ii)                               the confirmation that the patient order form was signed by a Surgeon.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

18

 

10.2                     Marketing of ChondroCelect

 

10.2.1            Sobi shall determine the price to the market of the Product. Sobi shall where commercially reasonable and by using commercially reasonable efforts to maintain existing pricing and reimbursement approvals, and, where commercially reasonable, to obtain additional pricing and reimbursement approval where applicable in the Territory.

 

10.2.2            Sobi may make the Product available for sale in countries in the Territory without Marketing Authorization and apply for and manage the necessary approvals to sell or otherwise make available the Product in these countries, including named patient and compassionate use programs.

 

10.2.3            Sobi shall use its commercially reasonable efforts to perform market development activities to promote, market and sell ChondroCelect in the Territory for the Indication, to achieve at least the Minimum Sales agreed upon, and to stimulate and increase interest in ChondroCelect in the Territory in accordance with market practices.

 

10.2.4            Sobi will annually create a brand plan for the marketing and sales of the Product, including without limiting strategic plans for marketing campaigns and expansion into new countries.

 

(i)

 

10.2.5            Sobi shall submit to TiGenix, on a quarterly basis, the following information:

 

(i)                                  an inventory of the contacts with Hospitals;

 

(ii)                               the topline summary of the promotional initiatives undertaken;

 

(iii)                            any negative publicity, Regulatory Authority’s observations, technical problems and suggestions for improvements;

 

(iv)                           topline summary of the planned promotional initiatives;

 

(v)                              the overall state of the market; and

 

(vi)                           a report of quarterly sales.

 

10.2.6            Sobi shall enter into contracts with Hospitals (as specified under 10.3), manage orders from (as specified under Schedule 3 and Schedule 4) and invoices to the Hospitals, organise medical training of and provide proper instructions to Hospitals regarding the use of Products.

 

10.3                     Relations with Hospitals

 

10.3.1            Sobi agrees to act in accordance with the User Manual and applicable SOPs and shall conduct and maintain its business in strict compliance with all applicable laws, regulations and rules of any and all applicable government authorities.

 

10.3.2            Sobi shall, with a view to selling the Product to customers to perform the ChondroCelect Process, contract hospitals in the Territory in accordance with the requirements in Schedule 7 (the “Hospital Agreement Requirements”).

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

19

 

10.3.3            Sobi shall make available technically skilled staff which will be trained by TiGenix in accordance with the User Manual, to enable said staff to train surgeons and other healthcare providers in the Hospitals in accordance with the applicable SOPs.

 

10.3.4            Sobi shall comply with TiGenix’ logistics and documentation systems as set out in the relevant SOPs and under the Hospital Agreements oblige the Hospitals involved in the administration of ChondroCelect to Patients to implement the applicable SOPs including but not limited to the SOPs on Procurement, Biopsy and Traceability.

 

10.3.5            Sobi shall under the Hospital Agreements oblige the Hospitals and facilitate implementation of all required procedures, reporting and communication by the Hospital.

 

10.3.6            Except for Hospitals in Belgium and the Netherlands (where TiGenix shall provide local customer support):

 

(i)                                  Sobi shall provide local customer support and act as link between the Hospitals and TiGenix, and

 

(ii)                               TiGenix shall not be in contact directly with the Hospitals (except for receiving and verifying personal patient data required under the Tissue Establishment License and/or as otherwise agreed between the Parties), but only with central customer support at Sobi.

 

Communication between TiGenix and Sobi will be in English.

 

10.3.7            Sobi shall grant TiGenix the right to inspect on its own expense the Hospital facilities within working hours and with reasonable notice.

 

10.3.8            Sobi shall make sure that the Hospital Agreements shall include:

 

(i)                                  all obligations of the Hospitals contained in this Agreement, and

 

(ii)                               that the Hospitals shall comply with all legislation applicable to them.

 

10.4                     General

 

10.4.1            Sobi shall, based on materials provided by TiGenix hereunder, develop all training material, documentation, forms, manuals, official documents and marketing material. Any such documents and materials which shall be used towards a Third Party shall be approved by TiGenix as Marketing Authorisation holder in accordance with the conditions of the Marketing Authorisation and applicable law and in accordance with the following review and approval process:

 

(i)                                  Sobi can from pre-existing materials develop translations of pre-existing and signed-off documents (e.g. detail-aid, user manual, technical guides, patient guide, etc) without TiGenix approval but subject to notification of the materials to TiGenix, so that TiGenix is at all times aware of what is being communicated to Third Parties, and

 

(ii)                               Sobi can x) propose changes to the User Manual and y) develop new materials (e.g. invitation for congress, symposium slide show, interview with expert in local medical paper, new detail-aid, new patient materials, etc) only with the prior

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

20

 

written approval of (the responsible person promotional communications within) TiGenix

 

TiGenix shall review such documents and materials and provide comments to Sobi within ten (10) working days from receipt. If no changes are required to be made, TiGenix shall give approval within ten (10) working days from receipt. In the event changes are required, Sobi shall provide TiGenix with revised documents and materials, which TiGenix will subsequently review as soon as practicably possible and in any case within ten (10) working days from receipt of the revised documents and materials. This is repeated until TiGenix has no more comments on the documents and materials, after which TiGenix shall give approval within five (5) working days from receipt of the last revised documents and materials. In no event shall any documents or materials be considered approved without the explicit written approval of TiGenix. Where Sobi develops educational materials in languages other than the languages for which TiGenix has provided/approved the materials, it shall be responsible for the correct translation and, if applicable outside of the scope of TiGenix’ current Marketing Authorisation, for obtaining approval by the relevant Regulatory Authority of the materials in such other languages.

 

10.4.2            Sobi shall ensure that all marketing materials are in line with the scientific data and applicable legislation. Sobi will keep local catalogue texts in the Territory, if applicable, updated.

 

10.4.3            Sobi shall respect TiGenix’ limitations of liability and indemnification, as well as TiGenix’ limited warranties as indicated on the Product and in this Agreement, and not make any representation (regarding the ChondroCelect Process or anything else) to any Third Party (including Hospitals and Patients) that is broader than TiGenix’ liability or TiGenix’ representations and warranties as set out on the Product or in this Agreement.

 

10.4.4            In no event shall Sobi, unless duly authorised, act in any way whatsoever to pledge TiGenix’ credit, make any promise, warranty or representation on behalf of TiGenix or express any opinion on behalf of TiGenix.

 

10.4.5            Sobi shall be solely responsible for all approvals, registrations, filings, social security contributions, insurance fees, taxes, charges or any other dues related to or arising out of the performance of this Agreement by Sobi in the Territory. Sobi shall in accordance with clause 10.1.1 hold Regulatory Approvals necessary for the performance of its obligations under this Agreement. TiGenix shall at its own expense co-operate fully with and assist Sobi if such co-operation or assistance is necessary to permit Sobi to fulfil these obligations, including giving Sobi such regulatory support and provide Sobi with such documentation as may be required by local laws and regulations (provided that TiGenix shall not be obliged to produce any documentation it does not already have or is obliged to have according to applicable laws and regulations). All statements made by Sobi regarding ChondroCelect or the ChondroCelect Process with regard to said Regulatory Approvals shall be subject to prior written approval (which can be given by e-mail) from TiGenix.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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11                               TiGenix’ additional duties and obligations

 

11.1                     Regulatory and Procedures

 

11.1.1            TiGenix shall be Marketing Authorization holder of the Product in the European Union, and shall maintain ownership over the Marketing Authorization in the European Union. In accordance with clause 10.1.4, TiGenix shall decide in its sole discretion if, when and where it wishes to register the Product in the remainder of the Territory. As long as TiGenix decides not to register the Product in any country outside the European Union, it may be that there is no Marketing Authorization holder of the Product in the remainder of the Territory.

 

11.1.2            Sobi has an option to take over the Marketing Authorization for ChondroCelect after 2 (two) years, in which event the Parties will negotiate in good faith a separate amendment to this Agreement. Such amendment shall include, without limiting, amendments and revisions of provisions regarding assignment of the Marketing Authorization and efforts to effectuate such transfer, indemnification, financial compensation between the Parties including Royalty Rate and costs, pharmacovigilance, quality, recalls, release of Product, audits and Hospital Agreement Requirements. Should Sobi wish to exercise the option to acquire the Marketing Authorization, it shall notify TiGenix and the Parties shall without undue delay initiate good faith negotiations to amend this Agreement accordingly.

 

11.1.3            TiGenix shall be the holder of and maintain (i) a Tissue Establishment License, if and where legally required in the Territory to perform its obligations under this Agreement in the Territory and comply with all related local legislation. The Parties recognize that the national requirements for Tissue Establishment Licenses may be different and when determining which Party between Sobi and TiGenix might be obliged to hold a Tissue Establishment License, this will be determined based on the Parties’ respective obligations under this Agreement. Notwithstanding the aforementioned, the decision to obtain any new Tissue Establishment License after the Commencement Date shall be the sole decision of each Party. In the event a Tissue Establishment License is necessary in a country in the Territory and the Party who, after the Commencement Date and based on the Parties’ respective obligations under this Agreement, should obtain the Tissue Establishment License decides not to obtain it, then Products will not be sold in such country.

 

11.1.4            Notwithstanding clause 11.1.3, TiGenix shall be the holder of and maintain a Tissue Establishment License in Belgium (known as “production establishment license”), for as long as a Belgian production establishment license is required for purposes of this Agreement and comply with all related legislation.

 

11.1.5            TiGenix shall be responsible for management of supply and logistics (to the extent specified below), as well as for manufacturing and release of the Product.

 

11.1.6            TiGenix shall be responsible for all central regulatory and pharmacovigilance duties derived from being Marketing Authorization holder and shall fulfil any regulatory and/or other obligations or requirements imposed by EMA with a view to maintaining the Marketing Authorization including without limiting central pharmacovigilance

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

22

 

responsibilities (as specified in the pharmacovigilance agreement to be entered into between the Parties prior to the Closing Date) and post marketing commitments, with the exception that, if [***], the Parties will determine together the economic feasibility and responsibility of such a request and, if no agreement can be reached, be entitled to terminate this agreement.

 

11.1.7            TiGenix shall provide Sobi with (i) all relevant Product information (including but not limited to medical information including medical Q&A) (provided that TiGenix shall not be obliged to produce any documentation it does not already have or is obliged to have according to applicable laws and regulations), and (ii) with information about any variations submitted to Regulatory Authorities which may affect the manufacturing, distribution, marketing or sales of the Product, as needed for Sobi to fulfil its responsibilities according to this Agreement.

 

11.1.8            TiGenix shall provide to Sobi the marketing materials used by TiGenix at the Commencement Date and any marketing guidelines regarding promotion of the Product and the ChondroCelect Process and use of the Trade Marks.

 

11.2                     Manufacturing and Logistics

 

11.2.1            TiGenix shall be responsible for manufacturing and release of the Product in accordance with the ChondroCelect Specifications and cGMP. TiGenix shall ensure that prior to pick-up of the Implantation-kit, the Product has been released by the qualified person in accordance with the Marketing Authorization. Manufacturing will only commence after the Knee Cartilage Biopsy has been released by the Tissue Establishment according to the currently valid SOP and all other requirements have been fulfilled, including but not limited to the verification of the Informed Consent Form of the Patient and verification of the Laboratory Test results.

 

11.2.2            TiGenix shall provide local customer support for Hospitals in Belgium and the Netherlands.

 

11.2.3            TiGenix shall manage logistical co-ordination with the courier (for the transportation of Biopsy-kits, Biopsies, and Products in Implantation-kit), the Manufacturing Facility and Sobi’s central customer support. .

 

11.2.4            TiGenix shall perform initial ChondroCelect Training on the Product to Sobi key personnel, as specified in Schedule 8 and thereafter as mutually agreed between the Parties.

 

11.2.5            TiGenix shall provide Sobi with general training material, documentation, forms and updates thereof as needed for the Biopsy and Implantation in English with the understanding that Sobi shall remain responsible for all national documentation needed in the Territory as specified in clause 10.4.1

 

11.2.6            All transportation of Biopsy-kits, Knee Cartilage and/or the Product shall be carried out in accordance with applicable laws including cGDP, the User Manual, and the then valid SOPs.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

23

 

11.2.7            In the event the logistical partners used by TiGenix raise material concerns in terms of quality of service or because their prices are unreasonably high, the Parties shall discuss and in good faith try to find a solution.

 

11.2.8            TiGenix shall inform Sobi of any proposed amendments to existing courier agreements or the introduction of any proposed new couriers in advance and shall give Sobi the opportunity to review and provide comments on the proposed amendments or new couriers and TiGenix shall take into account any reasonable comments. Changes to a courier agreement which are required by applicable laws and regulations are in TiGenix sole discretion to include. Changes to a courier agreement which are not required by applicable law or regulations require Sobi’s prior approval, such approval not to be unreasonably withheld.

 

11.3                     General

 

11.3.1            TiGenix shall in all obligations under this Agreement act in accordance with the User Manual and applicable SOP’s and shall conduct and maintain its business in strict compliance with all laws, regulations and administrative rules of any competent Governmental Authority, including without limiting applicable to or governing or controlling the processing of knee cartilage in any relevant jurisdiction, including manufacturing (or having manufactured) ChondroCelect in accordance with the requirements of good manufacturing practice (CGMP) and the ChondroCelect Specifications.

 

11.3.2            TiGenix shall promptly inform Sobi of any material facts or opinions relevant to the marketing of ChondroCelect in the Territory that it has become aware of.

 

11.3.3            In no event shall TiGenix, unless duly authorised, act in any way whatsoever to pledge Sobi’s credit, make any promise, warranty or representation on behalf of Sobi or express any opinion on behalf of Sobi.

 

11.3.4            Any personnel performing the obligations TiGenix has assumed under this Agreement are employed, subcontracted, managed, controlled and the sole responsibility of TiGenix. Sobi’s sole compensation to TiGenix for its performance of these obligations is specified under clause 4 of this Agreement. Without limiting the generality of the aforementioned, Sobi does not assume any Liabilities under or relating to (A) any employee benefit plan, or relating to wages, bonuses, payroll, vacation, sick leave, workers’ compensation, unemployment benefits, pension benefits, employee stock option or profit sharing plans, health care plans or benefits, phantom stock, deferred compensation or other similar plan or arrangement, or any other employee plans or benefits of any kind, in each case, which TiGenix has entered into, maintains or administers to which TiGenix has or may have any Liability, and, (B) any actual or alleged violation by TiGenix of any equal employment or employment discrimination laws.

 

12                               Closing and Assigned Agreements

 

12.1                     Upon the terms and subject to the conditions set forth in this Agreement, at the Closing Date, TiGenix assigns to Sobi all its right, title and interest in the Assigned Agreements, excluding the Excluded Liabilities, and Sobi accepts such assignment from TiGenix.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

24

 

12.2                     Notwithstanding anything contained in this Agreement to the contrary, TiGenix shall retain and be fully responsible for paying, performing and discharging when due, and Sobi shall not assume or have any responsibility for any of the following Liabilities which shall be excluded from the assignment in clause 12.1 (“Excluded Liabilities”):

 

12.2.1            any Liabilities arising out of any claim for injury to any Person that resulted from the use of Products manufactured and sold (or otherwise provided by TiGenix for patient use) prior to the Closing Date; and

 

12.2.2            any Liabilities for rebates, discounts, chargebacks, adjustments and returns of Product sold prior to the Closing Date.

 

12.3                     At the Closing Date, TiGenix shall deliver to Sobi (i) an unredacted, fully executed copy of each of the Assigned Agreements and (ii) such other instruments of conveyance or documents, in form and substance reasonably acceptable to TiGenix and Sobi, as may be necessary to convey the Assigned Agreements from TiGenix to Sobi.

 

12.4                     TiGenix recognizes that the Assigned Agreements have been drafted without consideration to this Agreement and that certain obligations are not included in the Assigned Agreements, including the Hospital Agreement Requirements and other obligations under this Agreement which require that the Hospitals perform certain obligations. Sobi shall not in any way be liable for any failure to comply with the provisions of this Agreement if compliance with such provisions would require performance of the Hospitals under the Assigned Agreements and such Assigned Agreement(s) do not impose the necessary obligations on the Hospital(s).

 

12.5                     Any hospitals listed under Schedule 6 which as of the Closing Date have not been assigned shall be governed by the provisions in Schedule 8 bis.

 

12.6                     Unless otherwise explicitly set forth under this Agreement, the following clauses shall not be applicable until the Closing Date: 2.1-3, 4, 7, 8, 9, 10.1-3, 10.4.3-5, 11.2.1-2, 11.2.5-7, 12.1-4, 13, 15.3-4, 21 and 22.

 

13                               Forecasts, ordering, delivery and minimum sales

 

13.1                     Sobi shall provide TiGenix with binding forecasts and non-binding estimates of the volumes of Products to be purchased, as set in Schedule 2b.

 

13.2                     Minimum Sales

 

13.2.1            The minimum quantity of Products to be sold in the Territory (“Minimum Sales”) is set forth in a table in Schedule 11.

 

13.2.2            If the Minimum Sales are not met during [***], TiGenix is entitled to unilaterally render this Agreement non-exclusive towards Sobi or terminate this Agreement. In such case, Sobi shall use commercially reasonable efforts to transfer the pricing reimbursements, as well as any pricing and reimbursement approvals, permits or other authorizations which may have been obtained in the name of Sobi or jointly in the name of TiGenix and Sobi

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

25

 

pursuant to this Agreement, to either TiGenix or any other Third Party to whom TiGenix would grant a license for the Territory, as quickly as possible.

 

13.2.3            Ordering of the Product is made in accordance with the process specified in Schedule 2c and Schedule 4.

 

14                               Technical Information

 

14.1                     TiGenix, at its expense, will make available to Sobi all information relating to the Product and the Technology which is required for the performance under this Agreement and to the extent TiGenix has the right to divulge the information, including without limiting information necessary to obtain pricing and reimbursement for the Product and the ChondroCelect Process.

 

14.2                     Nothing in this Agreement shall oblige TiGenix to make available to Sobi any information, technical or otherwise, which is in any way referable to the manufacture or formulation of ChondroCelect or the processing of the Knee Cartilage unless otherwise required by applicable laws or regulations or necessary permits, including but not limited to the License for Pharmaceutical Wholesale Distribution.

 

14.3                     Sobi may use any technical information made available to it pursuant to this clause only for fulfilling its obligations under this Agreement. Sobi must not use any of the technical information made available to it for any purpose after this Agreement unless otherwise required by applicable laws or regulations or necessary permits, including but not limited to the License for Pharmaceutical Wholesale Distribution.

 

15                               Intellectual Property Rights

 

15.1                     Ownership of Sobi IPR

 

15.1.1            TiGenix recognises that Sobi, or its Affiliates, may own or Control certain IPR related to subject matter that was created by or on behalf of Sobi outside of the performance of this Agreement or under the performance of this Agreement but not relating to the Product or the ChondroCelect Process, whether or not prior to or during the term of this Agreement (“Sobi Background IPR”) and that such Sobi Background IPR remains the exclusive property of Sobi or, where applicable, of Sobi’s Affiliates.

 

15.1.2            If under the performance of this Agreement and within the scope of the license provided under clause 15.3.1, Sobi, or its Affiliates, create IPR which can be used in respect of the Product or the ChondroCelect Process and such IPR was created based on Sobi Background IPR, hence qualifying as an improvement to the Sobi Background IPR, then such IPR remains the exclusive property of Sobi or, where applicable, of Sobi’s Affiliates.

 

15.1.3            TiGenix, its Affiliates, subcontractors or sublicensees shall not register any of the Sobi Background IPR or any of the IPR referred to in clause 15.1.2 (in particular Sobi’s unregistered IPR).

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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15.1.4            Unless expressly provided otherwise in this Agreement, no provision of this Agreement shall constitute or be deemed to constitute a grant to TiGenix, its Affiliates, subcontractors or sublicensees, of any license or full or partial assignment of Sobi Background IPR.

 

15.1.5            Only in case Sobi, or its Affiliates, would apply (part of) the Sobi Background IPR or the IPR referred to in clause 15.1.2 for the rendering of services under this Agreement, Sobi, or its Affiliates, hereby grants to TiGenix a non-exclusive, sub-licensable, non-assignable, fully paid up license to use such Sobi Background IPR and the IPR referred to in clause 15.1.2 (i) during the term of this Agreement to the extent necessary or useful for TiGenix to perform its obligations or enjoy its rights under this Agreement (it being understood that TiGenix cannot sub-license such IPR to competitors of Sobi) and (ii) following the term of this Agreement to the extent necessary or useful for TiGenix to sell, have sold, distribute, market and promote the Product.

 

15.2                     Ownership of TiGenix IPR

 

15.2.1            Sobi, as well as its Affiliates, recognize that (i) the Technology and the Trade Marks; and (ii) any other IPR from TiGenix or TiGenix’ Affiliates, are and remain the exclusive property of TiGenix or where applicable of TiGenix’ Affiliates.

 

15.2.2            All documents, data, drawings, plans, designs, documentation, texts, manuals, reports, tools, know how, and all other work that have come or will come into existence as a result of the performance of this Agreement and which relate to the Product or the ChondroCelect Process and which is not Sobi Background IPR or IPR referred to in clause 15.1.2, and whether or not created through the joint intervention of TiGenix, Sobi, its Affiliates, subcontractors or sublicensees or otherwise following the directions of TiGenix (hereinafter referred to as “Works”) belong exclusively to and remain with TiGenix. All IPR in the Works are immediately and exclusively transferred and assigned to TiGenix as from their coming into existence. Sobi shall, at its own cost, perform (or procure the performance of) all further acts and things, and execute and deliver (or procure the execution and/or delivery of) all further documents, required by law or which TiGenix requests to vest in TiGenix the full benefit of the right, title and interest assigned to TiGenix under this Agreement. Such transfer and assignment of all IPR include but is not limited to the transfer and assignment of the right to reproduce, adapt, translate, modify, distribute, rent, lend, make available the Works to the public, partially or completely, in each and any way, whether private or public, for internal - including but not limited to research and development - and external use. The transfer and assignment of rights is valid for commercial or non-commercial purposes, final for each and every form of exploitation and for all countries. Sobi shall grant to TiGenix such rights on IPR owned or controlled by Sobi or licensed to Sobi by a Third Party sufficient to allow TiGenix the full benefit of the terms of this Agreement. Sobi and its Affiliates are hereby granted a license for the Term of this Agreement to use the Works for the performance under this Agreement.

 

15.2.3            Sobi, its Affiliates, subcontractors or sublicensees shall not register any of the Technology (in particular TiGenix’ unregistered IPR) or Trade Marks.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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15.2.4            Unless expressly provided otherwise in this Agreement, no provision of this Agreement shall constitute or be deemed to constitute a grant to Sobi, its Affiliates, subcontractors or sublicensees, of any license or full or partial assignment of IPR of TiGenix or of its Affiliates.

 

15.3                     License

 

15.3.1            Sobi is hereby during the term of this Agreement granted a sole sub-licensable license to apply the Technology and to use the Trade Marks as is necessary or useful to sell, have sold, promote, market and distribute the Product in the Territory in accordance with the terms of this Agreement. For the avoidance of doubt:

 

(i)                                  In accordance with clause 2.1, Sobi, including its Affiliates, shall have the exclusive right (exclusive even to TiGenix) to sell, distribute, market, promote and file for pricing and reimbursement of the Product in the Territory;

 

(ii)                               TiGenix shall not be restricted from itself using the Technology and the Trade Marks, whether inside or outside of the Territory; and

 

(iii)                            TiGenix shall be allowed to outsource and subcontract its rights and obligations under this Agreement to Third Parties, whether inside or outside of the Territory; For the avoidance of doubt, TiGenix shall remain directly responsible for the acts of its subcontractors.

 

15.3.2            The license granted under 15.3.1 shall be sublicensable to any other third party (i) upon the prior written consent of TiGenix, (ii) under the same limitations as the license granted to Sobi in this Agreement, and (iii) on the terms of clause 2.2, it being understood that these conditions apply cumulatively.

 

15.3.3            Unless expressly agreed otherwise with TiGenix, Sobi shall not apply the Technology or use the Trade Marks for any purpose other than in the performance of Sobi’s duties under this Agreement. In particular, Sobi shall not use the Technology for research, development or improvement purposes.

 

15.3.4            Sobi shall not impair the Technology or the Trademarks.

 

15.4                     Use of name and marks

 

15.4.1            Sobi shall not employ as part of its trade or corporate name or identification, or identify its business premises, vehicles or documents with any name, mark, symbol or other identifying characteristic owned by or designating TiGenix, other than to perform its obligations under this Agreement. Sobi shall properly identify and accurately describe as a product of TiGenix any of the products manufactured or assembled by TiGenix or which bear a Trade Mark. Sobi shall not alter, remove, deface or mark over a Trade Mark on a Product and, except with prior written consent by TiGenix, shall not add to a Product any other or additional trade mark.

 

15.4.2            Sobi must not use any trade marks which are confusingly similar to the Trade Marks and/or which are likely to cause deception or confusion.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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15.4.3            Sobi shall only apply the Technology and use the Trade Marks as approved by TiGenix in writing (including but not limited in accordance with TiGenix’ brand guidelines, to be added in Schedule 10).

 

15.4.4            Sobi shall not use, reference to, or otherwise employ the TiGenix’ corporate name, except as expressly authorized by TiGenix in writing.

 

15.5                     Third Party infringements and claims

 

15.5.1            Sobi shall promptly notify TiGenix of any actual or suspected infringement of any of the Technology or Trade Marks that comes to its attention. Sobi shall, at TiGenix expense, reasonably co-operate with TiGenix, in connection with any infringement, including, without limitation, legal proceedings. TiGenix shall be responsible for the cost of any legal proceedings it instigates against Third Parties, and, without limiting the applicability of clause 19.1, is entitled to any damages, account of profits and awards of costs recovered.

 

15.5.2            TiGenix shall promptly notify Sobi if it receives notice or is aware of a Third Party claim that the use of the Technology or of the Trade Marks by Sobi would be in breach of such Third Party’s IPR.

 

16                               Publications

 

16.1                     If Sobi wants to publish any publication, presentation or manuscript about TiGenix, the Product and/or the ChondroCelect Process, it shall notify TiGenix at least 60 (sixty) days before submission of the proposed publication, presentation or manuscript and TiGenix shall have the right to review and comment on the proposed publication presentation or manuscript. Sobi shall consider any reasonable comments made by TiGenix, delete any confidential information from the proposed publication, presentation or manuscript and delay the publication with maximum 90 (ninety) days if necessary to protect intellectual property of TiGenix.

 

16.2                     Sobi shall oblige the Hospitals in the Hospital Agreements that if a Hospital wants to publish any publication, presentation or manuscript about TiGenix, the Product and/or the ChondroCelect Process, it shall notify Sobi at least 60 (sixty) days before submission of the proposed publication, presentation or manuscript and TiGenix shall have the right to review and comment on the proposed publication presentation or manuscript. Sobi shall further oblige the Hospitals in the Hospital Agreements to consider any reasonable comments made by TiGenix, to delete any confidential information from the proposed publication, presentation or manuscript and to delay the publication with maximum 90 (ninety) days if necessary to protect intellectual property of TiGenix.

 

16.3                     Whenever one of the Parties has cause for a press release or some other public communication on a subject matter related to the activities governed by this Agreement, then the other Party has the right to review and have final authorisation on the use of their name, any trade marks, or any other sensitive information that is likely to have an impact on their reputation or ability to carry out their business.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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16.4                     TiGenix shall ensure that Sobi is notified in writing of any potential publication, presentation or manuscript in the Territory about the Product and/or the ChondroCelect Process at least 60 (sixty) days before submission.

 

17                               Confidentiality

 

17.1                     The Party receiving Confidential Material (the “Receiving Party”) shall:

 

17.1.1            keep all Confidential Material disclosed to it by or on behalf of the disclosing Party (including through the Hospitals) (the “Disclosing Party”) confidential;

 

17.1.2            use the Confidential Material only for the purpose of this Agreement;

 

17.1.3            not permit Confidential Material to be disclosed other than in confidence to its Affiliates, employees, the Hospitals and subcontractors to the extent strictly necessary for the purposes of this Agreement and under provisions of confidentiality;

 

17.1.4            not copy or reduce to writing the Confidential Material except as reasonably necessary for the purposes of this Agreement or unless otherwise required by applicable laws or regulations or necessary permits, including but not limited to the License for Pharmaceutical Wholesale Distribution;

 

17.1.5            maintain the Confidential Material in a way which provides adequate protection from unauthorized disclosure, copying or use; and

 

17.1.6            destroy or return promptly to the Disclosing Party all documents and materials (and all copies thereof) containing Confidential Material at the end of this Agreement or upon request by the Disclosing Party unless otherwise required by applicable laws or regulations or necessary permits, including but not limited to the License for Pharmaceutical Wholesale Distribution, and provided that the Receiving Party may retain one copy of the Confidential Material for the sole purpose of ensuring compliance with and to the extent required by the terms of this Agreement.

 

17.2                     “Confidential Material” means all information relating to the Disclosing Party’s operations, processes, plans, intentions, product information, know-how, data, formulae, expertise, methodology, drawings, specifications, design rights, trade secrets, market opportunities and business affairs, and any new and novel combinations thereof, disclosed by or on behalf of the Disclosing Party to the Receiving Party in the framework of this Agreement, whether disclosed in writing, verbally or by any other means.

 

17.3                     Confidential Material excludes information which (i) was in the possession of the Receiving Party prior to disclosure hereunder; or (ii) was in the public domain at the time of disclosure or later became part of the public domain without breach of the confidentiality obligations herein contained; or (iii) was disclosed by a Third Party without breach of any obligation of confidentiality owed to the Disclosing Party; (iv) is independently developed by personnel of the Receiving Party; or (v) is required to be disclosed by law or by order of a court of competent jurisdiction, provided, however, that, in so far as is lawful and reasonably practical, the Disclosing Party is

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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granted due advance notice of such a requirement in order to be able to contest the same and then only to the minimum extent of disclosure so required.

 

17.4                     Obligations of non-use and non-disclosure of the Confidential Material shall be in effect during the term of this Agreement and for 3 (three) years after termination or expiration of this Agreement.

 

18                               Representations and warranties

 

18.1                     Each Party represents and warrants that it is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including the right to grant the licenses granted by it hereunder.

 

18.2                     Each Party represents and warrants that it has the full corporate power and authority to enter into this Agreement and that this Agreement constitutes the binding legal obligation of such Party.

 

18.3                     Each Party represents and warrants that the execution, delivery and performance of this Agreement does not: (i) conflict with, nor result in any violation of or Default under, any agreement, to which it is a Party; (ii) conflict with any rights granted to any Third Party or breach any obligation towards any Third Party; nor (iii) violate any law or regulation.

 

18.4                     Each Party represents and warrants that it and its staff members have all governmental consents, registrations, licenses, permits, approvals, permissions and similar governmental authorizations necessary to conduct the activities to be conducted by it under this Agreement and to fulfil its obligations under this Agreement in a professional manner. In particular, Each Party represents and warrants that it has no knowledge of anything that may be a hinder to obtain or maintain the necessary regulatory approvals for the distribution of ChondroCelect in the Territory, the import of the Biopsy-kit, the export of the Knee Cartilage and the blood samples, and the import of the Product in the Implantation-kit in the Territory and the subsequent release of the Product into the market of the Territory or any other required permits or licenses.

 

18.5                     Each Party represents and warrants that its business is carried on in compliance with all applicable legislative conditions and conditions of any applicable governmental authorisations and there are no circumstances or events which prevent full compliance with such conditions of any of the governmental authorizations.

 

18.6                     Additional representations, warranties and covenants by TiGenix. TiGenix hereby represents, warrants and covenants to Sobi that, as of the Commencement Date:

 

18.6.1            To the best of its knowledge, TiGenix is the owner of or Controls the Trade Marks in the Territory and is the owner of or Controls the Technology necessary to make, promote, distribute, sell and use the Product within the Territory;

 

18.6.2            Neither TiGenix nor its Affiliates, nor, to TiGenix’s knowledge, its subcontractors, has received any notice in writing or otherwise has knowledge of any facts which have led TiGenix to believe that any of the Regulatory Approvals relating to the Product are not currently in good standing with the EMA or other Regulatory Authorities;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

31

 

18.6.3            To the knowledge of TiGenix, (a) the Technology consists of valid and enforceable IPR, and (b) there are no facts which would render the IPR encompassed within the Technology, invalid or unenforceable. To the knowledge of TiGenix, no Third Party (i) is infringing any such Technology or has misappropriated any Technology or (ii) has successfully challenged the ownership, scope, duration, validity, enforceability, priority of the Technology;

 

18.6.4            TiGenix (or its Affiliates) is the owner of or Controls the Trade Marks. It has no knowledge of any trade marks or other rights which would prevent the use of the Trade Marks in any of the countries of the Territory;

 

18.6.5            As of the Commencement Date, there are no claims, judgments or settlements against or owed by TiGenix, nor any pending reissue, reexamination, interference, opposition or similar proceedings with respect to the Trade Marks, and TiGenix has not received notice as of the Commencement Date of any threatened claims or litigation or any reissue, reexamination, interference, opposition or similar proceedings seeking to invalidate or otherwise challenge the rights in the Technology or in the Trade Marks;

 

18.6.6            To the knowledge of TiGenix, the use, sale, offer for sale, or importation by TiGenix or Sobi (or their respective Affiliates), as applicable, of the Product in compliance with the terms of this Agreement, (i) does, at the Commencement Date, not infringe any issued Patent of any Third Party and (ii) does not misappropriate any know-how of any Third Party;

 

18.6.7            All Products manufactured and supplied hereunder by, or under authority of, TiGenix shall be manufactured and supplied such that the Product furnished by TiGenix to Sobi under this Agreement:

 

(a)                       shall be manufactured, handled, stored and shipped by TiGenix, in accordance with, and shall conform to, the applicable ChondroCelect Specifications; and

 

(b)                       shall be manufactured, handled, stored and shipped by TiGenix in compliance with all applicable laws including CGMPs and GDPs.

 

18.6.8            All Assigned Agreements in effect as of the Commencement Date are listed in Schedule 6. Each of the Assigned Agreements is legal, valid and in full force and effect, and enforceable in accordance with its terms by TiGenix against the other parties thereto and TiGenix has not received any written notice, or, to the knowledge of TiGenix, other notice, of the intention of any party to terminate any Assigned Agreement. TiGenix has performed all material obligations required to be performed by TiGenix under the Assigned Agreements and is not in material Default under any Assigned Agreements and, to the knowledge of TiGenix, no other party to any Assigned Agreements is in material Default thereunder. As per the Commencement Date, TiGenix has not received written notice of any material claim arising out of any claim for injury to any Person which resulted from, or was alleged to have resulted from, the use of Products or the ChondroCelect Process (excluding adverse events routinely reported to Regulatory Authorities which are not expected to result in claims against TiGenix or any of its Affiliates for compensation). Neither TiGenix, any of its Affiliates, nor, to TiGenix’s

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

32

 

knowledge, any other party to any of the Assigned Agreements has waived any of its material rights thereunder or modified any material terms thereof. Complete and correct copies of all Assigned Contracts and amendments thereto have been disclosed to Sobi.

 

19                               Indemnification

 

19.1                     Indemnification by TiGenix.  Subject to the terms and conditions of this Agreement, and to the extent finally determined pursuant to clause 23.12, TiGenix hereby shall be held liable for and agrees to save, indemnify, defend and hold Sobi, its Affiliates, and their respective directors, officers, agents and employees harmless from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) (collectively, “Losses”) arising in connection with any and all charges, complaints, actions, suits, proceedings, hearings, investigations, claims, demands, judgments, orders, decrees, stipulations or injunctions by a Third Party (each a “Claim”) resulting or otherwise arising from (a) any breach by TiGenix of any of its representations, warranties, covenants or obligations pursuant to this Agreement, (b) the negligence or willful misconduct by TiGenix or its Affiliates or their respective officers, directors, employees, agents or consultants in performing any obligations under this Agreement, (c) infringement in Third Party’s IPR when selling, distributing, marketing and promoting the Product or the ChondroCelect Process in accordance with the requirements specified under this Agreement, (d) the Excluded Liabilities, or (e) any matter related to the Product hereunder (including, for clarity, product liability Losses including defects in design and failure to warn, in each case resulting therefrom) by TiGenix or its Affiliates or their respective officers, directors, employees, agents, consultants or sublicensees; in each case except to the extent that such Losses are subject to indemnification by Sobi pursuant to clause 19.6.

 

19.2                     Sobi shall make sure that the Hospital Agreements shall provide provisions that (i) the Hospital and the Surgeon shall ensure that the Patient does or did not start with or use any other treatment, or procedure, unless with the prior explicit approval of the Surgeon and upon his instruction; (ii) the Hospital must sufficiently inform the Patient that the Patient must immediately inform the Surgeon of any injury and of any other unforeseeable or unexpected adverse event and (iii) the Surgeon on his turn must immediately notify Sobi of such injury or other adverse event.

 

19.3                     Sobi shall further ensure that the Hospital Agreements limit the liability for injuries that (i) are inflicted as a consequence of the underlying illness/injury of the Patient, (ii) result from diagnostic or therapeutic measures not specifically required or necessary to use or administer ChondroCelect in accordance with this Agreement, or (iii) result from negligence of the Surgeon or any other surgeon, or Hospital clinical staff member or from the Hospital’s facilities. With respect to points (ii) and (iii), Parties acknowledge that this is not under the control of either TiGenix or Sobi, but Sobi shall make sure that the Hospital Agreements shall provide that the Hospital shall be liable for injuries resulting from situations set out in points (ii) and (iii).

 

19.4                     Sobi shall further ensure, to the extent not prohibited by applicable law, that the liability of Sobi and TiGenix under the Hospital Agreements is capped at [***] EUR per occurrence. For the purpose of this clause, if the word “occurrence” is interpreted by a court or similar authority as a result of a liability arising under a Hospital Agreement, the Parties agree to interpret the word “occurrence” similarly between themselves as such court.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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19.5                     To the extent a Hospital Agreement does not provide for a limited liability of Sobi and TiGenix as provided for under clause 19.4 (an “Uncapped Hospital Agreement”), while it was legally permitted to include such cap, TiGenix’ liability towards Sobi for claims from a Hospital under such an Uncapped Hospital Agreement shall be limited to the cap that should have been provided for in the Hospital Agreement.

 

19.6                     Indemnification by Sobi.  Subject to the terms and conditions of this Agreement, and to the extent finally determined pursuant to clause 23.12, Sobi hereby shall be held liable for and agrees to save, indemnify, defend and hold TiGenix, its Affiliates, and their respective directors, agents and employees harmless from and against any and all Losses arising in connection with any and all Claims resulting or otherwise arising from (a) any breach by Sobi of any of its representations, warranties, covenants or obligations pursuant to this Agreement, (b) the negligence or willful misconduct by Sobi or its Affiliates or their respective officers, directors, employees, agents, consultants or sublicensees in performing any obligations under this Agreement, or (c) infringement in Third Party’s IPR when selling, distributing, marketing and promoting the Product or the ChondroCelect Process in breach of the requirements specified under this Agreement or (d) any matter related to the commercialization of the Product hereunder (including, for clarity, product liability Losses including defects in design and failure to warn, in each case resulting therefrom) by Sobi or its Affiliates or their respective officers, directors, employees, agents or consultants; in each case except to the extent that such Losses are subject to indemnification by TiGenix pursuant to clause 19.1.

 

19.7                     Insurance.  Each Party shall (provided that either Party shall be allowed to self-insure), as of the Closing Date, procure and maintain insurance, including product liability insurance, adequate to cover its obligations hereunder and which is consistent with normal business practices of prudent companies similarly situated at all times during which the Product is being commercially distributed or sold by such Party pursuant to this Agreement, and the coverage shall in no event be less than [***] Euro (€[***]) per loss occurrence and [***] Euro (€[***]) in the aggregate. It is understood that such insurance shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this clause 19. Each Party shall provide the other Party with written evidence of such insurance upon the other Party’s request.

 

19.8                     Indemnification Procedures

 

19.8.1            Notice of Claim.  All indemnification claims in respect of any indemnitee seeking indemnity under clause 19, as applicable (collectively, the “Indemnitees” and each an “Indemnitee”) will be made solely by the corresponding Party (the “Indemnified Party”). The Indemnified Party will give the indemnifying Party (the “Indemnifying Party”) prompt written notice (an “Indemnification Claim Notice”) of any Losses and any legal proceeding initiated by a Third Party against the Indemnified Party as to which the Indemnified Party intends to make a request for indemnification under clause 19, as applicable, but in no event will the Indemnifying Party be liable for any Losses that result from any delay in providing such notice which materially prejudices the defense of such proceeding. Each Indemnification Claim Notice shall contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss are known at such time). Together with the Indemnification Claim Notice, the Indemnified Party will furnish promptly to the Indemnifying Party copies of all notices and

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

34

 

documents (including court papers) received by any Indemnitee in connection with the Claim.

 

19.8.2            Control of Defense.  At its option, the Indemnifying Party may assume the defense of any Claim subject to indemnification as provided for in clause 19.1 or 19.2, as applicable, by giving written notice to the Indemnified Party within thirty (30) days after the Indemnifying Party’s receipt of an Indemnification Claim Notice. Upon assuming the defense of a Claim, the Indemnifying Party may appoint as lead counsel in the defense of the Claim any legal counsel it selects, and such Indemnifying Party shall thereafter continue to defend such Claim in good faith. Should the Indemnifying Party assume the defense of a Claim (and continue to defend such Claim in good faith), the Indemnifying Party will not be liable to the Indemnified Party or any other Indemnitee for any legal expenses subsequently incurred by such Indemnified Party or other Indemnitee in connection with the analysis, defense or settlement of the Claim, unless the Indemnifying Party has failed to assume the defense and employ counsel in accordance with this clause 19.8.

 

19.8.3            Right to Participate in Defense.  Without limiting clause 19.8.2, any Indemnitee will be entitled to participate in the defense of a Claim for which it has sought indemnification hereunder and to employ counsel of its choice for such purpose; provided, however, that such employment will be at the Indemnitee’s own expense unless (a) the employment thereof has been specifically authorized by the Indemnifying Party in writing, or (b) the Indemnifying Party has failed to assume the defense (or continue to defend such Claim in good faith) and employ counsel in accordance with this clause 19.8, in which case the Indemnified Party will be allowed to control the defense.

 

19.8.4            Settlement.  With respect to any Losses relating solely to the payment of money damages in connection with a Claim and that will not result in the Indemnitee becoming subject to injunctive or other relief or otherwise adversely affect the business of the Indemnitee in any manner, and as to which the Indemnifying Party will have acknowledged in writing the obligation to indemnify the Indemnitee hereunder, the Indemnifying Party will have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as the Indemnifying Party, in its reasonable discretion, will deem appropriate (provided, however, that such terms shall include a complete and unconditional release of the Indemnified Party from all liability with respect thereto), and will transfer to the Indemnified Party all amounts which said Indemnified Party will be liable to pay prior to the time of the entry of judgment. With respect to all other Losses in connection with Claims, where the Indemnifying Party has assumed the defense of the Claim in accordance with clause 19.8.2, the Indemnifying Party will have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, provided it obtains the prior written consent of the Indemnified Party (which consent will be at the Indemnified Party’s reasonable discretion). The Indemnifying Party that has assumed the defense of (and continues to defend) the Claim in accordance with clause 19.8.2 will not be liable for any settlement or other disposition of a Loss by an Indemnitee that is reached without the written consent of such Indemnifying Party. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Claim, no Indemnitee will admit any liability with respect to, or settle, compromise or discharge, any Claim without first offering to the Indemnifying Party the opportunity to assume the defense of the Claim in accordance with clause 19.8.2.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

35

 

19.8.5            Cooperation.  If the Indemnifying Party chooses to defend or prosecute any Claim, the Indemnified Party will, and will cause each other Indemnitee to, cooperate in the defense or prosecution thereof and will furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection with such Claim. Such cooperation will include access during normal business hours afforded to the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Claim, and making Indemnitees and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the Indemnifying Party will reimburse the Indemnified Party for all its reasonable out-of-pocket expenses incurred in connection with such cooperation.

 

19.8.6            Expenses of the Indemnified Party.  Except as provided above, the reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any Claim will be reimbursed on a calendar quarter basis by the Indemnifying Party, without prejudice to the Indemnifying Party’s right to contest the Indemnified Party’s right to indemnification and subject to refund in the event the Indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party.

 

19.9                     Limitation of Liability.  NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY CONSEQUENTIAL, INCIDENTAL, LOST PROFITS, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES, PROVIDED HOWEVER THAT NOTHING IN THIS AGREEMENT SHALL EXCLUDE OR RESTRICT THE LIABILITY OF EITHER PARTY FOR DEATH OR PERSONAL INJURY RESULTING FROM ITS NEGLIGENCE OR IN ANY CIRCUMSTANCES WHERE LIABILITY MAY NOT BE SO LIMITED UNDER ANY APPLICABLE LAW.

 

20                               Term and Termination

 

20.1                     This Agreement will begin on the Commencement Date and shall continue in effect for an initial term of 10 (ten) years.

 

20.2                     Unless either Party gives to the other Party a written notice of non-renewal at least 6 (six) months prior to the expiration of the current term of this Agreement, this Agreement shall be automatically renewed for successive terms of 2 (two) years, provided however that the terms of the Agreement may be renegotiated in connection with such renewal upon either Party’s request and, if the Parties fail to reach agreement on terms, the Agreement may be terminated by written notice by either Party (such termination to be effective as of the expiry of the then current term or effective immediately if the expiry of the term is passed in time while negotiations were still on-going).

 

20.3                     Either Party may immediately terminate this Agreement by giving to the other Party written notice to terminate on the date specified in the notice:

 

20.3.1            in the event of insolvency of the other Party, or the filing of a petition in bankruptcy by or against the other Party, or the appointment of a receiver for the other Party or the other

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

36

 

Party’s property, or an assignment by the other Party for the benefit of the creditors, or liquidation or dissolution proceedings of the other Party or any other proceedings with a view to discontinuing the business of the other Party;

 

20.3.2            if the other Party assigns or tentatively assigns this Agreement without the prior written consent of the other Party; or

 

20.3.3            if the other Party waives or tries to waive any right to an indemnity in violation of its indemnification obligations under this Agreement.

 

20.4                     Either Party may further terminate this Agreement by providing [***] written notice in the event the business interest under this Agreement becomes commercially non-viable despite commercially reasonable efforts and the Parties fail to re-negotiate terms reasonably satisfactory to both Parties. “Commercially non-viable” under this clause shall mean that a Party, despite best commercial efforts and after the [***] year of the Agreement, has made or can show that it will make a loss over a consecutive [***] term and that this situation is not just temporary. For clarity, the earliest notice of termination under this clause 20.4 would be after [***] years from the Closing Date. In case of a change by a Regulatory Authority in the Territory that renders the business case for ChondroCelect no longer commercially viable (whereby “commercially non-viable” means that a Party, despite best commercial efforts, has made or can show that it will make a loss over a consecutive [***] term and that this situation is not just temporary), each Party may terminate this Agreement subject to a [***] written notice.

 

20.5                     Either Party may also terminate this Agreement with immediate effect without intervention of a court upon a 60 (sixty) days written notice to the other Party if the other Party breaches this Agreement in a material way and fails to remedy such breach within three (3) months of a written notice regarding the breach.

 

20.6                     TiGenix is entitled to terminate the Agreement according to clause 13.2.2.

 

20.7                     At the termination of this Agreement:

 

20.7.1            Sobi shall, upon TiGenix’ request and at TiGenix expense, promptly return to TiGenix, and agree with the Hospital that the Hospital undertakes to return to Sobi (who shall forward the information to TiGenix) all TiGenix’ Confidential Material, as well as all promotional and advertising materials and all technical information relating to this Agreement in its possession or in the possession of the Hospital and Sobi will not keep any copies except for 1 (one) copy for archival purposes as well as any copy or copies as required by applicable laws, regulations or permits;

 

20.7.2            Sobi shall, upon request by TiGenix, immediately perform all required actions to transfer or assign any product registrations, licenses, permits or other authorizations which may have been obtained in the name of Sobi or jointly in the name of TiGenix and Sobi pursuant to this Agreement, to TiGenix or another party appointed by TiGenix who can legally distribute the Product in the Territory, and to terminate the status of legal representative of TiGenix in the Territory. All information required to effect such transfer or assignment, as well as any other relevant documentation, including documentation on donor and patient traceability, will be handed over to TiGenix;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

37

 

20.7.3            TiGenix shall, upon Sobi’s request and at Sobi’s expense, promptly return to Sobi all Sobi’s Confidential Material in its possession and TiGenix will not keep any copies except for 1 (one) copy for archival purposes as well as any copy or copies as required by applicable laws, regulations or permits;

 

20.7.4            Sobi shall not be entitled to compensation for goodwill which may have accrued to ChondroCelect in the Territory. TiGenix may make such other arrangements for marketing ChondroCelect as it thinks fit in order to preserve such goodwill;

 

20.7.5            In the event that Sobi should be found in breach of contract, then TiGenix shall be further entitled to use the translations (described in clause 10.4.1) for a duration of 10 (ten) years after termination of this Agreement for any reason whether itself or through Third Parties. In the event that this Agreement is terminated for a reason which does not constitute breach of contract by Sobi, then TiGenix shall be entitled to use these translations only with the consent of Sobi.

 

20.8                     Termination will not affect any other rights or obligations which may have accrued prior to termination.

 

21                               Audits

 

21.1                     Sobi shall under the Hospital Agreements oblige the Hospitals to allow TiGenix (a) to conduct quality assurance audits of the Hospitals’ facilities and the procedures implemented in connection with the Hospital Agreement and/or (b) to be present at such audits performed by Sobi, in each time at reasonable times and upon reasonable notice. If Sobi intends to perform an audit of a Hospital, it shall give reasonable notice thereof to TiGenix. .

 

21.2                     Sobi shall notify the Hospitals of any serious quality deficiencies identified in any such audit, and Sobi shall under the Hospital Agreements oblige the Hospitals to remedy such deficiency as soon as practicable and in any case within not more than 30 (thirty) days from the date of notification. Sobi shall provide in the Hospital Agreements that, in the event that a Hospital does not remedy such deficiencies within 60 (sixty) days, such failure to remedy the deficiencies shall constitute a breach by the Hospital of the Hospital Agreement and that Sobi shall no longer sell the Product to such Hospital until the deficiencies have been satisfactorily resolved.

 

21.3                     Sobi and TiGenix will cooperate, and Sobi shall under the Hospital Agreements oblige the Hospitals to cooperate with Sobi, in organising and reporting the audits in a manner that also the requirements set for Tissue Establishments in the Territory, if applicable, are fulfilled.

 

21.4                     Sobi shall under the Hospital Agreements oblige the Hospitals to fully cooperate with any inspections by regulatory authorities, to notify Sobi (who will forward this information to TiGenix) as soon as they become aware of an inspection relating to the Product of their or their suppliers’ facilities by a Regulatory Authority, and to allow a representative from TiGenix to attend such inspection.

 

21.5                     Sobi shall under the Hospital Agreements oblige the Hospitals to provide Sobi (who will forward this information to TiGenix) with copies of (i) any audits (other than financial or tax audits) conducted by any Regulatory Authority associated with this Agreement or the Hospital

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

38

 

Agreements; and (ii) any written communication by any Regulatory Authority alleging a failure to comply with any applicable law or regulation associated with this Agreement or the Hospital Agreements.

 

21.6                     Sobi shall ensure that TiGenix, at reasonable times and upon reasonable notice (at least thirty day notice), may visit Sobi’s facilities to conduct quality assurance audits of these facilities and the procedures implemented in connection with this Agreement. At its option TiGenix may elect to use a third party to conduct such audit provided such Third Party is reasonably acceptable to Sobi and that such Third Party enters into confidentiality obligations in a confidentiality agreement with Sobi. Sobi shall cooperate as far as is reasonable with such audit.

 

22                               Data Protection

 

22.1                     General

 

For the purposes of this Agreement, the terms “Personal Data”, “Data Controller”, “Data Processor”, “Data Subject” and “process” shall have the same meaning and interpretation as set out in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.

 

22.2                     ChondroCelect Personal Data

 

22.2.1            TiGenix (in its capacity of Data Controller) has chosen Sobi (in its capacity of Data Processor) to process ChondroCelect Personal Data on behalf and upon instruction of TiGenix and Sobi has agreed to process ChondroCelect Personal Data on behalf and upon instruction of TiGenix.

 

22.2.2            In connection with the processing of ChondroCelect Personal Data, Sobi warrants that:

 

(i)                                  it has in place appropriate technical and organizational measures against accidental or unlawful destruction or accidental loss, alteration, unauthorized disclosure or access and adequate security programs and procedures to ensure that unauthorized persons will not have access to the data processing equipment used to process the ChondroCelect Personal Data;

 

(ii)                               it has in place appropriate security measures, which reflect the nature of the ChondroCelect Personal Data and the level of harm that might be suffered by a Data Subject as a result of unauthorized access or disclosure of the ChondroCelect Personal Data; and

 

(iii)                            each of its employees, agents or subcontractors are and shall be made aware of its obligations with regard to the security and protection of the ChondroCelect Personal Data and that they enter into binding obligations with Sobi in order to maintain the levels of security and protection provided for in this Agreement.

 

22.2.3            In connection with the processing of ChondroCelect Personal Data, Sobi undertakes to:

 

(i)                                  act only on behalf and upon instruction of TiGenix;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

39

 

(ii)                               do such actions as are necessary to ensure it has fulfilled, and will continue to fulfil, the warranties set out in clause 22.2.2;

 

(iii)                            submit its data processing facilities, data files and documentation needed for processing to auditing and/or certification by TiGenix (or other duly qualified auditors of inspection authorities not reasonably objected to by Sobi and approved by TiGenix) to ascertain compliance with the warranties and undertakings in this Agreement;

 

(iv)                           adequately protect any ChondroCelect Personal Data that may become accessible to Sobi against disclosure, whether directly or indirectly, to any Third Party and shall use such data only for the performance of its obligations under this Agreement and for no other purpose. All ChondroCelect Personal Data that is no longer required for Sobi’s performance of its obligations under this Agreement shall be deleted or returned to TiGenix, at the option of TiGenix. Sobi shall immediately report any violation of data protection laws identified by Sobi to TiGenix.

 

(v)                              ensure by written contract that any agent or subcontractor employed by Sobi to process ChondroCelect Personal Data to which this Agreement relates also provides Sobi with a plan of the technical and organizational means it has adopted to prevent unauthorized or unlawful processing or accidental loss or destruction of the ChondroCelect Personal Data and confirms to Sobi the implementation of those means;

 

(vi)                           provide reasonable assistance to TiGenix in order to enable the latter to comply with its obligations as Data Controller vis-à-vis Data Subjects; and

 

(vii)                        comply with all applicable data protection laws when performing its obligations under this Agreement. In the event Sobi is unable to do so, it shall forthwith notify TiGenix and TiGenix shall be entitled to terminate this Agreement, unless the Parties have agreed or forthwith agree to take such steps as shall enable Sobi to so comply.

 

22.2.4            In the event of termination of this Agreement, Sobi must return all Personal Data and all copies of the ChondroCelect Personal Data to TiGenix forthwith or, at TiGenix’ choice, will destroy all copies of the same and certify to TiGenix that it has done so, unless Sobi is prevented by law from destroying all or part of such ChondroCelect Personal Data, in which event the ChondroCelect Personal Data will be kept confidential and will not be processed for any purpose. Sobi irrevocably agrees with TiGenix that, if so requested by TiGenix, it will allow TiGenix access to any of its premises to verify that this has been done or will allow access for this purpose by any duly authorized representative of TiGenix.

 

22.3                     Other Personal Data

 

In respect of the processing of Personal Data other than ChondroCelect Personal Data in the framework of or in connection with this Agreement, each of the Parties shall, as Data Controller, comply with applicable data protection (privacy) laws and regulations, including but not limited to national legislation and regulation implementing Directive 95/46/EC of the European Parliament

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

40

 

and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.

 

23                               Miscellaneous

 

23.1                     No waiver of any provision of this Agreement will be of any force or effect unless confirmed in writing and signed by the Parties.

 

23.2                     The invalidity or unenforceability of any provision of this Agreement will not affect the validity and enforceability of all other provisions which are self-sustaining and capable of separate enforcement.

 

23.3                     This Agreement constitutes the entire agreement and understanding between the Parties with respect to this subject matter. It replaces all previous agreements between the Parties with respect to its subject matter. Without limiting the generality of the aforementioned, the initial execution copy of this Agreement, executed and duly signed by the Parties on April 2, 2014, as restated on April 23, 2014, is replaced in its entirety by the current execution copy, dated as of the last date set forth below.

 

23.4                     This Agreement, including this clause, can only be changed by written agreement duly signed by authorized representatives of the Parties.

 

23.5                     Unless expressly provided elsewhere in this Agreement, the relationship between the Parties is that of independent Parties and will not be deemed to be that of joint venture, agent, partnership or otherwise. Neither Party is authorized to act on behalf of the other Party. Sobi acts as an independent contractor buying for itself and selling in its own name and its own risk.

 

23.6                     Clauses 1, 3, 8, 15, 16, 17, 19, 20, 22, 23 and 24 will continue to apply after this Agreement ends.

 

23.7                     Neither Party is liable for any failure or delay in the performance of its obligations under this Agreement to the extent that such failure or delay arises from any circumstances beyond its control including any strikes, lock-outs or labour disputes (“Force Majeure”). Where such failure or delay continues for a period exceeding 6 (six) months, the Party not experiencing such failure or delay may terminate this Agreement without penalty by written notice.

 

23.8                     Neither this Agreement nor any obligation, commitment or liability hereunder may be assigned by either Party without the other Party’s express written consent, except that either Party may assign or transfer all or part of its obligations under this Agreement to its Affiliates or to any Party that acquires all or substantially all of the business to which this Agreement pertains.

 

23.9                     Headings are for convenience only and shall not affect the interpretation of this Agreement.

 

23.10              The following Schedules are attached to this Agreement:

 

Schedule 1: User Manual

 

Schedule 2a: Price

 

Schedule 2b:Forecast

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

41

 

Schedule 2c: Peak capacity

 

Schedule 2d: Calculation example: management of flexibility for ChondroCelect

 

Schedule 2e: Biopsy-kits in consignment

 

Schedule 3: Responsibilities

 

Schedule 3bis: TiGenix staff

 

Schedule 4: ChondroCelect Process

 

Schedule 5: SOP’s on Procurement, Biopsy and Traceability

 

Schedule 6: Assigned Agreements

 

Schedule 7: Hospital Agreement Requirements

 

Schedule 8: Transitional Phase

 

Schedule 8bis: Non-Assigned Hospitals

 

Schedule 9: Pharmacovigliance Agreement

 

Schedule 10: Trade Marks and Branding guidelines

 

Schedule 11: Minimum Sales

 

Schedules constitute an integral part of this Agreement. In case of discrepancies between this Agreement and Schedules, the provisions of this Agreement shall prevail provided however that the Quality Agreement shall prevail in matters relating to quality and the Pharmacovigliance agreement shall prevail in matters relating to pharmacovigliance.

 

23.11              This Agreement and any non-contractual obligations arising out of or in connection with it are governed by, and shall be interpreted in accordance with, Swedish law excluding the UN Convention on the International Sale of Goods (CISG).

 

23.12              Dispute Resolution and Arbitration

 

23.12.1     Disputes.  The Parties recognize that, from time to time during the Term, disputes may arise as to certain matters which relate to either Party’s rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this clause 23.12 to resolve any controversy or claim arising out of, relating to or in connection with any provision of this Agreement.

 

23.12.2     Dispute Resolutions. With respect to all disputes arising between the Parties, including any alleged failure to perform, or breach, of this Agreement, or any issue relating to the interpretation or application of this Agreement, if the Parties are unable to resolve such dispute within thirty (30) days after such dispute is first identified by either Party in writing to the other, the Parties shall refer such dispute to the designated senior officers of each of the Parties, or a designee from senior management with decision-making authority for attempted resolution by good-faith negotiations within thirty (30) days after such notice is received. If the designated officers are not able to resolve such dispute referred to them

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

42

 

within such thirty (30) day period, then either Party shall have right to initiate arbitration according to clause 24.12.3.

 

23.12.3     Arbitration. Any disputes which may arise out of or in connection with this Agreement (including a dispute relating to non-contractual obligations arising out of or in connection with this Agreement) and which has not been settled between the Parties according to 23.12.2 shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce. The arbitral tribunal shall be composed of three arbitrators. The seat of arbitration shall be London (UK). The language to be used in the arbitral proceedings shall be English. The arbitrators shall determine the allocation of the costs of the arbitration between the Parties.

 

23.12.4     Injunctive Relief.  Nothing herein may prevent either Party from seeking a preliminary injunction or temporary restraining order, in any court of competent jurisdiction, so as to prevent any Confidential Material from being disclosed in violation of this Agreement.

 

24                               Notices

 

Any written notice required under this Agreement must meet all of the following:

 

24.1                     be given by pre-paid post, personal delivery or facsimile transmission; a notice may also be given by e-mail, it being understood that as long as no acknowledgement of receipt is received by the sender of the e-mail, the e-mail notice will not be deemed received. If within 24 hours of sending the e-mail, no acknowledgement of receipt is received by the sender of an e-mail, the notice should be repeated by pre-paid post or personal delivery; and

 

24.2                     be sent to the following addresses, contact persons and/or facsimile numbers (or any other address, contact person and/or facsimile number previously advised in writing by the recipient):

 

If the notice is sent to TiGenix:

 

Address:

Romeinse straat 12, box 2

3001 Leuven

Belgium

 

For the attention of: Legal Counsel

Telephone number: +32 16 39 60 60

E-mail:           an.moonen@tigenix.com

 

If the notice is sent to Sobi:

 

Address: Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm

Sweden

 

For the attention of: General Counsel

Telephone number: +46 8 697 20 00

E-mail: legal@sobi.com

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

43

 

The Parties hereto have caused this Agreement to be executed in duplicate, as of the Commencement Date, by their duly authorised representatives.

 

 

	
TiGenix   NV
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
/s/   Eduardo Bravo
    	
 
    
	
 
    	
 
    
	
Eduardo Bravo, CEO
    	
 
    
	
 
    	
 
    
	
Date:
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
Swedish   Orphan Biovitrum AB (publ)
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
/s/   Anders   Edvell
    	
 
    
	
 
    	
 
    
	
Anders Edvell
    	
 
    
	
 
    	
 
    
	
Head of Global   Marketing and Sobi Partner Products
    	
 
    
	
 
    	
 
    
	
Date:
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
/s/   Fredrik   Berg
    	
 
    
	
 
    	
 
    
	
Fredrik Berg,   General Counsel
    	
 
    
	
 
    	
 
    
	
Date:
    	
 
    

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

44

 

Schedule 1 - User Manual

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

45

 

Schedule 2a — Price

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

46

 

Schedule 2b — Forecast

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

47

 

Schedule 2c — Peak capacity

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

48

 

Schedule 2d — Calculation example: management of flexibility for ChondroCelect

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

49

 

Schedule 2e — Biopsy-kits in consignment

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

50

 

Schedule 3 — Responsibilities

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

51

 

Schedule 3bis — TiGenix staff

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

52

 

Schedule 4 — ChondroCelect Process

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

53

 

Schedule 5 - SOP’s on Procurement, Biopsy and Traceability

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

54

 

Schedule 6 — Assigned Agreements

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

55

 

Schedule 7 — Hospital Agreement Requirements

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

56

 

Schedule 8 — Transitional Phase

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

57

 

Schedule 8bis — Non Assigned Hospitals

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

58

 

Schedule 9 — Pharmacovigilance Agreement

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

59

 

Schedule 10 — Trade Marks and Branding Guidelines

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

60

 

Schedule 11:    Minimum Sales

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

61Exhibit 10.2

 

AGREEMENT FOR THE PROVISION OF A LOAN FACILITY 
 OF UP TO €10,000,000

 

Dated 20 December 2013

 

Between

 

KREOS CAPITAL IV (UK) LIMITED a company incorporated in England and Wales under registered number 07758282 whose registered office is at 25-28 Old Burlington Street, London W1S 3AN (the “Lender”, which expression shall include its permitted successors and assigns);

 

TIGENIX NV, a company which has made a public call on savings (openbaar beroep op het spaarwezen/appel public à l’épargne), incorporated in Belgium under registered number 0471.340.123 and listed on the regulated market of Euronext, Brussels, whose registered office is at Romeinse straat 12, box 2, 3001 Heverlee, Belgium (the “Borrower”);

 

and

 

TIGENIX S.A.U., a company incorporated under the laws of Spain registered with the Commercial Registry of Madrid section 8 at volume 2,0117, sheet 222, page M-355159, with registered office at C/ Marconi 1- Planta Baja, Parque Tecnológico Tres Cantos Madrid (Spain) and with Spanish tax ID number A84008986 (the “Guarantor”).

 

WHEREAS:

 

1.                                      The Borrower wishes to borrow up to the Total Loan Facility (as defined below) and the Lender wishes to make the Total Loan Facility available to the Borrower on the terms of this agreement (the “Loan Agreement”);

 

2.                                      The Borrower hereby confirms that on or about the date hereof it shall enter into the Initial Security Documents as security for monies borrowed by the Borrower hereunder; and

 

3.                                      The Guarantor has agreed to enter into this Loan Agreement for the purpose of guaranteeing to the Lender the Obligors’ liabilities from time to time outstanding to the Lender.

 

LOAN FACILITY TERMS:

 

	
Total   Loan Facility
    	
 
    	
€10,000,000   available to be drawn down in 3 (three) tranches as follows:

 

Tranche   1: €5,000,000 (five million Euros);

 

Tranche   2: €2,500,000 (two million five hundred thousand Euros); and
    

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

1

 

	
 
    	
 
    	
Tranche   3: €2,500,000 (two million five hundred thousand Euros)
    
	
 
    	
 
    	
 
    
	
Tranche   Expiry Date
    	
 
    	
Tranche   1: 3 February 2014

 

Tranche   2: 31 May 2014

 

Tranche   3: 30 September 2014
    
	
 
    	
 
    	
 
    
	
Advance   Payment
    	
 
    	
In   respect of each Tranche

 

1:   €[***]

 

2:   €[***]

 

3:   €[***]
    
	
 
    	
 
    	
 
    
	
Repayment   Term
    	
 
    	
In   respect of each Tranche, forty-eight (48) months from the date such Tranche   is advanced by the Lender to the Borrower
    
	
 
    	
 
    	
 
    
	
Transaction   Fee
    	
 
    	
[***]   of the Total Loan Facility payable upon execution of this Loan Agreement
    
	
 
    	
 
    	
 
    
	
End   of Loan Fee
    	
 
    	
[***]   of the amount drawn down under each Tranche, payable at the end of each   Tranche
    
	
 
    	
 
    	
 
    
	
Additional   End of Loan Fee
    	
 
    	
an   amount up to [***]
    
	
 
    	
 
    	
 
    
	
Warrant   Fee
    	
 
    	
€897,000   payable to the Lender in accordance with Clause 13.3 below
    
	
 
    	
 
    	
 
    
	
Minimum   Drawdown Amount
    	
 
    	
€5,000,000   (five million Euros) in respect of Tranche 1

 

€2,500,000   (two million five hundred thousand Euros) in respect of Tranche 2

 

€2,500,000   (two million five hundred thousand Euros) in respect of Tranche 3
    

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

2

 

1                                         DEFINITIONS

 

In this Loan Agreement, including the recitals set out above, unless otherwise defined:

 

1.1                               “Accounts” means the audited annual consolidated profit and loss account and balance sheet of the Borrower and the Group for the period ended on 31 December 2012 as approved by the annual general meeting of the Borrower;

 

1.2                               “Additional End of Loan Fee” means the Additional End of Loan Fee and set forth above under the Loan Facility Terms;

 

1.3                               “Advance Payment” is in the amount set forth above in the Loan Facility Terms;

 

1.4                               “Affiliate” means, in relation to any person, a subsidiary of that person or a holding company of that person or any other subsidiary of that holding company;

 

1.5                               “Applicable Interest Rate” has the meaning given in Clause 6.1;

 

1.6                               “Assignee” has the meaning given in Clause 21.5;

 

1.7                               “Authorisation” means an authorisation, consent, approval, resolution, licence, permit exemption, filing, notarisation or registration;

 

1.8                               “Base Case Model” means the financial model including profit and loss and pro forma cash flow projections relating to the Group, each prepared by the Borrower and approved by the Lender in writing;

 

1.9                               “Business Day” means any day on which banks are generally open for business in London other than a Saturday or Sunday;

 

1.10                        “Charged Assets” means the assets and undertaking charged or to be charged to the Lender from time to time pursuant to the Security Documents;

 

1.11                        “Company Code” means the Belgian Wetboek van Vennootschappen/Code des Sociétés dated 7 May 1999, as amended from time to time;

 

1.12                        “Confidential Information” means all information relating to the Borrower, any Obligor, the Group, the Finance Documents or the Loan of which the Lender becomes aware in its capacity as, or for the purpose of becoming, a Lender or which is received by the Lender in relation to, or for the purpose of becoming the Lender under, the Finance Documents or the Loan, from any member of the Group or any of its advisers, in whatever form, and includes information given orally and any document, electronic file or any other way of representing or recording information which contains or is derived or copied from such information but excludes information that:

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

3

 

(i)                                     is or becomes public information other than as a direct or indirect result of any breach by the Lender of Clause 20;

 

(ii)                                  is identified in writing at the time of delivery as non-confidential by any member of the Group or any of its advisers; or

 

(iii)                               is known by the Lender before the date the information is disclosed to it in accordance with paragraphs (i) or (ii) above or is lawfully obtained by the Lender after that date, from a source which is, as far as the Lender is aware, unconnected with the Group and which, in either case, as far as the Lender is aware, has not been obtained in breach of, and is not otherwise subject to, any obligation of confidentiality;

 

1.13                        “Drawdown” means the drawdown of a Tranche under the Loan Facility;

 

1.14                        “Drawdown Date” means, unless otherwise provided herein, the date on which any Tranche is actually advanced to the Borrower by the Lender;

 

1.15                        “Drawdown Notice” means a drawdown notice served in accordance with Clause 3.2 in the form attached hereto as Schedule A (as may be amended with the prior written consent of the Lender);

 

1.16                        “Dutch Facility” means GMP manufacturing facility located in Geleen, the Netherlands, leased and operated by the Dutch Subsidiary;

 

1.17                        “Dutch Subsidiary” means Tigenix B.V. a company incorporated under the laws of the Netherlands, under registered number 14121664 whose registered office is at Urmonderbaan 20b, 6167RD Geleen, the Netherlands;

 

1.18                        “End of Loan Fee” means the End of Loan Fee set forth above under the Loan Facility Terms;

 

1.19                        “Event of Default” means any of the events or circumstances described in Clause 11;

 

1.20                        “Excluded Assets” means

 

(a)                                 all Intellectual Property or other assets newly acquired or developed by any Group Company, provided the acquisition or development of such assets is funded (i) by Soft Loans, (ii) from the proceeds of an equity issuance made specifically for the purpose of such acquisition of development; (iii) by Subordinated Financial Indebtedness raised specifically for such acquisition or development or (iv) by debt or equity raised by a Ring-fenced Company;

 

(b)                                 co-owned Intellectual Property; and

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

4

 

(c)                                  rights in undisclosed or confidential information (including know-how), except if (i) it is legally possible to take security over rights in undisclosed or confidential information (including know-how) in the jurisdiction where the relevant security provider is located, (ii) the creation or perfection of the Security Interest does not result in costs which are unreasonable and disproportionate to the value of the Security Interest for the Lender, and (iii) the rights in undisclosed or confidential information (including know-how) are documented by the relevant Group Company and (iv) in respect of rights in undisclosed or confidential information (including know-how) of a Group Company located in Belgium only, up to a maximum secured amount of [***].

 

1.21                        “Existing Financial Indebtedness” means the Financial Indebtedness listed in Schedule C;

 

1.22                        “Tranche Expiry Date” means in respect of each Tranche the date set forth above under the heading Loan Facility Terms;

 

1.23                        “Finance Documents” means this Loan Agreement, the Security Documents, the Drawdown Notice, and any other document designated as such by the Lender and the Borrower;

 

1.24                        “Financial Indebtedness” means (i) monies borrowed, (ii) finance or capital leases, (iii) receivables sold or discounted (other than on a non-recourse basis), (iv) other transactions or arrangements having the commercial effect of borrowing (but excluding trade credit incurred in the ordinary course of business), (v) the market to market value of derivative transactions entered into in connection with protection against or benefit from fluctuation in any rate or price, (vi) counter-indemnity obligations in respect of guarantees or other instruments issued by a bank or financial institution, and (vii) liabilities under guarantees or indemnities for any of the obligations referred to in items (i) to (vi);

 

1.25                        “Group” means (i) the Borrower and its subsidiaries (if any), (ii) any holding company of the Borrower, and (iii) any subsidiaries of such holding companies from time to time, other than Arcarios B.V. and “Group Company” means any member of the Group;

 

1.26                        “Guaranteed Obligations”:  all monies, debts and liabilities of any nature from time to time due, owing or incurred by the Borrower to the Lender on any current or other account under or in connection with any present or future debt facilities provided by the Lender to the Borrower;

 

1.27                        “Initial Period” means the period from the date of this Loan Agreement to 30 September 2014;

 

1.28                        “Intellectual Property” means copyrights and related rights (including, without limitation, rights in computer software), patents, inventions, supplementary protection

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

5

 

certificates, utility models, trademarks, trade names, service marks, domain name registrations, registered and unregistered rights in designs, database rights, semi-conductor topography rights, plant variety rights, rights protectable by the law of passing off or by laws against unfair competition, rights in undisclosed or confidential information (such as know-how, trade secrets and inventions (whether patentable or not)), and other similar intellectual property rights (whether registered or not) and applications for such rights as may exist anywhere in the world;

 

1.29                        “Interim Repayment” means the payment in respect of interest accruing during the period from each Drawdown Date to the First Monthly Repayment Date being the amount of interest accruing at the Applicable Interest Rate on the amount drawn down for the period from and including the Drawdown Date to First Monthly Repayment Date;

 

1.30                        “Initial Security Documents” means the documents set out in Schedule B;

 

1.31                        “Legal Reservations” means:

 

(i)                                   the principle that equitable remedies may be granted or refused at the discretion of a court and the limitation of enforcement by laws relating to insolvency, reorganisation and other laws generally affecting the rights of creditors;

 

(ii)                                the time barring of claims under the Limitation Acts, the possibility that an undertaking to assume liability for or indemnify a person against nonpayment of UK stamp duty may be void and defences of set-off or counterclaim;

 

(iii)                             the limitations imposed by overriding rules of a Relevant Jurisdiction;

 

(iv)                            the limitations on the enforceability of Security Interests over rights in undisclosed or confidential information (including know-how) which is not documented; and

 

(v)                               similar principles, rights and defences under the laws of any Relevant Jurisdiction;

 

1.32                        “Licencing”:  means the full or partial licence on arm’s length commercial terms of some or all Intellectual Property (whether registered or unregistered, which may now or in the future subsist) and/or rights in connection with and/or ancillary to Intellectual Property granting another party (either a member of the Group or a third party) the right to, including but not limited hereto, commercialise, market, sell, distribute, advertise, produce, manufacture, develop or further develop any existing or future product or right of the Borrower or any Group Company;

 

1.33                        “Licencing Agreement” means an agreement on arm’s length commercial terms evidencing the Licencing;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

6

 

1.34                        “Loan” means the loan to be made available under a Tranche in accordance with the terms of this Loan Agreement, and “Loans” means the Tranches collectively;

 

1.35                        “Loan Facility” means the loan facility set out in this Loan Agreement;

 

1.36                        “Loan Facility Terms” means the Loan Facility Terms set out at the beginning of this Loan Agreement;

 

1.37                        “Loan Term” means with respect to each Tranche, the period commencing on the Drawdown Date and expiring on the 48th Monthly Repayment Date thereafter;

 

1.38                        “Madrid Network Assets” means all Intellectual Property, stock, plants, equipment and assets which are either pledged to Madrid Network or relate to the Madrid Network financing;

 

1.39                        “Minimum Drawdown Amount” means the minimum amount permitted to be drawn down in each Tranche, as set forth above under the heading Loan Facility Terms;

 

1.40                        “Monthly Repayment Date” means the first Business Day of a calendar month, and in respect of each Tranche, the “First Monthly Repayment Date” shall mean the first Monthly Repayment Date following the Drawdown Date of such Tranche;

 

1.41                        “Notarial Deed” means the deed in agreed form to be duly passed before a Belgian Public Notary which records the resolutions to be passed by the shareholders’ meeting in respect of the issue of the Warrant;

 

1.42                        “Obligors” the Borrower and the Guarantor;

 

1.43                        “Party” means a party to this Loan Agreement;

 

1.44                        “Perfection Requirements” means the making of the appropriate registrations, filings or notifications for perfecting the Security Interests as set out in the Security Documents;

 

1.45                        “Permitted Bank Guarantee” means a bank guarantee obtained for the benefit of an entity which is the creditor under a Soft Loan to guarantee the repayment of such Soft Loan when repayable under the terms of such Soft Loan.

 

1.46                        “Permitted Disposal” means:

 

(i)                                   any Licencing by a Group Company (to the extent that such Licencing would constitute or involve a disposal), provided that all rights of the Group Company under each Licencing will be pledged in favour of the Lender, such pledge being on terms acceptable to the Lender at the time of signing the relevant Licencing Agreement;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

7

 

(ii)                                the disposal of the shares or assets in the Dutch Subsidiary as well as any conversion of intra-group receivables owing from the Dutch Subsidiary into equity prior to such disposal;

 

(iii)                             the disposal of the Dutch Facility;

 

(iv)                            the disposal of the shares or assets of the UK Subsidiary;

 

(v)                               any disposal of trading stock, cash assets, equipment, plants by a Group Company or the Borrower in the ordinary course of business on arms’ length terms of the disposing entity, excluding the Madrid Network Assets;

 

(vi)                            any disposal arising directly as a result of enforcement of any Permitted Security;

 

(vii)                         any disposal of assets to another Group Company provided that, if the transferor has granted security over the applicable assets to the Lender, the transferee shall grant equivalent security to the Lender on terms acceptable to the Lender;

 

(viii)                      any disposal or transfer of assets (including contracts) by a Group Company as part of a distribution or manufacturing agreement permitted under Clause 1.48 on arm’s length terms, provided that all rights of the Group Company under each such agreement will be pledged in favour of the Lender, such pledge being on terms acceptable to the Lender at the time of signing the relevant agreement;

 

(ix)                            subject to the Lender’s prior written consent, any disposal of assets to another Group Company;

 

1.47                        “Permitted Financial Indebtedness” means Financial Indebtedness incurred by the Borrower or any Group Company:

 

(i)                                   under this Loan Agreement or the Security Documents;

 

(ii)                                owed to another Group Company provided that the creditor Group Company has granted security to the Lender, such security being on terms acceptable to the Lender and not over Excluded Assets;

 

(iii)                             for non-speculative hedging transactions entered into in the ordinary course of business in connection with protection against interest rate or currency fluctuations;

 

(iv)                            for financial leases in the ordinary course of business of a capital value not to exceed [***] in respect of the Group;

 

(v)                               on terms (including interest, repayment and subordination) satisfactory to the Lender;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

8

 

(vi)                            Soft Loans up to a maximum of [***] in aggregate;

 

(vii)                         the Existing Financial Indebtedness, provided that no item of Existing Financial Indebtedness shall exceed the amount specified for such item in Schedule C;

 

(viii)                      in connection with the factoring arrangements up to an aggregate amount not to exceed [***]; provided that such factoring arrangements continue on materially the same terms as at the date hereof;

 

(ix)                            Subordinated Financial Indebtedness;

 

(x)                               Financial Indebtedness of any Ring-fenced Company, subject to clause 8.1.12; and

 

(xi)                            Permitted Bank Guarantees.

 

1.48                        “Permitted Transaction” means:

 

(i)                                   the entry into a Licensing Agreement by any Group Company provided that the relevant Group Company has granted security to the Lender on terms acceptable to the Lender;

 

(ii)                                the winding-up of the UK Subsidiary;

 

(iii)                             the winding-up of the US Subsidiary;

 

(iv)                            the entry into of manufacturing agreements for the manufacturing of existing or future products of any Group Company on arm’s length terms, provided that the relevant Group Company has granted security to the Lender on terms acceptable to the Lender; and

 

(v)                               the entry into of distribution agreements for the distribution of existing or future products of any Group Company on arm’s length terms, provided that the relevant Group Company has granted security to the Lender on terms acceptable to the Lender.

 

1.49                        “Permitted Security” means:

 

(i)                                   any Security Interest provided to the Lender under this Loan Agreement;

 

(ii)                                any netting or set-off arrangement entered into by any Group Company in the ordinary course of its banking arrangements for the purpose of netting debit and credit balances;

 

(iii)                             any Security Interest arising by operation of law;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

9

 

(iv)                            any Security Interest over any bank account in favour of the bank or with which the applicable account is held;

 

(v)                               any Security Interest (other than as referred to in (viii) below) in favour of the provider of a Soft Loan over the cash proceeds of such Soft Loan before such proceeds are spent by the applicable Group Company;

 

(vi)                            any security deposit which is granted under or pursuant to a lease agreement relating to the premises where the lessee’s operations are conducted;

 

(vii)                         any Security Interest provided for the benefit of Bankinter in respect of counter indemnities given by Group Companies for various bank guarantees issued for the benefit of the Group up to [***];

 

(viii)                      any Security Interest granted by a Ring-fenced Company, subject to Clause 8.1.12;

 

(ix)                            any Security Interest (other than as referred to in the paragraphs (i) to and including (viii) above) arising in the ordinary course of trading up to a maximum aggregate amount of [***];

 

1.50                        “Related Fund” in relation to a fund (the “first fund”), means a fund which is managed or advised by the same investment manager or investment adviser as the first fund or, if it is managed by a different investment manager or investment adviser, a fund whose investment manager or investment adviser is an Affiliate of the investment manager or investment adviser of the first fund;

 

1.51                        “Repayment Schedule” has the meaning given in Clause 5.2.3;

 

1.52                        “Relevant Jurisdiction” means Belgium, Spain, England and Wales and the United States of America or any other jurisdiction where a Group Company is established from time to time;

 

1.53                        “Representative” means any delegate, agent, manager, administrator, nominee, attorney, trustee or custodian;

 

1.54                        “Rights” means any Security Rights or other right or benefit whether arising by set-off, counterclaim, subrogation, indemnity, proof in liquidation or otherwise and whether from contribution or otherwise;

 

1.55                        “Ring-fenced Company” means a special purpose entity formed for the purpose of acquiring or developing Intellectual Property or other assets;

 

1.56                        “Security Documents” means the Initial Security Documents, and any other applicable document evidencing the security over assets of the Borrower (or any Group Company) pursuant to Clause 8.1.12;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

10

 

1.57                        “Security Interest” means any mortgage, charge (whether fixed or floating, legal or equitable), pledge, lien, hypothecation, assignment by way of security or otherwise, trust arrangement, title retention or encumbrance or enforceable right of a third party, any other type of security interest or preferential arrangement having a similar effect to any of the foregoing or in the nature of security of any kind whatsoever and in any jurisdiction;

 

1.58                        “Security Period” means the period commencing on the Drawdown Date and ending on the date on which all amounts due and payable by the Borrower under this Loan Agreement and the Security Documents or otherwise have been indefeasibly repaid in full;

 

1.59                        “Senior Management” means the members of the executive committee of the Borrower from time to time;

 

1.60                        “Soft Loans” means loans or research and development grants made to a Group Company by a governmental agency for the purpose of developing or acquiring Intellectual Property at a cost which is materially lower than the cost of a loan to such Group Company which would reasonably be expected to be made available for the proposed transaction at the relevant time by a commercial lender in the local market on arm’s length commercial terms;

 

1.61                        “Subordinated Financial Indebtedness” means Financial Indebtedness owed to shareholders or their Affiliates of the Borrower on terms as the relevant shareholder or Affiliate and the Borrower may agree, provided that such Financial Indebtedness is fully subordinated to the Borrower’s obligations under the Finance Documents such that all cash due and payable to the shareholders or their Affiliates of the Borrower shall only be repaid after the Borrower has paid all principal interest and other amount due and payable under this Loan Agreement to Lender.  (For the avoidance of doubt, the conversion of a convertible loan into equity shall not constitute a “repayment of cash” for purposes of this Clause.”);

 

1.62                        “Subsequent Period” means the period from 1 October 2014 to the end of the Security Period;

 

1.63                        “Taxes” means all present and future income, value added and other taxes, levies, imposts, deductions, charges and withholdings in the nature of taxes (other than taxes on the profits of the Lender) whatsoever together with interest thereon and penalties with respect thereto made on or in respect thereof;

 

1.64                        “Total Loan Facility” means the amount set forth above under the heading Loan Facility Terms;

 

1.65                        “Tranche” an amount drawn down pursuant to this Loan Agreement as set forth above under the heading Loan Facility Terms;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

11

 

1.66                        “Transaction Fee” has the meaning given in Clause 13.1 and is the amount set forth above in the Loan Facility Terms;

 

1.67                        “US Subsidiary” means TiGenix Inc., a company incorporated under the laws of Delaware (USA) whose registered office is at 1209 Orange Street, Wilmington, Delaware;

 

1.68                        “UK Subsidiary” means TiGenix Limited, a company incorporated in England and Wales under company number 05405647 with registered office at c/o Hackwood Secretaries Limited, One Silk Street, London United Kingdom EC2Y 8HQ;

 

1.69                        “Warrants” means the rights created by the shareholders’ resolution entitling the holders thereof to subscribe for Warrant Shares on the terms set out in the Notarial Deed including the Warrant Plan;

 

1.70                        “Warrant Certificate” shall have the meaning given to such term in the Warrant Plan;

 

1.71                        “Warrant Fee” €897,000 payable to the Lender in accordance with Clause 13.3 below;

 

1.72                        “Warrant Plan” means a warrant plan in the form set out in Schedule F to be entered into by the Borrower and Kreos Capital IV Limited; and

 

1.73                        “Warrant Shares” means, subject to the provisions of the Warrant Plan, the ordinary shares without nominal value in the Borrower to be issued upon exercise of the Warrants.

 

2                                         INTERPRETATION

 

2.1                               In this Loan Agreement (unless the context requires otherwise) any reference to:

 

2.1.1                     any law or legislative provision includes a reference to any subordinate legislation made under that law or legislative provision before the date of this Loan Agreement, to any modification, re-enactment or extension of that law or legislative provision made before that date and to any former law or legislative provision which it consolidated or re-enacted before that date;

 

2.1.2                     any gender includes a reference to other genders and the singular includes a reference to the plural and vice versa;

 

2.1.3                     any warranty or undertaking or event of default relating to Group Companies in general shall not include the US Subsidiary or UK Subsidiary unless and until they restart any business activity;

 

2.1.4                     a Clause or Schedule is to a Clause or Schedule (as the case may be) of or to this Loan Agreement;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

12

 

2.1.5                     a “person” shall be construed as including a reference to an individual, firm, company, corporation, unincorporated body of persons or any country (or state thereof or any agency thereof);

 

2.1.6                     an “amendment” includes a supplement, novation or re-enactment in writing and “amended” is to be construed accordingly;

 

2.1.7                     “assets” includes present and future properties, undertakings, revenues, rights and benefits of every description;

 

2.1.8                     an “authorisation” includes an authorisation, consent, approval, resolution, licence, exemption, filing, registration and notarisation;

 

2.1.9                     a “regulation” includes any regulation, rule, official directive, request or guideline (whether or not having the force of law) of any governmental, inter-governmental or supranational body, agency, department or regulatory, self-regulatory or other authority or organisation;

 

2.1.10              “control” shall bear the meaning set out in sections 450 and 451 of the Corporation Tax Act 2010 or for a Belgian entity shall bear the meaning set out in section 5 and following of the Companies Code;

 

2.1.11              “controlling interest” shall be construed accordingly;

 

2.1.12              “holding company” means a holding company within the meaning of section 1159 of the Companies Act 2006;

 

2.1.13              “subsidiary” means a subsidiary company within the meaning of section 1159 of the Companies Act 2006 for a Belgian entity shall mean a subsidiary within the meaning of section 6 of the Companies Code, other than Arcarios B.V.;

 

2.1.14              this or any specified provision of the Loan Agreement, any other document or a provision of any other document, shall be construed as a reference to this Loan Agreement, that document or a provision of that document as in force for the time being and as amended in accordance with the terms thereof, or, as the case may be, with the agreement of the relevant parties and (where such consent is, by the terms of this Loan Agreement or the relevant document, required to be obtained as a condition to such amendment being permitted) the prior written consent of the Lender;

 

2.1.15              “other” and “otherwise” are not to be construed ejusdem generis with any foregoing words where a wider construction is possible and “including” and “in particular” are to be construed as being by way of illustration or emphasis only and are not to be construed as, nor shall they take effect as, limiting the generality of any foregoing words;

 

2.1.16              a document being in “agreed form” is a document which is previously agreed in writing by or on behalf of the Lender, if not so agreed, is in the form specified by the Lender;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

13

 

2.1.17              any reference to an Event of Default being continuing is a reference to an Event of Default that has not been waived or remedied to the satisfaction of the Lender; and

 

2.1.18              the headings in this Loan Agreement are inserted for convenience only and do not form part of this Loan Agreement and do not affect its interpretation.

 

2.2                               Belgian terms

 

2.2.1                     In this Loan Agreement, where it relates to any Belgian entity or any Security Interest governed by Belgian law, any reference to:

 

(i)                                   a “liquidator”, “receiver”, “administrator”, “compulsory manager” or other similar officer includes any curator/curateur, vereffenaar/liquidateur, voorlopig bewindvoerder/administrateur provisoire, gerechtelijk deskundige/expert judiciaire, mandataris ad hoc/mandataire ad hoc, ondernemingsbemiddelaar/médiat eur d’entreprise, as applicable, and sekwester/sequester;

 

(ii)                                a “Security Interest” includes any mortgage (hypotheek/hypothèque), pledge (pand/nantissement), any mandate to grant a mortgage, a pledge or any other real security (mandaat/mandat),  privilege (voorrecht/privilège), reservation of title arrangement (eigendomsvoorbehoud/réserve de propriété), any in rem security (zakelijke zekerheid/sûreté réelle) and any transfer by way of security (overdracht ten titel van zekerheid/transfert à titre de sûreté);

 

(iii)                             a “moratorium” or “reorganisation” includes any gerechtelijke reorganisatie/réorganisation judiciaire;

 

(iv)                            a “composition” or “arrangement” includes a minnelijk akkoord met schuldeisers/accord amiable avec des créanciers or gerechtelijke reorganisatie/réorganisation judiciaire, as applicable;

 

(v)                               “winding up” or “administration” includes any vereffening/liquidation, ontbinding/dissolution, faillissement/faillite and sluiting van een onderneming/ fermeture d’une enterprise;

 

(vi)                            a, “distress”, “execution” or “analogous process” includes any uitvoerendbeslag/saisie exécutoire and bewarend beslag/saisie conservatoire;

 

(vii)                         a “merger”, “consolidation” or “reorganisation” includes a overdracht van algemeenheid/transfert d’universalité, overdracht van bedrijfstak/transfert de branche d’activité, splitsing/scission and fusie/fusion and assimilated transaction in accordance with article 676 and 677 of the Belgian Companies Code (gelijkgestelde verrichting/opération assimilée);

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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(viii)                      “constitutional documents” means the oprichtingsakte/acte constitutif, statuten/statuts and uittreksel van de Kruispuntbank voor Ondernemingen/extrait de la Banque Carrefour des Entreprises.

 

2.3                               Spanish terms

 

2.3.1                     In this Loan Agreement, where it relates to the Guarantor, a reference to:

 

(i)                                   administration application:  includes a solicitud de concurso voluntario or solicitud de concurso necesario with the meaning attributed to them under the Spanish Insolvency Law (Ley Concursal);

 

(ii)                                winding-up includes, without limitation, disolución, liquidación, procedimiento concursal en fase de liquidación or any other similar proceedings;

 

(iii)                             a receiver, administrative receiver, administrator includes, without limitation, administrador del concurso or any other person performing the same function;

 

(iv)                            a composition with creditors includes the celebration of a convenio concursal as well as any pre-insolvency remedy and shielding mechanism for financing debt provided for under Spanish law, including but not limited to, those provided under articles 5 bis and 71.6 of Spanish insolvency Act;

 

(v)                               security Interest includes, without limitation, any prenda, hipoteca and any other garantía real, derecho de retención, crédito privilegiado, or other transaction having the same effect as each of the foregoing;

 

(vi)                            a person being unable to pay its debts includes that person being in a state of insolvencia or concurso; and

 

(vii)                         a guarantee:  includes any bond (fianza), performance bond (aval) and first demand guarantee (garantía a primer requerimiento).

 

3                                         LOAN FACILITY

 

3.1                               Lender’s Commitment

 

3.1.1                     Subject to Clause 3.5 below, the Lender agrees to make available to the Borrower the Total Loan Facility under the terms of this Loan Agreement, to be drawn down as set out in the Loan Facility Terms and in accordance with Clause 3.2.

 

3.1.2                     The Lender shall make each Tranche available up to the applicable Tranche Expiry Date, but shall not be under any commitment to advance any Tranche or any part thereof after the applicable Tranche Expiry Date or upon the earlier termination of the Loan Facility in accordance with Clause 3.4 or on any dates other than those specified in the Loan Facility Terms.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

15

 

3.1.3                     The unutilised portion (if any) of the Loan Facility in relation to each Tranche shall be cancelled after the expiry of the applicable Tranche Expiry Date , whereupon the Total Loan Facility shall be reduced accordingly.

 

3.1.4                     In granting the Loan Facility the Lender is relying on the representations and warranties contained in Clause 7.

 

3.1.5                     Each Drawdown made under the Loan Facility shall be secured by the Security Documents.

 

3.2                               Date of Advance(s) of the Loan

 

Subject to Clause 3.1.2, (and subject to the satisfaction of the relevant conditions set forth in Clause 3.5), each Tranche shall be advanced and made available to the Borrower within [***] Business Days from receipt by the Lender of an executed Drawdown Notice.  Each Drawdown Notice must be received by the Lender [***] Business Days prior to the end of the relevant drawdown period (as set out in the Loan Facility Terms).  Each Drawdown Notice shall constitute a separate and independent obligation of the Borrower incorporating the terms of this Loan Agreement.  No more than one Drawdown Notice may be served in respect of each Tranche.  Once a Drawdown Notice has been delivered to the Lender, it is irrevocable.  Each Tranche requested to be advanced pursuant to a Drawdown Notice shall be in an amount equal to the Minimum Drawdown Amount.

 

3.3                               Method of Disbursement

 

The payment by the Lender to the account specified in the Drawdown Notice shall constitute the making of the Loan (or the relevant part thereof) and the Borrower shall thereupon become indebted, as principal and direct obligor, to the Lender in an amount equal to the Loan (or the relevant part thereof).

 

3.4                               Termination or Modification of Funding Commitment

 

3.4.1                     The Lender’s commitment to advance each Tranche of the Loan in accordance with the terms of this Loan Agreement is limited in aggregate to the amount of the Total Loan Facility.

 

3.4.2                     The Lender acting in its sole discretion, may terminate its funding commitment pursuant to this Loan Agreement at any time if:

 

(i)                                   an Event of Default has occurred and is continuing or would result from the borrowing to be made pursuant to the Drawdown Notice; or

 

(ii)                                the Borrower’s representations and warranties in Clause 7.1 or those which are set out in any Security Document would not be true if repeated on each of those dates with reference to the circumstances then existing.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

16

 

3.5                               Conditions Precedent requirements relative to the Advance of the Loan

 

3.5.1                     The Lender’s obligation to provide Tranche 1 is subject to the prior satisfaction by the Borrower or the Guarantor (as applicable) of delivery of the documents stated below or compliance with the following conditions (as appropriate):

 

(i)                                   certified copy of the resolutions of the Borrower’s and the Guarantor’s board of directors authorising the transactions contemplated by this Loan Agreement and the execution and delivery to the Lender of this Loan Agreement and associated documents, including but not limited to, the Security Documents;

 

(ii)                                certified copies of the constitutional documents of the Borrower and the Guarantor;

 

(iii)                             a certificate of an authorised signatory of the Borrower and the Guarantor confirming that the borrowing of the Loan Facility in full and the guaranteeing hereto would not cause any borrowing or guaranteeing limit binding on the Borrower to be exceeded;

 

(iv)                            specimen signatures, authenticated by an authorised signatory of the Borrower and the Guarantor, of the persons authorised to execute and deliver this Loan Agreement and associated documents including but not limited to, the Security Documents, in the resolutions of the board of directors referred to in Clause 3.5 (i);

 

(v)                               the Parties having executed and delivered to the Lender the originals of (i) this Loan Agreement and (ii) the Initial Security Documents in the form as set out in Schedule B attached hereto, together with evidence that the registration forms for purposes of registering the security over Intellectual Property pursuant to the Initial Security Documents have been sent to the relevant offices (which in the case of the IP Mortgage in Schedule B.1 shall be complied with by the filing of the deed formalising the Spanish IP Mortgage with the Spanish Movable Property Registry) and that the notices have been sent to the debtors of the bank account receivables in accordance with the Initial Security Documents;

 

(vi)                            the Borrower’s compliance with Clauses 13.1 and 13.2;

 

(vii)                         the most recent management accounts of the Group;

 

(viii)                      copies of the policies of insurance required to be maintained by the Borrower under the terms of this Loan Agreement;

 

(ix)                            any other documentation in form and substance satisfactory to the Lender as the Lender may request (acting reasonably);

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

17

 

(x)                               the Charged Assets being free and clear of all Security Interests whatsoever (except Permitted Security);

 

(xi)                            the Base Case Model;

 

(xii)                         the Accounts;

 

(xiii)                      a group structure chart containing all Subsidiaries (including Arcarios B.V.) and details of all shareholdings held directly or indirectly by the Borrower,

 

each copy document delivered under this Clause 3.5 shall be certified as a true and up to date copy by an authorised signatory of the Borrower.

 

3.5.2                     The Lender’s obligation to provide Tranche 2 and Tranche 3, respectively, is subject to the provision by the Borrower or the Guarantor (as applicable) to the Lender of any other documentation in form and substance satisfactory to the Lender as the Lender may request (acting reasonably).

 

3.6                               Waiver Possibility

 

If the Lender advances all or any part of the Loan to the Borrower prior to the satisfaction of all or any of the conditions referred to in Clause 3.5 (which the Lender has no obligation to do) the Borrower shall satisfy or procure the satisfaction of such condition or conditions which have not been satisfied within [***] Business Days of the relevant Drawdown Date (or within such longer period as the Lender may agree or specify in writing), provided, that the Lender at its discretion may waive the satisfaction of any condition, in whole or in part and with or without conditions, without prejudicing the Lender’s right to require subsequent fulfilment of such conditions.

 

3.7                               Charged Assets

 

The Charged Assets charged to the Lender pursuant to the Security Documents shall form security for the monies borrowed by the Borrower.

 

3.8                               Purpose of the Loan

 

Unless the Lender shall otherwise agree in writing, the Borrower shall use the amounts drawn under the Loan Facility solely for the purpose of general working capital.  The Lender shall not be under any obligation to concern itself with the application of the Loans.

 

4                                         TERM

 

4.1                               This Loan Agreement is effective upon execution by the Lender and the Borrower and shall continue until the later of (i) the Expiry Date and (ii) the date upon which the Borrower shall have indefeasibly performed all its payment obligations hereunder.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

18

 

4.2                               If the conditions set out in Clause 3.5 have not been satisfied on or prior to the Expiry Date (except to the extent waived in writing by the Lender), the Lender shall in its sole discretion have the option to either terminate this Loan Agreement or extend the period in which such conditions must be satisfied.

 

5                                         REPAYMENT AND PREPAYMENT

 

5.1                               Advance Payment

 

5.1.1                     The Borrower shall pay to the Lender, in accordance with Clause 5.1.2 the Advance Payment in respect of each Tranche (the “Advance Payment”) which shall be held by the Lender and applied in or towards payment of the last repayment in respect of that particular Tranche.

 

5.1.2                     The Advance Payment is to be paid by the Borrower to the Lender in respect of each Tranche in four equal payments at the time when the first four interest payments are made as follows:

 

(i)                                   1st Payment - to be paid when the first interest payment in respect of the applicable Tranche is paid in accordance with the terms of this Loan Agreement;

 

(ii)                                2nd Payment - to be paid when the second interest payment in respect of the applicable Tranche is paid in accordance with the terms of this Loan Agreement;

 

(iii)                             3rd Payment - to be paid when the third interest payment in respect of the applicable Tranche is paid in accordance with the terms of this Loan Agreement; and

 

(iv)                            4th Payment - to be paid when the fourth interest payment in respect of the applicable Tranche is paid in accordance with the terms of this Loan Agreement.

 

5.2                               Repayments

 

5.2.1                     The Borrower shall pay all unpaid and accrued interest in respect of each Tranche outstanding on each Monthly Repayment Date.

 

5.2.2                     The Borrower shall repay principal in respect of each Tranche outstanding in accordance with Clause 5.2.3.

 

5.2.3                     The Borrower shall on each Monthly Repayment Date other than the First Monthly Repayment Date and in respect of each Tranche, pay a fixed monthly amount to the Lender as specified in a fully-amortising repayment schedule (fully-amortised except for the initial one-year interest-only period) issued by the Lender prior to the Drawdown Date as may be revised from time to time if the parties so agree (the “Repayment Schedule”).

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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5.2.4                     On the date of this Loan Agreement, the Lender shall provide a repayment schedule to the Borrower setting out the repayment of the Loan Agreement based on the assumption that each Tranche shall be drawn on the last day of the relevant Availability Period.  Such repayment schedule shall be attached to this Loan Agreement in Schedule D.

 

5.2.5                     All payments that the Borrower makes under this Loan Agreement shall be made in full, without any deduction, set-off or counterclaim and in immediately available cleared funds on the due date to an account which the Lender may specify to the Borrower for the purpose.

 

5.2.6                     Except for the initial one year interest-only period, the Repayment Schedule shall set out equal monthly payments comprising accrued interest and principal, so that each Tranche shall amortise fully over the Repayment Term.

 

5.2.7                     The Borrower shall repay the principal amount of each Loan outstanding together with all accrued and unpaid interest, and the End of Loan Fee on expiry of the relevant Loan Term.  All other sums due and payable by the Borrower to the Lender under this Loan Agreement and the Security Documents shall be paid when due and payable.

 

5.2.8                     Subject to clause 5.2.9, each payment received by the Lender in respect of any Tranche shall be applied as follows:

 

5.2.8.1           firstly, to discharge all accrued interest in respect of such Tranche; and

 

5.2.8.2           secondly, to reduce the outstanding principal balance of such Tranche.

 

5.2.9                     The Lender may in its discretion apply any payment received or recovered from the Borrower to discharge any due and unpaid fees, costs, expenses or indemnities under the Finance Documents.

 

5.2.10              Any amount repaid or prepaid may not be redrawn.

 

5.2.11              If the Drawdown Date is not a Monthly Repayment Date, the Borrower shall pay to the Lender on the Drawdown Date (by way of deduction by the Lender of the amount of the Tranche actually advanced to the Borrower) the Interim Repayment which shall discharge interest accrued on the Tranche for the period from the Drawdown Date to First Monthly Repayment Date.

 

5.3                               Currency of Payments

 

Repayment of the Loans and payment of all other amounts owed to the Lender will be paid in Euro (€), unless otherwise agreed by the Parties in writing.  The Borrower shall bear the cost in the event of and in respect of any conversion of a currency to Euro.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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5.4                               Prepayments

 

The Borrower shall be entitled to prepay the Loans, in whole but not in part, subject to the following conditions:

 

5.4.1                     the Borrower shall submit to the Lender an irrevocable written request to prepay the Loans, at least [***] Business Days in advance, indicating the amount to be prepaid and the date of the proposed prepayment, provided that such prepayment shall be made on the last Business Day of a calendar month;

 

5.4.2                     on the date of prepayment the Borrower shall pay the Lender an amount equal to:

 

(i)                                   the outstanding principal amount of the Loans;

 

(ii)                                all accrued and unpaid interest;

 

(iii)                             in respect of each Tranche, the aggregate of the monthly interest payments scheduled to be paid by the Borrower on each Monthly Repayment Date (as is set out in the most recent Repayment Schedule issued by the Lender) for the period from the date of prepayment to the expiry of the Loan Term, in each case discounted from the applicable Monthly Repayment Date to the date of prepayment at the rate of [***] % per annum;

 

(iv)                            the End of Loan Fee, and the Additional End of Loan fee;

 

(v)                               all unpaid fees, costs and expenses; and

 

(vi)                            all other sums payable by the Borrower to the Lender under this Loan Agreement.

 

6                                         INTEREST

 

6.1                               Interest on the principal amount of each Tranche from time to time shall accrue from day to day at a rate of 12.5% per annum (and be compounded on a monthly basis) (the “Applicable Interest Rate”), from the Drawdown Date until the repayment in full of the Loan.  Interest on the Loan and each part thereof shall be calculated and paid in the Contractual Currency.

 

6.2                               Time of payment of any sum due from the Borrower is of the essence under this Loan Agreement.  If the Borrower fails to pay any sum to the Lender after the expiry of any applicable grace period (the “Default Sum”), the Borrower shall pay to the Lender forthwith on demand default interest on such Default Sum (compounded on a monthly basis) as of the first Business Day following the expiry of the applicable grace period until the date of actual payment at a rate equal to the Applicable Interest Rate plus [***] % per annum.  If the Borrower does not pay the Default Sum within [***] Business Days after the end of the applicable grace period, the Borrower shall pay the Lender a one-off late payment charge of [***] % of such the Default Sum to compensate the Lender for additional administrative expense.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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6.3                               For the avoidance of doubt, the default payment mechanism set out in Clause 6.2 does not apply to any sums due under Clause 11.4 (Acceleration).

 

7                                         REPRESENTATIONS AND WARRANTIES

 

7.1                               The Borrower warrants and represents the following as at the date hereof:

 

7.1.1                     the Borrower is a public listed company duly organised and validly existing under the laws of Belgium, and listed on Euronext Brussels;

 

7.1.2                     the Guarantor is a private company duly organised and validly existing under the laws of Spain;

 

7.1.3                     each Group Company is duly organised as a private limited company and validly existing under the laws of its country of incorporation;

 

7.1.4                     subject to Legal Reservations, any Perfection Requirements and Permitted Security, the Borrower and the Guarantor has the corporate capacity, and has taken all corporate action and obtained all consents, including third party consents, necessary for it:

 

(i)                                   to execute this Loan Agreement and the Security Documents to which the Borrower and the Guarantor is or is to be party;

 

(ii)                                to borrow under this Loan Agreement and to make all the payments contemplated by, and to comply with all its other obligations under this Loan Agreement and the Security Documents to which the Borrower and the Guarantor is or is to be party; and

 

(iii)                             to grant the Lender first priority Security Interest in respect of the Charged Assets pursuant to the Security Documents to which the Borrower and the Guarantor is or is to be party.

 

7.1.5                     subject to the Legal Reservations and any Perfection Requirements, this Loan Agreement and the Security Documents to which the Borrower and the Guarantor is or is to be party, do now or, as the case may be, will, upon execution and delivery (and, where applicable, registration as provided for in the Finance Documents):

 

(i)                                   constitute the Borrower’s and the Guarantor’s legal, valid and binding obligations enforceable against the Borrower and the Guarantor in accordance with their respective terms; and

 

(ii)                                create legal, valid and binding security interests enforceable in accordance with their respective terms, subject to any relevant insolvency laws affecting creditors’ rights generally;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

22

 

7.1.6                     subject to Legal Reservations, the execution and (where applicable) registration by the Borrower and the Guarantor of this Loan Agreement and each Security Document to which it is or is to be party, and the borrowing by the Borrower of the Loan and the Borrower’s and the Guarantor’s compliance with this Loan Agreement and each Security Document to which it is or is to be party, will not involve or lead to a contravention of:

 

(i)                                     any applicable law or other legal requirement; or

 

(ii)                                  the constitutional documents of the Borrower; or

 

(iii)                               any contractual or other obligation or restriction which is binding on the Borrower or any of its assets;

 

7.1.7                     subject to any Legal Reservations and any Perfection Requirements, all consents, licences, approvals and authorisations required by the Borrower and the Guarantor in connection with the entry into, performance, validity and enforceability of this Loan Agreement and the Security Documents to which it is or is to be party have been or (upon execution thereof) shall have been obtained by the Drawdown Date and are (or upon execution thereof shall be) in full force and effect during the life of this Loan Agreement;

 

7.1.8                     all financial and other information furnished by or on behalf of the Borrower and/or the Group in connection with the negotiation of this Loan Agreement and the Security Documents delivered to the Lender pursuant to this Loan Agreement or the Security Documents was true and accurate in all material respects when given, there are no other facts or matters the omission of which would have made any statement or information contained therein misleading in any material respect and all projections and statements of belief and opinion given to the Lender were made in good faith after due and careful enquiry;

 

7.1.9                     the Accounts were prepared in accordance with International Financial Reporting Standards (IFRS) and consistently applied and fairly represent (in conjunction with the notes thereto) the financial condition of the Group as at the date to which they were drawn up and the results of the Group’s operations during the financial year then ended;

 

7.1.10              since publication of the Accounts, there has been no material adverse change in the business or financial condition of the Group (unless fully disclosed by the Borrower in its capacity as a listed entity prior to the date of this Loan Agreement);

 

7.1.11              it has its centre of main interest (COMI) in Belgium and the Guarantor has its centre of main interest (COMI) in Marconi 1- Planta Baja, Parque Tecnológico Tres Cantos Madrid (Spain) for the purposes of the EU Regulations on Insolvency Proceedings 2000;

 

7.1.12              there is no action, proceeding or claim pending or, so far as the Borrower is aware or ought reasonably to be aware, threatened against any Group Company before any court or administrative agency which might have a material adverse effect on the business,

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

23

 

condition of operations of the Borrower or any subsidiary, except for litigation described or referred to in the annual report of the Borrower;

 

7.1.13              the Borrower and the Guarantor owns with good and marketable title all the Charged Assets, free from all security interests and other interests and rights of every kind other than the Permitted Security, and all the Charged Assets are in good operating condition and repair, and are adequate for the uses to which they are being put, and none of such Charged Assets are in need of maintenance or repairs except for ordinary, routine maintenance and repairs that are not material in nature or cost;

 

7.1.14              the group structure chart to be delivered pursuant to Clause 3.5(xiii) is true and accurate;

 

7.1.15              the US Subsidiary is either dormant and has no assets or liabilities and no plans exist for it to start any business activity, or has been wound up; and

 

7.1.16              the UK Subsidiary is either in the process of being wound up or has been wound up.

 

7.2                               With the exception of the representations and warranties set out in clauses 7.1.4(iii), 7.1.10, 7.1.12, 7.1.14, 7.1.15 and 7.1.16, the representations and warranties set out in this Clause 7 shall survive the execution of this Loan Agreement and shall be deemed to be repeated on each Drawdown Date and each date of repayment with respect to the facts and circumstances then existing, as if made at such time.

 

8                                         UNDERTAKINGS

 

8.1                               The Borrower undertakes to the Lender to comply with the following provisions of this Clause 8 at all times during the Security Period, except as the Lender may otherwise permit:

 

8.1.1                     the Borrower will (and will procure that each Group Company will) obtain, effect and keep effective all Authorisations which may from time to time be required (i) in connection with the Charged Assets under any law of a Relevant Jurisdiction (i) to enable it to perform its obligations under the Finance Documents including but not limited to ensure that the Finance Documents remain valid and enforceable and to continue to own the Charged Assets) and (ii) to conduct its business where failure to do so has or is reasonably likely to have a material adverse effect on the business, condition of operations of the Borrower;

 

8.1.2                     subject to Legal Reservation, Perfection Requirements and Permitted Security, the Borrower will (and to the extent any Group Company has charged its assets pursuant to a Security Document, the Borrower shall procure that this Group Company shall) own the Charged Assets free from all Security Interests and other interests and rights of every kind, except for those created by the Security Documents;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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8.1.3                     except for a sale, assignment, transfer or disposal which constitutes a Permitted Disposal or a Permitted Transaction, the Borrower will not (and shall procure that each Group Company will not) sell, assign, transfer or otherwise dispose of the Charged Assets, any of its material assets or any share therein and shall give immediate notice to the Lender of any judicial process or encumbrance affecting the Charged Assets;

 

8.1.4                     the Borrower shall promptly obtain, comply with and do all that is necessary to maintain in full force and effect, and, if requested by the Lender, supply copies to the Lender of, any Authorisation required under any law or regulation of its jurisdiction of incorporation to enable it to perform its obligations under the Finance Documents and to ensure the legality, validity, enforceability or admissibility in evidence in its jurisdiction of incorporation of any Finance Document;

 

8.1.5                     the Borrower shall not (and shall ensure that no Group Company will) incur or allow to remain outstanding any Financial Indebtedness other than any Permitted Financial Indebtedness;

 

8.1.6                     the Borrower shall not (and shall ensure that no other Group Company will) create or permit to subsist any Security Interest over any of its assets;

 

8.1.7                     the Borrower shall not (and shall ensure that no other Group Company will):

 

(i)                                   sell, transfer or otherwise dispose of any of its assets on terms whereby they are leased to or intended to be re-acquired by any Group Company; or

 

(ii)                                sell, transfer or otherwise dispose of any of its receivables on recourse terms;

 

(iii)                             enter into any arrangement under which money or the benefit of a bank or other account may be applied, set-off or made subject to a combination of accounts; or

 

(iv)                            enter into any other preferential arrangement having a similar effect) in circumstances where the arrangement or transaction is entered into primarily as a method of raising Financial Indebtedness or of financing the acquisition of an asset.

 

8.1.8                     Clauses 8.1.6 and 8.1.7 do not apply to:

 

(i)                                   any Permitted Disposal;

 

(ii)                                any Permitted Transaction;

 

(iii)                             any Permitted Financial Indebtedness; and

 

(iv)                            any Permitted Security;

 

8.1.9                    the Borrower shall procure that within twelve weeks after the first Drawdown Date:

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

25

 

(i)                                   it shall convene a shareholders’ meeting in order to grant the Warrants to Kreos Capital IV Limited;

 

(ii)                                the resolutions of the shareholders of the Borrower shall be filed with the clerk of the relevant commercial court in accordance with article 556 of the Belgian Companies Code;

 

8.1.10              the Borrower shall pay or discharge all fees associated with registering of any Security Interest granted in connection with the Loans;

 

8.1.11              the Borrower shall at the request of the Lender from time to time execute and deliver such further documents creating Security Interests in favour of the Lender over such assets and in such form as the Lender may reasonably require in its discretion from time to time to:

 

(i)                                   secure all monies, obligations and liabilities of the Borrower and/or any Group Company to the Lender;

 

(ii)                                facilitate the realisation of the Charged Assets; or

 

(iii)                             exercise the powers conferred on the Lender or a receiver appointed under any Security Document, from time to time,

 

provided that the Lender shall not be able to require any Group Company to create security over Excluded Assets;

 

8.1.12              [A] Except as provided under (B), (C) and (D) below, no member of the Group shall:

 

(i)                                   guarantee or otherwise be liable for debt or other obligations of a Ring Fenced Company; or

 

(ii)                                transfer any assets (including cash) to the Ring Fenced Company or enter into any contract with the Ring Fenced Company.

 

[B] A member of the Group may however transfer assets to the Ring Fenced Company or enter into a contract with the Ring Fenced Company:

 

(a)                               to incorporate the Ring Fenced Company;

 

(b)                               to allow the Ring Fenced Company to run its day-to-day business operations;

 

(c)                                in connection with the provision of management services by the Group Company to the Ring Fenced Company;

 

(d)                               to support the Ring Fenced Company to develop, manufacture, commercialise or market its Intellectual Property; provided that the aggregate value of all services

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

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or assets provided by the Group to all Ring-fenced Companies and which are not reimbursed to the Group shall not exceed EUR [***] per annum and provided that the Group does not incorporate more than two Ring Fenced Company during the life of the Loan Agreement.

 

[C] A member of the Group may transfer assets to the Ring Fenced Company or enter into a contract with the Ring Fenced Company provided such transfer or contract constitutes a Permitted Disposal, Permitted Financial Indebtedness, Permitted Transaction or Permitted Security.

 

[D] A Ring Fenced Company may transfer some or all of its assets to a Group Company for nil consideration and without assuming any liabilities.

 

9                                         INFORMATION UNDERTAKINGS

 

9.1                               At all times during the Initial Period, (i) the Borrower undertakes to the Lender to comply with the following provisions of this Clause 9, except as the Lender may otherwise permit and (ii) the Lender shall have the following rights:

 

9.1.1                     the Borrower will provide to the Lender all documents, confirmations and evidence required by the Lender to satisfy its “know your customer” requirements or similar identification checks in order to meet its obligations from time to time under applicable money laundering, or similar, laws and regulations;

 

9.1.2                     the Borrower will provide the Lender with its annual audited consolidated financial statements and the annual audited financial statements for each of the Borrower and the Guarantor at the time and in the format they are made public;

 

9.1.3                     the Borrower will provide the Lender with the half-year condensed consolidated financial statements of the Group at the time and in the format they are made public;

 

9.1.4                     the Borrower will provide the Lender with key financial information such as available cash and burn rate regarding the first and the third quarter of each financial year, at the time and in the format this information is made public;

 

(the items listed under Clauses 9.1.1 to 9.1.4 (included) being together, the On-going Information)

 

9.1.5                     the Borrower will provide the Lender with the half-year management accounts of the Borrower and the Guarantor and, to the extent available, the quarterly management accounts of the Borrower and the Guarantor as fairly presenting the data reflected, within two (2) months of the end of each calendar quarter;

 

9.1.6                    the Borrower shall, as soon as possible and in any event within [***] Business Days, upon it becoming aware of them, provide details of any material litigation commenced or threatened in writing against the Group and/or by the Group which must not be disclosed

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

27

 

to the market by the Borrower in its capacity as a listed company, together with any litigation commenced or threatened in writing against the Group and/or by the Group regarding Intellectual Property which is material to the Group, in each case provided that such litigation is reasonably likely to have a material adverse effect on the business, conditions or operations of the Group, and provided that such litigation had not yet been disclosed to the Lender pursuant to this Clause 9;

 

9.1.7                     the Borrower will provide to the Lender copies of all announcements which are made public by the Borrower concerning dividends, annual or interim financial positions and affairs of the Borrower at the time they are announced;

 

9.1.8                     the Borrower will no later than [***] Business Days from board approval, provide a budget for the Group showing a projected profit and loss account, and a cash flow forecast for the forthcoming financial year;

 

9.1.9                     the Borrower will provide the Lender with copies of the financial information [***]  any information in relation to (i) any material Licencing including potential Licencing, and (ii) interim and final results for the clinical trials to the extent such results substantially adversely deviate from the Borrower’s expectations in relation to the business of the Group as soon as possible and in any event no later than [***] ;

 

9.1.10              In case the Lender [***] , the Borrower will provide the Lender with copies of all notices, consents and other material [***]  as soon as possible and in any event no later than [***] ;

 

9.1.11              the Borrower will provide the Lender with copies of all [***]  within [***] ;

 

9.1.12              the Borrower will provide the Lender with details of any new Group Company incorporated within [***] Business Days from incorporation;

 

9.1.13              the Borrower will notify the Lender as soon as it becomes aware of:

 

(i)                                   the occurrence of an Event of Default; or

 

(ii)                                any matter which indicates that an Event of Default has occurred, may have occurred or is likely to occur,

 

and will thereafter keep the Lender fully up to date with all developments;

 

9.1.14              the Borrower will provide the Lender with details of any change to the Senior Management of the Borrower and to the board of directors of the Borrower at the time of the announcement of such change (if it is announceable) or otherwise within [***] Business Days following such change;

 

(the items listed under Clause 9.1.5 to 9.1.14 (inclusive) being together, the “Information”)

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

28

 

9.1.15              additionally, the Borrower will grant the Lender the right to have a representative to meet with the Senior Management either in person or by means of a telephone call [***]  to review and discuss the operating performance and financial condition of the Group, the status of and information regarding the Charged Assets and such other information concerning any Group Company and its affairs as the Lender may reasonably request (the “Monthly Meeting”); and

 

9.1.16              on the occurrence of an event of default pursuant to Clause 11.1.1, the Lender shall be entitled [***]  for as long as the event of default continues.  [***] .

 

9.2                               At all times during the Subsequent Period, the Borrower undertakes to the Lender to provide the On-going Information to the Lender.

 

9.3                               At all times during the Subsequent Period, the Borrower undertakes to the Lender to provide any or all the Information on a stand alone basis as requested by the Lender from time to time.

 

10                                  STANDSTILL

 

10.1                        Until [***]  months after the end of the Initial Period the Lender shall not whether directly or indirectly, through intermediaries, persons or entities acting in concert, or otherwise, purchase or sell, offer to purchase or sell, agree to purchase or sell, or otherwise acquire or transfer, offer to acquire or transfer, or in any way assist any other person in acquiring or transferring, directly or indirectly, any shares, securities or other financial instruments of the Borrower, or advise, assist or encourage or enter into any discussions, negotiations, agreements or arrangements with any other persons in connection with the foregoing (the Standstill).

 

10.2                        During the Subsequent Period, as of the end of the [***]  month following the expiry of the Initial Period and in the event the Lender does not request any Information, the Standstill shall cease to apply.  Should the Lender instead request any or all the Information, it will be bound by the Standstill for a [***]  months period commencing on the date the Information has been provided by the Borrower (the “Clearance Period”), it being understood that should at any time all the Information which has been provided during the last [***]  months have been made public, the Standstill shall cease to apply before the expiry of the Clearance Period as of the moment all Information has been made public.

 

10.3                        The Lender acknowledges that a breach of this Clause 10 may also constitute a violation of insider dealing and market abuse regulations applicable in Belgium or abroad and give rise to administrative and/or criminal sanctions.  The Lender shall bear full responsibility for compliance with such regulations by itself, its Affiliates and its officers, directors, employees, agents and advisors (and those of its Affiliates) and bear the full costs for any breach thereof.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

29

 

11                                  EVENTS OF DEFAULT

 

11.1                        An Event of Default occurs if:

 

11.1.1              any Group Company fails to pay when due and payable or (if so payable) on demand any sum payable under this Loan Agreement or the Security Documents or under any document relating to the Security Documents unless such non-payment is due to a technical or administrative error and payment is made within [***] Business Days of its due date; or

 

11.1.2              any other breach (other than a breach described under Clause 11.1.1) by any Group Company (as relevant) occurs of any provision of this Loan Agreement or any Security Document or the Borrower or any Group Company does not comply with, perform or observe any other obligation accepted or undertaking given by it to the Lender, unless the failure to comply is capable of remedy and is remedied within a period of [***] Business Days in respect of any breach of Clauses 8.1.1, 8.1.2, 8.1.3, 8.1.4, , 8.1.5, 8.1.6, 8.1.7, 8.1.8, 8.1.10 and Clause 9 of this Loan Agreement and any similar undertakings under the Security Documents, or a period of [***] Business Days in respect of any other breach, each time as of the earlier of (a) the Lender giving notice to the relevant Group Company of such breach, or (b) the Borrower becoming aware of the failure by itself or the Group Company to comply with its obligations; or

 

11.1.3              any representation, warranty or statement made by, or by an officer of, any Group Company in this Loan Agreement or the Security Documents or in the Drawdown Notice or any other notice or document relating to this Loan Agreement or any other Security Document is incorrect, untrue or misleading in any material respect when it is made or deemed repeated; or

 

11.1.4              Financial Indebtedness of any Group Company in an amount in excess of [***] (or [***]after the aggregate amount advanced by the Lender to the Borrower under this Loan Agreement is equal to €10,000,000) in aggregate is not paid when due, or any Security Interest over any of the assets of any Group Company is lawfully enforced; or

 

11.1.5              any order shall be made by any competent court, a petition presented or any resolution shall be passed by any Group Company for the appointment of a liquidator, administrator or receiver or similar official of, or for the winding up of, any Group Company or a moratorium is imposed or declared over any or all of the assets and business of any Group Company; or

 

11.1.6              an encumbrancer takes possession of or a receiver, liquidator, supervisor, compulsory manager, trustee, administrator or similar official is appointed over the whole or any material part of, the assets of any Group Company or a distress, execution or other process is levied or enforced upon or sued out against the whole or a material part of the assets of any Group Company; or

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

30

 

11.1.7              an administration application is presented or made for the making of an administration order or a notice of intention to appoint an administrator is issued by any Group Company or its directors under applicable insolvency laws or a notice of appointment of an administrator is filed by any person with the court; or

 

11.1.8              any final judgment made against any Group Company is not paid, stayed or discharged within [***] days or if later, the due date under the judgement; or

 

11.1.9              any Group Company shall stop payment or shall be unable to, or shall admit inability to, pay its debts as they fall due, or shall be adjudicated or found bankrupt or insolvent, or shall enter into any composition or other arrangement with its creditors generally; or

 

11.1.10                   any event shall occur which under the law of any jurisdiction to which any Group Company is subject has an effect equivalent or similar to any of the events referred to in Clause 11.1.5, 11.1.6 or 11.1.7; or

 

11.1.11                   any Group Company ceases, threatens to cease, or suspends carrying on its business or a part of its business unless it is a Permitted Disposal or a Permitted Transaction; or

 

11.1.12                   the Borrower (i) ceases to be listed on the regulated market of Euronext Brussels; or (ii) ceases to control the Group Companies it controlled on the date of this Loan Agreement, except, in either case, as a result of a disposal which is a Permitted Disposal or a Permitted Transaction; or

 

11.1.13                   there is a change of control in any Group Company other than in relation to a Permitted Disposal or a Permitted Transaction; for purposes of this Clause 11.1.13, a “change of control” shall mean that any person, or persons acting in concert, acquires through one or more connected transactions in aggregate 30% or more of the issued voting share capital of any Group Company, provided that the Lender may agree, by written notice to the Borrower, that a change of control shall not be deemed an Event of Default, but that nevertheless the consequences set forth in Clause 11.2.1 and 11.2.2 shall apply, and in such event the Loans, all accrued interest and all other amounts accrued or owing under this Loan Agreement and the Security Documents shall be due and payable simultaneously with the closing of the change of control transaction; or

 

11.1.14                   it becomes unlawful or impossible (i) for the Borrower and/or each Group Company (as relevant) to discharge any liability under this Loan Agreement or to comply with any other obligation which is material under this Loan Agreement or the Security Documents, or (ii) for the Lender to exercise or enforce any right under, or to enforce any Security Interest created by, this Loan Agreement or the Security Documents; or

 

11.1.15                   any material provision of this Loan Agreement or the Security Documents proves to have been or becomes invalid or unenforceable, or a Security Interest created by the Security Documents proves to have been or becomes invalid or unenforceable or such a Security Interest proves to have ranked after, or loses its priority to, another Security

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

31

 

Interest or any other third party claim or interest, provided however that if the Borrower and/or any Group Company proposes replacement security which the Lender accepts, and such replacement security is constituted in a manner acceptable to the Lender within such period of time as the Lender may require, such event shall cease to constitute an Event of Default; or

 

11.1.16                   the security constituted by the Security Documents is in any way materially imperilled or in jeopardy (including by way of depreciation in value beyond a normal depreciation) provided however that if the Borrower and/or any Group Company proposes replacement security which the Lender accepts, and such replacement security is constituted in a manner acceptable to the Lender within such period of time as the Lender may reasonably require, such event shall cease to constitute an Event of Default; or

 

11.1.17                   the Borrower fails to provide a copy of the resolutions of the Borrower’s shareholders for the purpose of article 556 of the Companies Code, together with evidence that an extract of such resolutions has been duly filed with the clerk of the relevant commercial court in accordance with article 556 of the Companies Code not later than 12 (twelve) weeks of the date of the first Drawdown (unless the failure to comply is capable of remedy and is remedied within a period of [***] Business Days); or

 

11.1.18                   any other event (whether related or not) occurs (including, without limitation, a material adverse change, from the position applicable as at the date of this Loan Agreement) in the business affairs, operations, assets or condition (financial or otherwise) of the Group), the effect of which is, , to materially imperil, delay or prevent the due fulfilment by the Borrower and each Group Company of any of its payment obligations in this Loan Agreement or the Security Documents.

 

11.2                        Lender’s Rights

 

On or at any time following the occurrence of any Event of Default the Lender may:

 

11.2.1              serve on the Borrower a notice stating that all obligations of the Lender to the Borrower under this Loan Agreement including (without limitation) the obligation to advance the Loans (or any part thereof) are terminated; and/or

 

11.2.2              serve on the Borrower a notice stating that the Loans, all accrued interest and all other amounts accrued or owing under this Loan Agreement and the Security Documents are immediately due and payable; and/or

 

11.2.3             declare the Security Documents to be enforceable (but take no action to enforce such Security Documents unless and until the Loans shall be accelerated pursuant to Clause 11.4); and/or

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

32

 

11.2.4              take any other action which, as a result of the Event of Default or any notice served under Clauses 11.2.1 or 11.2.2 above, the Lender is entitled to take under the Security Documents or any applicable law.

 

11.3                        End of Lender’s Obligations

 

On the service of a notice under Clause 11.2.1 and/or Clause 11.2.2, all the obligations of the Lender to the Borrower under this Loan Agreement shall terminate.

 

11.4                        Acceleration

 

On the service of a notice under Clause 11.2.2, the following sums shall become immediately due and payable:

 

11.4.1              the outstanding principal amount of the Loans;

 

11.4.2              all accrued and unpaid interest for each Tranche drawn down;

 

11.4.3              in respect of interest payments payable as from the Event of Default in respect of each Tranche, the aggregate of the monthly interest payments scheduled to be paid by the Borrower on each Monthly Repayment Date (as is set out in the most recent Repayment Schedule issued by the Lender) for the period from the date of prepayment to the expiry of the relevant Loan Term, in each case discounted from the applicable Monthly Repayment Date to the date of prepayment at the rate of [***] % per annum for the first two years of the relevant Loan Term, [***] % per annum for the third year of the relevant Loan Term and [***] % per annum for the fourth year of the relevant Loan Term;

 

11.4.4              the End of Loan Fee;

 

11.4.5              all unpaid fees, costs and expenses; and

 

11.4.6              all other sums payable by the Borrower to the Lender under this Loan Agreement and the Security Documents.

 

11.5                        Waiver of Event of Default

 

The Lender, at its sole and absolute discretion, may waive any Event of Default hereunder, prior to or after the event or events giving rise thereto, provided that such waiver may be effected only by written notice provided by the Lender to the Borrower to that effect (and subject further to Clause 21.3 below); it being understood and acknowledged, that if and so long as no notice of waiver of an Event of Default was so provided, such Event of Default shall be deemed as having occurred and in effect for all purposes hereunder.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

33

 

12                                  GUARANTEE AND INDEMNITY

 

12.1.1              In consideration of the Lender advancing the Loans to any Obligor as the Lender in its absolute discretion sees fit, the Guarantor guarantees to the Lender, whenever an Obligor does not pay any of the Guaranteed Obligations when due, to pay on demand the Guaranteed Obligations.

 

12.1.2              The Guarantor as principal obligor and as a separate and independent obligation and liability from its obligations and liabilities under clause 12.1.1 agrees to indemnify and keep indemnified the Lender in full and on demand from and against all and any losses, costs, claims, liabilities, damages, demands and expenses suffered or incurred by the Lender arising out of, or in connection with, any failure of an Obligor to perform or discharge any of its obligations or liabilities in respect of the Guaranteed Obligations.

 

12.2                        Lender’s Protections

 

12.2.1              This guarantee is and shall at all times be a continuing security and shall cover the ultimate balance from time to time owing to the Lender by each Obligor in respect of the Guaranteed Obligations.

 

12.2.2              The liability of the Guarantor under this guarantee shall not be reduced, discharged or otherwise adversely affected by:

 

(i)                                   any intermediate payment, settlement of account or discharge in whole or in part of the Guaranteed Obligations;

 

(ii)                                any variation, extension, discharge, compromise, dealing with, exchange or renewal of any right or remedy which the Lender may now or after the date of this guarantee have from or against any of an Obligor and any other person in connection with the Guaranteed Obligations;

 

(iii)                             any act or omission by the Lender or any other person in taking up, perfecting or enforcing any Security Interest, indemnity, or guarantee from or against an Obligor or any other person;

 

(iv)                            any termination, amendment, variation, novation, replacement or supplement of or to any of the Guaranteed Obligations including without limitation any change in the purpose of, any increase in or extension of the Guaranteed Obligations and any addition of new Guaranteed Obligations;

 

(v)                               any grant of time, indulgence, waiver or concession to an Obligor or any other person;

 

(vi)                            any insolvency, bankruptcy, liquidation, administration, winding up, incapacity, limitation, disability, the discharge by operation of law, or any change in the constitution, name or style of an Obligor or any other person;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

34

 

(vii)                         any invalidity,  illegality, unenforceability, irregularity or frustration of any actual or purported obligation of, or Security Interest held from, an Obligor or any other person in connection with the Guaranteed Obligations;

 

(viii)                      any claim or enforcement of payment from an Obligor or any other person; or

 

(ix)                            any act or omission which would not have discharged or affected the liability of the Guarantor had it been a principal debtor instead of a guarantor, or indemnifier or by anything done or omitted by any person which but for this provision might operate to exonerate or discharge the Guarantor or otherwise reduce or extinguish its liability under this guarantee.

 

12.2.3              The Lender shall not be obliged before taking steps to enforce any of its rights and remedies under this Guarantee:

 

(i)                                   to take any action or obtain judgment in any court against an Obligor or any other person;

 

(ii)                                to make or file any claim in a bankruptcy, liquidation, administration or insolvency of an Obligor or any other person; or

 

(iii)                             to make demand, enforce or seek to enforce any claim, right or remedy against an Obligor or any other person.

 

12.2.4              The Guarantor warrants to the Lender that it has not taken or received, and shall not take, exercise or receive the benefit of any Rights from or against an Obligor, its liquidator, an administrator, co-guarantor or any other person in connection with any liability of, or payment by, the Guarantor under this guarantee but:

 

(i)                                   if any of the Rights is taken, exercised or received by a Guarantor, those Rights and all monies at any time received or held in respect of those Rights shall be held by the Guarantor on trust for the Lender for application in or towards the discharge of the Guaranteed Obligations under this guarantee; and

 

(ii)                                on demand by the Lender, the Guarantor shall promptly transfer, assign or pay to the Lender all other Rights and all monies from time to time held on trust by that Guarantor under this clause 12.2.4.

 

12.2.5              This guarantee is in addition to and shall not affect nor be affected by or merge with any other judgment, Security Interest, right or remedy obtained or held by the Lender from time to time for the discharge and performance of an Obligor of the Guaranteed Obligations.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

35

 

12.3                        Accounts

 

12.3.1              The Lender may place to the credit of a suspense account any monies received under or in connection with this guarantee in order to preserve the rights of the Lender to prove for the full amount of all its claims against an Obligor or any other person in respect of the Guaranteed Obligations.

 

12.3.2              The Lender may at any time and from time to time apply all or any monies held in any suspense account in or towards satisfaction of any of the monies, obligations and liabilities the subject of this guarantee as the Lender, in its absolute discretion, may conclusively determine.

 

12.3.3              If this guarantee ceases for any reason whatsoever to be continuing, the Lender may open a new account or accounts in the name of an Obligor.

 

12.3.4              If the Lender does not open a new account or accounts pursuant to Clause 12.3.3 it shall nevertheless be treated as if it had done so at the time that this guarantee ceased to be continuing whether by termination, calling in or otherwise, in relation to an Obligor.

 

12.3.5              As from the time of opening or deemed opening of a new account or accounts, all payments made to the Lender by or on behalf of an Obligor shall be credited or be treated as having been credited to the new account or accounts and shall not operate to reduce the amount for which this guarantee is available at that time nor shall the liability of the Guarantor under this guarantee in any manner be reduced or affected by any subsequent transactions, receipts or payments.

 

12.4                        Interest

 

12.4.1              The Guarantor shall pay interest to the Lender after as well as before judgment at the annual rate which is [***] % above the base rate of Barclays Bank plc on all sums demanded under this guarantee from the date of demand by the Lender or, if earlier, the date on which the relevant damages, losses, costs or expenses arose in respect of which the demand has been made, until, but excluding, the date of actual payment.

 

12.4.2              Interest under Clause 12.4.1 shall accrue on a day-to-day basis calculated by the Lender on such terms as the Lender may from time to time determine and shall be compounded on the last Business Day of each month.

 

12.4.3              The Lender shall not be entitled to recover any amount in respect of interest under both this guarantee and any arrangements entered into between an Obligor and the Lender in respect of any failure by an Obligor to make any payment in respect of the Guaranteed Obligations.

 

12.5                        Discharge Conditional

 

12.5.1              Any release, discharge or settlement between the Guarantor and the Lender in relation to this guarantee shall be conditional on no right, Security Interest, disposition or payment

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

36

 

to the Lender by an Obligor or any other person in respect of the Guaranteed Obligations being avoided, set aside or ordered to be refunded pursuant to any enactment or law relating to breach of duty by any person, bankruptcy, liquidation, administration, protection from creditors generally or insolvency or for any other reason.

 

12.5.2              If any right, Security Interest, disposition or payment referred to in clause 12.5.1 is avoided, set aside or ordered to be refunded, the Lender shall be entitled subsequently to enforce this guarantee against the Guarantor as if such release, discharge or settlement had not occurred and any such right, Security, disposition or payment had not been given or made.

 

12.6                        Evidence of Amounts and Certificates

 

Any certificate, determination or notification by the Lender as to a rate or any amount payable under this guarantee is (in the absence of manifest error) conclusive evidence of the matter to which it relates and shall contain reasonable details of the basis of determination.

 

13                                  FEES, EXPENSES AND TAXES

 

13.1                        Transaction Fee

 

The Parties hereby agree and acknowledge that the Transaction Fee shall be paid by the Borrower to the Lender upon the execution of this Loan Agreement.

 

13.2                        Documentary Costs

 

Each of the Borrower and the Guarantor (as applicable) shall promptly pay to the Lender on the Lender’s demand, the reasonable legal expenses incurred by the Lender in connection with:

 

13.2.1              the negotiation, execution, preparation and perfection of this Loan Agreement and the Security Documents and the transactions contemplated hereby and thereby up to an aggregate total of [***]plus applicable VAT and disbursements (save that the [***]cap shall not apply to notary’s fees); and

 

13.2.2              any amendment or supplement to this Loan Agreement or the Security Documents, or any proposal for such an amendment to be made;

 

13.2.3              any consent or waiver by the Lender concerned under or in connection with this Loan Agreement or the Security Documents or any request for such a consent or waiver; and

 

13.2.4              any step taken by the Lender with a view to the protection, exercise or enforcement including any registration of any right or Security Interest created by this Loan Agreement or the Security Documents or for any similar purpose.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

37

 

13.3                        Warrant Fee

 

In the event the shareholders’ of the Borrower should not approve the issue of the Warrant in favour of Kreos Capital IV (Expert Fund) Limited within 12 weeks from the date of the first Drawdown, the Lender shall be entitled to the Warrant Fee to be paid in three equal tranches as follows:

 

13.3.1              €299,000 to be paid on the first day following the first anniversary of the first Drawdown;

 

13.3.2              €299,000 to be paid on the first day following the second anniversary of the first Drawdown; and

 

13.3.3              €299,000 to be paid on the first day following the third anniversary of the first Drawdown.

 

13.4                        Certain taxes and duties

 

The Borrower shall promptly pay any documentary, stamp or other equivalent tax or duty or notary fee payable on or by reference to this Loan Agreement or the Security Documents or any share warrant or local law equivalent, and shall, on the Lender’s demand, fully indemnify the Lender against any costs, losses, liabilities and expenses resulting from any failure or delay by the Borrower to pay such a tax or fee.

 

13.5                        Liability for Taxes

 

13.5.1              The Borrower shall make all payments to be made by it without any Tax deduction, unless a Tax deduction is required by law.  The Borrower shall promptly upon becoming aware that it must make a Tax deduction (or that there is any change in the rate or the basis of a Tax deduction) notify the Lender.

 

13.5.2              If a Tax deduction is required by law to be made by the Borrower, the amount of the payment due from the Borrower shall be increased to an amount which (after making any Tax deduction) leaves an amount equal to the payment which would have been due if no Tax deduction had been required.

 

13.5.3              If the Borrower is required to make a Tax deduction, the Borrower shall make that Tax deduction and any payment required in connection with that Tax deduction within the time allowed and in the minimum amount required by law.

 

13.5.4              Within [***] days of making either a Tax deduction or any payment required in connection with that Tax deduction, the Borrower shall deliver to the Lender evidence reasonably satisfactory to it that the Tax deduction has been made or (as applicable) any appropriate payment paid to the relevant taxing authority.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

38

 

13.6                        Illegality and Increased Costs

 

13.6.1              If it is or becomes contrary to any law or regulation for the Lender to make available the Loan Facility or to maintain its obligations to do so or fund the Loans, the Lender shall promptly notify the Borrower whereupon (a) the Lender’s obligations to make the Loan Facility available shall be terminated and (b) the Borrower shall be obliged to prepay the Loans either (i) forthwith or (ii) on a future specified date on or before the latest date permitted by the relevant law or regulation.

 

13.6.2              If the result of any change in (or in the interpretation, administration or application of), or to the generally accepted interpretation or application of, or the introduction of, any law or regulation is to subject the Lender to Taxes or change the basis of the payment of Taxes by the Lender with respect to any payment under this Loan Agreement (other than Taxes on the overall net income, profits or gains of the Lender), then (i) the Lender shall notify the Borrower in writing of such event promptly upon its becoming aware of the same; and (ii) the Borrower shall on demand, made at any time whether or not the Loans have been repaid, pay to the Lender the amount of the increased costs which the Lender has suffered as a result, (provided that the Borrower shall not be obliged to pay any sum relating to withholding taxes arising if the Lender assigns the benefit of this Loan Agreement to a person in a jurisdiction causing the levy of withholding tax and no relief therefrom exists).

 

14                                  INDEMNITIES

 

14.1                        General Indemnity

 

Without derogating from Clause 12 above, the Borrower shall indemnify the Lender fully on its demand in respect of all expenses, liabilities and losses which are suffered or incurred by the Lender, as a result of or in connection with:

 

(i)                                   any Tranche not being borrowed on the date specified in the Drawdown Notice for any reason other than a default by the Lender;

 

(ii)                                any failure (for whatever reason) by the Borrower to make payment of any amount due under this Loan Agreement or the Security Documents on the due date or, if so payable, on demand; or

 

(iii)                             the occurrence and/or continuance of an Event of Default and/or the acceleration of repayment of the Loans under Clause 9.4, and in respect of any Taxes for which the Lender is liable or held liable in connection with any amount paid or payable to the Lender (whether for its own account or otherwise) under this Loan Agreement or the Security Documents.

 

14.2                        Third Party Claims Indemnity

 

The Borrower shall indemnify the Lender fully on its demand in respect of claims, demands, proceedings, liabilities, taxes, losses and expenses of every kind, including

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

39

 

without limitation legal fees and expenses (“liability items”) which may be made or brought against, or incurred by, the Lender, in any country, in relation to:

 

(i)                                   any action lawfully taken, or omitted or neglected to be taken, under or in connection with this Loan Agreement or the Security Documents by the Lender or by any receiver appointed under the Security Documents after the occurrence of any Event of Default; and

 

(ii)                                any breach or inaccuracy of any of the representations and/or warranties contained in Clause 7 hereof or in the Security Documents or any breach of any covenant, commitment or agreement by the Borrower contained in Clause 8 hereof or elsewhere in this Loan Agreement or in the Security Documents.

 

15                                  RISK AND INSURANCE

 

15.1                        All risk of loss, theft and damage of and to the Charged Assets from any cause whatsoever shall be the risk of the Borrower, and no such event shall relieve the Borrower of any obligation under a Drawdown Notice.

 

15.2                        The Borrower shall:

 

15.2.1              bear all risk of loss of or damage to the Charged Assets whether insured against or not;

 

15.2.2              maintain adequate risk protection through insurances on and in relation to its business and assets to the extent reasonably required on the basis of good business practice taking into account, inter alia, its (and any Group Company’s) financial position and nature of operations.

 

16                                  END OF LOAN FEE and ADDITIONAL END OF LOAN FEE

 

The Borrower shall be required to pay the Lender (i) the End of Loan Fee at the time of the last payment on each Tranche, and (ii) the Additional End of Loan Fee at the time of the last payment under the Total Loan Facility.  Upon payment of these fees, subject to the terms of this Loan Agreement and the Security Documents (including the making of all payments hereunder and thereunder), the Lender shall take appropriate action to release the Security over the Charged Assets.  Failure to pay the End of Loan Fee or the Additional End of Loan Fee shall constitute a breach of this Loan Agreement.

 

17                                  POWER OF ATTORNEY

 

The Borrower by way of security hereby irrevocably appoints the Lender to be its attorney in its name and to act on its behalf and to execute and complete any deeds or documents which the Lender may require for perfecting future Security over its assets pursuant to Clause 8.1.11. in case the Borrower does not take the necessary steps within a reasonable period of time following the request of the Lender to grant Security over future assets pursuant to Clause 8.1.11.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

40

 

18                                  NOTICES

 

18.1                        Any notice, demand or other communication (“Notice”) to be given by any Party under, or in connection with, this Loan Agreement shall be in writing and signed by or on behalf of the Party giving it.  Any Notice shall be served by sending it by fax to the number set out in Clause 18.2, or delivering it by hand to the address set out in Clause 18.2 and in each case marked for the attention of the relevant Party set out in Clause 18.2 (or as otherwise notified from time to time in accordance with the provisions of this Clause 18).  Any Notice so served by fax or hand shall be deemed to have been duly given or made as follows:

 

18.1.1              if sent by fax, at the time of transmission; or

 

18.1.2              in the case of delivery by hand, when delivered,

 

provided that in each case where delivery by fax or by hand occurs after 5pm on a Business Day (local time in the place of receipt) or on a day which is not a Business Day, service shall be deemed to occur at 9am on the next following Business Day (local time in the place of receipt).

 

References to time in the Clause are to local time in the country of the addressee.

 

18.2                        The addresses and fax number of the parties for the purpose of Clause 18 are as follows:

 

18.2.1              Lender
 Address:                         Kreos Capital

25-28 Old Burlington Street 
 London W1S 3AN

Fax:                                               +44 (0)207 409 1034
 For the attention of:  [***]

 

with a copy to:

 

Address:                         Speechly Bircham LLP
 6 New Street Square
 London EC4A 3LX

Fax:                                               +44 (0)207 427 6600
 For the attention of:  Chris Putt

 

18.2.2              Borrower 
 Address:                         Tigenix NV,

Researchpark Haasrode 1724 
 Romeinse straat 12, box 2 
 3001 Leuven, Belgium

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

41

 

Fax:                                               +32 (0)1639 79 70
 For the attention of:  Claudia D’Augusta

 

18.3                        A Party may notify the other Party to this Loan Agreement of a change to its name, relevant addressee, address or fax number for the purposes of this Clause 18, provided that such notice shall only be effective on:

 

18.3.1              the date specified in the notification as the date on which the change is to take place; or

 

18.3.2              if no date is specified or the date specified is less than five Business Days after the date on which notice is given, the date following five Business Days after notice of any change has been given.

 

18.4                        In proving service it shall be sufficient to prove that the envelope containing such notice was properly addressed and delivered to the address shown thereon or that the facsimile transmission was made and a facsimile confirmation report was received, as the case may be.

 

19                                  SPANISH NOTARIAL DOCUMENT AND SUMMARY ENFORCEMENT PROCEEDINGS

 

19.1                        Notarial document

 

19.1.1              The Borrower agrees that, at its cost, this Loan Agreement, any amendment to it (including transfers or accessions) may, at the request of the Lender, be incorporated to a Spanish notarial document (“escritura pública” or “póliza”, at the choice of the Lender).

 

19.1.2              The Guarantor acknowledges that the escritura pública or póliza will expressly state that a Finance Party is entitled to claim all amounts outstanding under the Finance Documents following any non-payment of principal by the Guarantor.  This does not prejudice the exercise of any other right or remedy of the Lender.

 

19.2                        Summary Spanish Enforcement Proceedings

 

19.2.1              For the purpose of Article 571 et seq. of the Civil Procedural Law (Law 1/2000 of 7 January) (Ley de Enjuiciamiento Civil):

 

(i)                                   The amount due and payable under the Loan Agreement that may be claimed in any executive proceedings will be contained in a certificate supplied by the Lender and will be based on the accounts maintained by such Lender in connection with this Loan Agreement;

 

(ii)                                The parties expressly agree that such balance shall be considered as an acknowledgement of debt and may be claimed pursuant to the same provisions of such law;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

42

 

(iii)                             The determination of the debt to be claimed though the executive proceeding shall be effected by the Lender by means of the appropriate certificate evidencing the balance shown in the account or account of the Borrower; and

 

(iv)                            The Lender may (at the cost of the Borrower or the Guarantor) have the certificate notarised.

 

19.2.2              A Finance Party may start executive proceedings by presenting to any relevant court:

 

(i)                                     an original notarial copy of this Loan Agreement; and

 

(ii)                                  a notarial document (acta notarial) incorporating the certificate of that Finance Party referred to in subparagraph (a)(i) above.

 

20                                  CONFIDENTIALITY

 

20.1                        Confidential Information

 

The Lender agrees to keep all Confidential Information confidential and not to disclose it to anyone, save to the extent permitted by Clause 20.2, and to ensure that all Confidential Information is protected with security measures and a degree of care that would apply to its own confidential information.

 

20.2                        Disclosure of Confidential Information

 

20.2.1              The Lender may disclose Confidential Information:

 

(i)                                   to any of its Affiliates and Related Funds and any of its or their officers, directors, employees, professional advisers, auditors, partners and Representatives such Confidential Information as the Lender shall consider appropriate if any person to whom the Confidential Information is to be given pursuant to this paragraph (i) is informed in writing of its confidential nature and that some or all of such Confidential Information may be price-sensitive information except that there shall be no such requirement to so inform if the recipient is subject to professional obligations to maintain the confidentiality of the information or is otherwise bound by requirements of confidentiality in relation to the Confidential Information;

 

(ii)                                to any person:

 

(a)                               to (or through) whom it assigns or transfers (or may potentially assign or transfer) all or any of its rights and/or obligations under the Finance Documents in accordance with this Loan Agreement or which succeeds (or which may potentially succeed) it as Lender and, in each case, to any of that person’s Affiliates, Related Funds, Representatives and professional advisers;

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

43

 

(b)                               with (or through) whom it enters into (or may potentially enter into), whether directly or indirectly, any sub-participation in relation to, or any other transaction under which payments are to be made or may be made by reference to, one or more Finance Documents and/or the Borrower and to any of that person’s Affiliates, Related Funds, Representatives and professional advisers;

 

(c)                                appointed by the Lender or by a person to whom paragraph (ii)(a) or (b) above applies to receive communications, notices, information or documents delivered pursuant to the Finance Documents on its behalf;

 

(d)                               to whom information is required or requested to be disclosed by any court of competent jurisdiction or any governmental, banking, taxation or other regulatory authority or similar body, the rules of any relevant stock exchange or pursuant to any applicable law or regulation;

 

(e)                                to whom information is required to be disclosed in connection with, and for the purposes of, any litigation, arbitration, administrative or other investigations, proceedings or disputes;

 

(f)                                 to whom or for whose benefit that Lender charges, assigns or otherwise creates a Security Interest (or may do so) pursuant to this Loan Agreement;

 

(g)                                with the consent of the Borrower,

 

in each case, such Confidential Information as that Lender shall consider appropriate if:

 

(iii)                             in relation to paragraphs (ii)(a), (ii)(b) and (ii)(c) above, the person to whom the Confidential Information is to be given has entered into a Confidentiality Agreement except that there shall be no requirement for a Confidentiality Agreement if the recipient is a professional adviser and is subject to professional obligations to maintain the confidentiality of the Confidential Information;

 

(iv)                            in relation to paragraphs (ii)(d), (ii)(e) and (ii)() above, the person to whom the Confidential Information is to be given is informed of its confidential nature and that some or all of such Confidential Information may be price-sensitive information; and

 

(v)                               to any person appointed by that Lender or by a person to whom paragraph (ii)(a) or (ii)(b) above applies to provide administration or settlement services in respect of one or more of the Finance Documents including without limitation, in relation to the trading of participations in respect of the Finance Documents, such Confidential Information as may be required to be disclosed to enable such

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

44

 

service provider to provide any of the services referred to in this paragraph (v) if the service provider to whom the Confidential Information is to be given has entered into a confidentiality agreement substantially in the form of Confidentiality Agreement agreed between the Borrower and the Lender.

 

20.3                        Entire agreement on Confidential Information

 

Without prejudice to clause 10.3, this Clause 20 constitutes the entire agreement between the Parties in relation to the obligations of the Lender under the Finance Documents regarding Confidential Information and supersedes any previous agreement, whether express or implied, regarding Confidential Information.

 

20.4                        Notification of disclosure

 

20.4.1              The Lender agrees (to the extent permitted by law and regulation) to inform the Borrower:

 

(i)                                   of the circumstances of any disclosure of Confidential Information made pursuant to paragraph (ii)(d) of Clause 18.2 (Disclosure of Confidential Information) except where such disclosure is made to any of the persons referred to in that paragraph during the ordinary course of its supervisory or regulatory function; and

 

(ii)                                upon becoming aware that Confidential Information has been disclosed in breach of this Clause.

 

20.5                        Term

 

20.5.1              The obligations in this Clause 20 will end on the earlier of:

 

(i)                                   the date on which all amounts payable by the Borrower under or in connection with the Finance Documents have been paid in full and the Total Loan Facility has been cancelled or otherwise cease to be available; and

 

(ii)                                the date on which the Lender otherwise ceases to be a Lender.

 

21                                  GENERAL

 

21.1                        All agreements, covenants, representations and warranties of the Borrower contained in this Loan Agreement or in the Drawdown Notices or other documents delivered pursuant hereto or in connection herewith and continuing, shall survive and remain binding the execution and delivery, and the expiration, cancellation or other termination of this Loan Agreement and/or the Drawdown Notice.

 

21.2                       If the Borrower shall fail to perform any of its obligations under any Drawdown Notice duly and promptly, the Lender may, at its option and at any time, perform the same

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

45

 

without waiving any default on the part of the Borrower, or any of the Lender’s rights.  The Borrower shall reimburse the Lender, within [***] Business Days after notice thereof is given to the Borrower, for all expenses and liabilities incurred by the Lender in the performance of the Borrower’s obligations.

 

21.3                        No failure to exercise, nor any delay in exercising, on the part of the Lender, any right or remedy hereunder shall operate as a waiver, nor shall any single or partial exercise of any right or remedy prevent any further or other exercise or the exercise of any other right or remedy.  The rights and remedies provided in this Loan Agreement are cumulative and not exclusive of any rights or remedies provided by law or in equity.  Waiver by the Lender of any default shall not constitute waiver of any other default.

 

21.4                        If, during the term of the Loan Term Agreement, the Borrower wishes to obtain additional debt or loan financing, it shall give the Lender the opportunity, in parallel with any other potential lenders, to make a financing proposal.  [***] , the Borrower shall be allowed to accept the financing from the other funding source provided such financing is Permitted Financial Indebtedness under the Loan Agreement or, if it is not Permitted Financial Indebtedness, provided the Borrower has obtained the prior written consent of the Lender.

 

In addition, [***].

 

21.5                        The Borrower may not assign or transfer its rights, benefits and obligations under this Loan Agreement.  The Lender shall have the right, in its sole discretion, to assign, sell, pledge, grant a security interest in or otherwise encumber its rights under this Loan Agreement and/or one or more Drawdown Notices to (i) an Affiliate of the Lender; or (ii) to a fund which is a Related Fund of the existing Lender or (iii) with the Borrower’s prior written consent not to be unreasonably withheld or delayed, to a bank or financial institution or to a trust, fund or other entity which is regularly engaged in or established for the purpose of making, purchasing or investing in loans, securities or other financial assets (an “Assignee”), or to any person acting as an agent for any Assignee in entering into any Drawdown Notice.  The Borrower hereby irrevocably consents to any such assignment, sale, pledge, grant of a security interest or any other disposal to an Assignee.  The Borrower agrees that if it receives notice from the Lender that it is to make payments under this Loan Agreement and/or any Drawdown Notice to such Assignee rather than to the Lender, or that any of its other obligations under the relevant Drawdown Notice are to be owed to the named Assignee, the Borrower shall comply with any such notice.  Subject to the foregoing, this Loan Agreement and each Drawdown Notice inures to the benefit of, and is binding upon, the successors and assigns of the Lender.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

46

 

21.6                        The Borrower consents to the disclosure of information by the Lender to its Affiliates, Related Funds and to other parties to the Security Documents and potential assignees.

 

21.7                        Clause titles are solely for convenience and are not an aid in the interpretation of this Loan Agreement.

 

21.8                        If, at any time, any provision herein is or becomes illegal, invalid or unenforceable in any respect under any law of any jurisdiction, neither the legality, validity or enforceability of the remaining provisions nor the legality, validity or enforceability of such provision under the law of any other jurisdiction will in any way be affected or impaired.

 

21.9                        A person who is not a party to this Loan Agreement has no right under the Contract (Rights of Third Parties) Act 1999 to enforce or enjoy the benefits of this Loan Agreement.

 

21.10                 This Loan Agreement, together with the Security Documents, constitutes the entire agreement between the parties with respect to the subject matter hereof.  This Loan Agreement may not be modified except in writing executed by the Lender and the Borrower.  No supplier or agent of the Lender is authorised to bind the Lender or to waive or modify any term of this Loan Agreement.

 

21.11                 This Loan Agreement may be executed in counterparts (including facsimile copies), each of which shall be an original, but all such counterparts shall together constitute one and the same instrument.

 

21.12                 This Loan Agreement and any non-contractual obligations arising out of or in connection with it are governed by English law.  The courts of England have exclusive jurisdiction to settle any dispute arising out of or in connection with this Loan Agreement (including a dispute relating to the existence, validity or termination of this Loan Agreement or any non-contractual obligation arising out of or in connection with this Loan Agreement (a “Dispute”).  The parties to this Loan Agreement agree that the courts of England are the most appropriate and convenient courts to settle Disputes and accordingly no Party to this Loan Agreement will argue to the contrary.  This Clause 21.12 is for the benefit of the Lender only.  As a result, the Lender shall not be prevented from taking proceedings relating to a Dispute in any other courts with jurisdiction.  To the extent allowed by law, the Lender may take concurrent proceedings in any number of jurisdictions.

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

47

 

SCHEDULE A

 

FORM OF DRAWDOWN NOTICE

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

48

 

SCHEDULE B

 

INITIAL SECURITY DOCUMENTS

 

1. Spanish IP Mortgage

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

49

 

2. Spanish Bank Account Pledge

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

50

 

3. Spanish Share Pledge

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

51

 

4. Belgian IP Pledge

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

52

 

5. Belgian Bank Account and Receivables Pledge

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

53

 

6. US Assignment for Security — Patents and Trademarks

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

54

 

SCHEDULE C

 

EXISTING FINANCIAL INDEBTEDNESS

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

55

 

SCHEDULE D

 

EXAMPLE OF REPAYMENT SCHEDULE

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

56

 

SCHEDULE E

 

ADDITIONAL END OF LOAN FEE

 

[***]

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

57

 

SCHEDULE F

 

WARRANT PLAN

 

Incorporated by reference to Exhibit 10.7

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

58

 

Duly executed by the parties on the date first set out on the first page of this Loan Agreement.

 

	
BORROWER
    	
 
    
	
 
    	
 
    
	
Signed
    	
/s/   Eduardo Bravo
    	
 
    
	
 
    	
 
    
	
For and   on behalf of
    	
 
    
	
TIGENIX   NV
    	
 
    
	
Authorised   signatory
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
Name:
    	
Eduardo   Bravo
    	
 
    
	
 
    	
 
    	
 
    
	
Title:
    	
CEO
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
GUARANTOR
    	
 
    
	
 
    	
 
    
	
Signed
    	
/s/   Claudia D’Augusta
    	
 
    
	
 
    	
 
    
	
For and   on behalf of
    	
 
    
	
TIGENIX   S.A.U.
    	
 
    
	
Authorised   signatory
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
Name:
    	
Claudia   D’Augusta
    	
 
    
	
 
    	
 
    	
 
    
	
Title:
    	
CEO
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
LENDER
    	
 
    
	
 
    	
 
    
	
Signed
    	
/s/   Mario Petitbom
    	
 
    
	
 
    	
 
    
	
For and   on behalf of
    	
 
    
	
KREOS   CAPITAL IV (UK) LIMITED
    	
 
    
	
Authorised   signatory
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
Name:
    	
Mario   Petitbom
    	
 
    
	
 
    	
 
    	
 
    
	
Title:
    	
Director
    	
 
    

 

[***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions.

 

59

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