France
|
| |
2834
|
| |
Not applicable
|
(State or other jurisdiction of
incorporation or organization)
|
| |
(Primary Standard Industrial
Classification Code Number)
|
| |
(I.R.S. Employer
Identification No.)
|
Peter E. Devlin
Jones Day
250 Vesey Street
New York, New York 10281
+1 212 326 3939
|
| |
Renaud Bonnet
Jean-Gabriel Griboul
Jones Day
2, rue Saint-Florentin
75001 Paris, France
+33 1 56 59 39 39
|
| |
Brian F. Leaf
David C. Boles
Divakar Gupta
Courtney T. Thorne
Katie A. Kazem
Cooley LLP
55 Hudson Yards
New York, NY 10001
+1 212 479 6000
|
| |
Arnaud Duhamel
Guilhem Richard
Gide Loyrette Nouel A.A.R.P.I.
15, rue de Laborde
75008 Paris, France
+33 1 40 75 00 00
|
Title of each class of securities to be registered
|
| |
Proposed maximum aggregate offering price(2)(3)(4)
|
| |
Amount of registration fee
|
Ordinary Shares, €0.03 nominal value per share(1)
|
| |
US$60,000,000
|
| |
US$6,546
|
(1)
|
All ordinary shares will be in the form of American Depositary Shares (“ADSs”) in the offering in the United States. ADSs issuable upon deposit of the ordinary shares registered hereby will be registered pursuant to a separate registration statement on Form F-6. Each ADS represents ordinary shares.
|
(2)
|
Includes the additional ordinary shares, which may be represented by ADSs, that the registrant may issue at the option of the underwriters. See “Underwriting.”
|
(3)
|
Includes ordinary shares that are being offered in a private placement in Europe and other countries outside of the United States but which may be resold from time to time in the United States in transactions requiring registration under the Securities Act of 1933, as amended (the “Securities Act”), or pursuant to an exemption therefrom. The total number of ordinary shares in the U.S. offering and the private placement outside of the United States is subject to reallocation among them.
|
(4)
|
Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(o) under the Securities Act.
|
|
| |
Per Ordinary
Share
|
| |
Per ADS
|
| |
Total
|
Initial public offering price
|
| |
€
|
| |
$
|
| |
$
|
Underwriting commissions(1)
|
| |
€
|
| |
$
|
| |
$
|
Proceeds to Nanobiotix (before expenses)
|
| |
€
|
| |
$
|
| |
$
|
(1)
|
We refer you to “Underwriting” beginning on page 206 of this prospectus for additional information regarding underwriting compensation.
|
Jefferies
|
| |
Evercore ISI
|
| |
UBS Investment Bank
|
|
| |
Gilbert Dupont
|
| |
|
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| |
*
|
Study 312, a global Phase III clinical trial for elderly patients with locally-advanced head and neck cancer who are ineligible for platinum-based (cisplatin) chemotherapy, will be initiated as a U.S. Phase III clinical trial. Because Study 312 will commence as a Phase III trial, we have represented it with a dotted line in the table. For its evaluation of Study 312, the FDA has accepted the available data from our European dose-escalation study, Study 102 Escalation. NBTXR3 for the treatment of locally advanced head and neck cancers received Fast Track designation from the FDA in February 2020. We are in the process of making final protocol refinements in response to FDA feedback and intend to initiate Study 312 in the United States in 2021 with a portion of the proceeds from this offering.
|
†
|
PharmaEngine, Inc. (“PharmaEngine”) currently controls development and commercialization in the Asia-Pacific region. We believe that PharmaEngine has not complied with its obligations under our collaboration to use commercially reasonable efforts to develop NBTXR3 in this region and have notified PharmaEngine of this material breach. Unless an appropriate resolution is reached with PharmaEngine or we are able to identify and enter into a definitive agreement with a new collaborator for this region, these trials may not progress beyond the stage noted in the table. See “Business—Collaborations and Research Agreements—PharmaEngine” for additional details.
|
⯀
|
Advanced pipeline with promising clinical data in numerous cancer indications. As of the date of this prospectus, we have administered NBTXR3 to more than 230 patients across multiple cancer indications. In our completed Phase II/III clinical trial in patients with STS of the extremities and trunk wall, we observed a statistically significant improvement in complete pathological response rate following treatment with NBTXR3 activated by radiotherapy as compared to treatment with radiotherapy alone. Based on these results, we obtained the right to CE mark, and therefore to commercialize, on an accelerated basis NBTXR3 in the European Union as a treatment for locally advanced STS. Our preliminary results from other clinical trials suggest that NBTXR3 could generate durable, complete responses and extend patient survival in numerous solid tumor indications for patients who otherwise have limited treatment options. In our clinical trials conducted to date, treatment with NBTXR3 has been well tolerated.
|
⯀
|
Significant market opportunity in solid tumors. In developed countries with access to radiotherapy, approximately 60% of all cancer patients are treated with radiotherapy at some point in their treatment regimen. We believe that NBTXR3’s mode of action could improve outcomes for patient populations across all cancer indications currently treated with radiotherapy. In addition, NBTXR3 could bring opportunities to patients with solid tumor cancers that cannot otherwise be treated with radiotherapy because of sensitivities of the tissues near the tumor.
|
⯀
|
Improved benefit-risk ratio through intratumoral injection. NBTXR3 is administered by a physician through a single injection in which the solution is injected directly into the tumor prior to the first radiotherapy session. Using this method, we are able to create high concentrations of our product candidate inside the tumor while minimizing the systemic exposure that results from other methods, such as intravenous administration. In addition, NBTXR3 is only active while exposed to ionizing radiation and remains inert in the body until further radiation exposure.
|
⯀
|
Highly compatible with, and complementary to, existing standard of care. NBTXR3 can be easily incorporated into the current standard of care in radiotherapy. Hospitals and medical facilities where radiotherapy is delivered do not need any new equipment or to otherwise make significant capital investments in new technology in order to deliver NBTXR3 to patients.
|
⯀
|
Robust intellectual property protection with significant know-how creating barriers to entry. Our technology and product candidates are protected by more than 300 issued or pending patents and patent applications in over 20 patent families across the world, and none of the patents specifically covering injectable NBTXR3 in the United States are expected to expire until at least November 2031 (2029 in other countries with patents issued). Specifically, once issued, the patent covering the use of NBTXR3 in immuno-oncology is not expected to expire until at least 2036 in the United States and other countries. In addition, we maintain a significant level of proprietary know-how in the design and manufacture of nanoparticles. We believe that our intellectual property position protects our competitive position relative to other companies seeking to use metal-based nanoparticles in the enhancement of radiotherapy.
|
⯀
|
Established manufacturing facility with substantial production capacity. We currently manufacture NBTXR3 at a third-party facility in France. In 2017, we opened our own manufacturing site near Paris. We expect that our owned facility will allow us to expand our production capacity to more than 200,000 doses of NBTXR3 per year, which we believe will be sufficient to produce NBTXR3 for our current and contemplated clinical trials and the first few years following a commercial launch. We have designed our manufacturing process so that additional production lines can be added without significant capital investment.
|
⯀
|
Complete the development of, and satisfy applicable EU and U.S. regulatory requirements for, NBTXR3 for the treatment of locally advanced head and neck cancers. Based on encouraging results from Study 102 Escalation, we have commenced the Study 102 Expansion to collect additional preliminary efficacy data. In an interim analysis of efficacy data for 31 evaluable patients in the Study 102 Expansion presented in October 2020 at the annual meeting of the American Society for Radiation Oncology (ASTRO), researchers observed a high objective response rate (83.9% according to RECIST 1.1) at a median evaluation time of five months after NBTXR3 was administered. We intend to evaluate final Study 102 Escalation data in mid-2021 and could potentially use positive efficacy data, if observed, to obtain the right to CE mark, and therefore to commercialize, on an accelerated basis in the EU, where NBTXR3 has been classified as a medical device, at such time.
|
⯀
|
Complete post-approval trials for NBTXR3 for the treatment of locally advanced STS in the EU. Following positive results from our Phase II/III clinical trial, in April 2019 NBTXR3 became the first ever radioenhancer to have a CE mark, allowing it to be commercialized for the treatment of locally advanced STS under the brand name Hensify®. We are currently preparing Study 401 to continue evaluating safety and efficacy while providing patients in the EU with access to Hensify®. Following evaluation of the results from Studies 102 and 312, we intend to undertake a strategic review and to determine where we believe we are best positioned to pursue commercialization, including our commercialization strategy with respect to Hensify®.
|
⯀
|
Expand the opportunity for NBTXR3 as a treatment for solid tumor indications. We believe that NBTXR3’s physical mode of action could make it broadly applicable across a multitude of solid tumor indications. In addition to head and neck cancers and STS, we intend to continue to develop and pursue NBTXR3 for other indications, and we are already progressing clinical trials in liver cancers in the EU and prostate cancer in the United States. In addition, in December 2018 we entered into a collaboration with MD Anderson as part of which we intend to conduct a total of nine clinical trials in the United States to evaluate NBTXR3 plus radiotherapy across several cancer types. The first clinical trial under this collaboration, in patients with pancreatic cancer, has commenced enrollment with the first patient dosed during September 2020. The FDA has also indicated that the second, third, fourth and fifth clinical trials under this collaboration for lung cancer, esophageal cancer, R/M HNSCC (I-O program) and inoperable LRR HNSCC (I-O program), respectively, may proceed. The co-development with MD Anderson of two additional clinical trials —for advanced solid tumors and lung or liver metastases and for Stage IV lung cancer— within our I-O development program is ongoing. The design of the two remaining trials under the MD Anderson collaboration has yet to be determined. We expect to enroll a total of approximately 340 patients across the nine planned clinical trials. If we are able to demonstrate the applicability of NBTXR3 to solid
|
⯀
|
Establish NBTXR3 as a complementary product to immune checkpoint inhibitors. We are conducting, and continue to further develop, a global I-O development program to explore the use of NBTXR3 as a complement to immune checkpoint inhibitors across several solid tumor indications. In preclinical studies, NBTXR3 activated by radiation therapy in combination with immune checkpoint inhibitors demonstrated potential to convert checkpoint inhibitor non-responders into responders, provide better local and systemic control and increase survival. We are conducting Study 1100, a Phase I basket trial of NBTXR3 in combination with anti-PD-1 checkpoint inhibitors in patients with LRR or R/M HNSCC or with lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy. We presented first clinical results from Study 1100 at the SITC 35th Annual Meeting in November 2020. We believe NBTXR3 has the potential to benefit this patient population with the potential to increase the proportion of patients that respond to immune checkpoint inhibitors. See “Business—Our Clinical Programs—HNSCC, Lung Metastasis or Liver Metastasis” for additional detail. In addition, pursuant to our collaboration with MD Anderson, we are planning to evaluate NBTXR3 in combination with various checkpoint inhibitors (anti-PD-1, anti-PD-L1, and anti-CTLA-4) across several cancer indications.
|
⯀
|
Build an effective clinical development program and establish a global commercial infrastructure for NBTXR3. We have conducted clinical trials involving multiple therapeutic areas throughout the United States and the EU, in which more than 400 physicians have been involved. In addition, our global medical science liaison team has consulted closely with a number of physicians, hospitals, clinics, and cancer treatment centers in the United States and key European markets to better understand their needs as clinicians and institutions and to tailor NBTXR3 accordingly. We plan to focus our commercialization and marketing efforts for NBTXR3 in Europe and the United States, if approved. However, we may also develop and commercialize NBTXR3 in other specific regions, independently or through third-party collaborators.
|
⯀
|
an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002;
|
⯀
|
an exemption from compliance with any requirement that the Public Company Accounting Oversight Board (“PCAOB”) may adopt regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; and
|
⯀
|
to the extent that we no longer qualify as a foreign private issuer, (1) reduced disclosure about the company’s executive compensation arrangements, and (2) exemptions from the requirements to obtain a non-binding advisory vote on executive compensation or a shareholder approval of any golden parachute arrangements.
|
⯀
|
certain rules under the Exchange Act that regulate disclosure obligations and procedural requirements related to the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act;
|
⯀
|
the sections of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and liability for insiders who profit from trades made in a short period of time;
|
⯀
|
the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information, and current reports on Form 8-K, upon the occurrence of specified significant events; and
|
⯀
|
Regulation Fair Disclosure, or Regulation FD, which regulates selective disclosures of material information by issuers.
|
⯀
|
1,978,145 new ordinary shares issuable upon the exercise of founders’ warrants (BSPCE), warrants (BSA), and stock options (OSA) granted but not exercised as of June 30, 2020, at a weighted average exercise price of €10.55 per share;
|
⯀
|
452,750 free shares granted as of June 30, 2020, subject to future vesting;
|
⯀
|
6,000 ordinary shares granted as free shares prior to June 30, 2020, which vested and were issued on July 27, 2020;
|
⯀
|
3,300,000 ordinary shares issued pursuant to a private placement on July 30, 2020;
|
⯀
|
700,000 ordinary shares reserved for future issuance under our share-based compensation plans and other delegations of authority from our shareholders upon the completion of this offering; and
|
⯀
|
8,366,666 ordinary shares reserved pursuant to a delegation of authority from our shareholders for share capital increases by us through rights issuances and public or private offerings, which number of shares will be reduced by the number of shares issued in this offering.
|
⯀
|
No exercise of the BSPCE, BSA and options or vesting of the free shares listed above; and
|
⯀
|
No issuance by us of additional ordinary shares (including in the form of ADSs) pursuant to the exercise of the underwriters’ option to purchase additional ADSs and/or ordinary shares in this offering.
|
|
| |
Year Ended December 31,
|
| |
Six Months Ended June 30,
|
||||||||||||
|
| |
2019
|
| |
2018(1)
|
| |
2020
|
| |
2019
|
||||||
|
| |
€
|
| |
$(2)
|
| |
€
|
| |
€
|
| |
$(2)
|
| |
€
|
|
| |
(in thousands, except share and per share data)
|
|||||||||||||||
Statement of consolidated operations data:
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
Revenues
|
| |
68
|
| |
76
|
| |
116
|
| |
37
|
| |
42
|
| |
37
|
Other income
|
| |
2,473
|
| |
2,779
|
| |
3,363
|
| |
1,411
|
| |
1,586
|
| |
1,786
|
Total revenues and other income
|
| |
2,541
|
| |
2,855
|
| |
3,479
|
| |
1,448
|
| |
1,627
|
| |
1,823
|
Operating expenses:
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
Research and development expenses
|
| |
(30,411)
|
| |
(34,173)
|
| |
(20,893)
|
| |
(13,077)
|
| |
(14,695)
|
| |
(13,380)
|
Selling, general and administrative expenses
|
| |
(18,909)
|
| |
(21,248)
|
| |
(12,653)
|
| |
(6,755)
|
| |
(7,591)
|
| |
(8,910)
|
Total operating expenses
|
| |
(49,320)
|
| |
(55,421)
|
| |
(33,546)
|
| |
(19,832)
|
| |
(22,285)
|
| |
(22,290)
|
Operating loss
|
| |
(46,779)
|
| |
(52,566)
|
| |
(30,067)
|
| |
(18,384)
|
| |
(20,658)
|
| |
(20,467)
|
Financial loss
|
| |
(4,133)
|
| |
(4,644)
|
| |
(277)
|
| |
(2,194)
|
| |
(2,465)
|
| |
(3,452)
|
Income tax
|
| |
(3)
|
| |
(3)
|
| |
—
|
| |
(1)
|
| |
(1)
|
| |
—
|
Net loss
|
| |
(50,915)
|
| |
(57,213)
|
| |
(30,345)
|
| |
(20,579)
|
| |
(23,125)
|
| |
(23,920)
|
Basic and diluted loss per share
|
| |
(2.35)
|
| |
(2.64)
|
| |
(1.55)
|
| |
(0.91)
|
| |
(1.02)
|
| |
(1.15)
|
Weighted average number of outstanding ordinary shares used for calculating basic and diluted loss per share
|
| |
21,631,514
|
| |
21,631,514
|
| |
19,633,373
|
| |
22,608,408
|
| |
22,608,408
|
| |
20,844,245
|
(1)
|
We applied the new IFRS 16 standard — Leases starting January 1, 2019 following the modified retrospective method. Accordingly, financial statements for the year ended December 31, 2018 are not restated under the new IFRS 16 standard.
|
(2)
|
Translated solely for convenience into U.S. dollars at an exchange rate of €1.00 = $1.1237, the noon buying rate of the Federal Reserve Bank of New York on June 30, 2020.
|
|
| |
As of June 30, 2020
|
|||||||||||||||
|
| |
Actual
|
| |
Pro Forma(1)
|
| |
Pro Forma
As Adjusted(2)(3)
|
|||||||||
|
| |
€
|
| |
$(4)
|
| |
€
|
| |
$(4)
|
| |
€
|
| |
$(4)
|
|
| |
(in thousands)
|
|||||||||||||||
Statement of consolidated financial position data:
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
Cash and cash equivalents(5)
|
| |
26,590
|
| |
29,879
|
| |
50,433
|
| |
56,672
|
| |
|
| |
|
Total assets(5)
|
| |
44,765
|
| |
50,302
|
| |
68,565
|
| |
77,046
|
| |
|
| |
|
Total shareholders’ equity(5)
|
| |
(22,194)
|
| |
(24,939)
|
| |
(3,352)
|
| |
(3,767)
|
| |
|
| |
|
Total non-current liabilities(5)
|
| |
49,819
|
| |
55,982
|
| |
54,819
|
| |
61,600
|
| |
|
| |
|
Total current liabilities
|
| |
17,140
|
| |
19,260
|
| |
17,140
|
| |
19,260
|
| |
|
| |
|
(1)
|
The pro forma summary statement of consolidated financial position data reflects (i) the 6,000 ordinary shares granted as free shares prior to June 30, 2020, which vested and were issued on July 27, 2020, (ii) a €5.0 million non-dilutive, state guaranteed loan from Bpifrance Financement, a subsidiary of Banque publique d’investissement (“Bpifrance,” and such loan the “Bpifrance PGE Loan”) received in July 2020 and (iii) the 3,300,000 ordinary shares issued in the July 2020 Private Placement, resulting in net proceeds of €18.8 million.
|
(2)
|
The pro forma as adjusted summary statement of consolidated financial position data further reflects our issuance and sale of ordinary shares (including in the form of ADSs) in the offering at an assumed offering price of € per ordinary share (corresponding to $ per ADS, assuming an exchange rate of €1.00 = $ ), the closing price of our ordinary shares on Euronext Paris on , 2020, corresponding to € per ordinary share in the non-U.S. private placement (assuming an exchange rate of €1.00 = $ ), after deducting estimated underwriting commissions and estimated offering expenses payable by us.
|
(3)
|
The pro forma as adjusted summary statement of consolidated financial position data is illustrative only and will change based on the actual offering price, the actual number of ordinary shares (including ordinary shares in the form of ADSs) offered by us and other terms of the offering determined at pricing. The pro forma as adjusted information is unaudited and is not derived from our audited financial statements. Each €1.00 ($ ) increase or decrease in the assumed offering price of $ per ADS in the U.S. offering would increase or decrease the pro forma as adjusted amount of each of cash and cash equivalents, total assets and total shareholders’ equity by € million ($ million), assuming that the number of ordinary shares offered by us (including ordinary shares in the form of ADSs), as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting commissions. Each 1,000,000 increase or decrease in the total number of ordinary shares (including ordinary shares in the form of ADSs) sold in the offering would increase or decrease the pro forma as adjusted amount of each of cash and cash equivalents, total assets and total shareholders’ equity by € million ($ million), assuming the offering price remains the same and after deducting estimated underwriting commissions.
|
(4)
|
Translated solely for convenience into U.S. dollars at an exchange rate of €1.00 = $1.1237, the noon buying rate of the Federal Reserve Bank of New York on June 30, 2020.
|
(5)
|
Actual cash and cash equivalents, total assets and total shareholders’ equity as of June 30, 2020 exclude the net proceeds of the July 2020 Private Placement and actual cash and cash equivalents, total assets and total non-current liabilities as of June 30, 2020 exclude the proceeds of the Bpifrance PGE Loan.
|
⯀
|
continue our preclinical and clinical programs currently in progress;
|
⯀
|
expand the scope of our current clinical trials and commence new clinical trials to research new oncological applications for our nanotechnology;
|
⯀
|
expand our manufacturing capabilities for the production of our product candidates and maintain compliance with applicable manufacturing regulatory requirements;
|
⯀
|
seek regulatory and marketing approvals, or initiate the necessary conformity assessment procedures, as applicable, for our product candidates that successfully complete clinical trials;
|
⯀
|
establish a sales, marketing and distribution infrastructure to commercialize any products for which we may successfully complete applicable pre-marketing regulatory requirements;
|
⯀
|
advance our research and development efforts, which may include the acquisition of new technologies, products or licenses;
|
⯀
|
maintain, protect and expand our intellectual property portfolio;
|
⯀
|
attract new and retain existing skilled personnel; and
|
⯀
|
incur legal, accounting and other expenses as a U.S. public company.
|
⯀
|
Disruptions, interruptions or delays of our clinical trial activities, whether conducted by us or in collaboration with our partners (such as MD Anderson), due in particular to delays or difficulties in recruiting patients, challenges from quarantines, site closures, supply chain interruptions, limitations or redirection of human or material resources normally allocated to these clinical trials, interruptions in data collection, monitoring and/or processing, more limited access to physicians, delays in receiving, or shortages of, the supplies and materials necessary for the performance of clinical trials, or travel restrictions imposed or recommended by local authorities;
|
⯀
|
Changes in local regulations due to the measures taken in response to the COVID-19 pandemic, which could require us to modify the conditions of our clinical trials, potentially resulting in unforeseen costs or the interruption of our trials;
|
⯀
|
Delays in obtaining from regulatory authorities the approvals required to launch our contemplated clinical trials, as well as delays in the necessary interactions with local authorities or other important organizations and third-party partners;
|
⯀
|
The refusal of regulatory authorities such as the U.S. Food and Drug Administration (“FDA”), the Agence Nationale de la Sécurité du Médicament et des Produits de Santé (“ANSM”) or other competent authorities or certification bodies such as the Notified Bodies in the European Union to accept data from clinical trials conducted in geographic areas affected by the COVID-19 pandemic;
|
⯀
|
Overall reduced operational productivity, including interruptions to our research and development activity, resulting from challenges associated with remote work arrangements and limited resources available to employees working remotely; or
|
⯀
|
Challenges in accessing, in a timely manner or on acceptable terms, financing opportunities as a result of dislocations in the capital markets, liquidity constraints on potential commercial partners, and general disruptions to global and regional economies.
|
⯀
|
delay or reduce the number or extent of our preclinical and clinical trials or eliminate them entirely;
|
⯀
|
grant licenses to our technology to collaborative partners or third parties; or
|
⯀
|
enter into new collaboration agreements upon less favorable conditions than we would have been able to obtain under different circumstances.
|
⯀
|
dispose of any part of our business or assets outside of arm’s-length ordinary course transactions;
|
⯀
|
restructure or make substantial changes to the nature of our business;
|
⯀
|
enter into certain merger or consolidation transactions;
|
⯀
|
dispose of our shareholdings in our material subsidiaries;
|
⯀
|
pursue acquisitions or investments;
|
⯀
|
incur any indebtedness in excess of €1.0 million in the aggregate;
|
⯀
|
provide guarantees in respect of liabilities or other obligations;
|
⯀
|
engage in certain hedging activities;
|
⯀
|
grant security over our assets;
|
⯀
|
pay dividends or repurchase our shares; and
|
⯀
|
impair our intellectual property rights.
|
⯀
|
a product candidate is ineffective, inferior to existing approved treatments, unacceptably toxic, or has unacceptable side effects (both immediate or long-term);
|
⯀
|
patients may die or suffer other adverse effects for reasons that may or may not be related to the product candidate being tested;
|
⯀
|
extension studies on long-term tolerance could invalidate the use of our product;
|
⯀
|
the results may not confirm the positive results of earlier testing or trials;
|
⯀
|
the independent data monitoring committee assigned to review our testing and trials could identify potential flaws in, or recommend against advancement of or adjustments to, any particular trial or trial design; and
|
⯀
|
the results may not meet the level of statistical significance required by the FDA or other regulatory agencies to establish the safety and efficacy of our product candidates.
|
⯀
|
demonstrating sufficient preclinical safety and efficacy to obtain regulatory approval to commence a clinical trial;
|
⯀
|
validating test methods to support quality testing of the product candidate;
|
⯀
|
manufacturing sufficient quantities of the product candidate necessary to conduct clinical trials;
|
⯀
|
obtaining institutional review board approval to conduct a clinical trial at a prospective clinical trial site;
|
⯀
|
determining dosing and clinical trial design; and
|
⯀
|
patient enrollment, which is a function of many factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical trial sites, the availability of effective treatments for the relevant oncological indication and the eligibility criteria for the clinical trial.
|
⯀
|
lack of efficacy of product candidates during clinical trials;
|
⯀
|
adverse events, safety issues or side effects relating to the product candidates or their formulation;
|
⯀
|
unanticipated events during clinical trials requiring amendments to clinical trial designs or protocols;
|
⯀
|
inability to raise additional capital in sufficient amounts to continue funding clinical trials or development programs;
|
⯀
|
the need to sequence and prioritize clinical trials as opposed to conducting them concomitantly in order to conserve resources;
|
⯀
|
our inability to enter into collaborations relating to the development and commercialization of our product candidates;
|
⯀
|
our failure to conduct clinical trials in accordance with regulatory requirements or clinical trial protocols;
|
⯀
|
our inability to manufacture or obtain from third parties sufficient quantities of product candidates for use in preclinical studies and clinical trials or of raw materials necessary for such manufacture;
|
⯀
|
governmental or regulatory delays and changes in regulatory requirements or policy and guidance from regulatory authorities, including mandated changes in the scope or design of clinical trials or requests for supplemental information with respect to clinical trial results;
|
⯀
|
delays in patient enrollment, variability in the number and types of patients available for clinical trials, and lower-than anticipated retention rates for patients in clinical trials;
|
⯀
|
difficulty in patient monitoring and data collection due to failure of patients to maintain contact after treatment; and
|
⯀
|
varying interpretations of our data by the Notified Body, FDA and other regulatory agencies.
|
⯀
|
the third parties do not devote a sufficient amount of time or effort to our activities or otherwise fail to successfully carry out their contractual duties or to meet regulatory obligations or expected deadlines;
|
⯀
|
we replace a third party; or
|
⯀
|
the quality or accuracy of the data obtained by third parties is compromised due to their failure to adhere to clinical protocols, regulatory requirements, or for other reasons.
|
⯀
|
collaborators may not have sufficient resources or decide not to devote the necessary resources due to internal constraints such as budget limitations, lack of human resources, or a change in strategic focus;
|
⯀
|
collaborators may believe our intellectual property is not valid or is unenforceable or the product candidate infringes on the intellectual property rights of others;
|
⯀
|
collaborators may dispute their responsibility to conduct development and commercialization activities pursuant to the applicable collaboration, including the payment of related costs or the division of any revenues;
|
⯀
|
collaborators may decide to pursue a competitive product developed outside of the collaboration arrangement;
|
⯀
|
collaborators may not be able to obtain, or believe they cannot obtain, the necessary regulatory approvals or certifications; or
|
⯀
|
collaborators may delay the development or commercialization of our product candidates in favor of developing or commercializing another party’s product candidate.
|
⯀
|
our ability to continue to develop our product candidates currently in preliminary clinical phases and to move our products currently in preclinical development phase to a clinical phase or from one clinical phase to the next;
|
⯀
|
our ability, or the ability of a contracted third party, to successfully complete the clinical trials required by the set deadlines and with the human, technical and financial resources initially planned.
|
⯀
|
our ability to set a price we believe is fair for our products, if approved;
|
⯀
|
our ability to obtain and maintain market acceptance by the medical community and patients;
|
⯀
|
our ability to generate revenues and achieve profitability; and
|
⯀
|
the availability of capital.
|
⯀
|
levying fines and other civil penalties;
|
⯀
|
imposing consent decrees or injunctions;
|
⯀
|
requiring us to suspend or put on hold one or more of our clinical trials;
|
⯀
|
suspending or withdrawing regulatory approvals or certifications;
|
⯀
|
delaying or refusing to approve pending applications or supplements to approved applications;
|
⯀
|
requiring us to suspend manufacturing activities or product sales, imports or exports;
|
⯀
|
requiring us to communicate with physicians, hospitals and other stakeholders about concerns related to actual or potential safety, efficacy, and other issues involving our products;
|
⯀
|
ordering or requiring product recalls or seizing products;
|
⯀
|
imposing operating restrictions; and
|
⯀
|
seeking criminal prosecutions.
|
⯀
|
the perceived therapeutic benefit of the product by care prescribers;
|
⯀
|
the potential occurrence of unanticipated or harmful side effects;
|
⯀
|
the ease of integration of the product in current care/treatment processes;
|
⯀
|
the advantages and disadvantages of the product compared to existing or alternative treatments;
|
⯀
|
the ability of physicians to correctly and effectively administer our product to patients;
|
⯀
|
the cost of treatment, and coverage and reimbursement policies of third-party payors, including government payors, pertaining to the product;
|
⯀
|
our ability to educate the medical community about the safety and effectiveness of the product;
|
⯀
|
support from the medical community in the oncology field; and
|
⯀
|
the development of one or more competing products for the same oncological indication, including therapies with a mode of action similar to that of NBTXR3.
|
⯀
|
failing to receive regulatory clearances required to market them as drugs or medical devices, as applicable;
|
⯀
|
being subject to proprietary rights held by others;
|
⯀
|
failing to obtain clearance from regulatory authorities for the manufacturing of our products;
|
⯀
|
being difficult or expensive to manufacture on a commercial scale;
|
⯀
|
having adverse side effects that make their use less desirable;
|
⯀
|
failing to compete effectively with products or treatments commercialized by competitors;
|
⯀
|
failing to show that the long-term benefits of our products exceed their risks;
|
⯀
|
changes to our overall development priorities; or
|
⯀
|
shifting our commercialization strategy based upon our view that the market no longer supports commercialization of a particular product candidate or for a particular indication.
|
⯀
|
our inability to recruit, train, manage, motivate and retain adequate numbers of effective sales and marketing personnel;
|
⯀
|
the failure of an adequate number of physicians to adopt any future products as part of treatment; and
|
⯀
|
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
|
⯀
|
the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, including any kickback, bribe or rebate, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any item, good, facility or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid;
|
⯀
|
U.S. federal civil and criminal false claims laws and civil monetary penalties laws, including the civil False Claims Act, which can be enforced by individuals through civil whistleblower or qui tam actions, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government;
|
⯀
|
the U.S. federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal criminal statutes which prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or knowingly and willingly falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters;
|
⯀
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose certain requirements on covered entities, including certain healthcare providers, health plans and healthcare clearinghouses, and their business associates, individuals and entities that perform functions or activities that involve individually identifiable health information on behalf of covered entities, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
⯀
|
the laws and regulations relating to the protection of personal data, and in particular Regulation (EU) 2016/679 of April 27, 2016, or the General Data Protection Regulation (“GDPR“), which imposes strict requirements on activities that involve the processing of “personal data” (i.e., any information relating to an identified or identifiable natural person), as well as any national implementing law. For example, the GDPR requires the following: data processing activities must be justified by a legal basis, data subjects must be informed of the characteristics of the processing of their personal data, adequate security measures must be implemented, contractual relationships with data processors and transfers of personal data outside of the EU must be formalized and performed in compliance with data protection rules, data controllers must hold and maintain up to date records of data processing activities, data privacy impact assessments must be performed under certain circumstances, personal data breaches must be notified, etc. In 2019, a GDPR gap analysis was carried out by external experts on our behalf and we are in the process of implementing the most critical actions suggested to us to be taken;
|
⯀
|
U.S. federal transparency requirements under the Physician Payments Sunshine Act, enacted as part of the ACA, that require applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to track and annually report to CMS payments and other transfers of value provided to physicians and teaching hospitals, and certain ownership and investment interests held by physicians or their immediate family members; and
|
⯀
|
analogous state or foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the federal requirements, state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, state and local laws that require the registration of pharmaceutical sales representatives, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect as HIPAA, thus complicating compliance efforts.
|
⯀
|
we or our licensors may not have been the first to invent the technology covered by our or their pending patent applications or issued patents;
|
⯀
|
we cannot be certain that we or our licensors were the first to file patent applications covering our products, product candidates, processes or technologies, as patent applications in the United States and most other countries are confidential for a period of time after filing;
|
⯀
|
others may independently develop identical, similar or alternative products, product candidates, processes and technologies;
|
⯀
|
the disclosures in our patent applications or our licensors’ patent applications may not be sufficient to meet the statutory requirements for patentability;
|
⯀
|
any or all of our pending patent applications or our licensors’ pending patent applications may not result in issued patents;
|
⯀
|
we or our licensors may not seek or obtain patent protection in countries or jurisdictions that may eventually provide us a significant business opportunity;
|
⯀
|
any patents issued to us or our licensors may not provide a basis for commercially viable products, product candidates, processes and technologies, may not provide any competitive advantages, or may be successfully challenged by third parties, which may result in our patent claims or our licensors’ patent claims being narrowed, invalidated or held unenforceable;
|
⯀
|
our or our licensors’ products, product candidates, processes and technologies may not be patentable;
|
⯀
|
others may design around our patent claims or our licensors’ patent claims to produce competitive products, product candidates, processes and technologies that fall outside of the scope of our patents or our licensors’ patents;
|
⯀
|
others may identify prior art or other bases upon which to challenge and ultimately invalidate our or our licensors’ patents or otherwise render them unenforceable; and
|
⯀
|
our employees may claim intellectual property rights over, or demand remuneration with respect to, inventions they helped to develop.
|
⯀
|
payment of damages, potentially treble damages, if we are found to have willfully infringed a party’s patent rights;
|
⯀
|
injunctive or other equitable relief that may effectively block our ability to further develop, commercialize, and sell products; or
|
⯀
|
us or our collaborators having to enter into license arrangements that may not be available on commercially acceptable terms, if at all.
|
⯀
|
actual or anticipated fluctuations in our financial condition and operating results;
|
⯀
|
our failure to develop and commercialize our product candidates;
|
⯀
|
our failure to achieve our projected product candidate development and commercialization goals in our expected or announced timeframes;
|
⯀
|
actual or anticipated changes in our growth rate relative to our competitors;
|
⯀
|
competition from existing products or new products that may emerge;
|
⯀
|
announcements by us, our collaborators or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments;
|
⯀
|
the imposition of regulatory requirements on any of our products or product candidates;
|
⯀
|
failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public;
|
⯀
|
issuance of new or updated research or reports by securities analysts;
|
⯀
|
fluctuations in the valuation of companies perceived by investors to be comparable to us;
|
⯀
|
share price and volume fluctuations attributable to inconsistent trading volume levels of our shares (such as fluctuations in the exchange rate between the U.S. dollar and the euro that may result in temporary differences between the value of our ADSs and the value of our ordinary shares, which may result in heavy trading by investors seeking to exploit such differences);
|
⯀
|
additions or departures of key management or scientific personnel;
|
⯀
|
lawsuits threatened or filed against us, disputes or other developments related to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies;
|
⯀
|
changes to coverage policies or reimbursement levels by commercial third-party payors and government payors and any announcements relating to coverage policies or reimbursement levels;
|
⯀
|
announcement or expectation of additional debt or equity financing efforts;
|
⯀
|
sales of our ordinary shares or ADSs by us, our insiders or our other shareholders; and
|
⯀
|
general economic and market conditions.
|
⯀
|
provisions of French law allowing the owner of 90% of the share capital or voting rights of a public company to force out the minority shareholders following a tender offer made to all shareholders are only applicable to companies listed on a regulated market or a multilateral trading facility in a Member State of the EU or in a state party of the European Economic Area Agreement, including the main French stock exchange, and will therefore be applicable to us only if we continue to dual-list in France;
|
⯀
|
a merger (i.e., in a French law context, a stock-for-stock exchange after which our company would be dissolved without being liquidated into the acquiring entity and our shareholders would become shareholders of the acquiring entity) of our company into a company incorporated in the EU would require the approval of our executive board as well as a two-thirds majority of the votes cast by the shareholders present, represented by proxy or voting by mail at the relevant meeting;
|
⯀
|
a merger of our Company into a company incorporated outside of the EU would require the unanimous approval of our shareholders;
|
⯀
|
under French law, a cash merger is treated as a share purchase and would require the consent of each participating shareholder;
|
⯀
|
our shareholders have granted and may grant in the future to our executive board broad authorizations to increase our share capital or to issue additional ordinary shares or other securities (for example, warrants) to our shareholders, the public or qualified investors, including as a possible defense following the launching of a tender offer for our shares;
|
⯀
|
our shareholders have preferential subscription rights proportional to their shareholding in our company on the issuance by us of any additional shares or securities giving right, immediately or in the future, to new shares for cash or a set-off of cash debts, which rights may only be waived by the extraordinary shareholders’ general meeting (by a two-thirds majority vote) of our shareholders or on an individual basis by each shareholder;
|
⯀
|
our supervisory board has the right to appoint new members to fill a vacancy created by the resignation or death of a member, subject to the approval by the shareholders of such appointment at the next shareholders’ meeting, which prevents shareholders from having the sole right to fill vacancies on our supervisory board;
|
⯀
|
the members of our executive board are appointed by our supervisory board and can be removed either by our supervisory board or by the shareholders’ general meeting;
|
⯀
|
our supervisory board can only be convened by its chairman, or by its vice-president or, on a reasoned request (e.g. when no board meeting has been held for more than two consecutive months), by (1) members representing at least one-third of the total number of members of our supervisory board or (2) a member of the executive board;
|
⯀
|
our supervisory board’s meetings can only be regularly held if at least half of its members attend either physically or by way of videoconference or teleconference, enabling the members’ identification and ensuring their effective participation in the supervisory board’s decisions;
|
⯀
|
our ordinary shares are nominative or bearer, if the legislation so permits, according to the shareholder’s choice;
|
⯀
|
under French law, (a) any non-French citizen, (b) any French citizen not residing in France, (c) any non-French entity or (d) any French entity controlled by one of the aforementioned persons or entities may have to file a declaration for statistical purposes with the Bank of France (Banque de France) within 20 working days following
|
⯀
|
under French law, certain investments in any entity governed by French law relating to certain strategic industries (such as research and development in biotechnologies and activities relating to public health) and activities by individuals or entities not French, not resident in France or controlled by entities not French or not resident in France are subject to prior authorization of the Ministry of Economy; see “Limitations Affecting Shareholders of a French Company;”
|
⯀
|
approval of at least a majority of the votes cast by shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove members of the supervisory board with or without cause;
|
⯀
|
advance notice is required for nominations to the members of the supervisory board or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a member of our supervisory board can be proposed at any shareholders’ meeting without notice;
|
⯀
|
pursuant to French law, our By-laws, including the sections relating to the number of our supervisory board’s members and election and removal of a member of the supervisory board from office, may only be modified by a resolution adopted by a two-thirds majority vote of our shareholders present, represented by a proxy or voting by mail at the meeting;
|
⯀
|
in the event where certain ownership thresholds would be crossed, a number of disclosures should be made by the relevant shareholder and can impose certain obligations; see “Description of Share Capital—Key Provisions of Our By-laws and French Law Affecting Our Ordinary Shares—Declaration of Crossing of Ownership Thresholds”; and
|
⯀
|
transfers of shares shall comply with applicable insider trading rules and regulations, and in particular with the Market Abuse Directive and Regulation dated April 16, 2014.
|
⯀
|
currency exchange restrictions or costs and exchange rate fluctuations;
|
⯀
|
exposure to local economic or political instability, threatened or actual acts of terrorism and security concerns in general;
|
⯀
|
compliance with various laws and regulatory requirements relating to anti-corruption, antitrust or competition, economic sanctions, data content, data protection and privacy, employment and labor laws and health and safety;
|
⯀
|
difficulties in attracting and retaining qualified employees in certain international markets, as well as managing staffing and operations due to increased complexity, distance, time zones, language and cultural differences;
|
⯀
|
difficulty in enforcing agreements, judgments, and arbitration awards in various legal systems; and
|
⯀
|
inability to obtain, maintain or enforce our intellectual property rights.
|
⯀
|
our ability to successfully develop and commercialize NBTXR3;
|
⯀
|
our ability to expand our product pipeline by developing and commercializing NBTXR3 in additional indications, including in combination with chemotherapies or I-O treatment;
|
⯀
|
our ability to compete with institutions with greater financial resources and expertise in research and development, preclinical testing, clinical trials, manufacturing and marketing;
|
⯀
|
the completion of applicable pre-marketing regulatory requirements and/or our ability to maintain regulatory approvals and certifications for our products and product candidates and the rate and degree of market acceptance of our product candidates, including NBTXR3;
|
⯀
|
regulatory developments in the United States, the EU, and other countries;
|
⯀
|
the effects of the COVID-19 pandemic on our business operations and clinical development timelines and plans;
|
⯀
|
the initiation, timing, progress and results of our preclinical studies and clinical trials, including those trials to be conducted under our collaboration with MD Anderson;
|
⯀
|
the expected timeline of our clinical trial completion, including our ability, and the ability of third party collaborators, to successfully conduct, supervise and monitor clinical trials for our product candidates;
|
⯀
|
our ability to obtain raw resources and maintain and operate our facilities to manufacture our product candidates;
|
⯀
|
our ability to manufacture, market and distribute our products upon successful completion of applicable pre-marketing regulatory requirements, specifically NBTXR3;
|
⯀
|
our ability to achieve the commercialization goals for NBTXR3;
|
⯀
|
our ability to successfully resolve disputes under existing and future collaboration agreements, including our License and Collaboration Agreement with PharmaEngine;
|
⯀
|
our ability to obtain funding for our operations;
|
⯀
|
our ability to attract and retain key management and other qualified personnel;
|
⯀
|
our global operations and exposure to global markets;
|
⯀
|
our ability to protect and maintain our intellectual property rights, manufacturing know-how and proprietary technologies and our ability to operate our business without infringing upon the intellectual property rights and proprietary technologies of third parties;
|
⯀
|
our use of proceeds from the offering;
|
⯀
|
future revenue, expenses, capital expenditures, capital requirements and performance of our publicly traded equity securities;
|
⯀
|
our status as a foreign private issuer and emerging growth company and the reduced disclosure requirements associated with maintaining these statuses; and
|
⯀
|
other risks and uncertainties, including those listed under the caption “Risk Factors.”
|
⯀
|
approximately € ($ ) million to advance Study 312 for the treatment of locally advanced head and neck cancers through an interim analysis of efficacy data; and
|
⯀
|
approximately € ($ ) million to support compliance with applicable pre-marketing regulatory requirements in the United States and the EU.
|
⯀
|
an actual basis;
|
⯀
|
a pro forma basis to give effect to (i) the 6,000 ordinary shares granted as free shares prior to June 30, 2020, which vested and were issued on July 27, 2020, (ii) the €5 million Bpifrance PGE Loan and (iii) the 3,300,000 ordinary shares issued in the July 2020 Private Placement, resulting in net proceeds of €18.8 million; and
|
⯀
|
a pro forma as adjusted basis to reflect the pro forma items described above and our issuance and sale of ordinary shares (including in the form of ADSs) in the offering at an assumed offering price of € per ordinary share (corresponding to $ per ADS, assuming an exchange rate of €1.00 = $ ), the closing price of our ordinary shares on Euronext Paris on , 2020, after deducting estimated underwriting commissions and estimated offering expenses payable by us.
|
|
| |
As of June 30, 2020
|
|||||||||||||||
|
| |
Actual
|
| |
Pro Forma
|
| |
Pro Forma
As Adjusted(1)
|
|||||||||
|
| |
(in thousands, except share data)
|
|||||||||||||||
|
| |
€
|
| |
$(2)
|
| |
€
|
| |
$(2)
|
| |
€
|
| |
$(2)
|
Cash and cash equivalents(3)
|
| |
26,590
|
| |
29,879
|
| |
50,433
|
| |
56,672
|
| |
|
| |
|
Share capital:(3)
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
Ordinary shares, €0.03 nominal value: 22,731,122 shares issued and outstanding, actual; 26,037,122 shares issued and outstanding, pro forma; shares issued and outstanding, pro forma as adjusted
|
| |
682
|
| |
766
|
| |
781
|
| |
878
|
| |
|
| |
|
Premiums related to share capital(3)
|
| |
151,968
|
| |
170,766
|
| |
170,712
|
| |
191,829
|
| |
|
| |
|
Accumulated other comprehensive loss
|
| |
428
|
| |
481
|
| |
428
|
| |
481
|
| |
|
| |
|
Treasury shares
|
| |
(243)
|
| |
(273)
|
| |
(243)
|
| |
(273)
|
| |
|
| |
|
Reserve
|
| |
(154,451)
|
| |
(173,557)
|
| |
(154,451)
|
| |
(173,557)
|
| |
|
| |
|
Net loss
|
| |
(20,579)
|
| |
(23,125)
|
| |
(20,579)
|
| |
(23,125)
|
| |
|
| |
|
Total shareholders’ equity(3)
|
| |
(22,194)
|
| |
(24,939)
|
| |
(3,352)
|
| |
(3,767)
|
| |
|
| |
|
Non-current financial liabilities(3)
|
| |
49,448
|
| |
55,565
|
| |
54,448
|
| |
61,183
|
| |
|
| |
|
Current financial liabilities
|
| |
2,391
|
| |
2,687
|
| |
2,391
|
| |
2,687
|
| |
|
| |
|
Total financial liabilities(3)
|
| |
51,839
|
| |
58,251
|
| |
56,839
|
| |
63,870
|
| |
|
| |
|
Total capitalization(3)
|
| |
29,645
|
| |
33,312
|
| |
53,487
|
| |
60,103
|
| |
|
| |
|
(1)
|
Each €1.00 ($ ) increase or decrease in the assumed offering price of $ per ADS (€ per ordinary share), would increase or decrease each of pro forma as adjusted cash and cash equivalents, total shareholders’ equity and total capitalization by approximately € ($ ) million, assuming that the number of ordinary shares offered by us (including in the form of ADSs), as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting commissions. We may also increase or decrease the number of ordinary shares we are offering (including in the form of ADSs). Each increase or decrease of 1,000,000 ordinary shares offered by us (including in the form of ADSs) would increase or decrease each of pro forma as adjusted cash and cash equivalents, total shareholders’ equity and total capitalization by approximately € ($ ) million, assuming that the assumed offering price remains the same, and after deducting estimated underwriting commissions. The pro forma as adjusted information discussed above is illustrative only and will adjust based on the actual offering price, the actual number of ordinary shares offered by us (including in the form of ADSs), and other terms of the offering determined at pricing.
|
(2)
|
Translated solely for convenience into U.S. dollars at an exchange rate of €1.00 = $1.1237, the noon buying rate of the Federal Reserve Bank of New York on June 30, 2020.
|
(3)
|
Actual cash and cash equivalents, total assets, share capital and premiums related to share capital as of June 30, 2020 exclude the net proceeds of the July 2020 Private Placement and actual cash and cash equivalents, total assets and non-current financial liabilities as of June 30, 2020 exclude the proceeds of the Bpifrance PGE Loan.
|
⯀
|
1,978,145 new ordinary shares issuable upon the exercise of founders’ warrants (BSPCE), warrants (BSA), and stock options (OSA) granted but not exercised as of June 30, 2020, at a weighted average exercise price of €10.55 per share;
|
⯀
|
452,750 free shares granted as of June 30, 2020, subject to future vesting;
|
⯀
|
6,000 ordinary shares granted as free shares prior to June 30, 2020, which vested and were issued on July 27, 2020;
|
⯀
|
3,300,000 ordinary shares issued pursuant to a private placement on July 30, 2020;
|
⯀
|
700,000 ordinary shares reserved for future issuance under our share-based compensation plans and other delegations of authority from our shareholders upon the completion of this offering; and
|
⯀
|
8,366,666 ordinary shares reserved pursuant to a delegation of authority from our shareholders for share capital increases by us through rights issuances and public or private offerings, which number of shares will be reduced by the number of shares issued in this offering.
|
|
| |
As of June 30, 2020
|
|||||||||
|
| |
Per Ordinary
Share
|
| |
Per ADS
|
||||||
Assumed offering price
|
| |
|
| |
€
|
| |
|
| |
$
|
Historical net tangible book value (deficit) per ordinary share or ADS as of June 30, 2020
|
| |
€(0.98)
|
| |
|
| |
$
|
| |
|
Increase per ordinary share or ADS attributable to the pro forma adjustments described above
|
| |
€0.85
|
| |
|
| |
|
| |
|
Pro forma net tangible book value (deficit) per ordinary share or ADS as of June 30, 2020
|
| |
€(0.13)
|
| |
|
| |
|
| |
|
Increase in pro forma net tangible book value per ordinary share or ADS attributable to new investors purchasing ordinary shares or ADSs in this offering
|
| |
|
| |
|
| |
|
| |
|
Pro forma as adjusted net tangible book value per ordinary share or ADS after giving effect to the offering
|
| |
|
| |
€
|
| |
|
| |
$
|
Dilution per ordinary share or ADS to new investors participating in the offering
|
| |
|
| |
€
|
| |
|
| |
$
|
⯀
|
1,978,145 new ordinary shares issuable upon the exercise of founders’ warrants (BSPCE), warrants (BSA), and stock options (OSA) granted but not exercised as of June 30, 2020, at a weighted average exercise price of €10.55 per share;
|
⯀
|
452,750 free shares granted as of June 30, 2020, subject to future vesting;
|
⯀
|
6,000 ordinary shares granted as free shares prior to June 30, 2020, which vested and were issued on July 27, 2020;
|
⯀
|
3,300,000 ordinary shares issued pursuant to a private placement on July 30, 2020;
|
⯀
|
700,000 ordinary shares reserved for future issuance under our share-based compensation plans and other delegations of authority from our shareholders upon the completion of this offering; and
|
⯀
|
8,366,666 ordinary shares reserved pursuant to a delegation of authority from our shareholders for share capital increases by us through rights issuances and public or private offerings, which number of shares will be reduced by the number of shares issued in this offering.
|
|
| |
Year Ended December 31,
|
| |
Six Months Ended June 30,
|
||||||||||||
|
| |
2019
|
| |
2018(1)
|
| |
2020
|
| |
2019
|
||||||
|
| |
€
|
| |
$(2)
|
| |
€
|
| |
€
|
| |
$(2)
|
| |
€
|
|
| |
(in thousands, except share and per share data)
|
|||||||||||||||
Statement of consolidated operations data:
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
Revenues
|
| |
68
|
| |
76
|
| |
116
|
| |
37
|
| |
42
|
| |
37
|
Other income
|
| |
2,473
|
| |
2,779
|
| |
3,363
|
| |
1,411
|
| |
1,586
|
| |
1,786
|
Total revenues and other income
|
| |
2,541
|
| |
2,855
|
| |
3,479
|
| |
1,448
|
| |
1,627
|
| |
1,823
|
Operating expenses:
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
Research and development expenses
|
| |
(30,411)
|
| |
(34,173)
|
| |
(20,893)
|
| |
(13,077)
|
| |
(14,695)
|
| |
(13,380)
|
Selling, general and administrative expenses
|
| |
(18,909)
|
| |
(21,248)
|
| |
(12,653)
|
| |
(6,755)
|
| |
(7,591)
|
| |
(8,910)
|
Total operating expenses
|
| |
(49,320)
|
| |
(55,421)
|
| |
(33,546)
|
| |
(19,832)
|
| |
(22,285)
|
| |
(22,290)
|
Operating loss
|
| |
(46,779)
|
| |
(52,566)
|
| |
(30,067)
|
| |
(18,384)
|
| |
(20,658)
|
| |
(20,467)
|
Financial loss
|
| |
(4,133)
|
| |
(4,644)
|
| |
(277)
|
| |
(2,194)
|
| |
(2,465)
|
| |
(3,452)
|
Income tax
|
| |
(3)
|
| |
(3)
|
| |
—
|
| |
(1)
|
| |
(1)
|
| |
—
|
Net loss
|
| |
(50,915)
|
| |
(57,213)
|
| |
(30,345)
|
| |
(20,579)
|
| |
(23,125)
|
| |
(23,920)
|
Basic and diluted loss per share
|
| |
(2.35)
|
| |
(2.64)
|
| |
(1.55)
|
| |
(0.91)
|
| |
(1.02)
|
| |
(1.15)
|
Weighted average number of outstanding ordinary shares used for calculating basic and diluted loss per share
|
| |
21,631,514
|
| |
21,631,514
|
| |
19,633,373
|
| |
22,608,408
|
| |
22,608,408
|
| |
20,844,245
|
(1)
|
We applied the new IFRS 16 standard — Leases starting January 1, 2019 following the modified retrospective method. Accordingly, financial statements for the year ended December 31, 2018 are not restated under the new IFRS 16 standard.
|
(2)
|
Translated solely for convenience into U.S. dollars at an exchange rate of €1.00 = $1.1237, the noon buying rate of the Federal Reserve Bank of New York on June 30, 2020.
|
|
| |
As of December 31,
|
| |
As of June 30,
|
|||||||||
|
| |
2019
|
| |
2018(1)
|
| |
2020
|
||||||
|
| |
€
|
| |
$(2)
|
| |
€
|
| |
€
|
| |
$(2)
|
|
| |
(in thousands)
|
||||||||||||
Statement of consolidated financial position data:
|
| |
|
| |
|
| |
|
| |
|
| |
|
Cash and cash equivalents(3)
|
| |
35,094
|
| |
39,435
|
| |
36,203
|
| |
26,590
|
| |
29,879
|
Total assets(3)
|
| |
56,205
|
| |
63,158
|
| |
46,195
|
| |
44,765
|
| |
50,302
|
Total shareholders’ equity(3)
|
| |
(1,908)
|
| |
(2,144)
|
| |
14,243
|
| |
(22,194)
|
| |
(24,939)
|
Total non-current liabilities(3)
|
| |
43,766
|
| |
49,180
|
| |
20,358
|
| |
49,819
|
| |
55,982
|
Total current liabilities
|
| |
14,347
|
| |
16,122
|
| |
11,597
|
| |
17,140
|
| |
19,260
|
(1)
|
We applied the new IFRS 16 standard — Leases starting January 1, 2019 following the modified retrospective method. Accordingly, financial statements for the year ended December 31, 2018 are not restated under the new IFRS 16 standard.
|
(2)
|
Translated solely for convenience into U.S. dollars at an exchange rate of €1.00 = $1.1237, the noon buying rate of the Federal Reserve Bank of New York on June 30, 2020.
|
(3)
|
Actual cash and cash equivalents, total assets and total shareholders’ equity as of June 30, 2020 exclude the net proceeds of the July 2020 Private Placement and actual cash and cash equivalents, total assets and total non-current liabilities as of June 30, 2020 exclude the proceeds of the Bpifrance PGE Loan.
|
⯀
|
advance our ongoing clinical trials of NBTXR3;
|
⯀
|
initiate and conduct additional planned clinical trials of NBTXR3;
|
⯀
|
continue the research and development of other product candidates or other applications of NBTXR3;
|
⯀
|
seek regulatory approvals for any product candidates that successfully complete clinical trials;
|
⯀
|
scale-up our manufacturing capabilities to support the launch of additional clinical trials and the commercialization of our product candidates, if approved;
|
⯀
|
establish a sales and marketing infrastructure for the commercialization of our product candidates, if approved;
|
⯀
|
maintain, expand and protect our intellectual property portfolio;
|
⯀
|
hire additional clinical, quality control and scientific personnel; and
|
⯀
|
add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts and our operations as a public company listed in the United States.
|
⯀
|
the research tax credits result in a cash inflow to us from the tax authorities, either through an offset against the payment of corporate tax or through a direct payment to us for the portion that remains unused;
|
⯀
|
our income tax liability does not limit the amount of the research tax credit, as a company that does not pay any income tax can request direct cash payment of the research tax credit; and
|
⯀
|
the research tax credit is not included in the determination of income tax.
|
⯀
|
sub-contracting, collaboration and consultant expenses that primarily consist of the cost of third-party contractors, such as contract research organizations that conduct our non-clinical studies and clinical trials;
|
⯀
|
employee-related costs for employees in research and development functions;
|
⯀
|
expenses relating to preclinical studies and clinical trials for NBTXR3;
|
⯀
|
manufacturing costs for production of NBTXR3 to support clinical development;
|
⯀
|
certain intellectual property expenses;
|
⯀
|
expenses relating to regulatory affairs; and
|
⯀
|
expenses relating to the implementation of our quality assurance system.
|
⯀
|
the scope, rate of progress and expense of our ongoing and planned preclinical studies, clinical trials and other research and development activities;
|
⯀
|
clinical trial and early-stage results;
|
⯀
|
the terms and timing of regulatory approvals;
|
⯀
|
the expense of filing patent applications and maintaining and enforcing patents and other intellectual property rights and defending against claims or infringements raised by third parties; and
|
⯀
|
the ability to market, commercialize and achieve market acceptance for NBTXR3 or any other product candidate that we may develop in the future.
|
|
| |
For the year
ended December 31,
|
| |
For the six-month period
ended June 30,
|
||||||
(In thousands of euros)
|
| |
2019
|
| |
2018(1)
|
| |
2020
|
| |
2019
|
Revenues and other income
|
| |
|
| |
|
| |
|
| |
|
Revenues
|
| |
68
|
| |
116
|
| |
37
|
| |
37
|
Other income
|
| |
2,473
|
| |
3,363
|
| |
1,411
|
| |
1,786
|
Total revenues and other income
|
| |
2,541
|
| |
3,479
|
| |
1,448
|
| |
1,823
|
Operating expenses
|
| |
|
| |
|
| |
|
| |
|
Research and development expenses
|
| |
(30,411)
|
| |
(20,893)
|
| |
(13,077)
|
| |
(13,380)
|
Selling, general and administrative expenses.
|
| |
(18,909)
|
| |
(12,653)
|
| |
(6,755)
|
| |
(8,910)
|
Total Operating expenses
|
| |
(49,320)
|
| |
(33,546)
|
| |
(19,832)
|
| |
(22,290)
|
Operating income (loss)
|
| |
(46,779)
|
| |
(30,067)
|
| |
(18,384)
|
| |
(20,467)
|
Financial income
|
| |
837
|
| |
1,172
|
| |
234
|
| |
724
|
Financial expenses
|
| |
(4,970)
|
| |
(1,449)
|
| |
(2,428)
|
| |
(4,176)
|
Financial income (loss)
|
| |
(4,133)
|
| |
(277)
|
| |
(2,194)
|
| |
(3,452)
|
Income tax
|
| |
(3)
|
| |
—
|
| |
(1)
|
| |
—
|
Net loss for the period
|
| |
(50,915)
|
| |
(30,345)
|
| |
(20,579)
|
| |
(23,920)
|
(1)
|
We applied the new IFRS 16 standard — Leases starting January 1, 2019 following the modified retrospective method. Accordingly, financial statements for the year ended December 31, 2018 are not restated under the new IFRS 16 standard.
|
|
| |
For the year
ended December 31,
|
| |
For the six-month period
ended June 30,
|
||||||
(In thousands of euros)
|
| |
2019
|
| |
2018
|
| |
2020
|
| |
2019
|
Services
|
| |
40
|
| |
109
|
| |
37
|
| |
20
|
Other sales
|
| |
28
|
| |
7
|
| |
—
|
| |
17
|
Total revenues
|
| |
68
|
| |
116
|
| |
37
|
| |
37
|
Research tax credit
|
| |
2,437
|
| |
3,251
|
| |
888
|
| |
1,776
|
Subsidies
|
| |
20
|
| |
90
|
| |
494
|
| |
10
|
Other
|
| |
17
|
| |
22
|
| |
28
|
| |
—
|
Total other income
|
| |
2,473
|
| |
3,363
|
| |
1,411
|
| |
1,786
|
Total revenues and other income
|
| |
2,541
|
| |
3,479
|
| |
1,448
|
| |
1,823
|
|
| |
For the year
ended December 31,
|
| |
For the six-month period
ended June 30,
|
||||||
(In thousands of euros)
|
| |
2019
|
| |
2018
|
| |
2020
|
| |
2019
|
Purchases, sub-contracting and other expenses
|
| |
(16,804)
|
| |
(11,358)
|
| |
(7,096)
|
| |
(6,339)
|
Payroll costs (including share-based payments)
|
| |
(11,980)
|
| |
(9,002)
|
| |
(5,397)
|
| |
(6,297)
|
Depreciation, amortization and provision expenses
|
| |
(1,627)
|
| |
(534)
|
| |
(583)
|
| |
(744)
|
Total research and development expenses
|
| |
(30,411)
|
| |
(20,893)
|
| |
(13,077)
|
| |
(13,380)
|
⯀
|
an increase of €757 thousand, or 12%, in purchases, sub-contracting and other expenses, primarily comprising increased clinical expenses associated with maintaining clinical trial development during the COVID-19 pandemic;
|
⯀
|
a decrease of €900 thousand, or 14%, in payroll costs which was mainly due to a decrease of 12 research and development staff for the six-month period ended June 30, 2020 as compared with the same period in 2019. As of June 30, 2020, our workforce included 73 research and development staff; and
|
⯀
|
a decrease of €161 thousand in depreciation, amortization and provision expenses primarily due to the €112 thousand partial utilization of a provision for disputes for the six-month period ended June 30, 2020, which amount was zero for the same period in 2019.
|
⯀
|
an increase of €5.4 million, or 47.9%, in purchases, sub-contracting and other expenses, primarily comprising clinical trial expenses for NBTXR3 and research costs incurred for our various ongoing preclinical studies and clinical trials;
|
⯀
|
an increase of €3.0 million, or 33.1%, in payroll costs related to the growth of our research and development staff and salary increases among existing research and development staff. As of December 31, 2019, our workforce included 81 research and development staff, which included two additional positions created during the year ended December 31, 2019. These additional positions led to an increase in salary, wages and payroll taxes. Additionally, the share-based payments expenses (excluding employer’s contribution) increased by €0.5 million, from €0.3 million for the year ended December 31, 2018 to €0.9 million for the year ended December 31, 2019; and
|
⯀
|
an increase of €1.1 million in depreciation, amortization and provision expenses primarily due to the application of the IFRS 16 standard in 2019.
|
|
| |
For the year
ended December 31,
|
| |
For the six-month period
ended June 30,
|
||||||
(In thousands of euros)
|
| |
2019
|
| |
2018
|
| |
2020
|
| |
2019
|
Purchases, fees and other expenses
|
| |
(9,435)
|
| |
(5,918)
|
| |
(2,955)
|
| |
(3,956)
|
Payroll costs (including share-based payments)
|
| |
(9,205)
|
| |
(6,701)
|
| |
(3,641)
|
| |
(4,903)
|
Depreciation, amortization and provision expenses
|
| |
(270)
|
| |
(35)
|
| |
(159)
|
| |
(51)
|
Total selling, general and administrative expenses
|
| |
(18,910)
|
| |
(12,653)
|
| |
(6,755)
|
| |
(8,910)
|
⯀
|
the decrease in purchases, fees and other expenses by €1.0 million due to our efforts to decrease general and administrative costs in light of the COVID-19 pandemic; and
|
⯀
|
the payroll costs related to our administrative staff members, which decreased by €1.3 million, from €4.9 million for the six-month period ended June 30, 2019 to €3.6 million for the six-month period ended June 30, 2020, mainly resulting from the variation of employer’s contribution for payroll tax from an expense of €0.7 million for the six-month period ended June 30, 2019 to a net reversal of €0.2 million for the six-month period ended June 30, 2020 due to the cancellation of free shares over the period. At June 30, 2020, we employed 25 SG&A staff, which is a decrease of one position as compared to June 30, 2019.
|
⯀
|
the increase in purchases, fees and other expenses by €3.5 million due to additional consultancy, audit, recruitment, legal and communications services fees in 2019. This includes the expensing of €1.5 million in transaction costs related to a potential U.S. initial public offering, of which €1.0 million were recorded in 2018 and €507 thousand in 2019, that were initially recorded as a reduction of premiums related to share capital and then reversed to SG&A expenses upon the determination by management in 2019 that the offering would be delayed. This also includes costs associated with a change in the executive board members in July 2019, resulting in an internal reorganization. These increases in fees and other expenses were partially offset by the decrease in rental expenses following the application of IFRS 16; and
|
⯀
|
the payroll costs related to our administrative staff members, which increased by €2.5 million, mainly resulting from the increase in share-based payment expenses (excluding employer’s contribution) by €1.9 million, from €1.5 million in 2018 to €3.4 million in 2019. At December 31, 2019, we employed 29 SG&A staff, which included six positions that were created during the year ended December 31, 2019.
|
(In thousands of euros)
|
| |
2013
Bpifrance
|
| |
Interest-free
Bpifrance
loan
|
| |
EIB loan
|
| |
Curadigm
BPI
Advance
|
| |
HSBC
“PGE”
|
| |
Total
|
At January 1, 2019
|
| |
2,116
|
| |
1,675
|
| |
16,730
|
| |
—
|
| |
—
|
| |
20,521
|
Principal received
|
| |
—
|
| |
—
|
| |
14,000
|
| |
—
|
| |
—
|
| |
14,000
|
Impact of discounting and accretion
|
| |
32
|
| |
36
|
| |
(1,422)
|
| |
—
|
| |
—
|
| |
(1,354)
|
Accumulated fixed interest expense accrual
|
| |
16
|
| |
—
|
| |
1,545
|
| |
—
|
| |
—
|
| |
1,561
|
Accumulated variable interest expense accrual
|
| |
—
|
| |
—
|
| |
4,243
|
| |
—
|
| |
—
|
| |
4,243
|
Repayments
|
| |
—
|
| |
(500)
|
| |
(350)
|
| |
—
|
| |
—
|
| |
(850)
|
At December 31, 2019
|
| |
2,165
|
| |
1,210
|
| |
34,746
|
| |
—
|
| |
—
|
| |
38,121
|
Principal received
|
| |
—
|
| |
—
|
| |
—
|
| |
350
|
| |
5,000
|
| |
5,350
|
Impact of discounting and accretion
|
| |
7
|
| |
—
|
| |
(1,098)
|
| |
(74)
|
| |
—
|
| |
(1,163)
|
Accumulated fixed interest expense accrual
|
| |
16
|
| |
—
|
| |
859
|
| |
1
|
| |
—
|
| |
876
|
Accumulated variable interest expense accrual
|
| |
—
|
| |
—
|
| |
2,440
|
| |
—
|
| |
—
|
| |
2,440
|
Repayments
|
| |
—
|
| |
—
|
| |
(350)
|
| |
—
|
| |
1
|
| |
(349)
|
At June 30, 2020
|
| |
2,189
|
| |
1,211
|
| |
36,598
|
| |
277
|
| |
5,001
|
| |
45,276
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
| |
For the year ended
December 31,
|
| |
For the six-month
period ended June 30,
|
||||||
(In thousands of euros)
|
| |
2019
|
| |
2018
|
| |
2020
|
| |
2019
|
Net cash flows used in operating activities
|
| |
(41,169)
|
| |
(25,985)
|
| |
(12,879)
|
| |
(21,324)
|
Net cash flows from (used in) investing activities
|
| |
(1,459)
|
| |
71
|
| |
(83)
|
| |
(5,859)
|
Net cash flows from financing activities
|
| |
41,489
|
| |
14,850
|
| |
4,404
|
| |
42,070
|
Effect of exchange rates changes on cash
|
| |
29
|
| |
54
|
| |
54
|
| |
22
|
Net increase (decrease) in cash and cash equivalents
|
| |
(1,109)
|
| |
(11,009)
|
| |
(8,505)
|
| |
14,909
|
⯀
|
a one-time acquisition of €5.0 million in marketable securities during the six months ended June 30, 2019, which was sold before the end of the year 2019 with no cash impact. No investment in marketable securities was made for the six-month period ended June 30, 2020; and
|
⯀
|
a €0.7 million decrease in investments related to tangible and intangible assets.
|
|
| |
As of June 30, 2020
|
||||||||||||
(In thousands of euros)
|
| |
Less than
1 year
|
| |
1 to 3
years
|
| |
3 to 5
years
|
| |
More than
5 years
|
| |
Total
|
Long-term debt obligations(1)
|
| |
1,213
|
| |
13,518
|
| |
29,788
|
| |
1,925
|
| |
46,444
|
Lease liabilities
|
| |
1,199
|
| |
2,309
|
| |
2,267
|
| |
1,951
|
| |
7,726
|
Total
|
| |
2,412
|
| |
15,827
|
| |
32,055
|
| |
3,876
|
| |
54,170
|
(1)
|
Calculated according to principal amounts and fixed interest rates. Excludes the Bpifrance PGE Loan of €5.0 million received on July 10, 2020.
|
⯀
|
Our headquarters, located at 60 rue Wattignies in the 12th arrondissement of Paris, for which we signed a lease on July 1, 2017 for a term of 10 years and an amendment pursuant to which we leased additional space, with retroactive effect from January 1, 2019.
|
⯀
|
Our premises in the Villejuif BioPark in the south of Paris, for which the lease began on July 1, 2017 for a term of nine years.
|
⯀
|
New leases, which commenced during the six-month period ended June 30, 2020, one on Oberkampf Road in Paris, France, representing a lease liability at initial recognition of €155 thousand, to be amortized over 9 years and the other on Faubourg Saint-Antoine in Paris, France, representing a lease liability at initial recognition of €140 thousand, to be amortized over 9 years.
|
⯀
|
the size, progress, timing and completion of our clinical trials;
|
⯀
|
the number of potential new product candidates we identify and decide to develop;
|
⯀
|
the costs involved in filing patent applications and maintaining and enforcing patents or defending against claims or infringements raised by third parties;
|
⯀
|
the time and costs involved in obtaining regulatory approval for our product candidates and any delays we may encounter as a result of evolving regulatory requirements or adverse results with respect to any of these product candidates;
|
⯀
|
selling and marketing activities undertaken in connection with the anticipated commercialization of NBTXR3 and any other current or future product candidates and costs involved in the creation of an effective sales and marketing organization;
|
⯀
|
the amount of revenue, if any, we may derive either directly or in the form of milestones or royalty payments from our existing or future partnership or collaboration agreements; and
|
⯀
|
the severity, duration and impact of the COVID-19 pandemic, which may continue to adversely impact our business and clinical trials.
|
|
| |
For the year ended
December 31,
|
| |
For the six-month
period ended June 30,
|
||||||
(In thousands of euros)
|
| |
2019
|
| |
2018
|
| |
2020
|
| |
2019
|
Increases in software and other intangible assets
|
| |
353
|
| |
90
|
| |
17
|
| |
259
|
Increases in property, plant, and equipment
|
| |
1,091
|
| |
416
|
| |
57
|
| |
545
|
Total
|
| |
1,444
|
| |
506
|
| |
74
|
| |
804
|
⯀
|
an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002;
|
⯀
|
an exemption from compliance with any requirement that the PCAOB may adopt regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; and
|
⯀
|
to the extent that we no longer qualify as a foreign private issuer, reduced disclosure about our company’s executive compensation arrangements and exemptions from the requirements to obtain a non-binding advisory vote on executive compensation or a shareholder approval of any golden parachute arrangements.
|
*
|
Study 312, a global Phase III clinical trial for elderly patients with locally-advanced head and neck cancer who are ineligible for platinum-based (cisplatin) chemotherapy, will be initiated as a U.S. Phase III clinical trial. Because Study 312 will commence as a Phase III trial, we have represented it with a dotted line in the table. For its evaluation of Study 312, the FDA has accepted the available data from our European dose-escalation study, Study 102 Escalation.
|
†
|
PharmaEngine currently controls development and commercialization in the Asia-Pacific region. We believe that PharmaEngine has not complied with its obligations under our collaboration to use commercially reasonable efforts to develop NBTXR3 in this region and have notified PharmaEngine of this material breach. Unless an appropriate resolution is reached with PharmaEngine or we are able to identify and enter into a definitive agreement with a new collaborator for this region, these trials may not progress beyond the stage noted in the table. See “Business—Collaborations and Research Agreements—PharmaEngine” for additional details.
|
⯀
|
Advanced pipeline with promising clinical data in numerous cancer indications. As of the date of this prospectus, we have administered NBTXR3 to more than 230 patients across multiple cancer indications. In our completed Phase II/III clinical trial in patients with STS of the extremities and trunk wall, we observed a statistically significant improvement in complete pathological response rate following treatment with NBTXR3 activated by radiotherapy as compared to treatment with radiotherapy alone. Based on these results, we obtained the right to CE mark, and therefore to commercialize, on an accelerated basis NBTXR3 in the European Union as a treatment for locally advanced STS. Our preliminary results from other clinical trials suggest that NBTXR3 could generate durable, complete responses and extend patient survival in numerous solid tumor indications for patients who otherwise have limited treatment options. In our clinical trials conducted to date, treatment with NBTXR3 has been well tolerated.
|
⯀
|
Significant market opportunity in solid tumors. In developed countries with access to radiotherapy, approximately 60% of all cancer patients are treated with radiotherapy at some point in their treatment regimen. We believe that NBTXR3’s mode of action could improve outcomes for patient populations across all cancer indications currently treated with radiotherapy. In addition, NBTXR3 could bring opportunities to patients with solid tumor cancers that cannot otherwise be treated with radiotherapy because of sensitivities of the tissues near the tumor.
|
⯀
|
Improved benefit-risk ratio through intratumoral injection. NBTXR3 is administered by a physician through a single injection in which the solution is injected directly into the tumor prior to the first radiotherapy session. Using this method, we are able to create high concentrations of our product candidate inside the tumor while minimizing the systemic exposure that results from other methods, such as intravenous administration. In addition, NBTXR3 is only active while exposed to ionizing radiation and remains inert in the body until further radiation exposure.
|
⯀
|
Highly compatible with, and complementary to, existing standard of care. NBTXR3 can be easily incorporated into the current standard of care in radiotherapy. Hospitals and medical facilities where radiotherapy is delivered do not need any new equipment or to otherwise make significant capital investments in new technology in order to deliver NBTXR3 to patients.
|
⯀
|
Robust intellectual property protection with significant know-how creating barriers to entry. Our technology and product candidates are protected by more than 300 issued or pending patents and patent applications in over 20 patent families across the world, and none of the patents specifically covering injectable NBTXR3 in the United States are expected to expire until at least November 2031 (2029 in other countries with patents issued).
|
⯀
|
Established manufacturing facility with substantial production capacity. We currently manufacture NBTXR3 at a third-party facility in France. In 2017, we opened our own manufacturing site near Paris. We expect that our owned facility will allow us to expand our production capacity to more than 200,000 doses of NBTXR3 per year, which we believe will be sufficient to produce NBTXR3 for our current and contemplated clinical trials and the first few years following a commercial launch. We have designed our manufacturing process so that additional production lines can be added without significant capital investment.
|
⯀
|
Complete the development of, and satisfy applicable EU and U.S. regulatory requirements for, NBTXR3 for the treatment of locally advanced head and neck cancers. Based on encouraging results from Study 102 Escalation, we have commenced the Study 102 Expansion to collect additional preliminary efficacy data. In an interim analysis of efficacy data for 31 evaluable patients in the Study 102 Expansion presented in October 2020 at the annual meeting of the American Society for Radiation Oncology (ASTRO), researchers observed a high objective response rate (83.9% according to RECIST 1.1) at a median evaluation time of five months after NBTXR3 was administered. We intend to evaluate final Study 102 Escalation data in mid-2021 and could potentially use positive efficacy data, if observed, to obtain the right to CE mark, and therefore to commercialize, on an accelerated basis in the EU, where NBTXR3 has been classified as a medical device, at such time.
|
|
In the United States, where NBTXR3 has been classified as a drug, we plan to commence Study 312, a global Phase III clinical trial for elderly patients with head and neck cancer who are ineligible for platinum-based chemotherapy. In February 2020, we received Fast Track designation from the FDA for NBTXR3 for the treatment of locally advanced head and neck cancers, which we believe could allow for expedited clinical development. We expect approximately 500 patients to be treated in this global Phase III trial. The initial readout will be based on event-driven progression-free survival (“PFS”), and the final readout will be based on overall survival (“OS”). A futility analysis is expected at 18 months after the first patient is randomized, and the interim analysis for PFS superiority is expected at 24-30 months. The final analysis will report on PFS and OS. We may also potentially pursue Breakthrough Therapy designation from the FDA for NBTXR3 in this indication. However, there can be no assurance that we will obtain this designation or that, even if we do, it will lead to a faster development or regulatory review or approval process or increase the likelihood that NBTXR3 will receive regulatory approval.
|
⯀
|
Complete post-approval trials for NBTXR3 for the treatment of locally advanced STS in the EU. Following positive results from our Phase II/III clinical trial, in April 2019 NBTXR3 became the first ever radioenhancer to have a CE mark, allowing it to be commercialized in the 27 EU countries for the treatment of locally advanced STS under the brand name Hensify®. We are currently preparing Study 401 to continue evaluating safety and efficacy while providing patients in the EU with access to Hensify®. Following evaluation of the results from Studies 102 and 312, we intend to undertake a strategic review and to determine where we believe we are best positioned to pursue commercialization, including our commercialization strategy with respect to Hensify®.
|
⯀
|
Expand the opportunity for NBTXR3 as a treatment for solid tumor indications. We believe that NBTXR3’s physical mode of action could make it broadly applicable across a multitude of solid tumor indications. In addition to head and neck cancers and STS, we intend to continue to develop and pursue NBTXR3 for other indications, and we are already progressing clinical trials in liver cancers in the EU and prostate cancer in the United States. In addition, in December 2018 we entered into a collaboration with MD Anderson as part of which we intend to conduct a total of nine clinical trials in the United States to evaluate NBTXR3 plus radiotherapy across several cancer types. The first clinical trial under this collaboration, in patients with pancreatic cancer, has commenced
|
⯀
|
Establish NBTXR3 as a complementary product to immune checkpoint inhibitors. We are conducting, and continue to further develop, a global I-O development program to explore the use of NBTXR3 as a complement to immune checkpoint inhibitors across several solid tumor indications. In preclinical studies, NBTXR3 activated by radiation therapy in combination with immune checkpoint inhibitors demonstrated potential to convert checkpoint inhibitor non-responders into responders, provide better local and systemic control and increase survival. We are conducting Study 1100, a Phase I basket trial of NBTXR3 in combination with anti-PD-1 checkpoint inhibitors in patients with LRR or R/M HNSCC or with lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy. We presented first clinical results from Study 1100 at the SITC 35th Annual Meeting in November 2020. We believe NBTXR3 has the potential to increase the proportion of patients that respond to immune checkpoint inhibitors. See “—Our Clinical Programs—HNSCC, Lung Metastasis or Liver Metastasis” for additional detail. In addition, pursuant to our collaboration with MD Anderson, we are planning to evaluate NBTXR3 in combination with various checkpoint inhibitors (anti-PD-1, anti-PD-L1, and anti-CTLA-4) across several cancer indications.
|
⯀
|
Build an effective clinical development program and establish a global commercial infrastructure for NBTXR3. We have conducted clinical trials involving multiple therapeutic areas throughout the United States and the EU, in which more than 400 physicians have been involved. In addition, our global medical science liaison team has consulted closely with a number of physicians, hospitals, clinics, and cancer treatment centers in the United States and key European markets to better understand their needs as clinicians and institutions and to tailor NBTXR3 accordingly. We plan to focus our commercialization and marketing efforts for NBTXR3 in Europe and the United States, if approved. However, we may also develop and commercialize NBTXR3 in other specific regions, independently or through third-party collaborators.
|
⯀
|
By amplifying the intratumor killing effect of the radiation dose within cancer cells, NBTXR3 is designed to give a radiation dose greater efficacy.
|
⯀
|
By localizing the radiation dose within the tumor, NBTXR3 is designed to enhance the efficacy of radiotherapy without resulting in additional toxicities on the surrounding healthy tissues.
|
|
Patient Population
Elderly and
fragile patients
receiving
radiotherapy and NBTXR3
|
| |
Best Observed
Response
(Overall
response)
|
| |
Best Observed
Response
(Complete
response)
|
| |
Best Observed
Response
(Stable
Disease)
|
| |
Best Observed
Response
(Progressive
Disease)
|
| |||
|
Nanobiotix preliminary
data presented
at ASTRO 2020
(31 evaluable patients)
|
| |
84%
|
| |
48%
|
| |
16%
|
| |
0%
|
| |||
|
Median age (years)
|
| |
70.7
|
| ||||||||||||
|
ECOG (%)
|
| |
|
| ||||||||||||
|
0 (KPS 100)
|
| |
23
|
| ||||||||||||
|
1 (KPS 80-90)
|
| |
65
|
| ||||||||||||
|
2 (KPS 60-70)
|
| |
12
|
| ||||||||||||
|
Stage (%)
|
| |
|
| ||||||||||||
|
III
|
| |
12
|
| ||||||||||||
|
IVA/B
|
| |
79
|
| ||||||||||||
|
Primary tumor site (%)
|
| |
|
| ||||||||||||
|
Oral cavity
|
| |
53
|
| ||||||||||||
|
Oropharynx
|
| |
47
|
| ||||||||||||
|
HPV status OPSCC (%)
|
| |
|
| ||||||||||||
|
HPV+
|
| |
45
|
| ||||||||||||
|
HPV-
|
| |
50
|
|
Note:
|
Evaluable Population for Objective Tumor Response has included all patients who have had at least 80% of the intended
|
|
| |
Any Grade
|
| |
Grade 1-2
|
| |
Grade 3
|
| |
Grade 4
|
Adverse Events
|
| |
461
|
| |
363
|
| |
71
|
| |
21
|
AEs related to the Injection Procedure
|
| |
15
|
| |
11
|
| |
3
|
| |
1
|
AEs related to NBTXR3
|
| |
20
|
| |
19
|
| |
4
|
| |
2
|
AEs related to radiotherapy
|
| |
232
|
| |
180
|
| |
43
|
| |
7
|
|
| |
|
| |
|
| |
|
| |
|
Serious Adverse Events
|
| |
47
|
| |
10
|
| |
19
|
| |
18
|
SAEs related to the Injection Procedure
|
| |
2
|
| |
1
|
| |
0
|
| |
1
|
SAEs related to NBTXR3
|
| |
4
|
| |
1
|
| |
1
|
| |
2
|
SAEs related to radiotherapy
|
| |
21
|
| |
4
|
| |
10
|
| |
7
|
*
|
Includes events deemed to be unrelated to treatment, such as events deemed to be related solely to underlying disease.
|
Note:
|
Patients are recruited at different points in time during the trial; those who have received the highest doses have received the lowest amount of follow-up.
|
anti-PD-1 Naïve Patients
|
| |
anti-PD-1 Non-Responders
|
|
| |
|
Percent Change from Baseline Over Time
Overall Response
|
| |
Percent Change from Baseline Over Time
Overall Response
|
|
|
Technology
|
| |
Number of
Patent Families
|
| |
Expiration
Years for Each
Patent Family*
|
| |
Countries in which
Patents are Issued
|
|
|
NanoXray technology(1)
|
| |
10
|
| |
2025
2031
|
| |
France, Australia, Canada, China, Eurasia (1 country), Europe (21 countries), Israel, India, Japan, South Korea, Mexico, South Africa, Hong Kong
United States
**
|
|
|
†
|
| |
|
| |
2029
2031
|
| |
Australia, Canada, China, Algeria, Eurasia (9 countries), Europe (34 countries), Indonesia, India, Israel, Japan, South Korea, Morocco, Mexico, New Zealand, South Africa, Macau, Hong Kong, Singapore
United States
**
|
|
|
|
| |
|
| |
2030
|
| |
Australia, Canada, China, Eurasia (4 countries), Europe (36 countries), Indonesia, Israel, India, Japan, South Korea, Morocco, Mexico, New Zealand, United States, Singapore, South Africa, Hong Kong, Brazil (expected Q4 2020)
**
|
|
|
|
| |
|
| |
2032
2035
|
| |
China, Europe (19 countries), Japan
United States
|
|
|
|
| |
|
| |
2032
|
| |
Australia, Canada, China, Eurasia (1 country), Europe (19 countries), Indonesia, Israel, India, Japan, South Korea, Morocco, Mexico, New Zealand, Singapore, Ukraine, South Africa
**
|
|
|
††
|
| |
|
| |
2034
|
| |
Australia, China, Europe (36 countries), Indonesia, Japan, Mexico, New Zealand, Israel, Ukraine, United States, Eurasia (1 country), Hong Kong, South Africa
**
|
|
|
|
| |
|
| |
2034
|
| |
Australia, China, Europe (36 countries), Indonesia, Israel, Japan, New Zealand, Singapore, South Africa, Hong Kong, Eurasia (1 country)
**
|
|
|
|
| |
|
| |
2034
|
| |
Japan, United States, Europe (expected Q4 2020)
**
|
|
|
|
| |
|
| |
2034
|
| |
United States, Japan
**
|
|
|
†††
|
| |
|
| |
2036
|
| |
Israel (expected Q3 2020)
**
|
|
|
Other technologies/candidates
|
| |
10
|
| |
2034
|
| |
Australia, India, Indonesia, Japan, Mexico, New Zealand, Ukraine, Singapore, South Africa
|
|
|
Technology
|
| |
Number of
Patent Families
|
| |
Expiration
Years for Each
Patent Family*
|
| |
Countries in which
Patents are Issued
|
|
|
|
| |
|
| |
2035
|
| |
United States
**, #
|
|
|
|
| |
|
| |
2035
|
| |
Europe (23 countries), Japan
**, #
|
|
|
|
| |
|
| |
2035
|
| |
**, #
|
|
|
|
| |
|
| |
2035
|
| |
United States
**, #
|
|
|
|
| |
|
| |
2035
|
| |
Japan, United States, Singapore
**, #
|
|
|
|
| |
|
| |
2037
|
| |
**
|
|
|
|
| |
|
| |
2037
|
| |
**
|
|
|
|
| |
|
| |
2037
|
| |
**
|
|
|
|
| |
|
| |
2038
|
| |
**
|
|
|
|
| |
|
| |
2038
|
| |
**
|
|
|
|
| |
|
| |
2040
|
| |
**
|
|
(1)
|
The NanoXray technology covers, among other things, three product candidates, each of which is based on the same hafnium oxide core. The goal of each of these three product candidates is to help patients receiving radiotherapy by enhancing the effect of radiotherapy within tumor cells, without increasing the dose to surrounding healthy tissues. The three product candidates differ in the composition of the nanoparticle coating or formulation, which have been developed for three different modes of administration to cover most oncology applications. The most advanced product candidate in the NanoXray portfolio, and our current focus for development and commercialization, is injectable NBTXR3.
|
#
|
Patent family owned by Curadigm S.A.S.
|
*
|
This expiration year does not take into account supplementary patent protection that could be obtained for some of our patents in the United States, Europe and other countries. Expiration dates for U.S. patents not yet granted may be subject to patent term adjustment.
|
**
|
Patent application pending in at least one country/jurisdiction.
|
†
|
Patent family covering the specific composition utilized in NBTXR3 (i.e., composition of matter). This patent family covers the injectable use of metal oxide nanoparticles with a specific density for killing tumor cells, including cancer cells. The injectable use of an efficient dose of NBTXR3 in oncology is covered by this patent family.
|
††
|
Patent family covering the specific composition utilized in injectable NBTXR3 (i.e., composition of matter). This patent family covers the injectable use of metal oxide nanoparticles with a specific density for killing tumor cells and shrinking tumors where a certain number of electrons are delivered to the targeted tumor. The injectable use of an efficient dose of NBTXR3 in oncology is covered by this patent family.
|
†††
|
Patent family covering the specific composition utilized in NBTXR3 (i.e., composition of matter). This patent family covers the injectable use of NBTXR3 as a therapeutic vaccine used to induce an immune response, including its use in immuno-oncology and its combination with other checkpoint inhibitors.
|
⯀
|
Completion of extensive preclinical laboratory tests, preclinical animal studies and formulation studies in accordance with applicable regulations, including good laboratory practice (“GLP”) regulations;
|
⯀
|
Submission to the FDA of an IND, which must become effective before human clinical trials may begin;
|
⯀
|
Performance of adequate and well-controlled human clinical trials in accordance with applicable regulations, including current good clinical practice (“GCP”) regulations to establish the safety and efficacy of the drug candidate for its proposed indication;
|
⯀
|
Submission to the FDA of a new drug application (“NDA”) for a new drug product;
|
⯀
|
A determination by the FDA within 60 days of its receipt of an NDA to accept the submitted NDA for filing and thereafter begin a substantive review of the application;
|
⯀
|
Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the drug is produced to assess compliance with cGMP regulations to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;
|
⯀
|
Potential FDA audit of the preclinical and/or clinical trial sites that generated the data in support of the NDA; and
|
⯀
|
FDA review and approval of the NDA prior to any commercial marketing or sale of the drug in the United States.
|
⯀
|
Phase I. The drug is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion, the side effects associated with increasing doses, and if possible, to gain early evidence of effectiveness. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.
|
⯀
|
Phase II. The drug is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases or conditions and to determine dosage tolerance, optimal dosage and dosing schedule.
|
⯀
|
Phase III. Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall benefit/risk ratio of the product and provide an adequate basis for product approval. Generally, two adequate and well-controlled Phase III clinical trials are required by the FDA for approval of an NDA. Phase III clinical trials usually involve several hundred to several thousand participants.
|
⯀
|
the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, including any kickback, bribe or rebate, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any item, good, facility or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid;
|
⯀
|
U.S. federal civil and criminal false claims laws and civil monetary penalties laws, including the civil False Claims Act, which can be enforced by individuals through civil whistleblower or qui tam actions, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government;
|
⯀
|
HIPAA, which created additional federal criminal statutes which prohibit, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or knowingly and willingly falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters;
|
⯀
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose certain requirements on covered entities, including certain healthcare providers, health plans and healthcare clearinghouses, and their business associates, individuals and entities that perform functions or activities that involve individually identifiable health information on behalf of covered entities, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
⯀
|
U.S. federal transparency requirements under the Physician Payments Sunshine Act, enacted as part of the ACA, that require applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to track and annually report to CMS payments and other transfers of value provided to physicians and teaching hospitals, and certain ownership and investment interests held by physicians or their immediate family members; and
|
⯀
|
analogous state or foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the federal requirements, state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, state and local laws that require the registration of pharmaceutical sales representatives, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect as HIPAA, thus complicating compliance efforts.
|
⯀
|
Decision No. 2018-154 (May 3, 2018) concerning the approval of a standard methodology for processing personal data in the context of research in the field of health, which does not require the express consent of the person involved (methodology MR-003);
|
⯀
|
Decision No. 2018-153 (May 3, 2018) concerning the approval of a standard methodology for the processing of personal data carried out within the context of research in the field of clinical trials, which requires the express consent of the person involved (standard methodology MR-001);
|
⯀
|
Extensive preclinical laboratory tests, preclinical animal studies and formulation studies in accordance with applicable regulations.
|
⯀
|
Submission to the TFDA of an IND, which must be approved by the TFDA before human clinical trials may begin.
|
⯀
|
Human clinical trials in Taiwan typically include:
|
−
|
Phase I trials. The new drug product is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism and side effects associated with increasing doses. If possible, early evidence of effectiveness of the new drug product is collected as well.
|
−
|
Phase II trials. The new drug product is evaluated for its efficacy and proposed indication in a limited patient population, as well as its adverse effects and safety risks.
|
−
|
Phase III trials. The new drug product is further evaluated for dosage tolerance, efficacy and safety in an expanded patient population.
|
⯀
|
Submission to the TFDA of an NDA, which generally requires two Phase III trials, unless the NDA otherwise qualifies for exemptions as provided by the TFDA.
|
Name
|
| |
Age
|
| |
Position(s)
|
Executive Board Members:
|
| |
|
| |
|
Dr. Laurent Levy, Ph.D.
|
| |
49
|
| |
Chief Executive Officer and Co-founder, Chairman
|
Mr. Philippe Mauberna
|
| |
56
|
| |
Chief Financial Officer
|
Ms. Anne-Juliette Hermant
|
| |
47
|
| |
Chief People Officer
|
|
| |
|
| |
|
Supervisory Board Members:
|
| |
|
| |
|
Mr. Laurent Condomine
|
| |
76
|
| |
Chairman
|
Ms. Anne-Marie Graffin
|
| |
59
|
| |
Deputy Chairman
|
Dr. Alain Herrera, M.D.
|
| |
69
|
| |
Member
|
Mr. Enno Spillner
|
| |
50
|
| |
Member
|
Mr. Christophe Douat
|
| |
57
|
| |
Observer
|
Name
|
| |
Current Position
|
| |
Year of Initial
Appointment
|
| |
Current Term
Expiration Year
|
Dr. Laurent Levy, Ph.D.
|
| |
Chairman
|
| |
2004
|
| |
2024
|
Mr. Philippe Mauberna
|
| |
Member
|
| |
2013
|
| |
2024
|
Ms. Anne-Juliette Hermant
|
| |
Member
|
| |
2019
|
| |
2024
|
Name
|
| |
Current Position
|
| |
Year of Initial
Appointment
|
| |
Current Term Expiration Year
|
Mr. Laurent Condomine
|
| |
Chairman
|
| |
2011
|
| |
2023
|
Ms. Anne-Marie Graffin
|
| |
Deputy Chairman
|
| |
2013
|
| |
2024
|
Dr. Alain Herrera, M.D.
|
| |
Member
|
| |
2013
|
| |
2024
|
Mr. Enno Spillner
|
| |
Member
|
| |
2014
|
| |
2026
|
Mr. Christophe Douat(1)
|
| |
Observer
|
| |
2017
|
| |
2023
|
(1)
|
Mr. Christophe Douat previously served as member of the supervisory board from 2011 until 2017. Since 2017, Mr. Christophe Douat has served as an observer and is entitled to attend all meetings of the supervisory board in a non-voting capacity.
|
⯀
|
must not be a salaried employee or corporate officer of us or any of our affiliates and must not have held such a position within the last five years;
|
⯀
|
must not be in a significant business relationship with us or any of our affiliates (e.g., client, supplier, competitor, provider, creditor, banker, etc.) within the last two years;
|
⯀
|
must not be a reference shareholder or hold a significant number of voting rights;
|
⯀
|
must not have close relationships or family ties with any of our corporate officers or reference shareholders; and
|
⯀
|
must not have been our auditor within the last six years.
|
⯀
|
monitoring the financial reporting process;
|
⯀
|
monitoring the effectiveness of internal control and risk management systems;
|
⯀
|
monitoring the legal audit of the annual and consolidated accounts of the statutory auditors;
|
⯀
|
making recommendations regarding the selection of our statutory auditors to be appointed by our shareholders, determining their compensation and ensuring their independence;
|
⯀
|
making recommendations regarding the selection of any accounting firm, other than our statutory auditors, to be appointed for non-audit services;
|
⯀
|
examining our procedures for the receipt, retention and treatment of complaints received by us regarding accounting, internal accounting controls or auditing matters, as well as for the confidential, anonymous submissions by our employees of concerns regarding questionable accounting or auditing matters; and
|
⯀
|
generally advising the supervisory board and making recommendations with respect to all of the areas above.
|
⯀
|
making recommendations on the composition of the executive and supervisory boards and the supervisory board’s committees;
|
⯀
|
annually evaluating independence and submitting to our supervisory board a list of its members who may qualify as independent members based on Nasdaq's listing rules and Rule 10A-3 of the Exchange Act as well as the criteria set forth in the MiddleNext Corporate Governance Code;
|
⯀
|
establishing a succession plan for our executive officers and assisting our supervisory board in the selection and evaluation of executive and supervisory board members;
|
⯀
|
reviewing the main objectives recommended by management regarding the compensation granted to the non-executive officers of the Company, including under free share and stock option plans;
|
⯀
|
reviewing equity incentive plans, including free share plans and stock options or stock purchase options, pension and contingency schemes and benefits in kind for non-executive officers;
|
⯀
|
making recommendations to our supervisory board regarding:
|
—
|
the compensation, pension and contingency schemes, benefits in kind and other various pecuniary rights, including termination, of the members of the executive board. The committee makes recommendations on the amount and structure of executive board member compensation, taking into account strategy, objectives, outcomes, and general market practice, and
|
—
|
the free share and stock option plans, as well as any similar equity incentive instrument and in particular, the allocation to members of the executive board,
|
⯀
|
making recommendations to our supervisory board regarding compensation, including equity-based compensation and expense reimbursement, for the members of the supervisory board, taking into account corporate goals and objectives and performance of supervisory board members in light of such goals and objectives;
|
⯀
|
preparing and presenting the reports provided for in the supervisory board charter (règlement intérieur);
|
⯀
|
making any other recommendation that might be requested by our supervisory board regarding compensation; and
|
⯀
|
generally advising the supervisory board and making recommendations with respect to all of the areas above.
|
Name
|
| |
Fixed
compensation (€)
|
| |
Bonus
(€)
|
| |
Free Shares
(€)
|
| |
Stock
Options (€)
|
| |
All other
compensation (€)
|
| |
Total
(€)
|
Dr. Laurent Levy
|
| |
330,000(1)
|
| |
132,000(4)
|
| |
1,578,000(5)
|
| |
435,500(7)
|
| |
17,757(8)
|
| |
2,493,257
|
Ms. Anne-Juliette Hermant
|
| |
90,000(2)(3)
|
| |
54,000(4)
|
| |
—
|
| |
—
|
| |
—
|
| |
144,000
|
Mr. Philippe Mauberna
|
| |
242,000(2)
|
| |
96,800(4)
|
| |
673,280(6)
|
| |
—
|
| |
—
|
| |
1,012,080
|
(1)
|
Compensation earned for his corporate office (Chairman of the executive board) that was set by the supervisory board.
|
(2)
|
Compensation earned under an employment agreement.
|
(3)
|
Ms. Hermant entered into an employment agreement with us on April 1, 2019 and was appointed as a member of the executive board by the supervisory board on June 20, 2019, effective July 1, 2019. The compensation due to her for the year ended December 31, 2019 covers the six months during which she served as a member of the executive board. Her fixed compensation in 2019 amounted to €180,000, to which was added variable compensation of up to 50% of her fixed compensation, i.e., up to €90,000.
|
(4)
|
Reflects compensation earned for the achievement of specified individual (representing 20% of said bonus), as well as company-wide, performance criteria (representing the remaining 80%) (together, the “strategic goals”). The executive board proposes the strategic goals annually, which are reviewed by the appointments and compensation committee and ultimately approved by the supervisory board.
|
(5)
|
Reflects the valuation of 150,000 free shares granted during the year ended December 31, 2019.
|
(6)
|
Reflects the valuation of 64,000 free shares granted during the year ended December 31, 2019.
|
(7)
|
Reflects the valuation of 500,000 stock options granted during the year ended December 31, 2019.
|
(8)
|
Reflects the value of premiums paid for an unemployment insurance policy with the Garantie Sociale des Chefs et Dirigeants d’Entreprise.
|
⯀
|
Fees for the chairman of the supervisory board: €15,000;
|
⯀
|
Fees for the members of the supervisory board: €7,500;
|
⯀
|
Fees for the chairperson of the appointments and compensation committee: €1,500 (additional); and
|
⯀
|
Fees for the chairperson of the audit committee: €2,500 (additional).
|
Name
|
| |
Fees earned (€)
|
| |
Equity Incentives (€)
|
| |
Total (€)
|
Mr. Laurent Condomine
|
| |
21,428
|
| |
8,215(1)
|
| |
29,643
|
Ms. Anne-Marie Graffin
|
| |
12,857
|
| |
2,813(2)
|
| |
15,670
|
Dr. Alain Herrera
|
| |
10,715
|
| |
2,900(3)
|
| |
13,615
|
Mr. Enno Spillner
|
| |
14,286
|
| |
4,080(4)
|
| |
18,365
|
Mr. Christophe Douat
|
| |
10,715
|
| |
6,148(5)
|
| |
16,863
|
(1)
|
Reflects the valuation of 5,300 warrants (BSA) granted during the year ended December 31, 2019, it being specified that Mr. Laurent Condomine paid the Company a total amount of €6,095 for these BSA.
|
(2)
|
Reflects the valuation of 2,900 warrants (BSA) granted during the year ended December 31, 2019, it being specified that Ms. Anne-Marie Graffin paid the Company a total amount of €3,335 for these BSA.
|
(3)
|
Reflects the valuation of 2,900 warrants (BSA) granted during the year ended December 31, 2019, it being specified that Dr. Alain Herrera paid the Company a total amount of €3,335 for these BSA.
|
(4)
|
Reflects the valuation of 4,000 warrants (BSA) granted during the year ended December 31, 2019, it being specified that Mr. Enno Spillner paid the Company a total amount of €4,600 for these BSA.
|
(5)
|
Reflects the valuation of 2,900 warrants (BSA) granted during the year ended December 31, 2019, it being specified that Mr. Christophe Douat paid the Company a total amount of €3,335 for these BSA.
|
(i)
|
dismissal or non-renewal of executive board membership for any reason other than gross negligence or willful misconduct (“faute lourde” as defined under French case law); or
|
(ii)
|
resignation within six months following a change of control (within the meaning of Article L. 233-3 of the French Commercial Code) due to a significant reduction in duties and responsibilities or compensation (including fixed compensation, benefits in kind, variable compensation or severance pay) or transfer of workplace to another country, in each case, without consent.
|
⯀
|
founders’ warrants (bons de souscription de parts de créateur d’entreprise or BSPCE), granted only to employees and members of our executive board. We can no longer issue these instruments;
|
⯀
|
warrants (bons de souscription d’actions or BSA), granted only to non-employee supervisory board members and service providers not eligible for either founders’ warrants or stock options;
|
⯀
|
restricted stock units (actions gratuites or free shares or AGA), generally granted to our employees and corporate officers (including members of the executive board) and the employees and corporate officers of our subsidiaries; and
|
⯀
|
stock options (options de souscription et/ou d’achat d’actions or OSA), generally granted to the employees of our subsidiaries.
|
⯀
|
the term of the founders’ warrants granted on May 4, 2012 was seven years from the date of grant;
|
⯀
|
neither the founders’ warrants granted on May 4, 2012, nor those granted on April 28, 2013, are subject to continuous employment; and
|
⯀
|
on July 23, 2019, the executive board decided to lift, for two of our employees and for Mr. Bernd Muehlenweg, a former member of the executive board, the continued service condition, and, for Bernd Muehlenweg, where applicable, the performance conditions to which the exercise of certain founders’ warrants was subject, notwithstanding the termination of their employment agreement or corporate office.
|
⯀
|
for founders’ warrants granted on May 4, 2012, the shareholders’ meeting decided to limit Liquidity Events to the filing of a tender offer for our shares and that the number of shares that may be exercised by holders in such event be subject to the price per share offered in the tender offer; and
|
⯀
|
for founders’ warrants granted on April 10, 2013, the executive board decided not to include any right of acceleration of the founders’ warrants in the event of a change in control.
|
Plan Title
|
| |
BSPCE2012-2(1)
|
| |
BSPCE08-2013(1)
|
| |
BSPCE09-2014(1)
|
| |
BSPCE2015-01(1)
|
| |
BSPCE2015-03(1)
|
| |
BSPCE2016(1)
|
| |
BSPCE2016 Performance(2)
|
| |
BSPCE2017 Ordinary(1)
|
| |
BSPCE2017(1)
|
Date of the shareholders' meeting
|
| |
May 4,
2012
|
| |
June 28,
2013
|
| |
June 18,
2014
|
| |
June 18,
2014
|
| |
June 18,
2014
|
| |
June 25,
2015
|
| |
June 25,
2015
|
| |
June 23,
2016
|
| |
June 23,
2016
|
Grant date
|
| |
December 18,
2012
|
| |
August 28,
2013
|
| |
September 16,
2014
|
| |
February 10,
2015
|
| |
June 10,
2015
|
| |
February 2,
2016
|
| |
February 2,
2016
|
| |
January 7,
2017
|
| |
January 7,
2017
|
Total number of BSPCE authorized
|
| |
500,000
|
| |
500,000
|
| |
450,000
|
| |
450,000
|
| |
450,000
|
| |
450,000
|
| |
450,000
|
| |
450,000
|
| |
450,000
|
Total number of BSPCE granted
|
| |
100,000
|
| |
50,000
|
| |
97,200
|
| |
71,650
|
| |
53,050
|
| |
126,400
|
| |
129,250
|
| |
117,650
|
| |
80,000
|
Starting date of the exercise of the BSPCE
|
| |
December 18,
2012
|
| |
August 28,
2013
|
| |
September 16,
2015
|
| |
February 10,
2016
|
| |
June 10,
2016
|
| |
February 2,
2017
|
| |
February 2,
2016
|
| |
January 8,
2018
|
| |
January 7,
2017
|
BSPCE expiry date(3)
|
| |
December 18,
2022
|
| |
August 28,
2023
|
| |
September 16,
2024
|
| |
February 10,
2025
|
| |
June 10,
2025
|
| |
February 2,
2026
|
| |
February 2,
2026
|
| |
January 8,
2027
|
| |
January 7,
2027
|
Exercise price per BSPCE
|
| |
6.63€
|
| |
5.92€
|
| |
18.68€
|
| |
18.57€
|
| |
20.28€
|
| |
14.46€
|
| |
14.46€
|
| |
15.93€
|
| |
15.93€
|
Number of shares subscribed as of September 30, 2020
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
333
|
| |
—
|
| |
—
|
| |
—
|
Total number of BSPCEs lapsed or cancelled as of September 30, 2020
|
| |
—
|
| |
—
|
| |
11,050
|
| |
3,200
|
| |
22,350
|
| |
25,150
|
| |
28,950
|
| |
16,800
|
| |
—
|
Total number of BSPCEs outstanding as of September 30, 2020
|
| |
100,000
|
| |
50,000
|
| |
86,150
|
| |
68,450
|
| |
30,700
|
| |
100,917
|
| |
100,300
|
| |
100,850
|
| |
80,000
|
Total number of shares available for subscription as of September 30, 2020
|
| |
100,000
|
| |
50,000
|
| |
86,150
|
| |
68,450
|
| |
30,700
|
| |
100,917
|
| |
38,544
|
| |
100,850
|
| |
80,000
|
Maximum total number of shares that can be issued
|
| |
100,000
|
| |
50,000
|
| |
86,150
|
| |
68,450
|
| |
30,700
|
| |
100,917
|
| |
100,300
|
| |
100,850
|
| |
80,000
|
(1)
|
All such BSPCE can be exercised.
|
(2)
|
The BSPCE2016-Performance may be exercised as from their date of grant, subject to the achievement of the following targets:
|
•
|
up to 15% of the BSPCE may be exercised if the number of patients under treatment is at least equal to 200,
|
•
|
additional 15% of the BSPCE may be exercised if the number of patients under treatment is at least equal to 300,
|
•
|
additional 30% of the BSPCE may be exercised if the number of patients under treatment is at least equal to 400, and
|
•
|
the balance, i.e., 40% of the BSPCE, may be exercised if the number of patients under treatment is at least equal to 500. As of September 30, 2020, 30% of the BSPCE2016-Performance can be exercised, it being specified that, on July 23, 2019, the executive board decided to lift the performance conditions to which the exercise of Mr. Bernd Muehlenweg’s 11,500 BSPCE2016 Performance was subject. Accordingly, all of Mr. Bernd Muehlenweg’s BSPCE2016 Performance may be exercised.
|
(3)
|
See also “—Founders’ Warrants (BSPCE)—Term” and “—Founders’ Warrants (BSPCE)—Change in Control.”
|
Plan Title
|
| |
BSA
04-2012(1)
|
| |
BSA
2013(2)
|
| |
BSA
2014(3)
|
| |
BSA
2015-1(4)
|
| |
BSA
2015-2 (a)(5)
|
| |
BSA
2016 Ordinary(6)
|
| |
BSA
2016 Performance (7)
|
| |
BSA
2016-02(8)
|
| |
BSA
2017(9)
|
| |
BSA
2018(10)
|
| |
BSA
2018-01(11)
|
| |
BSA
2018-02(12)
|
| |
BSA
2019-1(13)
|
| |
BSA
2020(14)
|
Date of the shareholders' meeting
|
| |
May 4,
2012
|
| |
May 4,
2012
|
| |
June 18,
2014
|
| |
June 18,
2014
|
| |
June 18,
2014
|
| |
June 25,
2015
|
| |
June 25,
2015
|
| |
June 23,
2016
|
| |
June 23,
2016
|
| |
June 14,
2017
|
| |
June 14,
2017
|
| |
May 23,
2018
|
| |
May 23,
2018
|
| |
April 11,
2019
|
Grant date
|
| |
May 4,
2012
|
| |
April 10,
2013
|
| |
September 16,
2014
|
| |
February 10,
2015
|
| |
June 25,
2015
|
| |
February 2,
2016
|
| |
February 2,
2016
|
| |
November 3,
2016
|
| |
January 7,
2017
|
| |
March 6,
2018
|
| |
March 6,
2018
|
| |
July 27,
2018
|
| |
March 29,
2019
|
| |
March 17,
2020
|
Total number of BSA authorized
|
| |
200,000
|
| |
200,000
|
| |
100,000
|
| |
100,000
|
| |
100,000
|
| |
100,000
|
| |
100,000
|
| |
100,000
|
| |
100,000
|
| |
116,000
|
| |
116,000
|
| |
140,000
|
| |
140,000
|
| |
500,000
|
Total number of BSA granted
|
| |
52,500
|
| |
10,000
|
| |
14,000
|
| |
26,000
|
| |
64,000
|
| |
18,103
|
| |
18,105
|
| |
8,000
|
| |
18,000
|
| |
18,000
|
| |
10,000
|
| |
5,820
|
| |
18,000
|
| |
18,000(15)
|
Starting date of the exercise of the BSA
|
| |
October 23,
2013
|
| |
April 30,
2014
|
| |
September 16,
2014
|
| |
February 10,
2015
|
| |
June 25,
2015
|
| |
February 2,
2016
|
| |
February 2,
2016
|
| |
November 3,
2016
|
| |
January 7,
2017
|
| |
March 6,
2018
|
| |
March 6,
2018
|
| |
July 27,
2018
|
| |
March 29,
2019
|
| |
March 17,
2020
|
BSA expiry date(16)
|
| |
May 4,
2022
|
| |
April 10,
2023
|
| |
September 16,
2024
|
| |
February 10,
2025
|
| |
June 25,
2025
|
| |
February 2,
2021
|
| |
February 2,
2021
|
| |
November 3,
2021
|
| |
January 7,
2022
|
| |
March 6,
2023
|
| |
March 6,
2023
|
| |
July 27,
2028
|
| |
March 29,
2029
|
| |
March 17,
2030
|
Exercise price per BSA
|
| |
6.00€
|
| |
6.37€
|
| |
17.67€
|
| |
17.67€
|
| |
19.54€
|
| |
13.74€
|
| |
13.74€
|
| |
15.01€
|
| |
15.76€
|
| |
13.55€
|
| |
13.55€
|
| |
16.102€
|
| |
11.66€
|
| |
6.59€
|
Number of shares subscribed as of September 30, 2020
|
| |
22,500
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Total number of forfeited or cancelled BSAs as of September 30, 2020
|
| |
—
|
| |
4,000
|
| |
4,000
|
| |
5,000
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Total number of BSAs outstanding as of September 30, 2020
|
| |
30,000
|
| |
6,000
|
| |
10,000
|
| |
21,000
|
| |
64,000
|
| |
18,103
|
| |
18,105
|
| |
8,000
|
| |
18,000
|
| |
18,000
|
| |
10,000
|
| |
5,820
|
| |
18,000
|
| |
18,000
|
Total number of shares available for subscription as of September 30, 2020
|
| |
30,000
|
| |
6,000
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
5,431
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Maximum total number of shares that can be issued
|
| |
30,000
|
| |
6,000
|
| |
10,000
|
| |
21,000
|
| |
64,000
|
| |
18,103
|
| |
18,105
|
| |
8,000
|
| |
18,000
|
| |
18,000
|
| |
10,000
|
| |
5,820
|
| |
18,000
|
| |
18,000
|
(1)
|
Each BSA04-2012 gives the right to subscribe to one share at the fixed price of €6 (issue premium included) provided that, on the day the BSA is exercised, the relevant beneficiary, when a supervisory board member, has attended at least 75% of the supervisory board meetings held during the period preceding the exercise of the warrants or, as the case may be, the date the beneficiary ceases to be part of our group.
|
(2)
|
Each BSA2013 gives the right to subscribe to one share at the fixed price of €6.37 (issue premium included) provided that, on the day the BSA is exercised, the relevant beneficiary, when a supervisory board member, has attended at least 75% of the supervisory board meetings held during the period preceding the exercise of the warrants or, as the case may be, the date the beneficiary ceases to be part of our group.
|
(3)
|
Each BSA2014 gives the right to subscribe to one share at the fixed price of €17.67 (issue premium included) provided that, on the day the BSA is exercised, (i) the relevant beneficiary, when a supervisory board member, has attended at least 75% of the supervisory board meetings held during the period preceding the exercise of the warrants or, as the case may be, the date the beneficiary ceases to be part of our group, and (ii) the market value of a share shall be at least equal to €40.
|
(4)
|
Each BSA2015-1 gives the right to subscribe to one share at the fixed price of €17.67 (issue premium included) provided that, on the day the BSA is exercised, (i) the relevant beneficiary, when a supervisory board member, has attended at least 75% of the supervisory board meetings held during the period preceding the exercise of the warrants or, as the case may be, the date the beneficiary ceases to be part of our group, and (ii) the market value of a share shall be at least equal to €40.
|
(5)
|
Each BSA2015-2 (a) gives the right to subscribe to one share at the fixed price of €19.54 (issue premium included) provided that, on the day the BSA is exercised, the market value of a share shall be at least equal to €50.
|
(6)
|
Each BSA2016-01-Ordinary gives the right to subscribe to one share at the fixed price of €13.74 (issue premium included) provided that, on the day the BSA is exercised, (i) the relevant beneficiary, when a supervisory board member, has attended at least 75% of the supervisory board meetings held during the period preceding the exercise of the warrants or, as the case may be, the date the beneficiary ceases to be part of our group, and (ii) the market value of a share shall be at least equal to €40.
|
(7)
|
Each BSA2016-01-Performance gives the right to subscribe to one share at the fixed price of €13.74 (issue premium included), subject to the achievement of the following targets:
|
•
|
up to 15% of the BSA may be exercised if the number of patients under treatment is at least equal to 200,
|
•
|
additional 15% of the BSA may be exercised if the number of patients under treatment is at least equal to 300,
|
•
|
additional 30% of the BSA may be exercised if the number of patients under treatment is at least equal to 400, and
|
•
|
additional 40% of the BSA may be exercised if the number of patients under treatment is at least equal to 500.
|
(8)
|
Each BSA2016-2 gives the right to subscribe to one share at the fixed price of €15.01 (issue premium included) provided that, on the day the BSA is exercised, the market value of a share shall be at least equal to €40.
|
(9)
|
Each BSA2017 gives the right to subscribe to one share at the fixed price of €15.76 (issue premium included) provided that, on the day the BSA is exercised, (i) the relevant beneficiary, when a supervisory board member, has attended at least 75% of the supervisory board meetings held during the period preceding the exercise of the warrants or, as the case may be, the date the beneficiary ceases to be part of our group and, (ii) the market value of a share shall be at least equal to €40.
|
(10)
|
Each BSA2018 gives the right to subscribe to one share at the fixed price of €13.55 (issue premium included) provided that, on the day the BSA is exercised, (i) the relevant beneficiary, when a supervisory board member, has attended at least 75% of the supervisory board meetings held during the period preceding the exercise of
|
(11)
|
Each BSA2018-01 gives the right to subscribe to one share at the fixed price of €13.55 (issue premium included) provided that, on the day the BSA is exercised, the market value of a share shall be at least equal to €40.
|
(12)
|
Each BSA2018-02 gives the right to subscribe to one share at the fixed price of €16.102 (issue premium included) provided that, on the day the BSA is exercised, the market value of a share shall be at least equal to €40.
|
(13)
|
Each BSA2019-01 gives the right to subscribe to one share at the fixed price of €11.66 (issue premium included) provided that, on the day the BSA is exercised, (i) the relevant beneficiary, when a supervisory board member, has attended at least 75% of the supervisory board meetings held during the period preceding the exercise of the warrants or, as the case may be, the date the beneficiary ceases to be part of our group, and (ii) the market value of a share shall be at least equal to €40.
|
(14)
|
Each BSA2020 gives the right to subscribe to one share at the fixed price of €6.59 (issue premium included) provided that, on the day the BSA is exercised, (i) the relevant beneficiary, when a supervisory board member, has attended at least 75% of the supervisory board meetings held during the period preceding the exercise of the warrants or, as the case may be, the date the beneficiary ceases to be part of our group, and (ii) the market value of a share shall be at least equal to €40.
|
(15)
|
Includes 3,976 to Mr. Condomine, 3,843 to Ms. Graffin, 3,195 to Dr. Hererra, 3,829 to Mr. Spillner and 3,157 to Mr. Douat.
|
(16)
|
See also “—Warrants (BSA)—Term” and “—Warrants (BSA)—Change in Control.”
|
Plan Title
|
| |
OSA2016-1 Performance(1)
|
| |
OSA2016-2(2)
|
| |
OSA2017 Ordinary(3)
|
| |
OSA2018(4)
|
| |
OSA2019-1(5)
|
| |
OSALLY 2019(6)
|
| |
OSA2020(7)
|
Date of the shareholders’ meeting
|
| |
June 25,
2015
|
| |
June 23,
2016
|
| |
June 23,
2016
|
| |
June 14,
2017
|
| |
May 23,
2018
|
| |
April 11,
2019
|
| |
April 11,
2019
|
Grant date
|
| |
February 2,
2016
|
| |
November 3,
2016
|
| |
January 7,
2017
|
| |
March 6,
2018
|
| |
March 29,
2019
|
| |
October 24,
2019
|
| |
March 11,
2020
|
Total number of stock options authorized
|
| |
450,000
|
| |
450,000
|
| |
450,000
|
| |
526,800
|
| |
648,000
|
| |
500,000
|
| |
500,000
|
Total number of stock options granted
|
| |
6,400
|
| |
4,000
|
| |
3,500
|
| |
62,000
|
| |
37,500
|
| |
500,000
|
| |
407,972(8)
|
Starting date of the exercise of the stock options
|
| |
February 2,
2016
|
| |
November 3,
2017
|
| |
January 7,
2018
|
| |
March 7,
2019
|
| |
March 30,
2021
|
| |
October 24,
2019
|
| |
March 11,
2021
|
Stock options expiry date
|
| |
February 2,
2026
|
| |
November 3,
2026
|
| |
January 7,
2027
|
| |
March 6,
2028
|
| |
March 29,
2029
|
| |
October 24,
2029
|
| |
March 11,
2030
|
Exercise price per stock option
|
| |
€13.05
|
| |
€14.26
|
| |
€14.97
|
| |
€12.87
|
| |
€11.08
|
| |
€6.41
|
| |
€6.25
|
Number of shares subscribed as of September 30, 2020
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Total number of stock options lapsed or cancelled as of September 30, 2020
|
| |
6,000
|
| |
—
|
| |
3,000
|
| |
10,000
|
| |
8,750
|
| |
—
|
| |
5,962
|
Total number of stock options outstanding as of September 30, 2020
|
| |
400
|
| |
4,000
|
| |
500
|
| |
52,000
|
| |
28,750
|
| |
500,000
|
| |
402,010
|
Maximum number of shares available for subscription as of September 30, 2020
|
| |
120
|
| |
4,000
|
| |
500
|
| |
51,333
|
| |
—
|
| |
—
|
| |
—
|
Maximum total number of shares that can be issued
|
| |
400
|
| |
4,000
|
| |
500
|
| |
52,000
|
| |
28,750
|
| |
500,000
|
| |
402,010
|
(1)
|
The OSA2016-1 Performance may be exercised as from their date of grant, subject to the achievement of the following targets:
|
•
|
up to 15% of the OSA may be exercised if the number of patients under treatment is at least equal to 200,
|
•
|
an additional 15% of the OSA may be exercised if the number of patients under treatment is at least equal to 300,
|
•
|
an additional 30% of the OSA may be exercised if the number of patients under treatment is at least equal to 400, and
|
•
|
the balance, i.e. 40% of the OSA, may be exercised if the number of patients under treatment is at least equal to 500. As of September 30, 2020, 30% of the OSA2016-1-Performance, i.e., 120 OSA2016-1 Performance, can be exercised.
|
(2)
|
All of the OSA2016-2 may be exercised.
|
(3)
|
All of the OSA2017 Ordinary may be exercised.
|
(4)
|
The OSA2018 may be exercised as follows:
|
•
|
up to one-third of the OSA2018 as from March 7, 2019;
|
•
|
an additional one-third of the OSA2018, as from March 7, 2020; and
|
•
|
the balance, i.e., one-third of the OSA2018, as from March 7, 2021,
|
(5)
|
The OSA2019-1 may be exercised as follows:
|
•
|
up to two-thirds of the OSA2019-1as from March 30, 2021; and
|
•
|
the balance, i.e., one-third of the OSA2019-1as from March 30, 2022, subject to, for each increment, a continued service condition.
|
(6)
|
The OSALLY 2019 may be exercised under the following conditions:
|
•
|
10% of the OSALLY 2019 may be exercised when the market value of a share on the regulated market of Euronext in Paris reaches €24;
|
•
|
an additional 10% of the OSALLY 2019 may be exercised when the market value of a share on the regulated market of Euronext in Paris reaches €30;
|
•
|
an additional 40% of the OSALLY 2019 may be exercised when the market value of a share on the regulated market of Euronext in Paris reaches €40;
|
•
|
the balance, i.e. 40% of the OSALLY 2019 may be exercised when the market value of a share on the regulated market of Euronext in Paris reaches €60; and
|
•
|
it being specified that, in the event of a Liquidity Event, the performance conditions regarding the price of the Company’s share price on the regulated market of Euronext in Paris will be automatically waived.
|
(7)
|
The OSA2020 may be exercised as follows:
|
•
|
up to one-third of the OSA2020 as from March 11, 2021;
|
•
|
an additional one-third of the OSA2020 as from March 11, 2022, and
|
•
|
the balance, i.e., one-third of the OSA2020 as from March 11, 2023,
|
(8)
|
Includes 120,000 granted to Dr. Levy, 60,000 granted to Mr. Mauberna and 60,000 granted to Ms. Hermant.
|
1.
|
For French tax residents, (i) if the Liquidity Event occurs before or on the first anniversary date of the grant and (ii) if the change of control occurs after the first anniversary of grant, on the date of completion of the Liquidity Event, it being specified that, in both cases, the relevant free shares will then be subject to a holding period until the second anniversary of the grant.
|
2.
|
For foreign tax residents, if the Liquidity Event occurs before the second anniversary of the grant, on the first anniversary of the grant, it being specified that, the relevant free shares will then be subject to a year-long holding period as from their date of acquisition.
|
Plan Title
|
| |
AGA2018-1
|
| |
AGA2019-1
|
| |
AGA2020
|
Date of the shareholders’ meeting
|
| |
June 14, 2017
|
| |
May 23, 2018
|
| |
April 11, 2019
|
Grant date
|
| |
March 6, 2018
|
| |
March 29, 2019
|
| |
March 11, 2020
|
Total number of free shares authorized
|
| |
526,800
|
| |
648,000
|
| |
500,000
|
Total number of free shares granted
|
| |
396,250
|
| |
438,250
|
| |
50,000
|
Date of acquisition (end of the acquisition period)(5)
|
| |
(1)(2)
|
| |
(3)
|
| |
March 11, 2022(4)
|
Duration of the holding period(5)
|
| |
(1)
|
| |
(3)
|
| |
1 year
|
Number of shares acquired as of September 30, 2020
|
| |
316,083
|
| |
—
|
| |
—
|
Total number of free shares lapsed or cancelled as of September 30, 2020
|
| |
55,667
|
| |
67,250
|
| |
—
|
Total number of free shares outstanding as of September 30, 2020
|
| |
24,500
|
| |
371,000
|
| |
50,000
|
Maximum total number of shares that may be created
|
| |
24,500
|
| |
371,000
|
| |
50,000
|
(1)
|
The AGA2018-1 granted to French tax residents were definitely acquired on March 6, 2020 and are now subject to a one-year holding period ending on March 6, 2021. The AGA2018-1 granted to foreign tax residents will be definitely acquired on March 6, 2021 and will not be subject to any holding period.
|
(2)
|
The definitive acquisition of the AGA2018-1 granted to the members of the executive board was subject to the achievement of clinical and strategic objectives in the head and neck indication, the completion of which was recorded by the executive board and the supervisory board on March 15, 2019. On July 23, 2019, the executive board decided that the two-thirds of the AGA2018-1 granted to Mr. Bernd Muehlenweg, i.e. 28,333 AGA2018-1 would be definitively acquired on March 6, 2020. The balance, i.e. 14,167 AGA2018-1, was subject to the conclusion of a clinical trial supply contract before March 6, 2020. As this performance condition was not met, these 14,167 AGA2018-1 lapsed on March 6, 2020.
|
(3)
|
The AGA2019-1 granted to French tax residents will be definitely acquired on March 29, 2021 and will then be subject to a one-year holding period ending on March 29, 2022. The AGA2019-1 granted to foreign tax residents will be definitely acquired on March 29, 2022 and will not be subject to any holding period. The acquisition of the AGA2019-1 granted to members of our executive board was subject to NBTXR3 receiving the CE mark before June 30, 2019. The satisfaction of this performance condition was recorded by the supervisory board on April 6, 2020 and by the executive board on April 27, 2020.
|
(4)
|
The acquisition of the AGA2020 granted to Ms. Hermant is conditioned upon the achievement of positive results in Study 1100 in 2020. The satisfaction of this performance condition must be acknowledged by the executive board, with the approval of the supervisory board, before March 11, 2021.
|
(5)
|
See also “—Free Shares (AGA)—Vesting” and “—Free Shares (AGA)—Change In Control.”
|
⯀
|
the benefits and perceived benefits to us;
|
⯀
|
the opportunity costs of alternative transactions;
|
⯀
|
the materiality and character of the related party’s interest;
|
⯀
|
the actual or apparent conflict of interest of the related party; and
|
⯀
|
the terms available to or from, as the case may be, unrelated third parties or to or from employees generally.
|
⯀
|
each person, or group of affiliated persons, known by us to beneficially own more than 5% of our outstanding ordinary shares;
|
⯀
|
each of our supervisory board members and executive board members; and
|
⯀
|
all of our supervisory board members and executive board members as a group.
|
Name of Beneficial Owner
|
| |
Ordinary Shares
Beneficially Owned
Prior to the Offering
|
| |
Ordinary
Shares
Beneficially
Owned After
the Offering
|
| |
Ordinary Shares
Beneficially
Owned After the
Offering if
Underwriters’
Option is
Exercised in Full
|
|||
|
| |
Number
|
| |
%
|
| |
%
|
| |
%
|
Supervisory Board and Executive Board Members:
|
| |
|
| |
|
| |
|
| |
|
Laurent Levy, Ph.D.(1)
|
| |
943,010
|
| |
3.60
|
| |
|
| |
|
Philippe Mauberna(2)
|
| |
174,750
|
| |
*
|
| |
|
| |
|
Anne-Juliette Hermant
|
| |
—
|
| |
—
|
| |
|
| |
|
Laurent Condomine(3)
|
| |
141,662
|
| |
*
|
| |
|
| |
|
Alain Herrera, M.D.(4)
|
| |
1,298
|
| |
*
|
| |
|
| |
|
Christophe Douat(5)
|
| |
973
|
| |
*
|
| |
|
| |
|
Anne-Marie Graffin(6)
|
| |
600
|
| |
*
|
| |
|
| |
|
Enno Spillner(7)
|
| |
450
|
| |
*
|
| |
|
| |
|
All Supervisory Board and Executive Board members as a group (8 persons)(8)
|
| |
1,262,743
|
| |
4.79
|
| |
|
| |
|
*
|
Represents beneficial ownership of less than 1%.
|
(1)
|
Consists of 809,060 ordinary shares and 133,950 ordinary shares issuable upon exercise of founders’ warrants and stock options.
|
(2)
|
Consists of 50,000 ordinary shares and 124,750 ordinary shares issuable upon exercise of founders’ warrants.
|
(3)
|
Consists of 103,553 ordinary shares held by SCI Toucondo, of which entity Mr. Condomine serves as managing partner, and 38,109 ordinary shares issuable upon exercise of warrants.
|
(4)
|
Consists of 1,298 ordinary shares issuable upon exercise of warrants.
|
(5)
|
Consists of 973 ordinary shares issuable upon exercise of warrants.
|
(6)
|
Consists of 600 ordinary shares issuable upon exercise of warrants.
|
(7)
|
Consists of 450 ordinary shares issuable upon exercise of warrants.
|
(8)
|
Consists of 962,613 ordinary shares and 300,130 ordinary shares issuable upon exercise of founders’ warrants and warrants.
|
Shares outstanding at January 1, 2017
|
| |
15,965,272
|
Number of ordinary shares issued in connection with the exercise of founders’ warrants (BSPCE) and stock options (OSA)
|
| |
129,785
|
Number of ordinary shares issued on April 11, 2017 in connection with the share capital increase decided on April 7, 2017
|
| |
1,596,527
|
Number of ordinary shares issued on November 2, 2017 in connection with the share capital increase decided on October 31, 2017
|
| |
1,941,789
|
Shares outstanding at December 31, 2017
|
| |
19,633,373
|
Shares outstanding at December 31, 2018
|
| |
19,633,373
|
Number of ordinary shares issued on April 9, 2019 in connection with the share capital increase decided on April 9, 2019
|
| |
2,566,666
|
Number of ordinary shares issued in connection with the exercise of founders’ warrants (BSPCE)
|
| |
215,000
|
Shares outstanding at December 31, 2019
|
| |
22,415,039
|
Number of ordinary shares issued in connection with the definitive acquisition of free shares (AGA)
|
| |
316,083
|
Shares outstanding at June 30, 2020
|
| |
22,731,122
|
Number of ordinary shares issued in connection with the definitive acquisition of free shares (AGA)
|
| |
6,000
|
Number of ordinary shares issued on July 30, 2020 in connection with the share capital increase decided on July 28, 2020
|
| |
3,300,000
|
Shares outstanding at September 30, 2020
|
| |
26,037,122
|
⯀
|
the research and development in natural and physical sciences;
|
⯀
|
the filing, study, acquisition, granting of any patents, licenses, methods, trademarks and protection of specialized knowledge connected or relating in any way to the fields or technologies covering our corporate purpose;
|
⯀
|
the design, development, production, marketing, importation, exportation and exploitation by any means of drugs, pharmaceutical specialties, medical devices and other health possessions;
|
⯀
|
the creation, acquisition, rental, lease-management of all business assets or facilities (fonds de commerce), lease, installation, operation of all establishments (fonds de commerce) factories and workshops, relating to any of the specified activities;
|
⯀
|
the participation in any transactions that may relate to our corporate purpose by creating new companies, subscribing or purchasing securities or corporate rights, merging or otherwise; and
|
⯀
|
more generally, all financial, commercial, industrial transactions and transactions involving real estate or movable properties relating directly or indirectly to any of the aforementioned corporate purposes or any similar or related purpose, in order to promote their development or extension.
|
⯀
|
to decrease our share capital, provided that such a decision is not driven by losses and that a purchase offer is made to all shareholders on a pro rata basis, with the approval of the shareholders at an extraordinary general meeting; in this case, the shares repurchased must be cancelled within one month from their repurchase date;
|
⯀
|
to meet obligations arising from debt securities that are exchangeable into shares; or
|
⯀
|
to meet our obligations arising from share option programs, or other allocations of shares, to our employees or to our managers our the employees or managers of our affiliate. In this case the shares repurchased must be distributed within 12 months from their repurchase, after which they must be cancelled.
|
⯀
|
provisions of French law allowing the owner of 90% of the share capital or voting rights of a public company to force out the minority shareholders following a tender offer made to all shareholders are only applicable to companies listed on a regulated market or a multilateral trading facility in a Member State of the EU or in a state party of the European Economic Area Agreement, including the main French stock exchange, and will therefore be applicable to us only if we continue to dual-list in France;
|
⯀
|
a merger (i.e., in a French law context, a stock-for-stock exchange after which our Company would be dissolved without being liquidated into the acquiring entity and our shareholders would become shareholders of the acquiring entity) of our Company into a company incorporated in the EU would require the approval of our executive board as well as a two-thirds majority of the votes cast by the shareholders present, represented by proxy or voting by mail at the relevant meeting;
|
⯀
|
a merger of our Company into a company incorporated outside of the EU would require the unanimous approval of our shareholders;
|
⯀
|
under French law, a cash merger is treated as a share purchase and would require the consent of each participating shareholder;
|
⯀
|
our shareholders have granted and may grant in the future to our executive board broad authorizations to increase our share capital or to issue additional ordinary shares or other securities (for example, warrants) to our shareholders, the public or qualified investors, including as a possible defense following the launching of a tender offer for our shares;
|
⯀
|
our shareholders have preferential subscription rights proportional to their shareholding in our Company on the issuance by us of any additional shares or securities giving right, immediately or in the future, to new shares for cash or a set-off of cash debts, which rights may only be waived by the extraordinary shareholders’ general meeting (by a two-thirds majority vote) of our shareholders or on an individual basis by each shareholder;
|
⯀
|
our supervisory board has the right to appoint new members to fill a vacancy created by the resignation or death of a member, subject to the approval by the shareholders of such appointment at the next shareholders’ meeting, which prevents shareholders from having the sole right to fill vacancies on our supervisory board;
|
⯀
|
the members of our executive board are appointed by our supervisory board and can be removed either by our supervisory board or at the shareholders’ general meeting;
|
⯀
|
our supervisory board can only be convened by its chairman, or by its vice-president or, on a reasoned request (e.g. when no board meeting has been held for more than two consecutive months), by (1) members representing at least one-third of the total number of members of our supervisory board or (2) a member of the executive board;
|
⯀
|
our supervisory board’s meetings can only be regularly held if at least half of its members attend either physically or by way of videoconference or teleconference, enabling the members’ identification and ensuring their effective participation in the supervisory board’s decisions;
|
⯀
|
our shares are nominative or bearer, if the legislation so permits, according to the shareholder’s choice;
|
⯀
|
under French law, (a) any non-French citizen, (b) any French citizen not residing in France, (c) any non-French entity or (d) any French entity controlled by one of the aforementioned persons or entities may have to file a declaration for statistical purposes with the Bank of France (Banque de France) within 20 working days following
|
⯀
|
under French law, certain investments in any entity governed by a French law relating to certain strategic industries (such as research and development in biotechnologies and activities relating to public health) and activities by individuals or entities not French, not resident in France or controlled by entities not French or not resident in France are subject to prior authorization of the Ministry of Economy; see “Limitations Affecting Shareholders of a French Company;”
|
⯀
|
approval of at least a majority of the votes held by shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove members of the supervisory board with or without cause;
|
⯀
|
advance notice is required for nominations to the members of the supervisory board or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a member of our supervisory board can be proposed at any shareholders’ meeting without notice;
|
⯀
|
pursuant to French law, our By-laws, including the sections relating to the number of our supervisory board’s members and election and removal of a member of the supervisory board from office, may only be modified by a resolution adopted by a two-thirds majority vote of our shareholders present, represented by a proxy or voting by mail at the meeting;
|
⯀
|
in the event where certain ownership thresholds would be crossed, a number of disclosures should be made by the relevant shareholder and can impose certain obligations; see “—Declaration of Crossing of Ownership Thresholds”; and
|
⯀
|
transfers of shares shall comply with applicable insider trading rules and regulations, and in particular with the MAR.
|
⯀
|
issuing additional shares;
|
⯀
|
increasing the par value of existing shares;
|
⯀
|
creating a new class of equity securities; and
|
⯀
|
exercising the rights attached to securities giving access to the share capital.
|
⯀
|
issuances in consideration for cash;
|
⯀
|
issuances in consideration for assets contributed in kind;
|
⯀
|
issuances through an exchange offer;
|
⯀
|
issuances by conversion of previously issued debt instruments;
|
⯀
|
issuances by capitalization of profits, reserves or share premium; and
|
⯀
|
subject to certain conditions, issuances by way of offset against debt incurred by us.
|
|
| |
France
|
| |
Delaware
|
||||||
Number of Directors
|
| |
Under French law, a société anonyme with an executive board (directoire) and a supervisory board (conseil de surveillance) (i) must have at least 2 (or 1 when its share capital is below €150,000) and may have up to 5 (or 7 when the company is listed on a regulated market) executive board members and (ii) must have at least three but no more than 18 supervisory board members. The number of members is fixed by or in the manner provided in the by-laws. The members of the supervisory board are appointed at the shareholders’ general meetings. The number of supervisory board members of each gender may not be less than 40%. As an exception, for a supervisory board having up to 8 members, the difference between each gender may not exceed 2. Any appointment made in violation thereof will be null and void. Moreover, the deliberations of the board in which the member appointed in contravention of the aforementioned rule would have participated will also be deemed null and void.
|
| |
Under Delaware law, a corporation must have at least one director and the number of directors shall be fixed by or in the manner provided in the certificate of incorporation or by-laws.
|
||||||
|
| |
|
| |
|
| |
|
| |
|
Director Qualifications
|
| |
Under French law, a corporation may prescribe qualifications for executive and supervisory board members under its by-laws. In addition, under French law, members of a supervisory board of a corporation may be legal entities, and such legal entities may designate an individual to represent them and to act on their behalf at meetings of the supervisory board. However, only individuals may be appointed members of an executive board.
|
| |
Under Delaware law, a corporation may prescribe qualifications for directors under its certificate of incorporation or by-laws. Under Delaware law, only individuals may be members of a corporation’s board of directors.
|
||||||
|
| |
|
| |
|
| |
|
| |
|
Removal of Directors
|
| |
Under French law, the supervisory board members may be removed from office, at any time, with or without cause, at any shareholders’ meeting by a simple majority vote. The members of the executive board may be removed at the shareholders’ meeting or, if provided in the by-laws, by the supervisory board. The executive board member removed without cause may claim damages.
|
| |
Under Delaware law, unless otherwise provided in the certificate of incorporation, directors may be removed from office, with or without cause, by a majority stockholder vote, though in the case of a corporation (1) whose board of directors is classified, stockholders may effect such removal only for cause (unless the certificate of incorporation provides otherwise), or (2) who has cumulative voting, if less than the entire
|
|
| |
France
|
| |
Delaware
|
||||||
|
| |
|
| |
board of directors is to be removed, no director may be removed without cause if the votes cast against such director’s removal would be sufficient to elect such director if then cumulatively voted at an election of the entire board of directors, or, if there are classes of directors, at an election of the class of directors of which such director is a part.
|
||||||
|
| |
|
| |
|
| |||||
Vacancies on the Board of Directors
|
| |
Under French law, vacancies on the executive board resulting from death or a resignation or for any other reason will have to be filled by the supervisory board within two months, unless the supervisory board decides to amend the number of executive board meetings. Vacancies on the supervisory board may be filled temporarily by such board pending ratification by the next shareholders’ meeting. The shareholders’ meeting will immediately be held to appoint new supervisory board members if their number went below the minimum required by law.
|
| |
Under Delaware law, unless the certificate of incorporation or by-laws provide otherwise, vacancies on a corporation’s board of directors, including those caused by an increase in the number of directors, may be filled by stockholders or by a majority of the remaining directors.
|
||||||
|
| |
|
| |
|
| |
|
| |
|
Annual General Meeting
|
| |
Under French law, the annual general meeting of shareholders shall be held at such place, on such date and at such time as decided each year by the executive board and notified to the shareholders in the convening notice of the annual meeting, within six months after the close of the relevant fiscal year unless such period is extended by court order.
|
| |
Under Delaware law, the annual meeting of stockholders shall be held at such place, on such date and at such time as may be designated from time to time by the board of directors or as provided in the certificate of incorporation or by the by-laws, provided that the court may order an annual meeting upon the application of a director or stockholder if a corporation has not held a meeting within 30 days of a date designated for the meeting or within 13 months after the latest of the Company’s organization, the last annual meeting or the last action by written consent to elect directors.
|
||||||
|
| |
|
| |
|
| |
|
| |
|
General Meeting
|
| |
Under French law, general meetings of the shareholders may be called by the executive board or, failing that, by the statutory auditors, or by a court appointed agent (mandataire ad hoc) or liquidator in certain circumstances, or by the majority shareholder in capital or voting rights following a public tender offer or exchange offer or the transfer of a controlling block, on the date decided by the executive board or the relevant person. General meetings of the shareholders may also be called by the supervisory board.
|
| |
Under Delaware law, special meetings of the stockholders may be called by the board of directors or by such person or persons as may be authorized by the certificate of incorporation or by the by-laws.
|
||||||
|
| |
|
| |
|
|
|
| |
France
|
| |
Delaware
|
||||||
Notice of General Meetings
|
| |
A first convening notice must be published in the mandatory statutory notices (BALO) at least 35 days prior to the meeting. Subject to limited exceptions provided by French law, additional convening notices must be given at least 15 days before the date of the meeting, by means of a notice inserted in both the BALO and a newspaper for legal notices (journal d’annonces légales) of the registered office department of the Company. Further, the shareholders holding registered shares for at least one month at the time of the latest insertion of the notices shall be summoned individually, by regular letter or by registered letter if the shareholders so request and include an advance of expenses, sent to their last known address. This notice to registered shareholders may also be transmitted by electronic means of telecommunication, in lieu of any such mailing, to any relevant shareholder requesting it beforehand by registered letter with acknowledgement of receipt in accordance with legal and regulatory requirements, specifying his e-mail address. When the shareholders’ meeting cannot deliberate due to the lack of required quorum, the second meeting must be called at least ten calendar days in advance in the same manner as used for the first notice. The convening notice shall specify the name, acronym, legal form, share capital, registered office address and registration number with the French Trade and Companies Register (Registre du commerce et des sociétés) of the company and the place, date, hour, agenda and nature (ordinary or extraordinary) of the meeting.
This notice must also indicate the conditions under which the shareholders may vote by correspondence and the places and conditions in which they can obtain voting forms by mail and, as the case may be, the email address to which they may send written questions.
|
| |
Under Delaware law, unless otherwise provided in the certificate of incorporation or by-laws, written notice of any meeting of the stockholders generally must be given to each stockholder entitled to vote at the meeting not less than 10 nor more than 60 days before the date of the meeting and shall specify the place, date, hour, and (in the case of a special meeting of stockholders) purpose or purposes of the meeting.
|
||||||
|
| |
|
| |
|
| |
|
| |
|
Proxy
|
| |
Under French law, any shareholder may attend the meetings and vote (1) in person, or (2) by granting a proxy to any person, or (3) by sending a proxy to us without indication of the beneficiary (in which case, such proxy shall be cast in favor of the
|
| |
Under Delaware law, at any meeting of stockholders, a stockholder may designate another person to act for such stockholder by proxy, but no such proxy shall be voted or acted upon after three years from its date, unless the proxy provides for a longer period.
|
|
| |
France
|
| |
Delaware
|
||||||
|
| |
resolutions supported by the executive board), or (4) by correspondence, or by videoconference or another means of telecommunication allowing identification of the relevant shareholder in accordance with applicable laws. The proxy is only valid for a single meeting or successive meeting convened with the same agenda. It can also be granted for two meetings, one ordinary, the other extraordinary, held within a period of fifteen days.
|
| |
|
||||||
|
| |
|
| |
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| |
|
| |
|
Shareholder action by written consent
|
| |
Under French law, shareholders’ action by written consent is not permitted in a société anonyme.
|
| |
Under Delaware law, unless otherwise provided in a corporation’s certificate of incorporation, stockholders may act by written consent signed by stockholders having the minimum number of votes that would be necessary to take such action at a meeting at which all shares entitled to vote thereon were present and voted.
|
||||||
|
| |
|
| |
|
| |
|
| |
|
Preemptive Rights
|
| |
Under French law, in case of issuance of additional shares or other securities giving the right, immediately or in the future, to new shares for cash or set-off against cash debts, the existing shareholders have preferential subscription rights to these securities on a pro rata basis unless such rights are waived by a two-thirds majority of the votes cast by the shareholders present, represented by proxy or voting by mail at the extraordinary meeting deciding or authorizing the capital increase. The votes cast do not include votes attached to shares held by shareholders who did not take part in the vote, abstained or whose votes were blank or null. In case such rights are not waived by the extraordinary general meeting, each shareholder may either exercise, assign or not exercise its preferential rights. Preferential subscription rights may only be exercised during the subscription period. In accordance with French law, the exercise period shall not be less than five trading days. Thus, the preferential subscription rights are transferable during a period equivalent to the subscription period but starting two business days prior to the opening of the subscription period and ending two business days prior to the closing of the subscription period.
|
| |
Under Delaware law, unless otherwise provided in a corporation’s certificate of incorporation, a stockholders does not, by operation of law, possess preemptive rights to subscribe to additional issuances of the corporation’s stock.
|
||||||
|
| |
|
| |
|
| |
|
| |
|
Sources of Dividends
|
| |
Under French law, dividends may only be paid by a French société anonyme out of “distributable profits,” plus any distributable
|
| |
Under Delaware law, subject to any restrictions under a corporation’s certificate of incorporation, dividends may be paid by a
|
|
| |
France
|
| |
Delaware
|
| ||||||||
|
| |
reserves and “distributable premium” that the shareholders decide to make available for distribution, other than those reserves that are specifically required by law.
“Distributable profits” (bénéfices distribuables) consist of the unconsolidated net profits of the relevant corporation for each fiscal year, as increased or reduced by any profit or loss carried forward from prior years.
“Distributable premium” refers to the contribution paid by the shareholders in addition to the par value of their shares for their subscription that the shareholders decide to make available for distribution.
|
| |
Delaware corporation either out of (1) surplus or (2) in case there is no surplus, out of its net profits for the fiscal year in which the dividend is declared and/or the preceding fiscal year, except when the Delaware statutory capital is diminished by depreciation in the value of its property, or by losses, or otherwise, to an amount less than the aggregate amount of capital represented by issued and outstanding stock having a preference on the distribution of assets.
|
| ||||||||
|
| |
Except in the case of a share capital reduction, no distribution can be made to the shareholders when the net equity is, or would become, lower than the amount of the share capital plus the reserves which cannot be distributed in accordance with the law or the by-laws.
|
| |
|
| |
|
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|
|||
|
| |
|
| |
|
| |
|
| |
|
| ||
Repurchase of Shares
|
| |
Under French law, a corporation may acquire its own shares.
|
| |
Under Delaware law, a corporation may generally redeem or repurchase shares of its stock unless the Delaware statutory capital of the corporation is impaired or such redemption or repurchase would impair the capital of the corporation.
|
| ||||||||
|
| |
Such acquisition may be challenged on the ground of market abuse regulations. However, MAR provides for safe harbor exemptions when the acquisition is made for the following purposes:
|
| |||||||||||
|
| |
|
| |
|
| |
|
| |
|
| ||
|
| |
•
|
| |
to decrease its share capital, provided that such decision is not driven by losses and that a purchase offer is made to all shareholders on a pro rata basis, with the approval of the shareholders at the extraordinary general meeting deciding the capital reduction, in which case, the shares repurchased must be cancelled within one month from the expiry of the purchase offer;
|
| |
|
| |
|
| ||
|
| |
|
| |
|
| |
|
| |
|
| ||
|
| |
•
|
| |
with a view to distributing within one year of their repurchase the relevant shares to employees or managers under a profit-sharing, restricted free share or share option plan, not to exceed 10% of the share capital; in which case the shares repurchased must be distributed within 12 months from their repurchase failing which they must be cancelled; or
|
| |
|
| |
|
| ||
|
| |
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| |
|
| |
|
| |
|
|
|
| |
France
|
| |
Delaware
|
||||||
|
| |
•
|
| |
to meet obligations arising from debt securities that are exchangeable into equity instruments.
|
| |
|
| |
|
|
| |
|
| |
|
| |
|
| |
|
|
| |
A simple exemption is provided when the acquisition is made under a liquidity contract in the context of a buy-back program to be authorized by the shareholders in accordance with the provisions of Article L. 225-209 of the French Commercial Code and in accordance with AMF General Regulations.
|
| |
|
| |
|
|||
|
| |
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| |
|
| |
|
| |
|
|
| |
All other purposes, and especially share buy-backs for external growth operations by virtue of Article L. 225-209 of the French Commercial Code, while not forbidden, must be pursued in strict compliance of market manipulations and insider dealing rules.
|
| |
|
| |
|
|||
|
| |
|
| |
|
| |
|
| |
|
|
| |
Under the MAR and in accordance with the General Regulations of the AMF, a corporation shall report to the AMF, no later than by the end of the seventh daily market session following the date of the execution of the transaction, all transactions relating to the buy-back program in a detailed form and in an aggregated form. By exception, a corporation shall provide to the AMF, on a monthly basis, and to the public, on a biannual basis, a summary report of the transactions made under a liquidity contract.
|
| |
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|
|||
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|
| ||
Liability of Directors and Officers
|
| |
Under French law, by-laws may not include any provisions limiting the liability of the members of the executive and supervisory boards.
|
| |
Under Delaware law, a corporation’s certificate of incorporation may generally include a provision eliminating or limiting the personal liability of a director to the corporation and its stockholders for damages arising from a breach of fiduciary duty as a director. However, no provision can limit the liability of a director for:
|
||||||
|
| |
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| |
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| |
|
| |
|
|
| |
|
| |
|
| |
•
|
| |
any breach of the director’s duty of loyalty to the corporation or its stockholders;
|
|
| |
|
| |
|
| |
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| |
|
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| |
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|
| |
•
|
| |
acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law;
|
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| |
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| |
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| |
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|
| |
•
|
| |
intentional or negligent payment of unlawful dividends or stock purchases or redemptions; or
|
|
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|
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| |
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| |
|
| |
•
|
| |
any transaction from which the director derives an improper personal benefit.
|
|
| |
France
|
| |
Delaware
|
||||||
Voting Rights
|
| |
French law provides that, unless otherwise provided in the by-laws, each shareholder is entitled to one vote for each share of capital stock held by such shareholder. As of April 2016, double voting rights are automatically granted to the shares being registered since more than two years, unless the by-laws are modified in order to provide otherwise.
|
| |
Delaware law provides that, unless otherwise provided in the certificate of incorporation, each stockholder is entitled to one vote for each share of capital stock held by such stockholder.
|
||||||
|
| |
|
| |
|
| |
|
| |
|
Shareholder Vote on Certain Transactions
|
| |
Generally, under French law, completion of a merger or dissolution requires:
|
| |
Generally, under Delaware law, unless the certificate of incorporation provides for the vote of a larger portion of the stock or under other certain circumstances, completion of a merger, consolidation, sale, lease or exchange of all or substantially all of a corporation’s assets or dissolution requires:
|
||||||
|
|
| |
|
| |||||||
|
•
|
| |
the approval of the executive board; and
|
| |||||||
|
|
| |
|
| |||||||
|
•
|
| |
the approval by a two-thirds majority of the votes cast by the shareholders present, represented by proxy or voting by mail at the relevant meeting, or in the case of a merger with a non-EU company, approval of all the shareholders of the corporation.
|
| |||||||
|
| |
|
| |
|
| |
|
|||
|
| |
|
| |
•
|
| |
the approval of the board of directors; and
|
|||
|
| |
|
| |
|
| |
|
|||
|
| |
|
| |
•
|
| |
approval by the vote of the holders of a majority of the outstanding stock or, if the certificate of incorporation provides for more or less than one vote per share, a majority of the votes of the outstanding stock of a corporation entitled to vote on the matter.
|
|||
|
| |
|
| |
|
| |
|
| |
|
Dissent or Dissenters’ Appraisal Rights
|
| |
French law does not provide for any such right but provides that a merger is subject to shareholders’ approval by a two-thirds majority vote as stated above.
|
| |
Under Delaware law, a holder of shares of any class or series has the right, in specified circumstances, to dissent from a merger or consolidation by demanding payment in cash for the stockholder’s shares equal to the fair value of those shares, as determined by the Delaware Court of Chancery in an action timely brought by the corporation or a dissenting stockholder. Unless otherwise provided in the certificate of incorporation, Delaware law grants these appraisal rights only in the case of mergers or consolidations and not in the case of a sale or transfer of assets or a purchase of assets for stock. Further, no appraisal rights are available for shares of any class or series that is listed on a national securities exchange or held of record by more than 2,000 stockholders, unless the agreement of merger or consolidation requires the holders to accept for their shares anything other than:
|
||||||
|
| |
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| |
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| |
|
| |
•
|
| |
shares of stock of the surviving corporation
|
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| |
|
| |
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| |
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| |
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| |
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| |
|
| |
•
|
| |
shares of stock of another corporation that are either listed on a national securities exchange or held of record by more than 2,000 stockholders;
|
|
| |
France
|
| |
Delaware
|
||||||
|
| |
|
| |
|
| |
belong only to the stockholder to challenge directors’ conduct.
|
|||
|
| |
|
| |
|
| |
|
| |
|
Amendment of Certificate of Incorporation
|
| |
Unlike companies incorporated under Delaware law, the organizational documents of which comprise both a certificate of incorporation and by-laws, companies incorporated under French law only have by-laws (statuts) as organizational documents. As indicated in the paragraph below, only the extraordinary shareholders’ meeting is authorized to adopt or amend the by-laws under French law.
|
| |
Under Delaware law, generally a corporation may amend its certificate of incorporation if:
|
||||||
|
|
| |
|
||||||||
|
•
|
| |
its board of directors has adopted a resolution setting forth the amendment proposed and declared its advisability, and
|
||||||||
|
|
| |
|
||||||||
|
•
|
| |
the amendment is adopted by the affirmative votes of a majority (or greater percentage as may be specified by the corporation) of the voting power of the outstanding shares entitled to vote on the amendment and a majority (or greater percentage as may be specified by the corporation) of the voting power of the outstanding shares of each class or series of stock, if any, entitled to vote on the amendment as a class or series.
|
||||||||
|
| |
|
| |
|
| |
|
| |
|
Amendment of By-laws
|
| |
Under French law, only the extraordinary shareholders’ meeting is authorized to adopt or amend the by-laws. The extraordinary shareholders' meeting may authorize the supervisory board to amend the by-laws to comply with legal provisions, subject to the ratification of such amendments by the next extraordinary shareholders’ meeting.
|
| |
Under Delaware law, the stockholders entitled to vote have the power to adopt, amend or repeal by-laws. A corporation may also confer, in its certificate of incorporation, that power upon the board of directors.
|
⯀
|
we do not timely request that the rights be distributed to you or we request that the rights not be distributed to you; or
|
⯀
|
we fail to deliver satisfactory documents to the depositary; or
|
⯀
|
it is not reasonably practicable to distribute the rights.
|
⯀
|
we do not request that the property be distributed to you or if we ask that the property not be distributed to you; or
|
⯀
|
we do not deliver satisfactory documents to the depositary bank; or
|
⯀
|
the depositary determines that all or a portion of the distribution to you is not reasonably practicable.
|
⯀
|
The ordinary shares are duly authorized, validly issued, fully paid, non-assessable and legally obtained.
|
⯀
|
All preemptive (and similar) rights, if any, with respect to such ordinary shares have been validly waived or exercised.
|
⯀
|
You are duly authorized to deposit the ordinary shares.
|
⯀
|
The ordinary shares presented for deposit are free and clear of any lien, encumbrance, security interest, charge, mortgage or adverse claim, and are not, and the ADSs issuable upon such deposit will not be, “restricted securities” (as defined in the deposit agreement).
|
⯀
|
The ordinary shares presented for deposit have not been stripped of any rights or entitlements.
|
⯀
|
ensure that the surrendered ADR is properly endorsed or otherwise in proper form for transfer;
|
⯀
|
provide such proof of identity and genuineness of signatures as the depositary deems appropriate;
|
⯀
|
provide any transfer stamps required by the State of New York or the United States; and
|
⯀
|
pay all applicable fees, charges, expenses, taxes and other government charges payable by ADR holders pursuant to the terms of the deposit agreement, upon the transfer of ADRs.
|
⯀
|
temporary delays that may arise because (1) the transfer books for the ordinary shares or ADSs are closed, or (2) ordinary shares are immobilized on account of a shareholders’ meeting or a payment of dividends;
|
⯀
|
obligations to pay fees, taxes and similar charges; or
|
⯀
|
restrictions imposed because of laws or regulations applicable to ADSs or the withdrawal of securities on deposit.
|
Service
|
| |
Fees
|
|||
•
|
| |
Issuance of ADSs (e.g., an issuance of ADS(s) upon a deposit of ordinary shares, upon a change in the ADS(s)-to-ordinary shares ratio, or for any other reason), excluding ADS issuances as a result of distributions of ordinary shares pursuant to stock dividends or other free stock distributions or to the exercise of rights to purchase additional ADSs
|
| |
Up to U.S. 5¢ per ADS issued
|
|
| |
|
| |
|
•
|
| |
Cancellation of ADSs (e.g., a cancellation of ADSs for delivery of deposited ordinary shares, upon a change in the ADS(s)-to-ordinary share ratio, or for any other reason)
|
| |
Up to U.S. 5¢ per ADS cancelled
|
Service
|
| |
Fees
|
|||
•
|
| |
Distribution of cash dividends or other cash distributions (e.g., upon a sale of rights and other entitlements)
|
| |
Up to U.S. 5¢ per ADS held
|
|
| |
|
| |
|
•
|
| |
Distribution of ADSs pursuant to (i) stock dividends or other free stock distributions, or (ii) exercise of rights to purchase additional ADSs
|
| |
Up to U.S. 5¢ per ADS held
|
|
| |
|
| |
|
•
|
| |
Distribution of securities other than ADSs or rights to purchase additional ADSs (e.g., upon a spin-off)
|
| |
Up to U.S. 5¢ per ADS held
|
|
| |
|
| |
|
•
|
| |
ADS Services
|
| |
Up to U.S. 5¢ per ADS held on the applicable record date(s) established by the depositary bank
|
|
| |
|
| |
|
•
|
| |
Registration of ADS Transfers (e.g., upon a registration of the transfer of registered ownership of ADSs, upon a transfer of ADSs into DTC and vice versa, or for any other reason)
|
| |
Up to U.S. 5¢ per ADS transferred
|
|
| |
|
| |
|
•
|
| |
Conversion of ADSs of one series for ADSs of another series (e.g., upon conversion of Partial Entitlement ADSs for Full Entitlement ADSs, or upon conversion of Restricted ADSs into freely transferable ADSs, and vice versa)
|
| |
Up to U.S. 5¢ per ADS converted
|
|
| |
|
| |
|
⯀
|
taxes (including applicable interest and penalties) and other governmental charges;
|
⯀
|
the registration fees as may from time to time be in effect for the registration of ordinary shares on the share register and applicable to transfers of ordinary shares to or from the name of the custodian, the depositary or any nominees upon the making of deposits and withdrawals, respectively;
|
⯀
|
certain cable, telex and facsimile transmission and delivery expenses;
|
⯀
|
the fees, expenses, spreads, taxes and other charges of the depositary and/or conversion service providers in connection with the conversion of foreign currency, such fees, expenses, spreads, taxes, and other charges to be deducted from the foreign currency;
|
⯀
|
any reasonable and customary out-of-pocket expenses incurred in such conversion and/or on behalf of holders and beneficial owners of ADSs in complying with currency exchange control or other governmental requirements; and
|
⯀
|
the fees, costs and expenses incurred by the depositary, the custodian, or any nominee in connection with the servicing or delivery of deposited property.
|
⯀
|
We and the depositary are obligated only to take the actions specifically stated in the deposit agreement without negligence or bad faith.
|
⯀
|
The depositary disclaims any liability for any failure to carry out voting instructions, for any manner in which a vote is cast or for the effect of any vote, provided it acts in good faith and in accordance with the terms of the deposit agreement.
|
⯀
|
The depositary disclaims any liability for any failure to determine the lawfulness or practicality of any action, for the content of any document forwarded to you on our behalf or for the accuracy of any translation of such a document, for the investment risks associated with investing in ordinary shares, for the validity or worth of the ordinary shares, for the market value of any ordinary shares or the market value of any distribution on any ordinary shares, for any interest on ordinary shares (other than interest actually received by the depositary), for any tax consequences that result from the ownership of ADSs, for the credit-worthiness of any third party, for allowing any rights to lapse under the terms of the deposit agreement, for the timeliness of any of our notices or for our failure to give notice.
|
⯀
|
We and the depositary will not be obligated to perform any act that is inconsistent with the terms of the deposit agreement.
|
⯀
|
We and the depositary disclaim any liability if we, the custodian or the depositary are prevented or forbidden from or subject to any civil or criminal penalty or restraint on account of, or delayed in, doing or performing any act or thing required by the terms of the deposit agreement, by reason of any provision, present or future of any law or regulation, or by reason of present or future provision of any provision of our By-laws, or any provision of or governing the securities on deposit, or by reason of any act of God or war or other circumstances beyond our control.
|
⯀
|
We and the depositary disclaim any liability by reason of any exercise of, or failure to exercise, any discretion provided for in the deposit agreement or in our By-laws or in any provisions of or governing the securities on deposit.
|
⯀
|
We and the depositary further disclaim any liability for any action or inaction in reliance on the advice or information received from legal counsel, accountants, any person presenting ordinary shares for deposit, any holder of ADSs or authorized representatives thereof, or any other person believed by either of us in good faith to be competent to give such advice or information.
|
⯀
|
We and the depositary also disclaim liability for the inability by a holder to benefit from any distribution, offering, right or other benefit that is made available to holders of ordinary shares but is not, under the terms of the deposit agreement, made available to you.
|
⯀
|
We and the depositary may rely without any liability upon any written notice, request or other document believed to be genuine and to have been signed or presented by the proper parties.
|
⯀
|
We and the depositary also disclaim liability for any action or inaction of any clearing or settlement system (and any participant of such system) for the ordinary shares or the ADSs.
|
⯀
|
We and the depositary also disclaim liability for any consequential or punitive damages for any breach of the terms of the deposit agreement.
|
⯀
|
Nothing in the deposit agreement gives rise to a partnership or joint venture, or establishes a fiduciary relationship, among us, the depositary bank and you as ADS holder.
|
⯀
|
Nothing in the deposit agreement precludes Citibank (or its affiliates) from engaging in transactions in which parties adverse to us or the ADS owners have interests, and nothing in the deposit agreement obligates Citibank to disclose those transactions, or any information obtained in the course of those transactions, to us or to the ADS owners, or to account for any payment received as part of those transactions.
|
⯀
|
convert the foreign currency to the extent practical and lawful and distribute the U.S. dollars to the holders for whom the conversion and distribution is lawful and practical;
|
⯀
|
distribute the foreign currency to holders for whom the distribution is lawful and practical; and
|
⯀
|
hold the foreign currency (without liability for interest) for the applicable holders.
|
⯀
|
approximately ordinary shares (including ordinary shares in the form of ADSs) will be eligible for immediate sale on the date of this prospectus; and
|
⯀
|
approximately 835,113 ordinary shares (including ordinary shares in the form of ADSs) will be eligible for sale upon the expiration of the lock-up and market stand-off agreements 90 days after the date of this prospectus, provided that shares held by our affiliates will remain subject to volume, manner of sale, and other resale limitations set forth in Rule 144 and subject to French law, both as described below.
|
⯀
|
1.0% of the number of ordinary shares (including ordinary shares in the form of ADSs) then outstanding, which will equal approximately ordinary shares immediately after the completion of the offering based on the number of ordinary shares (including ordinary shares in the form of ADSs) outstanding as of June 30, 2020 and assuming no issuance by us of additional ordinary shares (including in the form of ADSs) pursuant to the exercise of the underwriters’ option; and
|
⯀
|
the average weekly trading volume of the ADSs on the Nasdaq Global Market during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale;
|
⯀
|
a broker;
|
⯀
|
a dealer in securities, commodities or foreign currencies;
|
⯀
|
a trader in securities that elects to use a mark-to-market method of accounting for its securities holdings;
|
⯀
|
a bank or other financial institution;
|
⯀
|
a tax-exempt organization or governmental organization;
|
⯀
|
an insurance company;
|
⯀
|
a regulated investment company or real estate investment trust;
|
⯀
|
a U.S. expatriate, former U.S. citizen or former long term resident of the United States;
|
⯀
|
a mutual fund;
|
⯀
|
an individual retirement or other tax-deferred account;
|
⯀
|
a holder liable for alternative minimum tax;
|
⯀
|
a holder that actually or constructively owns 10% or more, by voting power or value, of our stock (including stock represented by ADSs);
|
⯀
|
a partnership or other pass-through entity for U.S. federal income tax purposes;
|
⯀
|
a holder that holds ADSs as part of a straddle, hedging, constructive sale, conversion or other integrated transaction for U.S. federal income tax purposes; or
|
⯀
|
a U.S. holder (as defined below) whose functional currency is not the U.S. dollar.
|
⯀
|
a citizen or resident of the United States;
|
⯀
|
a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) created or organized under the laws of the United States, any state thereof, or the District of Columbia;
|
⯀
|
an estate whose income is subject to U.S. federal income tax regardless of its source; or
|
⯀
|
a trust if (1) a U.S. court can exercise primary supervision over the trust’s administration and one or more U.S. persons are authorized to control all substantial decisions of the trust or (2) has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person for U.S. federal income tax purposes.
|
⯀
|
the gain is “effectively connected” with your conduct of a trade or business in the United States, and the gain is attributable to a permanent establishment (or in the case of an individual, a fixed place of business) that you maintain in the United States if that is required by an applicable income tax treaty as a condition for subjecting you to U.S. taxation on a net income basis; or
|
⯀
|
you are an individual, you are present in the United States for 183 or more days in the taxable year of such sale, exchange or other disposition and certain other conditions are met.
|
⯀
|
such holder establishes before the date of payment that it is a U.S. resident under the Treaty by completing and providing the depositary with treaty forms (Forms 5000 and 5001); or
|
⯀
|
the depositary or other financial institution managing the U.S. Holder’s securities account in the U.S. provides the French paying agent, which will complete Forms 5000 and 5001 (as described above), with a document listing certain information about the U.S. Holder and its ADSs and a certificate whereby the financial institution managing the U.S. Holder’s securities account in the U.S. takes full responsibility for the accuracy of the information provided in the document.
|
⯀
|
to obtain jurisdiction over us or our executive board members and supervisory board members in U.S. courts in actions predicated on the civil liability provisions of the U.S. federal securities laws;
|
⯀
|
to enforce in U.S. courts judgments obtained in such actions against us or our executive board members and supervisory board members;
|
⯀
|
to bring an original action in a French court to enforce liabilities based upon the U.S. federal securities laws against us or our executive board members or our supervisory board members; and/or
|
⯀
|
to enforce against us or our executive board members and supervisory board members in non-U.S. courts, including French courts, judgments of U.S. courts predicated upon the civil liability provisions of the U.S. federal securities laws.
|
UNDERWRITER
|
| |
NUMBER OF ADSs
|
| |
NUMBER OF
ORDINARY SHARES
|
Jefferies LLC
|
| |
|
| |
|
Evercore Group, L.L.C.
|
| |
|
| |
|
UBS Securities LLC
|
| |
|
| |
|
Gilbert Dupont
|
| |
|
| |
|
Total
|
| |
|
| |
|
|
| |
PER ADS
|
| |
PER ORDINARY SHARE
|
| |
TOTAL
|
|||||||||
|
| |
WITHOUT
OPTION TO
PURCHASE
ADDITIONAL
ADSs
|
| |
WITH
OPTION TO
PURCHASE
ADDITIONAL
ADSs
|
| |
WITHOUT
OPTION TO
PURCHASE
ADDITIONAL
ORDINARY
SHARES
|
| |
WITH OPTION
TO PURCHASE
ADDITIONAL
ORDINARY
SHARES
|
| |
WITHOUT
OPTION TO
PURCHASE
ADDITIONAL
ADSs AND/OR
ORDINARY
SHARES
|
| |
WITH OPTION
TO PURCHASE
ADDITIONAL
ADSs AND/OR
ORDINARY
SHARES
|
Offering price
|
| |
$
|
| |
$
|
| |
€
|
| |
€
|
| |
$
|
| |
$
|
Underwriting commissions
|
| |
$
|
| |
$
|
| |
€
|
| |
€
|
| |
$
|
| |
$
|
Proceeds to us, before expenses
|
| |
$
|
| |
$
|
| |
€
|
| |
€
|
| |
$
|
| |
$
|
⯀
|
sell, offer, contract or grant any option to sell (including any short sale), pledge, transfer, establish an open “put equivalent position” within the meaning of Rule 16a-l(h) under the Exchange Act;
|
⯀
|
otherwise dispose of any share capital, options or warrants to acquire share capital, or securities exchangeable or exercisable for or convertible into share capital currently or hereafter owned either of record or beneficially; or
|
⯀
|
publicly announce an intention to do any of the foregoing.
|
⯀
|
the purchaser is entitled under applicable provincial securities laws to purchase the securities without the benefit of a prospectus qualified under those securities laws as it is an “accredited investor” as defined under National Instrument 45-106—Prospectus Exemptions,
|
⯀
|
the purchaser is a “permitted client” as defined in National Instrument 31-103—Registration Requirements, Exemptions and Ongoing Registrant Obligations,
|
⯀
|
where required by law, the purchaser is purchasing as principal and not as agent, and
|
⯀
|
the purchaser has reviewed the text above under Resale Restrictions.
|
⯀
|
a “sophisticated investor” under section 708(8)(a) or (b) of the Corporations Act;
|
⯀
|
a “sophisticated investor” under section 708(8)(c) or (d) of the Corporations Act and that you have provided an accountant’s certificate to the company which complies with the requirements of section 708(8)(c)(i) or (ii) of the Corporations Act and related regulations before the offer has been made;
|
⯀
|
a person associated with us under section 708(12) of the Corporations Act; or
|
⯀
|
a “professional investor” within the meaning of section 708(11)(a) or (b) of the Corporations Act.
|
⯀
|
to any legal entity which is a “qualified investor” within the meaning of Article 2(e) of the Prospectus Regulation;
|
⯀
|
to fewer than 150 natural or legal persons per State (other than qualified investors as defined in the Prospectus Regulation), subject to obtaining the prior consent of the underwriters for any such offer; or
|
⯀
|
in any other circumstances falling within Article 1(4) of the Prospectus Regulation,
|
−
|
neither this prospectus nor any other offering materials relating to the ordinary shares in the form of ADSs described in this prospectus has been submitted for clearance to the French financial markets authority (Autorité des marchés financiers);
|
−
|
neither this prospectus, nor any offering material relating to the ordinary shares in the form of ADSs has been or will be released, issued, distributed or caused to be released, issued or distributed to the public in France or used in connection with any offer for subscription or sale of the ordinary shares in the form of ADSs to the public in France within the meaning of article L. 411-1 of the French Code monétaire et financier (other than public offerings defined in Article L. 411-2 1 of the French Code monétaire et financier);
|
−
|
individuals or entities referred to in article L. 411-2 1 of the French Code monétaire et financier may participate in the global offering, as provided under articles D.411-4, D.744-1, D.754-1 and D.764-1 of the French Code monétaire et financier; and
|
−
|
the direct and indirect distribution or sale to the public of the ordinary shares in the form of ADSs acquired by them may only be made in compliance with articles L. 411-1, L. 411-2 1°, L. 412-1 and L. 621-8 to L. 621-8-3 of the French Code monétaire et financier.
|
⯀
|
a corporation (which is not an accredited investor as defined in Section 4A of the SFA) the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor, or
|
⯀
|
a trust (where the trustee is not an accredited investor) whose sole purpose is to hold investments and each beneficiary of the trust is an individual who is an accredited investor,
|
⯀
|
to an institutional investor or to a relevant person defined in Section 275(2) of the SFA, or to any person arising from an offer referred to in Section 275(1A) or Section 276(4)(i)(B) of the SFA;
|
⯀
|
where no consideration is or will be given for the transfer;
|
⯀
|
where the transfer is by operation of law;
|
⯀
|
as specified in Section 276(7) of the SFA; or
|
⯀
|
as specified in Regulation 32 of the Securities and Futures (Offers of Investments) (Shares and Debentures) Regulations 2005 of Singapore.
|
(a)
|
it has only communicated or caused to be communicated and will only communicate or cause to be communicated an invitation or inducement to engage in investment activity (within the meaning of Section 21 of the Financial Services and Markets Act 2000 (the “FSMA”)) received by it in connection with the issue or sale of the ordinary shares (including ordinary shares in the form of ADSs) in circumstances in which Section 21(1) of the FSMA does not apply to us; and
|
(b)
|
it has complied and will comply with all applicable provisions of the FSMA with respect to anything done by it in relation to the ordinary shares (including ordinary shares in the form of ADSs), from or otherwise involving the United Kingdom.
|
Itemized Expenses
|
| |
Amount
|
SEC registration fee
|
| |
$6,546
|
Nasdaq initial listing fee
|
| |
150,000
|
FINRA filing fee
|
| |
9,500
|
Printing expenses
|
| |
150,000
|
Legal fees and expenses
|
| |
2,900,000
|
Accounting fees and expenses
|
| |
1,400,000
|
Miscellaneous fees and expenses
|
| |
383,954
|
Total
|
| |
$5,000,000
|
|
| |
|
| |
As of
|
|||
|
| |
Notes
|
| |
June 30,
2020
|
| |
December 31,
2019
|
ASSETS
|
| |
|
| |
|
| |
|
Non-current assets
|
| |
|
| |
|
| |
|
Intangible assets
|
| |
5
|
| |
73
|
| |
163
|
Property, plant and equipment
|
| |
6
|
| |
8,961
|
| |
9,386
|
Other non-current financial assets
|
| |
7
|
| |
465
|
| |
529
|
Total non-current assets
|
| |
|
| |
9,499
|
| |
10,078
|
Current assets
|
| |
|
| |
|
| |
|
Trade receivables
|
| |
8.1
|
| |
51
|
| |
11
|
Other current assets
|
| |
8.2
|
| |
8,626
|
| |
11,022
|
Cash and cash equivalents
|
| |
9
|
| |
26,590
|
| |
35,094
|
Total current assets
|
| |
|
| |
35,266
|
| |
46,127
|
TOTAL ASSETS
|
| |
|
| |
44,765
|
| |
56,205
|
|
| |
|
| |
|
| |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
| |
|
| |
|
| |
|
Shareholders’ equity
|
| |
|
| |
|
| |
|
Share capital
|
| |
10.1
|
| |
682
|
| |
672
|
Premiums related to share capital
|
| |
10.1
|
| |
151,968
|
| |
153,139
|
Accumulated other comprehensive income
|
| |
|
| |
428
|
| |
433
|
Treasury shares
|
| |
|
| |
(243)
|
| |
(169)
|
Reserve
|
| |
|
| |
(154,451)
|
| |
(105,069)
|
Net loss for the period
|
| |
|
| |
(20,579)
|
| |
(50,915)
|
Total shareholders’ equity
|
| |
|
| |
(22,194)
|
| |
(1,908)
|
Non-current liabilities
|
| |
|
| |
|
| |
|
Non-current provisions
|
| |
11.2
|
| |
371
|
| |
331
|
Non-current financial liabilities
|
| |
12
|
| |
49,448
|
| |
43,435
|
Total non-current liabilities
|
| |
|
| |
49,819
|
| |
43,766
|
Current liabilities
|
| |
|
| |
|
| |
|
Current provisions
|
| |
11.1
|
| |
—
|
| |
164
|
Current financial liabilities
|
| |
12
|
| |
2,391
|
| |
1,091
|
Trade payables and other payables
|
| |
13.1
|
| |
8,868
|
| |
7,770
|
Other current liabilities
|
| |
13.2
|
| |
5,881
|
| |
5,322
|
Total current liabilities
|
| |
|
| |
17,140
|
| |
14,347
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
|
| |
|
| |
44,765
|
| |
56,205
|
|
| |
|
| |
For the six months ended June 30,
|
|||
|
| |
Notes
|
| |
2020
|
| |
2019
|
Revenues and other income
|
| |
|
| |
|
| |
|
Revenues
|
| |
15
|
| |
37
|
| |
37
|
Other income
|
| |
15
|
| |
1,411
|
| |
1,786
|
Total revenues and other income
|
| |
|
| |
1,448
|
| |
1,823
|
Operating expenses
|
| |
|
| |
|
| |
|
Research and development expenses
|
| |
16.1
|
| |
(13,077)
|
| |
(13,380)
|
Selling, general and administrative expenses
|
| |
16.2
|
| |
(6,755)
|
| |
(8,910)
|
Total operating expenses
|
| |
|
| |
(19,832)
|
| |
(22,290)
|
Operating income (loss)
|
| |
|
| |
(18,384)
|
| |
(20,467)
|
Financial income
|
| |
18
|
| |
234
|
| |
724
|
Financial expenses
|
| |
18
|
| |
(2,428)
|
| |
(4,176)
|
Financial income (loss)
|
| |
|
| |
(2,194)
|
| |
(3,452)
|
Income tax
|
| |
|
| |
(1)
|
| |
—
|
Net loss for the period
|
| |
|
| |
(20,579)
|
| |
(23,920)
|
Basic loss per share (euros/share)
|
| |
20
|
| |
(0.91)
|
| |
(1.15)
|
Diluted loss per share (euros/share)
|
| |
20
|
| |
(0.91)
|
| |
(1.15)
|
|
| |
For the six months ended June 30,
|
|||
|
| |
2020
|
| |
2019
|
Net loss for the period
|
| |
(20,579)
|
| |
(23,920)
|
Actuarial gains and losses on retirement benefit obligations (IAS 19)
|
| |
—
|
| |
64
|
Tax impact
|
| |
—
|
| |
—
|
Other comprehensive loss that will not be reclassified subsequently to income or loss
|
| |
—
|
| |
64
|
Currency translation adjustment
|
| |
(5)
|
| |
(12)
|
Tax impact
|
| |
—
|
| |
—
|
Other comprehensive income that may be reclassified subsequently to income or loss
|
| |
(5)
|
| |
(12)
|
Total comprehensive loss
|
| |
(20,584)
|
| |
(23,869)
|
|
| |
|
| |
Share capital
Ordinary shares
|
| |
Premiums
related to
share
capital
|
| |
Accumulated
other
comprehensive
income
(loss)
|
| |
Treasury
shares
|
| |
Reserve
|
| |
Net loss
for the
period
|
| |
Total
shareholders’
equity
|
|||
|
| |
Notes
|
| |
Number
of shares
|
| |
Amount
|
| |||||||||||||||||
As of December 31, 2018
|
| |
|
| |
19,633,373
|
| |
589
|
| |
122,799
|
| |
381
|
| |
(124)
|
| |
(79,057)
|
| |
(30,345)
|
| |
14,243
|
Net loss for the period
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(23,920)
|
| |
(23,920)
|
Currency translation adjustments
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
(12)
|
| |
—
|
| |
—
|
| |
—
|
| |
(12)
|
Actuarial gains and losses (IAS 19)
|
| |
11.2
|
| |
—
|
| |
—
|
| |
—
|
| |
64
|
| |
—
|
| |
—
|
| |
—
|
| |
64
|
Total comprehensive loss
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
52
|
| |
—
|
| |
—
|
| |
(23,920)
|
| |
(23,868)
|
Allocation of prior period loss
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(30,345)
|
| |
30,345
|
| |
—
|
Capital increase
|
| |
|
| |
2,566,666
|
| |
77
|
| |
28,002
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
28,079
|
Subscription and exercise of founders’ warrants and warrants
|
| |
10.3
|
| |
160,000
|
| |
5
|
| |
963
|
| |
—
|
| |
—
|
| |
13
|
| |
—
|
| |
981
|
Share based payment
|
| |
17
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
1,716
|
| |
—
|
| |
1,716
|
Treasury shares
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
6
|
| |
—
|
| |
—
|
| |
6
|
U.S. Initial public offering costs offset
|
| |
|
| |
—
|
| |
—
|
| |
(423)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(423)
|
As of June 30, 2019
|
| |
|
| |
22,360,039
|
| |
671
|
| |
151,341
|
| |
433
|
| |
(118)
|
| |
(107,672)
|
| |
(23,920)
|
| |
20,734
|
|
| |
|
| |
Share capital
Ordinary shares
|
| |
Premiums
related to
share
capital
|
| |
Accumulated
other
comprehensive
income
(loss)
|
| |
Treasury
shares
|
| |
Reserve
|
| |
Net loss
for the
period
|
| |
Total
shareholders’
equity
|
|||
|
| |
Notes
|
| |
Number
of shares
|
| |
Amount
|
| |||||||||||||||||
As of December 31, 2019
|
| |
|
| |
22,415,039
|
| |
672
|
| |
153,139
|
| |
433
|
| |
(169)
|
| |
(105,070)
|
| |
(50,915)
|
| |
(1,909)
|
Net loss for the period
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(20,579)
|
| |
(20,579)
|
Currency translation adjustments
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
(5)
|
| |
—
|
| |
—
|
| |
—
|
| |
(5)
|
Actuarial gains and losses (IAS 19)
|
| |
11.2
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Total comprehensive loss
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
(5)
|
| |
—
|
| |
—
|
| |
(20,579)
|
| |
(20,584)
|
Allocation of prior period loss
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(50,915)
|
| |
50,915
|
| |
—
|
Capital increase
|
| |
10.1
|
| |
316,083
|
| |
9
|
| |
—
|
| |
—
|
| |
—
|
| |
(9)
|
| |
—
|
| |
—
|
Subscription and exercise of founders’ warrants and warrants
|
| |
10.3
|
| |
—
|
| |
—
|
| |
5
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
5
|
Share based payment
|
| |
17
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
1,542
|
| |
—
|
| |
1,542
|
Treasury shares
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(74)
|
| |
—
|
| |
—
|
| |
(74)
|
U.S. Initial public offering costs
|
| |
10.1
|
| |
—
|
| |
—
|
| |
(1,175)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(1,175)
|
As of June 30, 2020
|
| |
|
| |
22,731,122
|
| |
682
|
| |
151,968
|
| |
428
|
| |
(243)
|
| |
(154,451)
|
| |
(20,579)
|
| |
(22,194)
|
|
| |
|
| |
For the six months ended June 30,
|
|||
|
| |
Notes
|
| |
2020
|
| |
2019
|
Cash flows used in operating activities
|
| |
|
| |
|
| |
|
Net loss for the period
|
| |
|
| |
(20,579)
|
| |
(23,920)
|
Elimination of other non-cash, non-operating income and expenses
|
| |
|
| |
|
| |
|
Depreciation and amortization
|
| |
16.4
|
| |
906
|
| |
850
|
Provisions
|
| |
|
| |
(126)
|
| |
(17)
|
Expenses related to share-based payments
|
| |
17
|
| |
1,542
|
| |
1,716
|
Cost of net debt
|
| |
|
| |
1,046
|
| |
901
|
Impact of accrued royalties and the financial liabilities discounting effect
|
| |
|
| |
1,343
|
| |
1,923
|
Other charges with no impact on treasury
|
| |
|
| |
3
|
| |
3
|
Cash flows used in operations, before tax and changes in working capital
|
| |
|
| |
(15,864)
|
| |
(18,544)
|
(Increase) / Decrease in trade receivables
|
| |
8.1
|
| |
(39)
|
| |
(37)
|
Reimbursement of research tax credit
|
| |
8.2
|
| |
3,314
|
| |
—
|
(Increase) / Decrease in other receivables
|
| |
8.2
|
| |
(918)
|
| |
(2,198)
|
Increase in trade payables
|
| |
13.1
|
| |
192
|
| |
(1,461)
|
Increase in other current liabilities
|
| |
13.2
|
| |
435
|
| |
917
|
Changes in operating working capital
|
| |
|
| |
2,985
|
| |
(2,780)
|
Net cash flows used in operating activities
|
| |
|
| |
(12,879)
|
| |
(21,324)
|
Cash flows from (used in) investing activities
|
| |
|
| |
|
| |
|
Acquisitions of intangible assets
|
| |
5
|
| |
(17)
|
| |
(259)
|
Acquisitions of property, plant and equipment
|
| |
6
|
| |
(57)
|
| |
(545)
|
Addition in non-current financial assets
|
| |
|
| |
(9)
|
| |
(5,055)
|
Net cash flows from (used in) investing activities
|
| |
|
| |
(83)
|
| |
(5,859)
|
Cash flows from financing activities
|
| |
|
| |
|
| |
|
Capital increases
|
| |
|
| |
—
|
| |
28,079
|
Warrants subscription
|
| |
10.1
|
| |
5
|
| |
981
|
Transaction costs
|
| |
10.1
|
| |
(261)
|
| |
(423)
|
Increase in loans and conditional advances
|
| |
12
|
| |
5,350
|
| |
14,000
|
Decrease in conditional advances
|
| |
12
|
| |
—
|
| |
(125)
|
Payment of lease liabilities
|
| |
12
|
| |
(171)
|
| |
(260)
|
Interest paid
|
| |
12
|
| |
(519)
|
| |
(182)
|
Net cash flows from financing activities
|
| |
|
| |
4,404
|
| |
42,070
|
Effect of exchange rates changes on cash
|
| |
|
| |
54
|
| |
22
|
Net increase (decrease) in cash and cash equivalents
|
| |
|
| |
(8,505)
|
| |
14,909
|
Net cash and cash equivalents at beginning of period
|
| |
|
| |
35,094
|
| |
36,203
|
Net cash and cash equivalents at end of period
|
| |
9
|
| |
26,590
|
| |
51,112
|
|
| |
|
| |
|
| |
|
–
|
Amendments to IAS 39, IFRS 9 and IFRS 7 related to the interest rate benchmark reform (“IBOR”);
|
–
|
Amendments to IFRS 3 - Business combinations, definition of a business; and
|
–
|
Amendments to References to the Conceptual Framework in IFRS standards, issued in March 2018 (Amendments to IAS 1 - Presentation of financial statements and IAS 8 - Accounting policies, change in accounting policies, change in accounting estimates and errors) – definition of material applicable for periods beginning after January 1, 2020.
|
–
|
IFRS 16 - Amendments for COVID-19 related rent concessions, published on May 18, 2020. No significant impact is expected on the financial statements.
|
–
|
Amendments to IAS 1 and IAS 8 – Definition of material. No impact is expected on the consolidated financial statements.
|
–
|
IFRS 17 - Insurance contracts and related amendments. No impact is expected on the consolidated financial statements.
|
3.1
|
Basis of consolidation
|
3.2
|
Use of judgement, estimates and assumptions
|
3.3
|
Specific disclosure related to interim financial statements
|
4.1
|
PharmaEngine
|
4.2
|
Financing Agreement with the European Investment Bank (“EIB”)
|
4.3
|
Collaboration Agreement with the University of Texas MD Anderson Cancer Center
|
(in thousands of euros)
|
| |
As of
December 31,
2019
|
| |
Increases
|
| |
Decreases
|
| |
Transfer
|
| |
Currency
translation
|
| |
As of
June 30,
2020
|
Patents
|
| |
65
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
65
|
Software
|
| |
584
|
| |
11
|
| |
(5)
|
| |
61
|
| |
(0)
|
| |
652
|
Other intangible assets
|
| |
61
|
| |
6
|
| |
—
|
| |
(61)
|
| |
—
|
| |
6
|
Gross book value of intangible assets
|
| |
710
|
| |
17
|
| |
(5)
|
| |
—
|
| |
(0)
|
| |
722
|
Patents
|
| |
(65)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(65)
|
Software
|
| |
(483)
|
| |
(106)
|
| |
5
|
| |
—
|
| |
—
|
| |
(584)
|
Accumulated depreciation of intangible assets(1)
|
| |
(548)
|
| |
(106)
|
| |
5
|
| |
—
|
| |
—
|
| |
(649)
|
Net book value of intangible assets
|
| |
163
|
| |
(89)
|
| |
—
|
| |
—
|
| |
(0)
|
| |
73
|
(1)
|
Expenses for the period are detailed in Note 16.4 Depreciation, amortization and provisions expenses
|
(in thousands of euros)
|
| |
As of
December 31,
2019
|
| |
Increases
|
| |
Decreases
|
| |
Transfer of
assets in
progress
|
| |
Currency
translation
|
| |
As of
June 30,
2020
|
Fixtures, fittings and installations
|
| |
3,297
|
| |
11
|
| |
—
|
| |
—
|
| |
—
|
| |
3,307
|
Right of use – Buildings
|
| |
6,765
|
| |
310
|
| |
—
|
| |
—
|
| |
—
|
| |
7,076
|
Technical equipment
|
| |
2,019
|
| |
16
|
| |
—
|
| |
—
|
| |
—
|
| |
2,035
|
Office and IT equipment
|
| |
957
|
| |
25
|
| |
—
|
| |
—
|
| |
—
|
| |
981
|
Transport equipment
|
| |
34
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
34
|
Right of use – Transport equipment
|
| |
115
|
| |
—
|
| |
—
|
| |
(5)
|
| |
—
|
| |
111
|
Tangible assets in progress
|
| |
11
|
| |
6
|
| |
—
|
| |
(11)
|
| |
—
|
| |
6
|
Gross book value of tangible assets
|
| |
13,197
|
| |
367
|
| |
—
|
| |
(15)
|
| |
—
|
| |
13,550
|
Fixtures, fittings and installations
|
| |
(1,001)
|
| |
(160)
|
| |
—
|
| |
—
|
| |
—
|
| |
(1,160)
|
Right of use – Buildings
|
| |
(829)
|
| |
(444)
|
| |
—
|
| |
—
|
| |
—
|
| |
(1,273)
|
Technical equipment
|
| |
(1,272)
|
| |
(96)
|
| |
—
|
| |
—
|
| |
—
|
| |
(1,368)
|
Office and IT equipment
|
| |
(629)
|
| |
(82)
|
| |
—
|
| |
—
|
| |
—
|
| |
(711)
|
Transport equipment
|
| |
(34)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(34)
|
Right of use – Transport equipment
|
| |
(45)
|
| |
(18)
|
| |
—
|
| |
22
|
| |
—
|
| |
(42)
|
Accumulated depreciation of tangible assets(1)
|
| |
(3,811)
|
| |
(800)
|
| |
—
|
| |
22
|
| |
—
|
| |
(4,589)
|
Net book value of tangible assets
|
| |
9,386
|
| |
(433)
|
| |
—
|
| |
6
|
| |
—
|
| |
8,961
|
(1)
|
Expenses for the period are detailed in Note 16.4 Depreciation, amortization and provisions expenses
|
(in thousands of euros)
|
| |
Liquidity
contract - Cash
account(1)
|
| |
Security
deposits paid
|
| |
Total
|
Net book value as of December 31, 2018
|
| |
176
|
| |
383
|
| |
558
|
Additions
|
| |
—
|
| |
65
|
| |
65
|
Decreases
|
| |
(45)
|
| |
(49)
|
| |
(94)
|
Net book value as of December 31, 2019
|
| |
131
|
| |
399
|
| |
529
|
Additions
|
| |
—
|
| |
9
|
| |
9
|
Decreases
|
| |
(74)
|
| |
—
|
| |
(74)
|
Net book value as of June 30, 2020
|
| |
58
|
| |
408
|
| |
465
|
(1)
|
See Note 10.2 Treasury shares
|
8.1
|
Trade receivables
|
(in thousands of euros)
|
| |
As of
June 30,
2020
|
| |
As of
December 31,
2019
|
Trade receivables
|
| |
51
|
| |
11
|
Trade and other receivables
|
| |
51
|
| |
11
|
8.2
|
Other current assets
|
(in thousands of euros)
|
| |
As of
June 30,
2020
|
| |
As of
December 31,
2019
|
Research tax credit receivable
|
| |
3,262
|
| |
5,688
|
VAT receivable
|
| |
906
|
| |
1,419
|
Prepaid expenses
|
| |
3,088
|
| |
2,671
|
Other receivables
|
| |
1,370
|
| |
1,245
|
Other current assets
|
| |
8,626
|
| |
11,022
|
(1)
|
See Note 15 – Revenue and other income
|
(in thousands of euros)
|
| |
As of
June 30,
2020
|
| |
As of
December 31,
2019
|
Short-term bank deposits
|
| |
9,500
|
| |
10,000
|
Cash and bank accounts
|
| |
17,090
|
| |
25,094
|
Net cash and cash equivalents
|
| |
26,590
|
| |
35,094
|
10.1
|
Capital issued
|
(in thousands or number of shares)
Date
|
| |
Nature of transaction
|
| |
Share
Capital
|
| |
Premiums
related to
share capital
|
| |
Number of
shares
|
January 1, 2020
|
| |
|
| |
672
|
| |
153,139
|
| |
22,415,039
|
March 6, 2020
|
| |
Capital increase
|
| |
9
|
| |
—
|
| |
316,083
|
June 24, 2020
|
| |
Subscription of 2020 warrants
|
| |
—
|
| |
1
|
| |
—
|
June 26, 2020
|
| |
Subscription of 2020 warrants
|
| |
—
|
| |
1
|
| |
—
|
June 29, 2020
|
| |
Subscription of 2020 warrants
|
| |
—
|
| |
2
|
| |
—
|
June 30, 2020
|
| |
Subscription of 2020 warrants
|
| |
—
|
| |
1
|
| |
—
|
June 30, 2020
|
| |
U.S. Initial Public Offering costs
|
| |
—
|
| |
(1,175)
|
| |
—
|
June 30, 2020
|
| |
|
| |
682
|
| |
151,968
|
| |
22,731,122
|
10.2
|
Treasury shares
|
10.3
|
Founders’ warrants, warrants and stock options
|
–
|
Up to one third of the options can be exercised starting March 11, 2021; and
|
–
|
Up to another third of the options can be exercised starting March 11, 2022; and
|
–
|
The remaining third can be exercised starting March 11, 2023.
|
–
|
Up to two thirds of the options can be exercised starting March 30, 2021, and
|
–
|
The remaining third can be exercised starting March 30, 2022.
|
–
|
10% of the options can be exercised as soon as the market share price of the Company on Euronext Paris reaches €24;
|
–
|
An additional 10% of the options can be exercised as soon as the market share price of the Company on Euronext in Paris reaches €30;
|
–
|
An additional 40% of the options can be exercised as soon as the market share price of the Company on Euronext in Paris reaches €40; and
|
–
|
An additional 40% of the options can be exercised as soon as the market share price of the Company on Euronext in Paris reaches €60.
|
–
|
In the 10 years after their grant date at the latest, the options which have not been exercised by the end of this period of 10 years will be forfeited by law.
|
–
|
A two-year acquisition period starting on March 11, 2020. The holder remaining employed by the Company during the corresponding reference period is one condition for the definitive acquisition of the free shares.
|
–
|
A one-year holding period following the acquisition period of those shares.
|
(in thousands of euros)
|
| |
As of
December 31,
2019
|
| |
Increases
|
| |
Decreases
|
| |
As of
June 30,
2020
|
Lump-sum retirement benefits
|
| |
331
|
| |
40
|
| |
—
|
| |
371
|
Non-current provisions
|
| |
331
|
| |
40
|
| |
—
|
| |
371
|
Provisions for disputes
|
| |
164
|
| |
—
|
| |
(164)
|
| |
—
|
Current provisions
|
| |
164
|
| |
—
|
| |
(164)
|
| |
—
|
Total provisions
|
| |
495
|
| |
40
|
| |
(164)
|
| |
371
|
(in thousands of euros)
|
| |
As of
June 30,
2020
|
| |
As of
December 31,
2019
|
Provision as of beginning of period
|
| |
331
|
| |
337
|
Expense for the period
|
| |
40
|
| |
82
|
Actuarial gains or losses recognized in other comprehensive income
|
| |
—
|
| |
(88)
|
Provision as of end of period
|
| |
371
|
| |
331
|
|
Measurement date
|
| |
June 30, 2020
|
| |
December 31, 2019
|
|
|
Retirement assumptions
|
| |
Management: Age 66
Non-management: Age 64
|
| |
Management: Age 66
Non-management: Age 64
|
|
|
Social security contribution rate
|
| |
43%
|
| |
43%
|
|
|
Discount rate
|
| |
0.85%
|
| |
0.85%
|
|
|
Mortality tables
|
| |
Regulatory table
INSEE 2012-2014
|
| |
Regulatory table
INSEE 2012-2014
|
|
|
Salary increase rate (including inflation)
|
| |
2.5%
|
| |
2.5%
|
|
|
Staff turnover
|
| |
Constant average rate of 5.86%
|
| |
Constant average rate of 5.86%
|
|
|
Duration
|
| |
17 years
|
| |
17 years
|
|
(in thousands of euros)
|
| |
As of
June 30,
2020
|
| |
As of
December 31,
2019
|
Lease liabilities – Short term
|
| |
1,179
|
| |
591
|
Repayable advances OSEO/Bpifrance loan – Short term
|
| |
500
|
| |
500
|
State-guaranteed loan – Short term
|
| |
13
|
| |
—
|
EIB loan – Short term
|
| |
700
|
| |
—
|
Total current financial liabilities
|
| |
2,391
|
| |
1,091
|
Lease liabilities – Long term
|
| |
5,384
|
| |
5,814
|
Repayable OSEO/Bpifrance loan advances – Long term
|
| |
3,176
|
| |
2,875
|
State-guaranteed loan – Long term
|
| |
4,988
|
| |
—
|
EIB loan – Long term
|
| |
35,900
|
| |
34,746
|
Total non-current financial liabilities
|
| |
49,448
|
| |
43,435
|
Total financial liabilities
|
| |
51,839
|
| |
44,256
|
12.1
|
Conditional advance, bank loan and loans from government and public authorities
|
(in thousands of euros)
|
| |
Bpifrance
advance
|
| |
Interest-free
Bpifrance loan
|
| |
EIB loan
|
| |
Curadigm
Bpifrance
Advance
|
| |
Total
|
As of December 31, 2019
|
| |
2,165
|
| |
1,210
|
| |
34,746
|
| |
—
|
| |
38,121
|
Principal received
|
| |
—
|
| |
—
|
| |
—
|
| |
350
|
| |
350
|
Impact of discounting and accretion
|
| |
7
|
| |
0
|
| |
(1,098)
|
| |
(74)
|
| |
(1,164)
|
Accumulated fixed interest expense accrual
|
| |
16
|
| |
—
|
| |
859
|
| |
1
|
| |
875
|
Accumulated variable interest expense accrual
|
| |
—
|
| |
—
|
| |
2,440
|
| |
—
|
| |
2,440
|
Repayment
|
| |
—
|
| |
—
|
| |
(350)
|
| |
—
|
| |
(350)
|
As of June 30, 2020
|
| |
2,189
|
| |
1,211
|
| |
36,598
|
| |
277
|
| |
40,275
|
12.2
|
Bank loan
|
(in thousands of euros)
|
| |
HSBC
“PGE”(1)
|
As of December 31, 2019
|
| |
—
|
Principal received
|
| |
5,000
|
Financial expenses on liabilities
|
| |
—
|
Repayment of principal
|
| |
—
|
Accumulated fixed interest accrual(2)
|
| |
1
|
As of June 30, 2020
|
| |
5,001
|
(1)
|
“PGE” or in French “Prêts garantis par l’Etat” are state-guaranteed loans.
|
(2)
|
The fixed interest accrual refers to guarantee fee of 0.25% of the principal.
|
12.3
|
Lease liabilities
|
(in thousands of euros)
|
| |
Lease
liabilities
|
As of December 31, 2019
|
| |
6,405
|
New lease contracts
|
| |
403
|
Impact of discounting of the new lease contracts
|
| |
(74)
|
Fixed interest expense
|
| |
169
|
Repayment of lease
|
| |
(340)
|
As of June 30, 2020
|
| |
6,564
|
12.4
|
Due dates of the financial liabilities
|
|
| |
As of June 30, 2020
|
||||||||||||
(in thousands of euros)
|
| |
Less than
1 year
|
| |
Between 1 and
3 years
|
| |
Between 3 and
5 years
|
| |
More than
5 years
|
| |
Total
|
Bpifrance
|
| |
—
|
| |
300
|
| |
1,300
|
| |
808
|
| |
2,408
|
Interest-free Bpifrance loan
|
| |
500
|
| |
750
|
| |
—
|
| |
—
|
| |
1,250
|
Curadigm interest-free Bpifrance advance
|
| |
—
|
| |
50
|
| |
200
|
| |
100
|
| |
350
|
HSBC “PGE”
|
| |
13
|
| |
2,035
|
| |
2,035
|
| |
1,017
|
| |
5,099
|
EIB fixed rate loan
|
| |
700
|
| |
10,383
|
| |
26,253
|
| |
—
|
| |
37,337
|
Lease liabilities
|
| |
1,199
|
| |
2,309
|
| |
2,267
|
| |
1,951
|
| |
7,726
|
Total
|
| |
2,412
|
| |
15,827
|
| |
32,055
|
| |
3,876
|
| |
54,170
|
Note 13.
|
Trade payables and other current liabilities
|
13.1
|
Trade and other payables
|
(in thousands of euros)
|
| |
As of
June 30,
2019
|
| |
As of
December 31,
2019
|
Accrued expenses - clinical trials
|
| |
1,963
|
| |
1,620
|
Other trade payables
|
| |
6,905
|
| |
6,150
|
Total trade and other payables
|
| |
8,868
|
| |
7,770
|
13.2
|
Other current liabilities
|
(in thousands of euros)
|
| |
As of
June 30,
2020
|
| |
As of
December 31,
2019
|
Tax liabilities
|
| |
332
|
| |
216
|
Payroll tax and other payroll liabilities
|
| |
4,994
|
| |
4,912
|
Other payables
|
| |
555
|
| |
193
|
Other current liabilities
|
| |
5,881
|
| |
5,322
|
–
|
A deferred income of €178 thousand corresponding to the portion of the €350 thousand grant not incurred yet (see Note 15); and
|
–
|
An accrued income related to Nanobiotix S.A.’s advance from Bpifrance for an aggregate amount of €190 thousand, as compared with €93 thousand as of December 31, 2019.
|
Note 14.
|
Financial instruments included in the statement of financial position and impact on income
|
|
| |
As of June 30, 2020
|
|||||||||
(in thousands of euros)
|
| |
Book value on
the statement
of financial
position
|
| |
Financial assets
carried at fair
value through
profit or loss
|
| |
Assets and
liabilities
carried at
amortized cost
|
| |
Fair value
|
Non-current financial assets
|
| |
|
| |
|
| |
|
| |
|
Non-current financial assets
|
| |
465
|
| |
57
|
| |
408
|
| |
465
|
Trade receivables
|
| |
51
|
| |
—
|
| |
51
|
| |
51
|
Cash and cash equivalents
|
| |
26,590
|
| |
—
|
| |
26,590
|
| |
26,590
|
Total assets
|
| |
27,105
|
| |
57
|
| |
27,049
|
| |
27,105
|
Financial liabilities
|
| |
|
| |
|
| |
|
| |
|
Non-current financial liabilities
|
| |
49,448
|
| |
—
|
| |
49,448
|
| |
49,448(1)
|
Current financial liabilities
|
| |
2,391
|
| |
—
|
| |
2,391
|
| |
2,391
|
Trade payables and other payables
|
| |
8,868
|
| |
—
|
| |
8,868
|
| |
8,868
|
Total liabilities
|
| |
60,707
|
| |
—
|
| |
60,707
|
| |
60,707
|
(1)
|
The fair value of current and non-current liabilities include loans, repayable advances from Bpifrance, the EIB loan and the HSBC PGE loan, booked at amortized cost. They were assessed using Level 3 data, in the IFRS 13 classification for fair value.
|
Note 15.
|
Revenues and other income
|
–
|
the license of the right to use the Company’s patent and know-how;
|
–
|
the support provided by the Company to PharmaEngine until the first regulatory approval is granted in PharmaEngine’s territory that the Company views as a series of distinct periods of access to information and experience that is satisfied over time; and
|
–
|
the supply of NBTXR3 to PharmaEngine.
|
|
| |
For the six months ended June 30,
|
|||
(in thousands of euros)
|
| |
2020
|
| |
2019
|
Services
|
| |
37
|
| |
20
|
Other sales
|
| |
—
|
| |
17
|
Licenses
|
| |
—
|
| |
—
|
Total revenues
|
| |
37
|
| |
37
|
Research tax credit
|
| |
888
|
| |
1,776
|
Subsidies
|
| |
494
|
| |
10
|
Other
|
| |
28
|
| |
—
|
Total other income
|
| |
1,411
|
| |
1,786
|
Total revenues and other income
|
| |
1,448
|
| |
1,823
|
Note 16.
|
Operating expenses
|
16.1
|
Research and development expenses
|
|
| |
For the six months ended June 30,
|
|||
(in thousands of euros)
|
| |
2020
|
| |
2019
|
Purchases, sub-contracting and other expenses
|
| |
(7,096)
|
| |
(6,339)
|
Payroll costs (including share-based payments)
|
| |
(5,397)
|
| |
(6,297)
|
Depreciation, amortization and provision expenses(1)
|
| |
(583)
|
| |
(744)
|
Total research and development expenses
|
| |
(13,077)
|
| |
(13,380)
|
(1)
|
See Note 16.4
|
16.2
|
Selling, General and Administrative (SG&A) expenses
|
|
| |
For the six months ended June 30,
|
|||
(in thousands of euros)
|
| |
2020
|
| |
2019
|
Purchases, fees and other expenses
|
| |
(2,955)
|
| |
(3,956)
|
Payroll costs (including share-based payments)
|
| |
(3,641)
|
| |
(4,903)
|
Depreciation, amortization and provision expenses(1)
|
| |
(159)
|
| |
(51)
|
Total SG&A expenses
|
| |
(6,755)
|
| |
(8,910)
|
(1)
|
see Note 16.4
|
16.3
|
Payroll costs
|
|
| |
For the six months ended June 30,
|
|||
(in thousands of euros)
|
| |
2020
|
| |
2019
|
Wages and salaries
|
| |
(5,658)
|
| |
(6,322)
|
Payroll taxes
|
| |
(1,799)
|
| |
(3,124)
|
Share-based payments
|
| |
(1,542)
|
| |
(1,716)
|
Retirement benefit obligations
|
| |
(38)
|
| |
(38)
|
Total payroll costs
|
| |
(9,038)
|
| |
(11,200)
|
Average headcount
|
| |
104
|
| |
110
|
End-of-period headcount
|
| |
98
|
| |
111
|
16.4
|
Depreciation, amortization and provision expenses
|
|
| |
For the year ended June 30, 2020
|
||||||
(in thousands of euros)
|
| |
R&D
|
| |
SG&A
|
| |
Total
|
Amortization expense of intangible assets
|
| |
(73)
|
| |
(44)
|
| |
(117)
|
Depreciation expense of property, plant and equipment
|
| |
(623)
|
| |
(167)
|
| |
(789)
|
Utilization of provision for disputes
|
| |
112
|
| |
—
|
| |
112
|
Provision for charges
|
| |
—
|
| |
52
|
| |
52
|
Total depreciation, amortization and provision expenses
|
| |
(583)
|
| |
(159)
|
| |
(742)
|
Note 17.
|
Share-based payments
|
|
| |
Pre-2020 founders’ warrant plans
|
||||||||||||
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
|
| |
2012-2
|
| |
08-2013
|
| |
09-2014
|
| |
2015-1
|
| |
2015-3
|
Type of underlying asset
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
Number of founder’s warrants granted
|
| |
100,000
|
| |
50,000
|
| |
97,200
|
| |
71,650
|
| |
53,050
|
Date of shareholders' resolution approving the plan
|
| |
05/04/12
|
| |
06/28/13
|
| |
06/18/14
|
| |
06/18/14
|
| |
06/18/14
|
Grant date
|
| |
12/18/12
|
| |
08/28/13
|
| |
09/16/14
|
| |
02/10/15
|
| |
06/10/15
|
Contractual expiration date
|
| |
12/18/22
|
| |
08/28/23
|
| |
09/16/24
|
| |
02/10/25
|
| |
06/10/25
|
Grant price
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Exercise price
|
| |
€6.63
|
| |
€5.92
|
| |
€18.68
|
| |
€18.57
|
| |
€20.28
|
Number of founders’ warrants as of June 30, 2020
|
| |
100,000
|
| |
50,000
|
| |
86,900
|
| |
68,450
|
| |
31,700
|
Number of founders’ warrants exercised
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Including founders’ warrants exercised during the period
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Number of founders’ warrants lapsed or canceled
|
| |
—
|
| |
—
|
| |
10,300
|
| |
3,200
|
| |
21,350
|
Including founders’ warrants lapsed or canceled during the period
|
| |
—
|
| |
—
|
| |
5,200
|
| |
2,500
|
| |
6,700
|
|
| |
Pre-2020 founders’ warrant plans
|
|||||||||
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
|
| |
2016 Ordinary
|
| |
2016 Performance
|
| |
2017 Ordinary
|
| |
2017
|
Type of underlying asset
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
Number of founder’s warrants granted
|
| |
126,400
|
| |
129,250
|
| |
117,650
|
| |
80,000
|
Date of shareholders' resolution approving the plan
|
| |
06/25/15
|
| |
06/25/15
|
| |
06/23/16
|
| |
06/23/16
|
Grant date
|
| |
02/02/16
|
| |
02/02/16
|
| |
01/07/17
|
| |
01/07/17
|
Contractual expiration date
|
| |
02/02/26
|
| |
02/02/26
|
| |
01/07/27
|
| |
01/07/27
|
Grant price
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Exercise price
|
| |
€14.46
|
| |
€14.46
|
| |
€15.93
|
| |
€15.93
|
Number of founders’ warrants as of June 30, 2020
|
| |
101,617
|
| |
101,804
|
| |
101,600
|
| |
80,000
|
Number of founders’ warrants exercised
|
| |
333
|
| |
—
|
| |
—
|
| |
—
|
Including founders’ warrants exercised during the period
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Number of founders’ warrants lapsed or canceled
|
| |
24,450
|
| |
27,446
|
| |
16,050
|
| |
—
|
Including founders’ warrants lapsed or canceled during the period
|
| |
8,350
|
| |
1,198
|
| |
5,566
|
| |
—
|
|
| |
Pre-2020 warrant plans
|
||||||||||||||||||
|
| |
BSA
04-12
|
| |
BSA
2013
|
| |
BSA
2014
|
| |
BSA
2015-1
|
| |
BSA
2015-2 (a)
|
| |
BSA
2015-2 (b)
|
| |
BSA 2016
Ordinary
|
Type of warrants
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
Number of warrants granted
|
| |
52,500
|
| |
10,000
|
| |
14,000
|
| |
26,000
|
| |
64,000
|
| |
6,000
|
| |
18,103
|
Date of shareholders' resolution approving the plan
|
| |
05/04/12
|
| |
05/04/12
|
| |
06/18/14
|
| |
06/18/14
|
| |
06/18/14
|
| |
06/25/15
|
| |
06/25/15
|
Grant date
|
| |
05/04/12
|
| |
04/10/13
|
| |
09/16/14
|
| |
02/10/15
|
| |
06/25/15
|
| |
06/25/15
|
| |
02/02/16
|
Contractual expiration date
|
| |
05/04/22
|
| |
04/10/23
|
| |
09/16/24
|
| |
02/10/25
|
| |
06/25/25
|
| |
06/25/20
|
| |
02/02/21
|
Grant price
|
| |
€0.60
|
| |
€2.50
|
| |
€4.87
|
| |
€4.87
|
| |
€5.00
|
| |
€2.80
|
| |
€1.67
|
Exercise price
|
| |
€6.00
|
| |
€6.37
|
| |
€17.67
|
| |
€17.67
|
| |
€19.54
|
| |
€19.54
|
| |
€13.74
|
Number of warrants as of June 30, 2020
|
| |
30,000
|
| |
6,000
|
| |
10,000
|
| |
21,000
|
| |
64,000
|
| |
—
|
| |
18,103
|
Number of warrants exercised
|
| |
22,500
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Including warrants exercised during the period
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Number of warrants lapsed or canceled
|
| |
—
|
| |
4,000
|
| |
4,000
|
| |
5,000
|
| |
—
|
| |
6,000
|
| |
—
|
Including warrants lapsed or canceled during the period
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
6,000
|
| |
—
|
|
| |
Pre-2020 warrant plans
|
|||||||||||||||
|
| |
BSA 2016
Performance
|
| |
BSA
2016-2
|
| |
BSA
2017
|
| |
BSA
2018-1
|
| |
BSA
2018-2
|
| |
BSA
2019-1
|
Type of warrants
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
Number of warrants granted
|
| |
18,105
|
| |
8,000
|
| |
18,000
|
| |
28,000
|
| |
5,820
|
| |
18,000
|
Date of shareholders' resolution approving the plan
|
| |
06/25/15
|
| |
06/23/16
|
| |
06/23/16
|
| |
06/14/17
|
| |
05/23/18
|
| |
05/23/18
|
Grant date
|
| |
02/02/16
|
| |
11/03/16
|
| |
01/07/17
|
| |
03/06/18
|
| |
07/27/18
|
| |
03/29/19
|
Contractual expiration date
|
| |
02/02/21
|
| |
11/03/21
|
| |
01/07/22
|
| |
03/06/23
|
| |
07/27/28
|
| |
03/29/29
|
Grant price
|
| |
€1.67
|
| |
€2.03
|
| |
€2.03
|
| |
€1.62
|
| |
€2.36
|
| |
€1.15
|
Exercise price
|
| |
€13.74
|
| |
€15.01
|
| |
€15.76
|
| |
€13.55
|
| |
€16.102
|
| |
€11.66
|
Number of warrants as of June 30, 2020
|
| |
18,105
|
| |
8,000
|
| |
18,000
|
| |
28,000
|
| |
5,820
|
| |
18,000
|
Number of warrants exercised
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Including warrants exercised during the period
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Number of warrants lapsed or canceled
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Including warrants lapsed or canceled during the period
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
|
| |
Pre-2020 stock option plans
|
|||||||||||||||
|
| |
OSA 2016-1
Performance
|
| |
OSA
2016-2
|
| |
OSA
2017
Ordinary
|
| |
OSA
2018
|
| |
OSA
2019-1
|
| |
OSA
LLY 2019
|
Type of underlying asset
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
Number of options granted
|
| |
6,400
|
| |
4,000
|
| |
3,500
|
| |
62,000
|
| |
37,500
|
| |
500,000
|
Date of shareholders' resolution approving the plan
|
| |
06/25/15
|
| |
06/23/16
|
| |
06/23/16
|
| |
06/14/17
|
| |
05/23/18
|
| |
04/11/19
|
Grant date
|
| |
02/02/16
|
| |
11/03/16
|
| |
01/07/17
|
| |
03/06/18
|
| |
03/29/19
|
| |
10/24/19
|
Contractual expiration date
|
| |
02/02/26
|
| |
11/03/26
|
| |
01/07/27
|
| |
03/06/28
|
| |
03/29/29
|
| |
10/24/29
|
Grant price
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Exercise price
|
| |
€13.05
|
| |
€14.26
|
| |
€14.97
|
| |
€12.87
|
| |
€11.08
|
| |
€6.41
|
Number of options as of June 30, 2020
|
| |
400
|
| |
4,000
|
| |
500
|
| |
53,333
|
| |
28,750
|
| |
500,000
|
Number of options exercised
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Including options exercised during the period
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Number of options lapsed or canceled
|
| |
6,000
|
| |
—
|
| |
3,000
|
| |
8,667
|
| |
8,750
|
| |
—
|
Including options lapsed or canceled during the period
|
| |
—
|
| |
—
|
| |
—
|
| |
667
|
| |
1,500
|
| |
—
|
|
| |
Pre-2020 free shares plan not yet vested
|
| |
2020 free
shares plan
|
||||||
|
| |
AGA 2018
|
| |
AGA 2018 – 1
|
| |
AGA 2019 – 1
|
| |
AGA 2020
|
Type of underlying assets
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
| |
New shares
|
Number of free shares granted
|
| |
396,250
|
| |
6,000
|
| |
438,250
|
| |
50,000
|
Date of shareholders' resolution approving the plan
|
| |
06/14/2017
|
| |
05/23/2018
|
| |
05/23/2018
|
| |
04/11/2019
|
Grant date
|
| |
03/06/2018
|
| |
07/27/2018
|
| |
03/29/2019
|
| |
03/11/2020
|
Grant price
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Exercise price
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Number of free shares as of June 30, 2020
|
| |
24,500
|
| |
6,000
|
| |
378,250
|
| |
50,000
|
Number of free shares exercised
|
| |
316,083
|
| |
—
|
| |
—
|
| |
—
|
Including free shares exercised during the period
|
| |
316,083
|
| |
—
|
| |
—
|
| |
—
|
Number of free shares lapsed or canceled
|
| |
55,667
|
| |
—
|
| |
60,000
|
| |
—
|
Including free shares lapsed or canceled during the period
|
| |
14,667
|
| |
—
|
| |
6,750
|
| |
—
|
|
| |
BSPCE
|
| |
BSA
|
| |
OSA
|
| |
AGA
|
| |
Total
|
Total number of shares underlying grants outstanding as of June 30, 2020
|
| |
722,071
|
| |
263,028
|
| |
993,046
|
| |
458,750
|
| |
2,436,895
|
–
|
The share price on the grant date is equal to the exercise price, except for the BSA 2014 which exercise price was set at €40, taking into account both the average share price on the 20 days preceding the grant date and the expected development perspectives of the Company;
|
–
|
The risk-free rate was determined based on the average life of the instruments; and
|
–
|
Volatility was determined based on a sample of listed companies in the biotechnology sector on the grant date and for a period equal to the life of the warrant or option.
|
–
|
Performance conditions unrelated to the market were analyzed to determine the likely exercise date of the warrants and options and expense was recorded accordingly based on the probability these conditions would be met; and
|
–
|
Market-related performance conditions were directly included in the calculation of the fair value of the instruments.
|
BSPCE
|
| |
Share
price (in
euros)
|
| |
Exercise
price (in
euros)
|
| |
Volatility
|
| |
Maturity
(in years)
|
| |
Risk-free
rate
|
| |
Yield
|
| |
Value of
initial
plan (in
thousands
of euros)
|
| |
Expense
for the six-
month
period ended
June 30,
2020 (in
thousands
of euros)
|
| |
Expense
for the
six-month
period ended
June 30,
2019 (in
thousands
of euros)
|
BSPCE
2012-1
|
| |
5.26
|
| |
6.00
|
| |
41%
|
| |
3.49
|
| |
0.20%
|
| |
0.00%
|
| |
307
|
| |
0
|
| |
0
|
BSPCE
2012-2
|
| |
6.65
|
| |
6.63
|
| |
44.3% - 47.6%
|
| |
5 - 7.30
|
| |
0.84% - 1.22%
|
| |
0.00%
|
| |
288
|
| |
0
|
| |
0
|
BSPCE
04-2013
|
| |
6.30
|
| |
6.30
|
| |
56%
|
| |
5.00
|
| |
0.90%
|
| |
0.00%
|
| |
167
|
| |
0
|
| |
0
|
BSPCE
08-2013
|
| |
6.30
|
| |
6.30
|
| |
256%
|
| |
7.0
|
| |
0.90%
|
| |
0.00%
|
| |
152
|
| |
0
|
| |
0
|
BSPCE
09-2014
|
| |
18.68
|
| |
18.68
|
| |
58%
|
| |
5.5/6/6.5
|
| |
0.64%
|
| |
0.00%
|
| |
932
|
| |
0
|
| |
0
|
BSPCE
2015-1
|
| |
18.57
|
| |
18.57
|
| |
58% - 62% -
61%
|
| |
5.5/6/6.5
|
| |
0.39%
|
| |
0.00%
|
| |
50
|
| |
0
|
| |
0
|
BSPCE
2015-1
|
| |
18.57
|
| |
18.57
|
| |
58% - 62%
- 61%
|
| |
5.5/6/6.5
|
| |
0.39%
|
| |
0.00%
|
| |
650
|
| |
0
|
| |
0
|
BSPCE
2015-3
|
| |
20.28
|
| |
20.28
|
| |
61% - 62%
- 61%
|
| |
5.5/6/6.5
|
| |
0.56%
|
| |
0.00%
|
| |
483
|
| |
0
|
| |
0
|
BSPCE
2016 Ordinary
|
| |
14.46
|
| |
14.46
|
| |
59% - 62%
- 60%
|
| |
5.5/6/6.5
|
| |
0.32%
|
| |
0.00%
|
| |
1,080
|
| |
0
|
| |
10
|
BSPCE
2016
Performance
|
| |
14.46
|
| |
14.46
|
| |
59%
|
| |
5.00
|
| |
0.19%
|
| |
0.00%
|
| |
1,212
|
| |
63
|
| |
11
|
BSPCE
2017 Ordinary
|
| |
15.93
|
| |
15.93
|
| |
58% - 61%
- 59%
|
| |
5.5/6/6.5
|
| |
0.23%
|
| |
0.00%
|
| |
1,000
|
| |
8
|
| |
56
|
BSPCE
2017 Performance
|
| |
15.93
|
| |
15.93
|
| |
59%
|
| |
5.00
|
| |
0.11%
|
| |
0.00%
|
| |
622
|
| |
0
|
| |
0
|
BSPCE
2017
|
| |
15.93
|
| |
15.93
|
| |
59%
|
| |
5.00
|
| |
0.11%
|
| |
0.00%
|
| |
627
|
| |
0
|
| |
0
|
BSPCE
2017 Project
|
| |
15.93
|
| |
15.93
|
| |
59%
|
| |
5.00
|
| |
0.11%
|
| |
0.00%
|
| |
94
|
| |
0
|
| |
0
|
Total BSPCE
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
71
|
| |
77
|
BSA
|
| |
Share
price (in
euros)
|
| |
Exercise
price (in
euros)
|
| |
Volatility
|
| |
Maturity
(in years)
|
| |
Risk-free
rate
|
| |
Yield
|
| |
Value
of
initial
plan (in
thousands
of euros)
|
| |
Expense
for the
six-month
period
ended
June 30,
2020 (in
thousands
of euros)
|
| |
Expense
for the
six-month
period
ended
June 30,
2019 (in
thousands
of euros)
|
BSA 2012
|
| |
6.00
|
| |
6.00
|
| |
49%
|
| |
10.00
|
| |
0.96%
|
| |
0.00%
|
| |
183
|
| |
—
|
| |
—
|
BSA 2013
|
| |
6.30
|
| |
6.37
|
| |
156%
|
| |
6.00
|
| |
0.90%
|
| |
0.00%
|
| |
1
|
| |
—
|
| |
—
|
BSA 2014
|
| |
18.68
|
| |
17.67
|
| |
57%
|
| |
5.00
|
| |
0.41%
|
| |
0.00%
|
| |
—
|
| |
—
|
| |
—
|
BSA 2015-1
|
| |
17.67
|
| |
17.67
|
| |
58%
|
| |
5.00
|
| |
0.26% - 0.27%
|
| |
0.00%
|
| |
63
|
| |
—
|
| |
—
|
BSA 2015-2
|
| |
17.67
|
| |
19.54
|
| |
58% - 58%
- 57% - 58%
|
| |
5/5.1/5.3/5.4
|
| |
0.39%
|
| |
0.00%
|
| |
16
|
| |
—
|
| |
—
|
BSA 2015-3
|
| |
19.54
|
| |
19.54
|
| |
58% - 60%
|
| |
4.6 – 9.6
|
| |
0.25% - 0.91%
|
| |
0.00%
|
| |
284
|
| |
—
|
| |
—
|
BSA 2016o-1
|
| |
13.74
|
| |
13.74
|
| |
57%
|
| |
2.40
|
| |
0.00%
|
| |
0.00%
|
| |
37
|
| |
—
|
| |
—
|
BSA 2016p-1
|
| |
13.74
|
| |
13.74
|
| |
57%
|
| |
2.40
|
| |
0.00%
|
| |
0.00%
|
| |
143
|
| |
—
|
| |
(46)
|
BSA 2016-2
|
| |
15.01
|
| |
15.01
|
| |
57%
|
| |
2.40
|
| |
0.00%
|
| |
0.00%
|
| |
—
|
| |
—
|
| |
—
|
BSA 2017o-1
|
| |
15.76
|
| |
15.76
|
| |
33%
|
| |
2.40
|
| |
0.00%
|
| |
0.00%
|
| |
—
|
| |
—
|
| |
—
|
BSA 2018-1
|
| |
13.55
|
| |
13.55
|
| |
38%
|
| |
4.80
|
| |
0.7% -
0.10%
|
| |
0.00%
|
| |
2
|
| |
—
|
| |
—
|
BSA 2018-2
|
| |
16.10
|
| |
16.10
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
BSA 2019-1
|
| |
11.66
|
| |
11.66
|
| |
37%
|
| |
9.8/9.9
|
| |
0.16% - 0.50%
|
| |
0.00%
|
| |
24
|
| |
—
|
| |
24
|
BSA 2020
|
| |
—
|
| |
—
|
| |
38%
|
| |
10.00
|
| |
- 0.13%/- 0.07%
|
| |
0.00%
|
| |
19
|
| |
19
|
| |
0
|
Total BSA
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
19
|
| |
(22)
|
Stock
options
|
| |
Share
price (in
euros)
|
| |
Exercise
price (in
euros)
|
| |
Volatility
|
| |
Maturity
(in years)
|
| |
Risk-free
rate
|
| |
Yield
|
| |
Value
of
initial
plan
(in
thou
sands of
euros)
|
| |
Expense
for the
six-month
period
ended
June 30,
2020 (in
thousands
of euros)
|
| |
Expense
for the
six-month
period
ended
June 30,
2019 (in
thousands
of euros)
|
OSA 2016 Ordinary
|
| |
13.05
|
| |
13.05
|
| |
59% - 62%
- 60%
|
| |
5.5 / 6 / 6.5
|
| |
0.32%
|
| |
0.00%
|
| |
117
|
| |
—
|
| |
—
|
OSA 2016 Performance
|
| |
13.05
|
| |
13.05
|
| |
59%
|
| |
5.00
|
| |
0.19%
|
| |
0.00%
|
| |
69
|
| |
—
|
| |
—
|
OSA 2016-2
|
| |
14.26
|
| |
14.26
|
| |
58% - 62%
- 59%
|
| |
5.5 / 6 / 6.5
|
| |
0.04%
|
| |
0.00%
|
| |
27
|
| |
—
|
| |
2
|
OSA 2017 Ordinary
|
| |
15.93
|
| |
15.93
|
| |
58% - 61%
- 59%
|
| |
5.5 / 6 / 6.5
|
| |
0.23%
|
| |
0.00%
|
| |
31
|
| |
—
|
| |
—
|
OSA 2017 Performance
|
| |
15.93
|
| |
15.93
|
| |
59%
|
| |
5.00
|
| |
0.11%
|
| |
0.00%
|
| |
35
|
| |
—
|
| |
—
|
OSA 2018
|
| |
12.87
|
| |
12.87
|
| |
35%
|
| |
5.5 / 6 / 6.5
|
| |
0.00%
|
| |
0.00%
|
| |
252
|
| |
6
|
| |
45
|
OSA 2019-1
|
| |
11.08
|
| |
11.08
|
| |
38.10% /
37.40%
|
| |
6 / 6.5
|
| |
0.103% /
0.149%
|
| |
0.00%
|
| |
140
|
| |
27
|
| |
13
|
OSA LLY 2019
|
| |
6.41
|
| |
6.41
|
| |
37%
|
| |
10.00
|
| |
0.40%
|
| |
0.00%
|
| |
252
|
| |
—
|
| |
—
|
OSA 2020
|
| |
6.25
|
| |
6.25
|
| |
38.30%
|
| |
10.00
|
| |
0.31%
|
| |
0.00%
|
| |
939
|
| |
172
|
| |
—
|
Total Stock options
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
205
|
| |
59
|
free
shares
|
| |
Share
price (in
euros)
|
| |
Exercise
price (in
euros)
|
| |
Volatility
|
| |
Maturity (in
years)
|
| |
Risk-free
rate
|
| |
Yield
|
| |
Value of
initial plan
(in
thousands
of euros)
|
| |
Expense for the
six-month
period ended
June 30,
2020 (in
thousands
of euros)
|
| |
Expense
for the
six-month
period ended
June 30,
2019 (in
thousands
of euros)
|
AGA 2018-1
|
| |
12.87
|
| |
0.00
|
| |
n.a.
|
| |
n.a.
|
| |
0.00%
|
| |
0.00%
|
| |
4,951
|
| |
224
|
| |
1,063
|
AGA 2018-2
|
| |
12.87
|
| |
0.00
|
| |
n.a.
|
| |
n.a.
|
| |
0.00%
|
| |
0.00%
|
| |
75
|
| |
19
|
| |
19
|
AGA 2019-1
|
| |
10.90
|
| |
0.00
|
| |
n.a.
|
| |
n.a.
|
| |
0.19% /
0.141%
|
| |
0.00%
|
| |
4,776
|
| |
960
|
| |
520
|
AGA 2020
|
| |
5.90
|
| |
0.00
|
| |
n.a.
|
| |
n.a.
|
| |
- 0.74% /
-0.69%
|
| |
0.00%
|
| |
287
|
| |
43
|
| |
0
|
Total
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
1,246
|
| |
1,602
|
(in thousands of euros)
|
| |
BSPCE
|
| |
BSA
|
| |
OSA
|
| |
AGA
|
| |
Total
|
Expense for the six-month period ended June 30, 2020
|
| |
71
|
| |
19
|
| |
205
|
| |
1,246
|
| |
1,542
|
(in thousands of euros)
|
| |
BSPCE
|
| |
BSA
|
| |
OSA
|
| |
AGA
|
| |
Total
|
Expense for the six-month period ended June 30, 2019
|
| |
77
|
| |
(22)
|
| |
59
|
| |
1,602
|
| |
1,716
|
Note 18.
|
Net financial income (loss)
|
|
| |
For the six months ended June 30,
|
|||
(in thousands of euros)
|
| |
2020
|
| |
2019
|
Income from cash and cash equivalents
|
| |
—
|
| |
21
|
Foreign exchange gains
|
| |
177
|
| |
651
|
Other financial income
|
| |
56
|
| |
52
|
Total financial income
|
| |
234
|
| |
724
|
Interest cost
|
| |
(2,219)
|
| |
(3,611)
|
IFRS 16 related interests
|
| |
(169)
|
| |
(181)
|
Foreign exchange losses
|
| |
(39)
|
| |
(384)
|
Total financial expenses
|
| |
(2,428)
|
| |
(4,176)
|
Net financial income (loss)
|
| |
(2,194)
|
| |
(3,452)
|
Note 19.
|
Loss per share
|
|
| |
For the six months ended June 30,
|
|||
(in thousands of euros)
|
| |
2020
|
| |
2019
|
Net loss for the period (in thousands of euros)
|
| |
(20,579)
|
| |
(23,920)
|
Weighted average number of shares
|
| |
22,608,408
|
| |
20,844,245
|
Basic loss per share (in euros)
|
| |
(0.91)
|
| |
(1.15)
|
Diluted loss per share (in euros)
|
| |
(0.91)
|
| |
(1.15)
|
Note 20.
|
Commitments
|
20.1
|
Obligations under the loan agreement with the EIB
|
20.2
|
Obligations under the terms of the rental agreements part of the IFRS 16 exemptions
|
–
|
One short term lease for an office by Nanobiotix Corp., of which the annual rent is $140 thousand; and
|
–
|
Leases related to low-value assets for Nanobiotix S.A.’s printers, of which the annual rent is approximately €10 thousand.
|
20.3
|
Obligations related to the MD Anderson agreement
|
|
| |
For the six months ended June 30,
|
|||
(in thousands of euros)
|
| |
2020
|
| |
2019
|
Salaries, wages and benefits
|
| |
687
|
| |
1,008
|
Share-based payments
|
| |
859
|
| |
1,007
|
Supervisory Board’s fees
|
| |
35
|
| |
35
|
Total compensation to related parties
|
| |
1,581
|
| |
2,050
|
|
| |
|
| |
As of December 31,
|
|||
|
| |
Notes
|
| |
2019
|
| |
2018(1)
|
ASSETS
|
| |
|
| |
|
| |
|
Non-current assets
|
| |
|
| |
|
| |
|
Intangible assets
|
| |
5
|
| |
163
|
| |
102
|
Property, plant and equipment
|
| |
6
|
| |
9,386
|
| |
2,884
|
Non-current financial assets
|
| |
7
|
| |
529
|
| |
558
|
Total non-current assets
|
| |
|
| |
10,078
|
| |
3,544
|
Current assets
|
| |
|
| |
|
| |
|
Trade receivables
|
| |
8.1
|
| |
11
|
| |
25
|
Other current assets
|
| |
8.2
|
| |
11,022
|
| |
6,422
|
Cash and cash equivalents
|
| |
9
|
| |
35,094
|
| |
36,203
|
Total current assets
|
| |
|
| |
46,127
|
| |
42,651
|
TOTAL ASSETS
|
| |
|
| |
56,205
|
| |
46,195
|
|
| |
|
| |
|
| |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
| |
|
| |
|
| |
|
Shareholders’ equity
|
| |
|
| |
|
| |
|
Share capital
|
| |
10.1
|
| |
672
|
| |
589
|
Premiums related to share capital
|
| |
10.1
|
| |
153,139
|
| |
122,799
|
Accumulated other comprehensive income
|
| |
|
| |
433
|
| |
381
|
Treasury shares
|
| |
|
| |
(169)
|
| |
(124)
|
Reserve
|
| |
|
| |
(105,069)
|
| |
(79,057)
|
Net loss for the period
|
| |
|
| |
(50,915)
|
| |
(30,345)
|
Total shareholders’ equity
|
| |
|
| |
(1,908)
|
| |
14,243
|
Non-current liabilities
|
| |
|
| |
|
| |
|
Non-current provisions
|
| |
11.2
|
| |
331
|
| |
337
|
Non-current financial liabilities
|
| |
12
|
| |
43,435
|
| |
20,021
|
Total non-current liabilities
|
| |
|
| |
43,766
|
| |
20,358
|
Current liabilities
|
| |
|
| |
|
| |
|
Current provisions
|
| |
11.1
|
| |
164
|
| |
55
|
Current financial liabilities
|
| |
12
|
| |
1,091
|
| |
500
|
Trade payables and other payables
|
| |
13.1
|
| |
7,770
|
| |
6,509
|
Other current liabilities
|
| |
13.2
|
| |
5,322
|
| |
4,533
|
Total current liabilities
|
| |
|
| |
14,347
|
| |
11,597
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
|
| |
|
| |
56,205
|
| |
46,195
|
(1)
|
The Company applied the new standard IFRS 16 – Leases starting January 1, 2019 following the modified retrospective method, the comparative financial statements are therefore not restated (see Note 2.1 for further details on the impacts of the first application of IFRS 16 – Leases)
|
|
| |
|
| |
For the year ended December 31,
|
|||
|
| |
Notes
|
| |
2019
|
| |
2018(1)
|
Revenues and other income
|
| |
|
| |
|
| |
|
Revenues
|
| |
15
|
| |
68
|
| |
116
|
Other income
|
| |
15
|
| |
2,473
|
| |
3,363
|
Total revenues and other income
|
| |
|
| |
2,541
|
| |
3,479
|
Operating expenses
|
| |
|
| |
|
| |
|
Research and development expenses
|
| |
16.1
|
| |
(30,411)
|
| |
(20,893)
|
Selling, general and administrative expenses
|
| |
16.2
|
| |
(18,909)
|
| |
(12,653)
|
Total operating expenses
|
| |
|
| |
(49,320)
|
| |
(33,546)
|
Operating income (loss)
|
| |
|
| |
(46,779)
|
| |
(30,067)
|
Financial income
|
| |
18
|
| |
837
|
| |
1,172
|
Financial expenses
|
| |
18
|
| |
(4,970)
|
| |
(1,449)
|
Financial income (loss)
|
| |
|
| |
(4,133)
|
| |
(277)
|
Income tax
|
| |
19
|
| |
(3)
|
| |
—
|
Net loss for the period
|
| |
|
| |
(50,915)
|
| |
(30,345)
|
Basic loss per share (euros/share)
|
| |
21
|
| |
(2.35)
|
| |
(1.55)
|
Diluted loss per share (euros/share)
|
| |
21
|
| |
(2.35)
|
| |
(1.55)
|
(1)
|
The Company applied the new standard IFRS 16 – Leases starting January 1, 2019 following the modified retrospective method, the comparative financial statements are therefore not restated (see Note 2.1 for further details on the impacts of the first application of IFRS 16 – Leases)
|
|
| |
For the year ended December 31,
|
|||
|
| |
2019
|
| |
2018
|
Net loss for the period
|
| |
(50,915)
|
| |
(30,345)
|
Actuarial gains and losses on retirement benefit obligations (IAS 19)
|
| |
88
|
| |
(48)
|
Tax impact
|
| |
—
|
| |
—
|
Other comprehensive loss that will not be reclassified subsequently to income or loss
|
| |
88
|
| |
(48)
|
Currency translation adjustment
|
| |
(36)
|
| |
(85)
|
Tax impact
|
| |
—
|
| |
—
|
Other comprehensive income that may be reclassified subsequently to income or loss
|
| |
(36)
|
| |
(85)
|
Total comprehensive loss
|
| |
(50,863)
|
| |
(30,478)
|
|
| |
|
| |
Share capital
Ordinary shares
|
| |
Premiums
related
to share
capital
|
| |
Accumulated
other
comprehensive
income
(loss)
|
| |
Treasury
shares
|
| |
Reserve
|
| |
Net loss
for the
period
|
| |
Total
shareholders’
equity
|
|||
|
| |
Notes
|
| |
Number
of shares
|
| |
Amount
|
| |||||||||||||||||
As of January 1, 2018
|
| |
|
| |
19,633,373
|
| |
589
|
| |
123,782
|
| |
514
|
| |
(27)
|
| |
(54,793)
|
| |
(26,143)
|
| |
43,922
|
Net loss for the period
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(30,345)
|
| |
(30,345)
|
Currency translation adjustments
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
(85)
|
| |
—
|
| |
—
|
| |
—
|
| |
(85)
|
Actuarial gains and losses (IAS 19)
|
| |
11.2
|
| |
—
|
| |
—
|
| |
—
|
| |
(48)
|
| |
—
|
| |
—
|
| |
—
|
| |
(48)
|
Total comprehensive loss
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
(133)
|
| |
—
|
| |
—
|
| |
(30,345)
|
| |
(30,478)
|
Allocation of prior period loss
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(26,143)
|
| |
26,143
|
| |
—
|
Subscription of warrants
|
| |
10.3
|
| |
—
|
| |
—
|
| |
47
|
| |
—
|
| |
—
|
| |
12
|
| |
—
|
| |
59
|
Share based payment
|
| |
17
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
1,867
|
| |
—
|
| |
1,867
|
Treasury shares
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(97)
|
| |
—
|
| |
—
|
| |
(97)
|
U.S. Initial public offering costs
|
| |
10.1
|
| |
—
|
| |
—
|
| |
(1,030)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(1,030)
|
As of December 31, 2018
|
| |
|
| |
19,633,373
|
| |
589
|
| |
122,799
|
| |
381
|
| |
(124)
|
| |
(79,057)
|
| |
(30,345)
|
| |
14,243
|
Net loss for the period
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(50,915)
|
| |
(50,915)
|
Currency translation adjustments
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
(36)
|
| |
—
|
| |
—
|
| |
—
|
| |
(36)
|
Actuarial gains and losses (IAS 19)
|
| |
11.2
|
| |
—
|
| |
—
|
| |
—
|
| |
88
|
| |
—
|
| |
—
|
| |
—
|
| |
88
|
Total comprehensive loss
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
52
|
| |
—
|
| |
—
|
| |
(50,915)
|
| |
(50,863)
|
Allocation of prior period loss
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(30,345)
|
| |
30,345
|
| |
—
|
Capital increase
|
| |
|
| |
2,566,666
|
| |
77
|
| |
28,002
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
28,079
|
BSPCE exercise
|
| |
|
| |
215,000
|
| |
6
|
| |
1,300
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
1,306
|
Subscription of warrants and attribution of free shares
|
| |
10.3
|
| |
—
|
| |
—
|
| |
8
|
| |
—
|
| |
—
|
| |
13
|
| |
—
|
| |
21
|
Share based payment
|
| |
17
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
4,320
|
| |
—
|
| |
4,320
|
Treasury shares
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(45)
|
| |
—
|
| |
—
|
| |
(45)
|
U.S. Initial public offering costs reversal
|
| |
10.1
|
| |
—
|
| |
—
|
| |
1,030
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
1,030
|
As of December 31, 2019
|
| |
|
| |
22,415,039
|
| |
672
|
| |
153,139
|
| |
433
|
| |
(169)
|
| |
(105,070)
|
| |
(50,915)
|
| |
(1,908)
|
|
| |
|
| |
For the year ended December 31,
|
|||
|
| |
Notes
|
| |
2019
|
| |
2018(1)
|
Cash flows used in operating activities
|
| |
|
| |
|
| |
|
Net loss for the period
|
| |
|
| |
(50,915)
|
| |
(30,345)
|
Elimination of other non-cash, non-operating income and expenses
|
| |
|
| |
|
| |
|
Depreciation and amortization
|
| |
16.4
|
| |
1,767
|
| |
619
|
Provisions
|
| |
|
| |
164
|
| |
5
|
Expenses related to share-based payments
|
| |
17
|
| |
4,320
|
| |
1,867
|
Cost of net debt
|
| |
|
| |
1,940
|
| |
292
|
Loss on disposal
|
| |
|
| |
45
|
| |
—
|
U.S. Initial public offering 2018 costs reversal
|
| |
10.1
|
| |
201
|
| |
—
|
Impact of accrued royalties related to financial liabilities discounting effect
|
| |
|
| |
2,833
|
| |
535
|
Other charges with no impact on treasury
|
| |
|
| |
(5)
|
| |
(36)
|
Cash flows used in operations, before tax and changes in working capital
|
| |
|
| |
(39,647)
|
| |
(27,063)
|
(Increase) / Decrease in trade receivables
|
| |
8.1
|
| |
(85)
|
| |
144
|
Increase in other receivables
|
| |
8.2
|
| |
(4,640)
|
| |
(698)
|
Increase in trade and other payables
|
| |
13.1
|
| |
2,057
|
| |
633
|
Increase in other current liabilities
|
| |
13.2
|
| |
1,146
|
| |
999
|
Changes in operating working capital
|
| |
|
| |
(1,522)
|
| |
1,078
|
Net cash flows used in operating activities
|
| |
|
| |
(41,169)
|
| |
(25,985)
|
Cash flows from (used in) investing activities
|
| |
|
| |
|
| |
|
Acquisitions of intangible assets
|
| |
5
|
| |
(353)
|
| |
(90)
|
Acquisitions of property, plant and equipment
|
| |
6
|
| |
(1,091)
|
| |
(416)
|
Addition in non-current financial assets
|
| |
|
| |
(16)
|
| |
577
|
Net cash flows from (used in) investing activities
|
| |
|
| |
(1,459)
|
| |
71
|
Cash flows from financing activities
|
| |
|
| |
|
| |
|
Capital increases
|
| |
10.1
|
| |
29,517
|
| |
—
|
Warrants subscription
|
| |
10.1
|
| |
1,327
|
| |
59
|
Transaction costs
|
| |
10.1
|
| |
(1,438)
|
| |
(279)
|
Increase in loans
|
| |
12
|
| |
14,000
|
| |
16,000
|
Decrease in conditional advances
|
| |
12
|
| |
(500)
|
| |
(500)
|
Decrease in borrowings
|
| |
12
|
| |
—
|
| |
(427)
|
Payment of lease liabilities (2)
|
| |
12
|
| |
(1,067)
|
| |
—
|
Interest paid
|
| |
12
|
| |
(350)
|
| |
(3)
|
Net cash flows from financing activities
|
| |
|
| |
41,489
|
| |
14,850
|
Effect of exchange rates changes on cash
|
| |
|
| |
29
|
| |
54
|
Net increase (decrease) in cash and cash equivalents
|
| |
|
| |
(1,109)
|
| |
(11,009)
|
Net cash and cash equivalents at beginning of period
|
| |
|
| |
36,203
|
| |
47,212
|
Net cash and cash equivalents at end of period
|
| |
9
|
| |
35,094
|
| |
36,203
|
(1)
|
The Company applied the new standard IFRS 16 – Leases starting January 1, 2019 following the modified retrospective method, the comparative financial statements are therefore not restated (see Note 2.1 for further details on the impacts of the first application of IFRS 16 – Leases)
|
(2)
|
Lease contracts in the IFRS 16 scope (see Note 2.1 for further details on the impacts of the first application of IFRS 16 – Leases effective from January 1, 2019)
|
–
|
IFRIC 23 – Uncertainty over income tax treatments.
|
–
|
Amendments to IFRS 9 – Prepayment Features with negative Compensation and modifications of financial liabilities.
|
–
|
Amendments to IAS 19 – Employee benefits - plan amendments, curtailments or settlements.
|
–
|
Amendments to IAS 28 – Long term interests in associates and joint ventures.
|
–
|
IFRS 16 – Leases, which replaces IAS 17 and the related IFRIC and SIC interpretations and is effective for annual reporting periods beginning on or after January 1, 2019. This standard eliminates the difference between operating and financial leases, and requires leases be recognized in the balance sheet. The accounting consists of recognizing a right of use asset and recording a liability for the value of the discounted rentals to be paid over the lease term.
|
–
|
Annual improvements to IFRSs 2015-2017 Cycle (Amendments to IFRS 3, IFRS 11, IAS 12 and IAS 23, applicable for periods beginning after January 1, 2019).
|
–
|
Amendment to IFRS 3 – Business combination, definition of a business. No impact expected on the consolidated financial statements of the Company.
|
–
|
Amendment to IAS1 – Presentation of financial statements, classification of liabilities. No impact expected on the consolidated financial statements.
|
–
|
Amendment to IAS 39, IFRS 7 and IFRS 9 related to the BOR interest rates reform. No impact expected on the consolidated financial statements.
|
–
|
Amendments to References to the Conceptual Framework in IFRS Standards (Effective for the accounting periods as of January 1, 2020). No impact expected on the consolidated financial statements.
|
–
|
IFRS 17 – Insurance Contracts (applicable for periods beginning after January 1, 2021 and not yet adopted by the European Union). No impact is expected on the consolidated financial statements.
|
2.1
|
Impact of IFRS 16 first application
|
–
|
a right of use equivalent to the initial debt, net of any lease incentives provided by the lessor.
|
–
|
a lease liability for the discounted lease payments outstanding for the remaining reasonably certain lease term as of January 1, 2019.
|
–
|
the use of a single discount rate to a portfolio of leases with reasonably similar characteristics;
|
–
|
the reliance on previous assessments on whether leases are onerous;
|
–
|
the exclusion of payments related to operating leases with a remaining lease term of less than 12 months without option to buy (short-term leases) and leases related to low-value assets recorded in operating expenses;
|
–
|
the exclusion of initial direct costs for the measurement of the right-of-use asset at the date of initial application; and
|
–
|
the use of hindsight in determining the lease term where the contract contains options to extend or terminate the lease.
|
(in thousands of euros)
|
|||
Operating lease commitments disclosed as at December 31, 2018
|
| |
6,407
|
Rent reevaluated with the 2019 index(1)
|
| |
294
|
2018 contracts not previously included in commitments
|
| |
216
|
Discounting impact of lines above
|
| |
(1,234)
|
Prepaid expenses related to IFRS 16 contracts as of December 31, 2018
|
| |
(114)
|
Lease liabilities recognized as at January 1, 2019
|
| |
5,569
|
Of which:
|
| |
|
Current lease liabilities
|
| |
741
|
Non-current lease liabilities
|
| |
4,828
|
(1)
|
As of January 1, 2019, the lease payments were updated to take into account the lease payment increase required under the lease agreements based on various indices. This amount corresponds to the impact of these indices application to the operating leases commitments disclosed as of December 31, 2018
|
(in thousands of euros)
|
| |
As of
December 31,
2018
(As published)
|
| |
IFRS 16
impacts
|
| |
As of
January 1,
2019
(IFRS 16 restated)
|
ASSETS
|
| |
|
| |
|
| |
|
Total non-current assets
|
| |
3,544
|
| |
5,500
|
| |
9,044
|
Of which Property, plant and equipment
|
| |
2,884
|
| |
5,500
|
| |
8,384
|
Total current assets
|
| |
42,651
|
| |
(114)
|
| |
42,537
|
Of which Other current assets
|
| |
6,422
|
| |
(114)
|
| |
6,308
|
TOTAL ASSETS
|
| |
46,195
|
| |
5,386
|
| |
51,581
|
|
| |
|
| |
|
| |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
| |
|
| |
|
| |
|
Total shareholders’ equity
|
| |
14,243
|
| |
—
|
| |
14,243
|
Total non-current liabilities
|
| |
20,358
|
| |
4,828
|
| |
25,186
|
Of which Non-current financial liabilities
|
| |
20,021
|
| |
4,828
|
| |
24,849
|
Total current liabilities
|
| |
11,597
|
| |
558
|
| |
12,155
|
Of which Current financial liabilities
|
| |
500
|
| |
741
|
| |
1,241
|
Of which Other current liabilities
|
| |
4533
|
| |
(183)
|
| |
4,350
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
|
| |
46,195
|
| |
5,386
|
| |
51,581
|
⯀
|
An exclusive perpetual license granted to PharmaEngine, with the right to sublicense the Company’s technology in order to exploit or have NBTXR3 exploited and use the Company’s trademark in connection with the exploitation of NBTXR3 in the contractual territory (with exploitation including among others developing, obtaining and maintaining regulatory approval, commercializing, distributing, promoting and marketing);
|
⯀
|
The Company’s commitment to furnish PharmaEngine with know-how necessary and useful to develop and commercialize NBTXR3 in the contractual territory, know-how meaning any results of experimentation and pre-clinical, clinical and non-clinical trial data by providing PharmaEngine with access to an electronic data platform; and
|
⯀
|
The Company’s commitment to supplying or having supplied PharmaEngine with all quantities of NBTXR3 required and used by PharmaEngine for clinical testing and subsequent commercialization if and when regulatory approvals are obtained.
|
⯀
|
A $1.0 million up-front payment on signature of the contract, fully received in 2012;
|
⯀
|
Payments upon the achievement of development milestones, including key stages of product development, first filing for regulatory approval, and first regulatory approval in the contractual territory;
|
⯀
|
Payments upon the achievement of commercial milestones based on specified sales thresholds;
|
⯀
|
Up to double-digit royalties based on net product sales in the Asia-Pacific region; and
|
⯀
|
Payments for the supply of NBTXR3.
|
⯀
|
To join the global pivotal clinical trial of NBTXR3 for the treatment of soft tissue sarcoma initiated by the Company in the Asia-Pacific region, with each party committing itself to share clinical trial results in order to increase the tested population and to accelerate growth and value creation;
|
⯀
|
To pay the first development milestone ($1 million, received by the Company in 2014) and share external clinical research organization costs charged to the Company in proportion of its participation to the patient population included in clinical trial; and
|
⯀
|
To pay the development milestone ($1 million, received by the Company in 2016) related to the launch of the first Phase II of the pivotal study.
|
⯀
|
a first tranche of €16 million, received in October 2018, subject to a 6% fixed rate and that will be fully repaid within five years of disbursement;
|
⯀
|
a second tranche of €14 million, received in March 2019, subject to a 5% fixed rate, with repayments beginning in 2021 and continuing into 2024; and
|
⯀
|
a last tranche of €10 million, subject to a 4% fixed rate, that will be fully repaid after a period of five years, which begins within one year of obtaining it.
|
⯀
|
Determination of the recommended dose at 22% of the tumor volume for head and neck cancers treatment following the end of the Phase I clinical trial with NBTXR3; and
|
⯀
|
Positive evaluation of the clinical benefit/risk ratio of NBTXR3 in the Phase II/III clinical trial in soft tissue sarcomas by the clinical expert mandated by the French notified body covering medical devices, GMED.
|
(a)
|
it is technically feasible to complete the development of the intangible asset so that it will be available for use or sale;
|
(b)
|
the Company intends to complete the development of the intangible asset and use or sell it;
|
(c)
|
the Company has the ability to use or sell the intangible asset;
|
(d)
|
it is probable that the intangible asset will generate future economic benefits;
|
(e)
|
adequate technical, financial and other resources are available to complete the development of the intangible asset; and
|
(f)
|
the Company is able to reliably measure the expenditures attributable to the development of the intangible asset.
|
(in thousands of euros)
|
| |
As of
January 1,
2019
|
| |
Increases
|
| |
Decreases
|
| |
Transfer
|
| |
As of
December 31,
2019
|
Patents
|
| |
65
|
| |
—
|
| |
—
|
| |
—
|
| |
65
|
Software
|
| |
293
|
| |
291
|
| |
—
|
| |
—
|
| |
584
|
Intangible assets in progress
|
| |
—
|
| |
61
|
| |
—
|
| |
—
|
| |
61
|
Gross book value of intangible assets
|
| |
358
|
| |
353
|
| |
—
|
| |
—
|
| |
710
|
Patents
|
| |
(65)
|
| |
—
|
| |
—
|
| |
—
|
| |
(65)
|
Software
|
| |
(191)
|
| |
(292)
|
| |
—
|
| |
—
|
| |
(483)
|
Accumulated depreciation of intangible assets(1)
|
| |
(256)
|
| |
(292)
|
| |
—
|
| |
—
|
| |
(548)
|
Net book value of intangible assets
|
| |
102
|
| |
61
|
| |
—
|
| |
—
|
| |
163
|
(1)
|
Expenses for the period are detailed in Note 16.4 Depreciation, amortization and provisions expenses
|
(in thousands of euros)
|
| |
As of
January 1,
2018
|
| |
Increases
|
| |
Decreases
|
| |
Transfer
|
| |
As of
December 31,
2018
|
Patents
|
| |
65
|
| |
—
|
| |
—
|
| |
—
|
| |
65
|
Software
|
| |
202
|
| |
90
|
| |
—
|
| |
—
|
| |
293
|
Other intangible assets
|
| |
35
|
| |
—
|
| |
—
|
| |
(35)
|
| |
—
|
Gross book value of intangible assets
|
| |
302
|
| |
90
|
| |
—
|
| |
(35)
|
| |
358
|
Patents
|
| |
(65)
|
| |
—
|
| |
—
|
| |
—
|
| |
(65)
|
Software
|
| |
(101)
|
| |
(90)
|
| |
—
|
| |
—
|
| |
(191)
|
Accumulated depreciation of intangible assets(1)
|
| |
(166)
|
| |
(90)
|
| |
—
|
| |
—
|
| |
(256)
|
Net book value of intangible assets
|
| |
136
|
| |
—
|
| |
—
|
| |
(35)
|
| |
102
|
(1)
|
Expenses for the period are detailed in Note 16.4 Depreciation, amortization and provisions expenses
|
–
|
General fixtures and fittings, building work: 5 to 10 years;
|
–
|
Technical installations, equipment and industrial tooling: 3 to 10 years; and
|
–
|
Office and IT equipment and furniture: 1 to 10 years.
|
(in thousands of euros)
|
| |
As of
January 1,
2019
|
| |
Increases
|
| |
Decreases
|
| |
Other
movements &
transfer
|
| |
Currency
translation
|
| |
As of
December 31,
2019
|
Fixtures, fittings and installations
|
| |
2,480
|
| |
815
|
| |
—
|
| |
2
|
| |
—
|
| |
3,297
|
Right of use – Buildings(1)
|
| |
5,416
|
| |
1,349
|
| |
—
|
| |
—
|
| |
—
|
| |
6,765
|
Technical equipment
|
| |
1,925
|
| |
120
|
| |
—
|
| |
(25)
|
| |
—
|
| |
2,019
|
Office and IT equipment
|
| |
828
|
| |
145
|
| |
(13)
|
| |
(4)
|
| |
—
|
| |
957
|
Transport equipment
|
| |
33
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
34
|
Right of use – Transport equipment(1)
|
| |
83
|
| |
82
|
| |
(51)
|
| |
—
|
| |
—
|
| |
115
|
Tangible assets in progress
|
| |
—
|
| |
11
|
| |
—
|
| |
—
|
| |
—
|
| |
11
|
Prepayments on tangible assets
|
| |
2
|
| |
—
|
| |
—
|
| |
(2)
|
| |
—
|
| |
—
|
Gross book value of tangible assets
|
| |
10,768
|
| |
2,522
|
| |
(64)
|
| |
(29)
|
| |
—
|
| |
13,197
|
Fixtures, fittings and installations
|
| |
(750)
|
| |
(251)
|
| |
—
|
| |
—
|
| |
—
|
| |
(1,001)
|
Right of use – Buildings(1)
|
| |
—
|
| |
(829)
|
| |
—
|
| |
—
|
| |
—
|
| |
(829)
|
Technical equipment
|
| |
(1,123)
|
| |
(175)
|
| |
—
|
| |
25
|
| |
—
|
| |
(1,272)
|
Office and IT equipment
|
| |
(483)
|
| |
(162)
|
| |
12
|
| |
4
|
| |
—
|
| |
(629)
|
Transport equipment
|
| |
(28)
|
| |
(6)
|
| |
—
|
| |
—
|
| |
—
|
| |
(34)
|
Right of use – Transport equipment(1)
|
| |
—
|
| |
(55)
|
| |
10
|
| |
—
|
| |
—
|
| |
(45)
|
Accumulated depreciation of tangible assets(2)
|
| |
(2,384)
|
| |
(1,478)
|
| |
22
|
| |
29
|
| |
—
|
| |
(3,811)
|
Net book value of tangible assets
|
| |
8,384
|
| |
1,044
|
| |
(42)
|
| |
—
|
| |
—
|
| |
9,386
|
(1)
|
See Note 2.1 for further details on the IFRS 16 first application
|
(2)
|
Expenses for the period are detailed in Note 16.4 Depreciation, amortization and provisions expenses
|
(in thousands of euros)
|
| |
As of
January 1,
2018
|
| |
Increases
|
| |
Decreases
|
| |
Transfer of
assets in
progress
|
| |
Currency
translation
|
| |
As of
December 31,
2018
|
Fixtures, fittings and installations
|
| |
2,166
|
| |
135
|
| |
—
|
| |
179
|
| |
—
|
| |
2,480
|
Technical equipment
|
| |
1,868
|
| |
57
|
| |
—
|
| |
—
|
| |
—
|
| |
1,925
|
Office and IT equipment
|
| |
616
|
| |
206
|
| |
(1)
|
| |
6
|
| |
1
|
| |
828
|
Transport equipment
|
| |
32
|
| |
—
|
| |
—
|
| |
—
|
| |
1
|
| |
33
|
Tangible assets in progress
|
| |
163
|
| |
16
|
| |
—
|
| |
(179)
|
| |
—
|
| |
—
|
Prepayments on tangible assets
|
| |
—
|
| |
2
|
| |
—
|
| |
—
|
| |
—
|
| |
2
|
Gross book value of tangible assets
|
| |
4,845
|
| |
416
|
| |
(1)
|
| |
6
|
| |
2
|
| |
5,268
|
Fixtures, fittings and installations
|
| |
(527)
|
| |
(223)
|
| |
—
|
| |
—
|
| |
—
|
| |
(750)
|
Technical equipment
|
| |
(953)
|
| |
(170)
|
| |
—
|
| |
—
|
| |
—
|
| |
(1,123)
|
Office and IT equipment
|
| |
(358)
|
| |
(125)
|
| |
—
|
| |
—
|
| |
—
|
| |
(483)
|
Transport equipment
|
| |
(16)
|
| |
(12)
|
| |
1
|
| |
—
|
| |
(1)
|
| |
(28)
|
Accumulated depreciation of tangible assets(1)
|
| |
(1,854)
|
| |
(529)
|
| |
1
|
| |
—
|
| |
(1)
|
| |
(2,384)
|
Net book value of tangible assets
|
| |
2,990
|
| |
(113)
|
| |
—
|
| |
6
|
| |
1
|
| |
2,884
|
(1)
|
Expenses for the period are detailed in Note 16.4 Depreciation, amortization and provisions expenses
|
⯀
|
Financial assets at fair value through profit and loss; and
|
⯀
|
Financial assets at amortized cost.
|
(a)
|
The financial asset is held within a business model whose objective is to hold financial assets in order to collect contractual cash flows; and
|
(b)
|
The contractual terms of the financial asset give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding.
|
(in thousands of euros)
|
| |
Liquidity
contract -
Cash
account(1)
|
| |
Other long-
term
investments
pledged as
collateral
|
| |
Security
deposits paid
|
| |
Total
|
Net book value as of January 1, 2018
|
| |
273
|
| |
500
|
| |
459
|
| |
1,232
|
Additions
|
| |
—
|
| |
—
|
| |
7
|
| |
7
|
Decreases
|
| |
(97)
|
| |
—
|
| |
(83)
|
| |
(180)
|
Reclassifications
|
| |
—
|
| |
(500)
|
| |
—
|
| |
(500)
|
Currency translation adjustments
|
| |
—
|
| |
—
|
| |
1
|
| |
1
|
Net book value as of December 31, 2018
|
| |
176
|
| |
—
|
| |
383
|
| |
558
|
Additions
|
| |
—
|
| |
—
|
| |
65
|
| |
65
|
Decreases
|
| |
(45)
|
| |
—
|
| |
(49)
|
| |
(94)
|
Net book value as of December 31, 2019
|
| |
131
|
| |
—
|
| |
399
|
| |
529
|
(1)
|
See Note 10.2 Treasury shares
|
(in thousands of euros)
|
| |
As of
December 31,
2019
|
| |
As of
December 31,
2018
|
Trade receivables
|
| |
11
|
| |
25
|
Trade receivables
|
| |
11
|
| |
25
|
(in thousands of euros)
|
| |
As of
December 31,
2019
|
| |
As of
December 31,
2018
|
Due in 3 months or less
|
| |
11
|
| |
25
|
Due between 3 and 6 months
|
| |
—
|
| |
—
|
Due between 6 and 12 months
|
| |
—
|
| |
—
|
Due after more than 12 months
|
| |
—
|
| |
—
|
Trade receivables
|
| |
11
|
| |
25
|
(in thousands of euros)
|
| |
As of
December 31,
2019
|
| |
As of
December 31,
2018
|
Research tax credit receivable
|
| |
5,688
|
| |
3,251
|
VAT receivable
|
| |
1,419
|
| |
1,104
|
Prepaid expenses
|
| |
2,671
|
| |
1,095
|
Other receivables
|
| |
1,245
|
| |
972
|
Other current assets
|
| |
11,022
|
| |
6,422
|
(in thousands of euros)
|
| |
As of
December 31,
2019
|
| |
As of
December 31,
2018
|
Short-term bank deposits
|
| |
10,000
|
| |
11,503
|
Cash and bank accounts
|
| |
25,094
|
| |
24,700
|
Net cash and cash equivalents
|
| |
35,094
|
| |
36,203
|
(in thousands or number of shares)
Date
|
| |
Nature of transaction
|
| |
Share
Capital
|
| |
Premiums
related to share
capital
|
| |
Number of
shares
|
January 1, 2018
|
| |
|
| |
589
|
| |
123,782
|
| |
19,633,373
|
May 14, 2018
|
| |
Subscription of 2018 warrants
|
| |
—
|
| |
13
|
| |
—
|
June 1, 2018
|
| |
Subscription of 2018 warrants
|
| |
—
|
| |
6
|
| |
—
|
June 3, 2018
|
| |
Subscription of 2018 warrants
|
| |
—
|
| |
5
|
| |
—
|
June 6, 2018
|
| |
Subscription of 2018 warrants
|
| |
—
|
| |
21
|
| |
—
|
June 30, 2018
|
| |
Grant of 2018 free shares
|
| |
—
|
| |
(12)
|
| |
—
|
August 28, 2018
|
| |
Subscription of 2018 warrants
|
| |
—
|
| |
14
|
| |
—
|
August 28, 2018
|
| |
Grant of 2018 free shares
|
| |
—
|
| |
(0)
|
| |
—
|
December 31, 2018
|
| |
U.S. Initial public offering costs
|
| |
—
|
| |
(1,030)
|
| |
—
|
December 31, 2018
|
| |
|
| |
589
|
| |
122,799
|
| |
19,633,373
|
March 29, 2019
|
| |
Grant of 2019 free shares
|
| |
—
|
| |
(13)
|
| |
—
|
April 9, 2019
|
| |
Capital increase
|
| |
77
|
| |
29,440
|
| |
2,566,666
|
April 9, 2019
|
| |
Cost of capital increase
|
| |
—
|
| |
(1,438)
|
| |
—
|
April 25, 2019
|
| |
Exercise of 2012 founders’ warrants
|
| |
5
|
| |
955
|
| |
160,000
|
May 1, 2019
|
| |
Subscription of 2019 warrants
|
| |
—
|
| |
3
|
| |
—
|
May 21, 2019
|
| |
Subscription of 2019 warrants
|
| |
—
|
| |
6
|
| |
—
|
June 24, 2019
|
| |
Subscription of 2019 warrants
|
| |
—
|
| |
3
|
| |
—
|
June 25, 2019
|
| |
Subscription of 2019 warrants
|
| |
—
|
| |
3
|
| |
—
|
June 28, 2019
|
| |
Subscription of 2019 warrants
|
| |
—
|
| |
5
|
| |
—
|
July 17, 2019
|
| |
Exercise of 2013 founders’ warrants
|
| |
2
|
| |
345
|
| |
55,000
|
December 31, 2019
|
| |
U.S. Initial public offering costs reversal
|
| |
—
|
| |
1,030
|
| |
—
|
December 31, 2019
|
| |
|
| |
672
|
| |
153,139
|
| |
22,415,039
|
Type
|
| |
Grant date
|
| |
Exercise
price
(in euros)
|
| |
Outstanding
at Jan. 1,
2019
|
| |
Issued
|
| |
Exercised
|
| |
Forfeited
|
| |
Outstanding
at Dec. 31,
2019
|
| |
Number of
shares
issuable
|
BSA 04-12
|
| |
May 4, 2012
|
| |
6.00
|
| |
30,000
|
| |
—
|
| |
—
|
| |
—
|
| |
30,000
|
| |
30,000
|
BSA 2013
|
| |
April 10, 2013
|
| |
6.37
|
| |
6,000
|
| |
—
|
| |
—
|
| |
—
|
| |
6,000
|
| |
6,000
|
BSA 2014
|
| |
Sept. 16, 2014
|
| |
17.67
|
| |
10,000
|
| |
—
|
| |
—
|
| |
—
|
| |
10,000
|
| |
10,000
|
BSA 2015-1
|
| |
February 10, 2015
|
| |
17.67
|
| |
4,000
|
| |
—
|
| |
—
|
| |
—
|
| |
4,000
|
| |
4,000
|
BSA 2015-1
|
| |
February 10, 2015
|
| |
17.67
|
| |
17,000
|
| |
—
|
| |
—
|
| |
—
|
| |
17,000
|
| |
17,000
|
BSA 2015-2(a)
|
| |
June 25, 2015
|
| |
19.54
|
| |
64,000
|
| |
—
|
| |
—
|
| |
—
|
| |
64,000
|
| |
64,000
|
BSA 2015-2(b)
|
| |
June 25, 2015
|
| |
19.54
|
| |
6,000
|
| |
—
|
| |
—
|
| |
—
|
| |
6,000
|
| |
6,000
|
BSA 2016
|
| |
February 2, 2016
|
| |
13.74
|
| |
36,208
|
| |
—
|
| |
—
|
| |
—
|
| |
36,208
|
| |
36,208
|
BSA 2016-2
|
| |
November 3, 2016
|
| |
15.01
|
| |
8,000
|
| |
—
|
| |
—
|
| |
—
|
| |
8,000
|
| |
8,000
|
BSA 2017
|
| |
January 7, 2017
|
| |
15.76
|
| |
18,000
|
| |
—
|
| |
—
|
| |
—
|
| |
18,000
|
| |
18,000
|
BSA 2018-1
|
| |
March 6, 2018
|
| |
13.55
|
| |
28,000
|
| |
—
|
| |
—
|
| |
—
|
| |
28,000
|
| |
28,000
|
BSA 2018-2
|
| |
July 27, 2018
|
| |
16.102
|
| |
5,820
|
| |
—
|
| |
—
|
| |
—
|
| |
5,820
|
| |
5,820
|
BSA 2019-1
|
| |
March 29, 2019
|
| |
11.66
|
| |
—
|
| |
18,000
|
| |
—
|
| |
—
|
| |
18,000
|
| |
18,000
|
Total
|
| |
|
| |
|
| |
233,028
|
| |
18,000
|
| |
—
|
| |
—
|
| |
251,028
|
| |
251,028
|
Type
|
| |
Grant date
|
| |
Exercise
price
(in euros)
|
| |
Outstanding
at Jan. 1,
2018
|
| |
Issued
|
| |
Exercised
|
| |
Forfeited
|
| |
Outstanding
at Dec. 31,
2018
|
| |
Number of
shares
issuable
|
BSA 04-12
|
| |
May 04, 2012
|
| |
6.00
|
| |
30,000
|
| |
—
|
| |
—
|
| |
—
|
| |
30,000
|
| |
30,000
|
BSA 2013
|
| |
April 10, 2013
|
| |
6.37
|
| |
6,000
|
| |
—
|
| |
—
|
| |
—
|
| |
6,000
|
| |
6,000
|
BSA 2014
|
| |
Sept. 16, 2014
|
| |
17.67
|
| |
10,000
|
| |
—
|
| |
—
|
| |
—
|
| |
10,000
|
| |
10,000
|
BSA 2015-1
|
| |
February 10, 2015
|
| |
17.67
|
| |
4,000
|
| |
—
|
| |
—
|
| |
—
|
| |
4,000
|
| |
4,000
|
BSA 2015-1
|
| |
February 10, 2015
|
| |
17.67
|
| |
17,000
|
| |
—
|
| |
—
|
| |
—
|
| |
17,000
|
| |
17,000
|
BSA 2015-2(a)
|
| |
June 25, 2015
|
| |
19.54
|
| |
64,000
|
| |
—
|
| |
—
|
| |
—
|
| |
64,000
|
| |
64,000
|
BSA 2015-2(b)
|
| |
June 25, 2015
|
| |
19.54
|
| |
6,000
|
| |
—
|
| |
—
|
| |
—
|
| |
6,000
|
| |
6,000
|
BSA 2016
|
| |
February 2, 2016
|
| |
13.74
|
| |
36,208
|
| |
—
|
| |
—
|
| |
—
|
| |
36,208
|
| |
36,208
|
BSA 2016-2
|
| |
November 3, 2016
|
| |
15.01
|
| |
8,000
|
| |
—
|
| |
—
|
| |
—
|
| |
8,000
|
| |
8,000
|
BSA 2017
|
| |
January 7, 2017
|
| |
15.76
|
| |
18,000
|
| |
—
|
| |
—
|
| |
—
|
| |
18,000
|
| |
18,000
|
BSA 2018-1
|
| |
March 6, 2018
|
| |
13.55
|
| |
—
|
| |
28,000
|
| |
—
|
| |
—
|
| |
28,000
|
| |
28,000
|
BSA 2018-2
|
| |
July 27, 2018
|
| |
16.102
|
| |
—
|
| |
5,820
|
| |
—
|
| |
—
|
| |
5,820
|
| |
5,820
|
Total
|
| |
|
| |
|
| |
199,208
|
| |
33,820
|
| |
—
|
| |
—
|
| |
233,028
|
| |
233,028
|
Type
|
| |
Grant date
|
| |
Exercise
price
(in euros)
|
| |
Outstanding
at Jan. 1,
2019
|
| |
Issued
|
| |
Exercised
|
| |
Forfeited
|
| |
Outstanding
at Dec. 31,
2019
|
| |
Number of
shares
issuable
|
BSPCE 2012-1
|
| |
May 4, 2012
|
| |
6.00
|
| |
1,674,548
|
| |
—
|
| |
(160,000)
|
| |
(1,514,548)
|
| |
—
|
| |
—
|
BSPCE 2012-2
|
| |
December 18, 2012
|
| |
6.63
|
| |
100,000
|
| |
—
|
| |
—
|
| |
—
|
| |
100,000
|
| |
100,000
|
BSPCE 04-2013
|
| |
April 10, 2013
|
| |
6.30
|
| |
55,000
|
| |
—
|
| |
(55,000)
|
| |
—
|
| |
—
|
| |
—
|
BSPCE 08-2013
|
| |
August 28, 2013
|
| |
5.92
|
| |
50,000
|
| |
—
|
| |
—
|
| |
—
|
| |
50,000
|
| |
50,000
|
BSPCE 09-2014
|
| |
September 16, 2014
|
| |
18.68
|
| |
92,100
|
| |
—
|
| |
—
|
| |
—
|
| |
92,100
|
| |
92,100
|
BSPCE 2015-1
|
| |
February 10, 2015
|
| |
18.57
|
| |
70,950
|
| |
—
|
| |
—
|
| |
—
|
| |
70,950
|
| |
70,950
|
BSPCE 2015-3
|
| |
June 10, 2015
|
| |
20.28
|
| |
39,750
|
| |
—
|
| |
—
|
| |
(1,350)
|
| |
38,400
|
| |
38,400
|
BSPCE 2016
|
| |
February 2, 2016
|
| |
14.46
|
| |
220,967
|
| |
—
|
| |
—
|
| |
(7,998)
|
| |
212,969
|
| |
212,969
|
BSPCE 2017
|
| |
January 7, 2017
|
| |
15.93
|
| |
202,417
|
| |
—
|
| |
—
|
| |
(15,251)
|
| |
187,166
|
| |
187,166
|
Total
|
| |
|
| |
|
| |
2,505,732
|
| |
—
|
| |
(215,000)
|
| |
(1,539,147)
|
| |
751,585
|
| |
751,585
|
Type
|
| |
Grant date
|
| |
Exercise
price
(in euros)
|
| |
Outstanding
at Jan. 1,
2018
|
| |
Issued
|
| |
Exercised
|
| |
Forfeited
|
| |
Outstanding
at Dec. 31,
2018
|
| |
Number of
shares
issuable
|
BSPCE 2012-1
|
| |
May 4, 2012
|
| |
6.00
|
| |
1,674,548
|
| |
—
|
| |
—
|
| |
—
|
| |
1,674,548
|
| |
1,674,548
|
BSPCE 2012-2
|
| |
December 18, 2012
|
| |
6.63
|
| |
100,000
|
| |
—
|
| |
—
|
| |
—
|
| |
100,000
|
| |
100,000
|
BSPCE 04-2013
|
| |
April 10, 2013
|
| |
6.30
|
| |
55,000
|
| |
—
|
| |
—
|
| |
—
|
| |
55,000
|
| |
55,000
|
BSPCE 08-2013
|
| |
August 28, 2013
|
| |
5.92
|
| |
50,000
|
| |
—
|
| |
—
|
| |
—
|
| |
50,000
|
| |
50,000
|
BSPCE 09-2014
|
| |
September 16, 2014
|
| |
18.68
|
| |
92,100
|
| |
—
|
| |
—
|
| |
—
|
| |
92,100
|
| |
92,100
|
BSPCE 2015-1
|
| |
February 10, 2015
|
| |
18.57
|
| |
70,950
|
| |
—
|
| |
—
|
| |
—
|
| |
70,950
|
| |
70,950
|
BSPCE 2015-3
|
| |
June 10, 2015
|
| |
20.28
|
| |
41,383
|
| |
—
|
| |
—
|
| |
(1,633)
|
| |
39,750
|
| |
39,750
|
BSPCE 2016
|
| |
February 2, 2016
|
| |
14.46
|
| |
230,309
|
| |
—
|
| |
—
|
| |
(9,342)
|
| |
220,967
|
| |
220,967
|
BSPCE 2017
|
| |
January 7, 2017
|
| |
15.93
|
| |
288,350
|
| |
—
|
| |
—
|
| |
(85,933)
|
| |
202,417
|
| |
202,417
|
Total
|
| |
|
| |
|
| |
2,602,640
|
| |
—
|
| |
—
|
| |
(96,908)
|
| |
2,505,732
|
| |
2,505,732
|
Type
|
| |
Grant date
|
| |
Exercise
price
(in euros)
|
| |
Outstanding
at Jan. 1,
2019
|
| |
Issued
|
| |
Exercised
|
| |
Forfeited
|
| |
Outstanding
at Dec. 31,
2019
|
| |
Number of
shares
issuable
|
OSA 2016-1
|
| |
February 2, 2016
|
| |
13.05
|
| |
400
|
| |
—
|
| |
—
|
| |
—
|
| |
400
|
| |
400
|
OSA 2016-2
|
| |
November 3, 2016
|
| |
14.26
|
| |
4,000
|
| |
—
|
| |
—
|
| |
—
|
| |
4,000
|
| |
4,000
|
OSA 2017
|
| |
January 7, 2017
|
| |
14.97
|
| |
500
|
| |
—
|
| |
—
|
| |
—
|
| |
500
|
| |
500
|
OSA 2018
|
| |
March 6, 2018
|
| |
12.87
|
| |
58,000
|
| |
—
|
| |
—
|
| |
(4,000)
|
| |
54,000
|
| |
54,000
|
OSA 2019-1
|
| |
March 29, 2019
|
| |
11.08
|
| |
—
|
| |
37,500
|
| |
—
|
| |
(7,250)
|
| |
30,250
|
| |
30,250
|
OSA LLY 2019
|
| |
October 24, 2019
|
| |
6.41
|
| |
—
|
| |
500,000
|
| |
—
|
| |
—
|
| |
500,000
|
| |
500,000
|
Total
|
| |
|
| |
|
| |
62,900
|
| |
537,500
|
| |
—
|
| |
(11,250)
|
| |
589,150
|
| |
589,150
|
Type
|
| |
Grant date
|
| |
Exercise
price
(in euros)
|
| |
Outstanding
at Jan. 1,
2018
|
| |
Issued
|
| |
Exercised
|
| |
Forfeited
|
| |
Outstanding
at Dec. 31,
2018
|
| |
Number of
shares
issuable
|
OSA 2016-1
|
| |
February 2, 2016
|
| |
13.05
|
| |
14,400
|
| |
—
|
| |
—
|
| |
(14,000)
|
| |
400
|
| |
400
|
OSA 2016-2
|
| |
November 3, 2016
|
| |
14.26
|
| |
4,000
|
| |
—
|
| |
—
|
| |
—
|
| |
4,000
|
| |
4,000
|
OSA 2017
|
| |
January 7, 2017
|
| |
14.97
|
| |
7,850
|
| |
—
|
| |
—
|
| |
(7,350)
|
| |
500
|
| |
500
|
OSA 2018
|
| |
March 6, 2018
|
| |
12.87
|
| |
—
|
| |
62,000
|
| |
—
|
| |
(4,000)
|
| |
58,000
|
| |
58,000
|
Total
|
| |
|
| |
|
| |
26,250
|
| |
62,000
|
| |
—
|
| |
(25,350)
|
| |
62,900
|
| |
62,900
|
Type
|
| |
Grant date
|
| |
Exercise
price
(in euros)
|
| |
Outstanding
at Jan. 1,
2019
|
| |
Issued
|
| |
Exercised
|
| |
Forfeited
|
| |
Outstanding
at Dec. 31,
2019
|
| |
Number of
shares
exercisable
|
AGA 2018-1
|
| |
March 6, 2018
|
| |
n.a.
|
| |
369,250
|
| |
—
|
| |
—
|
| |
(14,000)
|
| |
355,250
|
| |
355,250
|
AGA 2018-2
|
| |
July 27, 2018
|
| |
n.a.
|
| |
6,000
|
| |
—
|
| |
—
|
| |
—
|
| |
6,000
|
| |
6,000
|
AGA 2019-1
|
| |
March 29, 2019
|
| |
n.a.
|
| |
—
|
| |
438,250
|
| |
—
|
| |
(53,250)
|
| |
385,000
|
| |
385,000
|
Total
|
| |
|
| |
|
| |
375,250
|
| |
438,250
|
| |
—
|
| |
(67,250)
|
| |
746,250
|
| |
746,250
|
Type
|
| |
Grant date
|
| |
Exercise
price
(in euros)
|
| |
Outstanding
at Jan. 1,
2018
|
| |
Issued
|
| |
Exercised
|
| |
Forfeited
|
| |
Outstanding
at Dec. 31,
2018
|
| |
Number of
shares
exercisable
|
AGA 2018-1
|
| |
March 6, 2018
|
| |
n.a.
|
| |
—
|
| |
396,250
|
| |
—
|
| |
(27,000)
|
| |
369,250
|
| |
369,250
|
AGA 2018-2
|
| |
July 27, 2018
|
| |
n.a.
|
| |
—
|
| |
6,000
|
| |
—
|
| |
—
|
| |
6,000
|
| |
6,000
|
Total
|
| |
|
| |
|
| |
—
|
| |
402,250
|
| |
—
|
| |
(27,000)
|
| |
375,250
|
| |
375,250
|
-
|
Up to two third of the options can be exercised starting March 30, 2021; and
|
-
|
The remaining third can be exercised starting March 30, 2022.
|
-
|
10% of the options can be exercised as soon as the market share price of the Company on Euronext Paris reaches €24;
|
-
|
An additional 10% of the options can be exercised as soon as the market share price of the Company on Euronext in Paris reaches €30;
|
-
|
An additional 40% of the options can be exercised as soon as the market share price of the Company on Euronext in Paris reaches €40;
|
-
|
An additional 40% of the options can be exercised as soon as the market share price of the Company on Euronext in Paris reaches €60; and
|
-
|
In the 10 years after their grant date at the latest, the options which would not have been exercised by the end of this period of 10 years would be forfeited by law.
|
-
|
One third can be exercised with effect from March 7, 2019;
|
-
|
One third can be exercised with effect from March 7, 2020; and
|
-
|
One third can be exercised with effect from March 8, 2021.
|
-
|
Two thirds can be exercised with effect from March 7, 2019 and
|
-
|
One third can be exercised with effect from March 7, 2020.
|
−
|
An acquisition period of two years with effect on March 29, 2019. The granting conditions state that the subscriber must remain an employee of the Company during the acquisition period; and
|
−
|
A holding period of one year following the acquisition period.
|
−
|
An acquisition period of two years with effect on March 7, 2018, and subject to the condition that the subscriber must remain an employee of the Company during the acquisition period; and
|
−
|
A holding period of one year following the acquisition period.
|
−
|
An acquisition period of two years with effect on July 27, 2018. The employee does not have to remain an employee of the Company during this period; and
|
−
|
A holding period of 1 year following the acquisition period.
|
−
|
Lump-sum retirement benefit paid by the Company to employees upon retirement (defined benefit plan); and
|
−
|
Pension benefits paid by social security agencies, which are financed through employer and employee contributions (State defined contribution plan).
|
(in thousands of euros)
|
| |
As of
January 1,
2019
|
| |
Increases
|
| |
Decreases(1)
|
| |
As of
December 31,
2019
|
Lump-sum retirement benefits
|
| |
337
|
| |
82
|
| |
(88)
|
| |
331
|
Non-current provisions
|
| |
337
|
| |
82
|
| |
(88)
|
| |
331
|
Provisions for disputes
|
| |
55
|
| |
—
|
| |
(55)
|
| |
—
|
Provision for charges
|
| |
—
|
| |
164
|
| |
—
|
| |
164
|
Current provisions
|
| |
55
|
| |
164
|
| |
(55)
|
| |
164
|
Total provisions
|
| |
392
|
| |
246
|
| |
(143)
|
| |
495
|
(1)
|
See Statement of consolidated cash flows and Note 16.4 for the nature of these decreases
|
(in thousands of euros)
|
| |
As of
January 1,
2018
|
| |
Increases
|
| |
Decreases(1)
|
| |
As of
December 31,
2018
|
Lump-sum retirement benefits
|
| |
233
|
| |
104
|
| |
—
|
| |
337
|
Non-current provisions
|
| |
233
|
| |
104
|
| |
—
|
| |
337
|
Provisions for disputes
|
| |
105
|
| |
—
|
| |
(50)
|
| |
55
|
Current provisions
|
| |
105
|
| |
—
|
| |
(50)
|
| |
55
|
Total provisions
|
| |
338
|
| |
104
|
| |
(50)
|
| |
392
|
(1)
|
See Statement of consolidated cash flows and Note 16.4 for the nature of these decreases
|
(in thousands of euros)
|
| |
As of
December 31,
2019
|
| |
As of
December 31,
2018
|
Provision as of beginning of period
|
| |
337
|
| |
233
|
Expense for the period
|
| |
82
|
| |
55
|
Actuarial gains or losses recognized in other comprehensive income
|
| |
(88)
|
| |
48
|
Provision as of end of period
|
| |
331
|
| |
337
|
|
Measurement date
|
| |
December 31, 2019
|
| |
December 31, 2018
|
|
|
Retirement assumptions
|
| |
Management: Age 66
Non-management: Age 64
|
| |
Management: Age 66
Non-management: Age 64
|
|
|
Social security contribution rate
|
| |
43%
|
| |
43%
|
|
|
Discount rate
|
| |
0.85%
|
| |
1.81%
|
|
|
Mortality tables
|
| |
Regulatory table
INSEE 2012 -2014
|
| |
Regulatory table
INSEE 2012 -2014
|
|
|
Salary increase rate (including inflation)
|
| |
2.5 %
|
| |
2.5 %
|
|
|
Staff turnover
|
| |
Constant average rate of 5.86%
|
| |
Constant average rate of 3.71%
|
|
|
Duration
|
| |
17 years
|
| |
19 years
|
|
(in thousands of euros)
|
| |
As of
December 31,
2019
|
| |
As of
December 31,
2018
|
Lease liabilities – Short term
|
| |
591
|
| |
—
|
Repayable advances OSEO/Bpifrance loan - Short term
|
| |
500
|
| |
500
|
Total current financial liabilities
|
| |
1,091
|
| |
500
|
Lease liabilities – Long term
|
| |
5,814
|
| |
—
|
Repayable OSEO/Bpifrance loan advances – Long term
|
| |
2,875
|
| |
3,291
|
EIB loan – Long term
|
| |
34,746
|
| |
16,730
|
Total non-current financial liabilities
|
| |
43,435
|
| |
20,021
|
Total financial liabilities
|
| |
44,526
|
| |
20,521
|
−
|
The right of use amortization amount, computed on a straight-line basis at each closing date; and
|
−
|
A financial expense for the interest component associated with the rent payment (with the principal amount reducing the lease liability).
|
(in thousands of euros)
|
| |
OSEO 3
|
| |
Bpifrance
advance
|
| |
Interest-free
Bpifrance loan
|
| |
EIB loan
|
| |
Total
|
As of January 1, 2018
|
| |
247
|
| |
1,962
|
| |
1,880
|
| |
—
|
| |
4,088
|
Principal received
|
| |
—
|
| |
—
|
| |
—
|
| |
16,000
|
| |
16,000
|
Impact of discounting and accretion
|
| |
3
|
| |
122
|
| |
45
|
| |
(223)
|
| |
(53)
|
Accumulated fixed interest expense accrual
|
| |
—
|
| |
32
|
| |
—
|
| |
211
|
| |
243
|
Accumulated variable interest expense accrual
|
| |
—
|
| |
—
|
| |
—
|
| |
742
|
| |
742
|
Repayment
|
| |
(250)
|
| |
—
|
| |
(250)
|
| |
—
|
| |
(500)
|
As of December 31, 2018
|
| |
—
|
| |
2,116
|
| |
1,675
|
| |
16,730
|
| |
20,521
|
Principal received
|
| |
—
|
| |
—
|
| |
—
|
| |
14,000
|
| |
14,000
|
Impact of discounting and accretion
|
| |
—
|
| |
32
|
| |
36
|
| |
(1,422)
|
| |
(1,354)
|
Accumulated fixed interest expense accrual
|
| |
—
|
| |
16
|
| |
—
|
| |
1,545
|
| |
1,561
|
Accumulated variable interest expense accrual
|
| |
—
|
| |
—
|
| |
—
|
| |
4,243
|
| |
4,243
|
Repayment
|
| |
—
|
| |
—
|
| |
(500)
|
| |
(350)
|
| |
(850)
|
As of December 31, 2019
|
| |
—
|
| |
2,165
|
| |
1,210
|
| |
34,746
|
| |
38,121
|
(in thousands of euros)
|
| |
BNP
|
As of January 1, 2018
|
| |
428
|
Financial expenses on liabilities
|
| |
—
|
Repayment of principal
|
| |
(427)
|
Payment of interest
|
| |
(1)
|
As of December 31, 2018
|
| |
—
|
Financial expenses on liabilities
|
| |
—
|
Repayment of principal
|
| |
—
|
Payment of interest
|
| |
—
|
As of December 31, 2019
|
| |
—
|
(in thousands of euros)
|
| |
Lease
liabilities
|
As of December 31, 2018
|
| |
—
|
Impact of IFRS 16 first application(1)
|
| |
5,569
|
As of January 1, 2019
|
| |
5,569
|
New lease contracts
|
| |
1,991
|
Impact of discounting of the new lease contracts
|
| |
(399)
|
Fixed interest expense
|
| |
359
|
Repayment of lease
|
| |
(1,067)
|
Early termination of moveable lease contracts during 2019
|
| |
(48)
|
As of December 31, 2019
|
| |
6,405
|
(1)
|
See Note 2.1 Impact of IFRS 16 first application for further details
|
|
| |
As of December 31, 2019
|
||||||||||||
(in thousands of euros)
|
| |
Less than
1 year
|
| |
Between 1 and
3 years
|
| |
Between 3 and
5 years
|
| |
More than
5 years
|
| |
Total
|
Bpifrance
|
| |
—
|
| |
300
|
| |
1,300
|
| |
639
|
| |
2,239
|
Interest-free Bpifrance loan
|
| |
500
|
| |
750
|
| |
—
|
| |
—
|
| |
1,250
|
EIB loan
|
| |
700
|
| |
8,225
|
| |
28,762
|
| |
—
|
| |
37,687
|
Lease liabilities
|
| |
1,131
|
| |
2,241
|
| |
2,160
|
| |
3,379
|
| |
8,911
|
Total
|
| |
2,331
|
| |
11,516
|
| |
32,222
|
| |
4,018
|
| |
50,087
|
(in thousands of euros)
|
| |
As of
December 31,
2019
|
| |
As of
December 31,
2018
|
Accrued expenses - clinical trials
|
| |
1,620
|
| |
1,973
|
Other trade payables
|
| |
6,150
|
| |
4,536
|
Total trade and other payables
|
| |
7,770
|
| |
6,509
|
(in thousands of euros)
|
| |
As of
December 31,
2019
|
| |
As of
December 31,
2018
|
Tax liabilities
|
| |
216
|
| |
180
|
Payroll tax and other payroll liabilities
|
| |
4,912
|
| |
3,928
|
Other payables
|
| |
193
|
| |
425
|
Other current liabilities
|
| |
5,322
|
| |
4,533
|
−
|
Rent deferral for the Company’s facilities in Villejuif and Wattignies decreased by €183 thousand, following the reclassification associated with the first application of IFRS 16 at January 1, 2019 (see Note 2.1 Impact of IFRS 16 first application), compared to €183 thousand as of December 31, 2018; and
|
−
|
An accrued income of €138 thousand as of December 31, 2019, compared to an aggregate amount of €93 thousand related to the Bpifrance advance as of December 31, 2018.
|
|
| |
As of December 31, 2019
|
|||||||||
(in thousands of euros)
|
| |
Book value on
the statement
of financial
position
|
| |
Financial assets
carried at fair
value through
profit or loss
|
| |
Assets and
liabilities
carried at
amortized cost
|
| |
Fair value
|
Non-current financial assets
|
| |
|
| |
|
| |
|
| |
|
Non-current financial assets
|
| |
529
|
| |
130
|
| |
399
|
| |
529
|
Trade receivables
|
| |
11
|
| |
—
|
| |
11
|
| |
11
|
Cash and cash equivalents
|
| |
35,094
|
| |
—
|
| |
35,094
|
| |
35,094
|
Total assets
|
| |
35,634
|
| |
130
|
| |
35,504
|
| |
35,634
|
Financial liabilities
|
| |
|
| |
|
| |
|
| |
|
Non-current financial liabilities
|
| |
43,435
|
| |
—
|
| |
43,435
|
| |
43,435(1)
|
Current financial liabilities
|
| |
1,091
|
| |
—
|
| |
1,091
|
| |
1,091
|
Trade payables and other payables
|
| |
7,770
|
| |
—
|
| |
7,770
|
| |
7,770
|
Total liabilities
|
| |
52,296
|
| |
—
|
| |
52,296
|
| |
52,296
|
(1)
|
The fair value of non-current and current financial liabilities consisting of the Bpifrance loan and the EIB loan recorded at amortized cost was assessed using unobservable “level 3” inputs
|
|
| |
As of December 31, 2018
|
|||||||||
(in thousands of euros)
|
| |
Book value on
the statement
of financial
position
|
| |
Financial
assets carried
at fair value
through profit
or loss
|
| |
Assets and
liabilities
carried at
amortized cost
|
| |
Fair value
|
Non-current financial assets
|
| |
|
| |
|
| |
|
| |
|
Non-current financial assets
|
| |
558
|
| |
176
|
| |
383
|
| |
558
|
Trade receivables
|
| |
25
|
| |
—
|
| |
25
|
| |
25
|
Cash and cash equivalents
|
| |
36,203
|
| |
—
|
| |
36,203
|
| |
36,203
|
Total assets
|
| |
36,787
|
| |
176
|
| |
36,611
|
| |
36,787
|
Financial liabilities
|
| |
|
| |
|
| |
|
| |
|
Non-current financial liabilities
|
| |
20,021
|
| |
—
|
| |
20,021
|
| |
20,021
|
Current financial liabilities
|
| |
500
|
| |
—
|
| |
500
|
| |
500
|
Trade payables and other payables
|
| |
6,509
|
| |
—
|
| |
6,509
|
| |
6,509
|
Total liabilities
|
| |
27,030
|
| |
—
|
| |
27,030
|
| |
27,030
|
|
| |
For the year ended December 31,
|
|||
(in thousands of euros)
|
| |
2019
|
| |
2018
|
Cost of gross debt
|
| |
1,354
|
| |
53
|
Income from cash equivalents
|
| |
105
|
| |
34
|
Total fair value through profit or loss
|
| |
1,459
|
| |
87
|
|
| |
For the year ended December 31, 2019
|
|||||||||
Impact
(in thousands of euros)
|
| |
Net income
|
| |
Equity
|
||||||
|
Increase
|
| |
Decrease
|
| |
Increase
|
| |
Decrease
|
||
USD / Euro exchange rate
|
| |
41
|
| |
(41)
|
| |
141
|
| |
(141)
|
Total
|
| |
41
|
| |
(41)
|
| |
141
|
| |
(141)
|
|
| |
For the year ended December 31, 2018
|
|||||||||
Impact
(in thousands of euros)
|
| |
Net income
|
| |
Equity
|
||||||
|
Increase
|
| |
Decrease
|
| |
Increase
|
| |
Decrease
|
||
USD / Euro exchange rate
|
| |
29
|
| |
(29)
|
| |
178
|
| |
(178)
|
Total
|
| |
29
|
| |
(29)
|
| |
178
|
| |
(178)
|
⯀
|
Development services performed by the Company to create or enhance an intellectual property controlled by the client, for which revenue is recognized over time, when services are rendered;
|
⯀
|
A transfer of control of an existing intellectual property of the Company for which revenue is recognized at the time such control is transferred;
|
⯀
|
A license:
|
−
|
If the license is assessed to be a right to access the Company’s intellectual property as it exists throughout the license period, revenue is recognized over the license period; or
|
−
|
If the license is a right to use the Company’s intellectual property as it exists (in term of forms and functionality), revenue is recognized when the other party is able to use and benefit from the license; or
|
⯀
|
Product supply for which the revenue is recognized once the control over the delivered products is transferred.
|
⯀
|
the license of the right to use the Company’s patent and know-how;
|
⯀
|
the support provided by the Company to PharmaEngine until the first regulatory approval is granted in PharmaEngine’s territory that the Company views as a series of distinct periods of access to information and experience that is satisfied over time; and
|
⯀
|
the supply of NBTXR3 to PharmaEngine.
|
|
| |
For the year ended December 31,
|
|||
(in thousands of euros)
|
| |
2019
|
| |
2018
|
Services
|
| |
40
|
| |
109
|
Other sales
|
| |
28
|
| |
7
|
Total revenues
|
| |
68
|
| |
116
|
Research tax credit
|
| |
2,437
|
| |
3,251
|
Subsidies
|
| |
20
|
| |
90
|
Other
|
| |
17
|
| |
22
|
Total other income
|
| |
2,474
|
| |
3,363
|
Total revenues and other income
|
| |
2,542
|
| |
3,479
|
|
| |
For the year ended December 31,
|
|||
(in thousands of euros)
|
| |
2019
|
| |
2018
|
Purchases, sub-contracting and other expenses
|
| |
(16,804)
|
| |
(11,358)
|
Payroll costs (including share-based payments)
|
| |
(11,980)
|
| |
(9,002)
|
Depreciation, amortization and provision expenses(1)
|
| |
(1,627)
|
| |
(534)
|
Total research and development expenses
|
| |
(30,411)
|
| |
(20,893)
|
(1)
|
See Note 16.4
|
|
| |
For the year ended December 31,
|
|||
(in thousands of euros)
|
| |
2019
|
| |
2018
|
Rent, fees and other expenses
|
| |
(9,435)
|
| |
(5,918)
|
Payroll costs (including share-based payments)
|
| |
(9,205)
|
| |
(6,701)
|
Depreciation, amortization and provision expenses(1)
|
| |
(270)
|
| |
(35)
|
Total SG&A expenses
|
| |
(18,910)
|
| |
(12,653)
|
(1)
|
See Note 16.4
|
−
|
the €1.5 million of transaction costs related to a potential U.S. initial public offering, of which €1.0 million were recorded in 2018 and €507 thousand in 2019 as a reduction of premiums related to share capital and then reversed to SG&A expenses upon the determination by management in 2019 that the offering would be delayed;
|
−
|
the €0.5 million increase in general consulting fees mostly related to market access; and
|
−
|
the increase in recruitment fees, communication agency fees and legal fees for €0.4 million, €0.4 million and €0.3 million, respectively.
|
|
| |
For the year ended December 31,
|
|||
(in thousands of euros)
|
| |
2019
|
| |
2018
|
Wages and salaries
|
| |
(11,876)
|
| |
(9,501)
|
Payroll taxes
|
| |
(4,913)
|
| |
(4,279)
|
Share-based payments
|
| |
(4,320)
|
| |
(1,867)
|
Retirement benefit obligations
|
| |
(76)
|
| |
(55)
|
Total payroll costs
|
| |
(21,185)
|
| |
(15,703)
|
Average headcount
|
| |
112
|
| |
94
|
End-of-period headcount
|
| |
110
|
| |
102
|
|
| |
For the year ended December 31, 2019
|
||||||
(in thousands of euros)
|
| |
R&D
|
| |
SG&A
|
| |
Total
|
Amortization expense of intangible assets
|
| |
(289)
|
| |
(3)
|
| |
(292)
|
Depreciation expense of property, plant and equipment
|
| |
(1,208)
|
| |
(270)
|
| |
(1,478)
|
Utilization of provision for disputes
|
| |
—
|
| |
55
|
| |
55
|
Provision for charges
|
| |
(112)
|
| |
(52)
|
| |
(164)
|
Total depreciation, amortization and provision expenses
|
| |
(1,627)
|
| |
(270)
|
| |
(1,879)
|
|
| |
For the year ended December 31, 2018
|
||||||
(in thousands of euros)
|
| |
R&D
|
| |
SG&A
|
| |
Total
|
Amortization expense of intangible assets
|
| |
(90)
|
| |
—
|
| |
(90)
|
Depreciation expense of property, plant and equipment
|
| |
(444)
|
| |
(85)
|
| |
(529)
|
Utilization of provision for disputes
|
| |
—
|
| |
50
|
| |
50
|
Total depreciation, amortization and provision expenses
|
| |
(534)
|
| |
(35)
|
| |
(569)
|
|
| |
Pre-2019 founders’ warrant plans
|
||||||||||||||||||
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
|
| |
2012-1
|
| |
2012-2
|
| |
04-2013
|
| |
08-2013
|
| |
09-2014
|
| |
2015-1
|
| |
2015-3
|
Type of underlying asset
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
Number of founders’ warrants granted
|
| |
1,800,000
|
| |
100,000
|
| |
55,000
|
| |
50,000
|
| |
97,200
|
| |
71,650
|
| |
53,050
|
Date of shareholders' resolution approving the plan
|
| |
05/04/12
|
| |
05/04/12
|
| |
05/04/12
|
| |
06/28/13
|
| |
06/18/14
|
| |
06/18/14
|
| |
06/18/14
|
Grant date
|
| |
05/04/12
|
| |
12/18/12
|
| |
04/10/13
|
| |
08/28/13
|
| |
09/16/14
|
| |
02/10/15
|
| |
06/10/15
|
Contractual expiration date
|
| |
04/25/19
|
| |
12/18/22
|
| |
04/10/23
|
| |
08/28/23
|
| |
09/16/24
|
| |
02/10/25
|
| |
06/10/25
|
Grant price
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Exercise price
|
| |
€6.00
|
| |
€6.63
|
| |
€6.30
|
| |
€5.92
|
| |
€18.68
|
| |
€18.57
|
| |
€20.28
|
Number of founders’ warrants as of December 31, 2019
|
| |
—
|
| |
100,000
|
| |
—
|
| |
50,000
|
| |
92,100
|
| |
70,950
|
| |
38,400
|
Number of founders’ warrants exercised
|
| |
285,452
|
| |
—
|
| |
55,000
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Number of founders’ warrants lapsed or canceled
|
| |
1,514,548
|
| |
—
|
| |
—
|
| |
—
|
| |
5,100
|
| |
700
|
| |
14,650
|
|
| |
Pre-2019 founders’ warrant plans
|
|||||||||||||||
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
| |
BSPCE
|
|
| |
2016
Ordinary
|
| |
2016
Performance
|
| |
2017
Ordinary
|
| |
2017
Performance
|
| |
2017
|
| |
2017
Project
|
Type of underlying asset
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
Number of founders’ warrants granted
|
| |
126,400
|
| |
129,250
|
| |
117,650
|
| |
79,750
|
| |
80,000
|
| |
12,000
|
Date of shareholders' resolution approving the plan
|
| |
06/25/15
|
| |
06/25/15
|
| |
06/23/16
|
| |
06/23/16
|
| |
06/23/16
|
| |
06/23/16
|
Grant date
|
| |
02/02/16
|
| |
02/02/16
|
| |
01/07/17
|
| |
01/07/17
|
| |
01/07/17
|
| |
01/07/17
|
Contractual expiration date
|
| |
02/02/26
|
| |
02/02/26
|
| |
01/07/27
|
| |
01/07/27
|
| |
01/07/27
|
| |
01/07/27
|
Grant price
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Exercise price
|
| |
€14.46
|
| |
€14.46
|
| |
€15.93
|
| |
€15.93
|
| |
€15.93
|
| |
€15.93
|
Number of founders’ warrants as of December 31, 2019
|
| |
109,967
|
| |
103,002
|
| |
107,166
|
| |
—
|
| |
80,000
|
| |
—
|
Number of founders’ warrants exercised
|
| |
333
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Number of founders’ warrants lapsed or canceled
|
| |
16,100
|
| |
26,248
|
| |
10,484
|
| |
79,750
|
| |
—
|
| |
12,000
|
|
| |
Pre-2019 warrant plans
|
||||||||||||||||||
|
| |
BSA
04-12
|
| |
BSA
2013
|
| |
BSA
2014
|
| |
BSA
2015-1
|
| |
BSA
2015-1
|
| |
BSA
2015-2 (a)
|
| |
BSA
2015-2 (b)
|
Type of warrants
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
Number of warrants granted
|
| |
52,500
|
| |
10,000
|
| |
14,000
|
| |
22,000
|
| |
4,000
|
| |
64,000
|
| |
6,000
|
Date of shareholders' resolution approving the plan
|
| |
05/04/12
|
| |
05/04/12
|
| |
06/18/14
|
| |
06/18/14
|
| |
06/18/14
|
| |
06/18/14
|
| |
06/25/15
|
Grant date
|
| |
05/04/12
|
| |
04/10/13
|
| |
09/16/14
|
| |
02/10/15
|
| |
02/10/15
|
| |
06/25/15
|
| |
06/25/15
|
Contractual expiration date
|
| |
05/04/22
|
| |
04/10/23
|
| |
09/16/24
|
| |
02/10/25
|
| |
02/10/25
|
| |
06/25/25
|
| |
06/25/20
|
Grant price
|
| |
€0.60
|
| |
€2.50
|
| |
€4.87
|
| |
€4.87
|
| |
€4.87
|
| |
5.00
|
| |
€2.80
|
Exercise price
|
| |
€6.00
|
| |
€6.37
|
| |
€17.67
|
| |
€17.67
|
| |
€17.67
|
| |
€19.54
|
| |
€19.54
|
Number of warrants as of December 31, 2019
|
| |
30,000
|
| |
6,000
|
| |
10,000
|
| |
17,000
|
| |
4,000
|
| |
64,000
|
| |
6,000
|
Number of warrants exercised
|
| |
22,500
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Number of warrants lapsed or canceled
|
| |
—
|
| |
—
|
| |
4,000
|
| |
5,000
|
| |
—
|
| |
—
|
| |
—
|
|
| |
Pre-2019 warrant plans
|
| |
2019
warrant
plan
|
|||||||||||||||
|
| |
BSA 2016
Ordinary
|
| |
BSA 2016
Performance
|
| |
BSA
2016-2
|
| |
BSA
2017
|
| |
BSA
2018-1
|
| |
BSA
2018-2
|
| |
BSA
2019-1
|
Type of warrants
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
Number of warrants granted
|
| |
18,103
|
| |
18,105
|
| |
8,000
|
| |
18,000
|
| |
28,000
|
| |
5,820
|
| |
18,000
|
Date of shareholders' resolution approving the plan
|
| |
06/25/15
|
| |
06/25/15
|
| |
06/23/16
|
| |
06/23/16
|
| |
06/14/17
|
| |
05/23/18
|
| |
05/23/18
|
Grant date
|
| |
02/02/16
|
| |
02/02/16
|
| |
11/03/16
|
| |
01/07/17
|
| |
03/06/18
|
| |
07/27/18
|
| |
03/29/19
|
Contractual expiration date
|
| |
02/02/21
|
| |
02/02/21
|
| |
11/03/21
|
| |
01/07/22
|
| |
03/06/23
|
| |
07/27/28
|
| |
03/29/29
|
Grant price
|
| |
€1.67
|
| |
€1.67
|
| |
€2.03
|
| |
€2.03
|
| |
€1.62
|
| |
€2.36
|
| |
€1.15
|
Exercise price
|
| |
€13.74
|
| |
€13.74
|
| |
€15.01
|
| |
€15.76
|
| |
€13.55
|
| |
€16.102
|
| |
€11.66
|
Number of warrants as of December 31, 2019
|
| |
18,103
|
| |
18,105
|
| |
8,000
|
| |
18,000
|
| |
28,000
|
| |
5,820
|
| |
18,000
|
Number of warrants exercised
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Number of warrants lapsed or canceled
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
|
| |
Pre-2019 stock option plans
|
|||||||||||||||
|
| |
OSA
2016-1
Ordinary
|
| |
OSA
2016-1
Performance
|
| |
OSA
2016-2
|
| |
OSA
2017
Ordinary
|
| |
OSA
2017
Performance
|
| |
OSA
2018
|
Type of underlying asset
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
Number of options granted
|
| |
12,000
|
| |
6,400
|
| |
4,000
|
| |
3,500
|
| |
4,350
|
| |
62,000
|
Date of shareholders' resolution approving the plan
|
| |
06/25/15
|
| |
06/25/15
|
| |
06/23/16
|
| |
06/23/16
|
| |
06/23/16
|
| |
06/14/17
|
Grant date
|
| |
02/02/16
|
| |
02/02/16
|
| |
11/03/16
|
| |
01/07/17
|
| |
01/07/17
|
| |
03/06/18
|
Contractual expiration date
|
| |
02/02/26
|
| |
02/02/26
|
| |
11/03/26
|
| |
01/07/27
|
| |
01/07/27
|
| |
03/06/28
|
Grant price
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Exercise price
|
| |
€13.05
|
| |
€13.05
|
| |
€14.26
|
| |
€14.97
|
| |
€14.97
|
| |
€12.87
|
Number of options as of December 31, 2019
|
| |
—
|
| |
400
|
| |
4,000
|
| |
500
|
| |
—
|
| |
54,000
|
Number of options exercised
|
| |
4,000
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Number of options lapsed or canceled
|
| |
8,000
|
| |
6,000
|
| |
—
|
| |
3,000
|
| |
4,350
|
| |
8,000
|
|
| |
2019 stock option plans
|
|||
|
| |
OSA
2019-1
|
| |
OSA
LLY 2019
|
Type of underlying asset
|
| |
New
shares
|
| |
New
shares
|
Number of options granted
|
| |
37,500
|
| |
500,000
|
Date of shareholders' resolution approving the plan
|
| |
05/23/18
|
| |
04/11/19
|
Grant date
|
| |
03/29/19
|
| |
10/24/19
|
Contractual expiration date
|
| |
03/29/29
|
| |
10/24/29
|
Grant price
|
| |
—
|
| |
—
|
Exercise price
|
| |
€11.08
|
| |
€6.41
|
Number of options as of December 31, 2019
|
| |
30,250
|
| |
500,000
|
Number of options exercised
|
| |
—
|
| |
—
|
Number of options lapsed or canceled
|
| |
7,250
|
| |
—
|
|
| |
Pre-2019 free shares plan not yet vested
|
| |
2019 free shares plan
|
|||
|
| |
AGA 2018-1
|
| |
AGA 2018–2
|
| |
AGA 2019–1
|
Type of underlying assets
|
| |
New
shares
|
| |
New
shares
|
| |
New
shares
|
Number of free shares granted
|
| |
396,250
|
| |
6,000
|
| |
438,250
|
Date of shareholders' resolution approving the plan
|
| |
06/14/17
|
| |
05/23/18
|
| |
05/23/18
|
Grant date
|
| |
03/06/18
|
| |
07/27/18
|
| |
03/29/19
|
Number of free shares as of December 31, 2019
|
| |
355,250
|
| |
6,000
|
| |
385,000
|
Number of free shares exercised
|
| |
—
|
| |
—
|
| |
—
|
Number of free shares lapsed or canceled
|
| |
41,000
|
| |
—
|
| |
53,250
|
|
| |
BSPCE
|
| |
BSA
|
| |
OSA
|
| |
AGA
|
| |
Total
|
Total number of shares underlying grants outstanding as of December 31, 2019
|
| |
751,585
|
| |
251,028
|
| |
589,150
|
| |
746,250
|
| |
2,338,013
|
|
| |
BSPCE
|
| |
BSA
|
| |
OSA
|
| |
AGA
|
| |
Total
|
Total number of shares underlying grants outstanding as of December 31, 2018
|
| |
2,505,732
|
| |
233,028
|
| |
62,900
|
| |
375,250
|
| |
3,176,910
|
⯀
|
The share price on the grant date is equal to the exercise price taking into account both the average share price on the 20 days preceding the grant date and the expected development perspectives of the Company;
|
⯀
|
The risk-free rate was determined based on the average life of the instruments; and
|
⯀
|
Volatility was determined based on a sample of listed companies in the biotechnology sector on the grant date and for a period equal to the life of the warrant or option.
|
BSPCE
|
| |
Share
price
(in euros)
|
| |
Exercise
price
(in euros)
|
| |
Volatility
|
| |
Maturity
(in years)
|
| |
Risk-free
rate
|
| |
Yield
|
| |
Value of
initial plan
(in thousands
of euros)
|
| |
Expense for
the year
ended
December 31,
2019
(in thousands
of euros)
|
| |
Expense for
the year
ended
December 31,
2018
(in thousands
of euros)
|
BSPCE
2012-1
|
| |
5.26
|
| |
6.00
|
| |
41%
|
| |
3.49
|
| |
0.20%
|
| |
0.00%
|
| |
307
|
| |
—
|
| |
—
|
BSPCE
2012-2
|
| |
6.65
|
| |
6.63
|
| |
44.3% - 47.6%
|
| |
5 - 7.30
|
| |
0.84% - 1.22%
|
| |
0.00%
|
| |
288
|
| |
—
|
| |
—
|
BSPCE
04-2013
|
| |
6.30
|
| |
6.30
|
| |
56%
|
| |
5.00
|
| |
0.90%
|
| |
0.00%
|
| |
167
|
| |
—
|
| |
—
|
BSPCE
08-2013
|
| |
6.30
|
| |
6.30
|
| |
256%
|
| |
7.0
|
| |
0.90%
|
| |
0.00%
|
| |
152
|
| |
—
|
| |
—
|
BSPCE
09-2014
|
| |
18.68
|
| |
18.68
|
| |
58%
|
| |
5.5/6/6.5
|
| |
0.64%
|
| |
0.00%
|
| |
932
|
| |
—
|
| |
2
|
BSPCE
2015-1
|
| |
18.57
|
| |
18.57
|
| |
58% - 62%
- 61%
|
| |
5.5/6/6.5
|
| |
0.39%
|
| |
0.00%
|
| |
50
|
| |
—
|
| |
1
|
BSPCE
2015-1
|
| |
18.57
|
| |
18.57
|
| |
58% - 62%
- 61%
|
| |
5.5/6/6.5
|
| |
0.39%
|
| |
0.00%
|
| |
650
|
| |
—
|
| |
9
|
BSPCE
2015-3
|
| |
20.28
|
| |
20.28
|
| |
61% - 62%
- 61%
|
| |
5.5/6/6.5
|
| |
0.56%
|
| |
0.00%
|
| |
483
|
| |
—
|
| |
18
|
BSPCE
2016 Ordinary
|
| |
14.46
|
| |
14.46
|
| |
59% - 62%
- 60%
|
| |
5.5/6/6.5
|
| |
0.32%
|
| |
0.00%
|
| |
1,080
|
| |
10
|
| |
128
|
BSPCE
2016 Performance
|
| |
14.46
|
| |
14.46
|
| |
59%
|
| |
5.00
|
| |
0.19%
|
| |
0.00%
|
| |
1,212
|
| |
79
|
| |
(405)
|
BSPCE
2017 Ordinary
|
| |
15.93
|
| |
15.93
|
| |
58% - 61%
- 59%
|
| |
5.5/6/6.5
|
| |
0.23%
|
| |
0.00%
|
| |
1,000
|
| |
86
|
| |
255
|
BSPCE
2017 Performance
|
| |
15.93
|
| |
15.93
|
| |
59%
|
| |
5.00
|
| |
0.11%
|
| |
0.00%
|
| |
622
|
| |
—
|
| |
0
|
BSPCE
2017
|
| |
15.93
|
| |
15.93
|
| |
59%
|
| |
5.00
|
| |
0.11%
|
| |
0.00%
|
| |
627
|
| |
—
|
| |
—
|
BSPCE
2017 Project
|
| |
15.93
|
| |
15.93
|
| |
59%
|
| |
5.00
|
| |
0.11%
|
| |
0.00%
|
| |
94
|
| |
—
|
| |
(47)
|
Total BSPCE
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
175
|
| |
(39)
|
BSA
|
| |
Share
price
(in euros)
|
| |
Exercise
price
(in euros)
|
| |
Volatility
|
| |
Maturity
(in years)
|
| |
Risk-free
rate
|
| |
Yield
|
| |
Value of
initial plan
(in thousands
of euros)
|
| |
Expense for
the year
ended
December 31,
2019
(in thousands
of euros)
|
| |
Expense for
the year
ended
December 31,
2018
(in thousands
of euros)
|
BSA 2012
|
| |
6.00
|
| |
6.00
|
| |
49%
|
| |
10.00
|
| |
0.96%
|
| |
0.00%
|
| |
183
|
| |
—
|
| |
—
|
BSA 2013
|
| |
6.30
|
| |
6.37
|
| |
156%
|
| |
6.00
|
| |
0.90%
|
| |
0.00%
|
| |
1
|
| |
—
|
| |
—
|
BSA 2014
|
| |
18.68
|
| |
17.67
|
| |
57%
|
| |
5.00
|
| |
0.41%
|
| |
0.00%
|
| |
—
|
| |
—
|
| |
—
|
BSA 2015-1
|
| |
17.67
|
| |
17.67
|
| |
58%
|
| |
5.00
|
| |
0.26% - 0.27%
|
| |
0.00%
|
| |
63
|
| |
—
|
| |
—
|
BSA 2015-2
|
| |
17.67
|
| |
19.54
|
| |
58%-58%
57%-58%
|
| |
5/5.1/5.3/5.4
|
| |
0.39%
|
| |
0.00%
|
| |
16
|
| |
—
|
| |
—
|
BSA 2015-3
|
| |
19.54
|
| |
19.54
|
| |
58% - 60%
|
| |
4.6 – 9.6
|
| |
0.25% - 0.91%
|
| |
0.00%
|
| |
284
|
| |
—
|
| |
—
|
BSA 2016o-1
|
| |
13.74
|
| |
13.74
|
| |
57%
|
| |
2.40
|
| |
0.00%
|
| |
0.00%
|
| |
37
|
| |
—
|
| |
—
|
BSA 2016p-1
|
| |
13.74
|
| |
13.74
|
| |
57%
|
| |
2.40
|
| |
0.00%
|
| |
0.00%
|
| |
143
|
| |
(41)
|
| |
(42)
|
BSA 2016-2
|
| |
15.01
|
| |
15.01
|
| |
57%
|
| |
2.40
|
| |
0.00%
|
| |
0.00%
|
| |
—
|
| |
—
|
| |
—
|
BSA 2017o-1
|
| |
15.76
|
| |
15.76
|
| |
33%
|
| |
2.40
|
| |
0.00%
|
| |
0.00%
|
| |
—
|
| |
—
|
| |
—
|
BSA 2018-1
|
| |
13.55
|
| |
13.55
|
| |
38%
|
| |
4.80
|
| |
0.7% - 0.10%
|
| |
0.00%
|
| |
2
|
| |
—
|
| |
3
|
BSA 2018-2
|
| |
16.10
|
| |
16.10
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
1
|
| |
—
|
| |
—
|
BSA 2019-1
|
| |
11.66
|
| |
11.66
|
| |
37%
|
| |
9.8/9.9
|
| |
0.16% - 0.50%
|
| |
0.00%
|
| |
24
|
| |
24
|
| |
—
|
Total BSA
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
(16)
|
| |
(39)
|
Stock
options
|
| |
Share
price
(in euros)
|
| |
Exercise
price
(in euros)
|
| |
Volatility
|
| |
Maturity
(in years)
|
| |
Risk-free
rate
|
| |
Yield
|
| |
Value of
initial plan
(in thousands
of euros)
|
| |
Expense for
the year
ended
December 31,
2019
(in thousands
of euros)
|
| |
Expense
for the
year
ended
December 31,
2018
(in thousands
of euros)
|
OSA 2016 Ordinary
|
| |
13.05
|
| |
13.05
|
| |
59% - 62%
- 60%
|
| |
5.5 / 6 /6.5
|
| |
0.32%
|
| |
0.00%
|
| |
117
|
| |
—
|
| |
(64)
|
OSA 2016 Performance
|
| |
13.05
|
| |
13.05
|
| |
59%
|
| |
5.00
|
| |
0.19%
|
| |
0.00%
|
| |
69
|
| |
—
|
| |
(55)
|
OSA 2016-2
|
| |
14.26
|
| |
14.26
|
| |
58% - 62%
- 59%
|
| |
5.5 / 6 /6.5
|
| |
0.04%
|
| |
0.00%
|
| |
27
|
| |
3
|
| |
7
|
OSA 2017 Ordinary
|
| |
15.93
|
| |
14.97
|
| |
58% - 61%
- 59%
|
| |
5.5 / 6 /6.5
|
| |
0.23%
|
| |
0.00%
|
| |
31
|
| |
1
|
| |
(14)
|
OSA 2017 Performance
|
| |
15.93
|
| |
14.97
|
| |
59%
|
| |
5.00
|
| |
0.11%
|
| |
0.00%
|
| |
35
|
| |
—
|
| |
0
|
OSA 2018
|
| |
12.87
|
| |
12.87
|
| |
35%
|
| |
5.5 / 6 /6.5
|
| |
0.00%
|
| |
0.00%
|
| |
252
|
| |
66
|
| |
164
|
OSA 2019-1
|
| |
11.08
|
| |
11.08
|
| |
38.10% /
37.40%
|
| |
6 /6.5
|
| |
0.103% /
0.149%
|
| |
0.00%
|
| |
140
|
| |
38
|
| |
n.a.
|
OSA LLY 2019
|
| |
6.41
|
| |
6.41
|
| |
37%
|
| |
10.00
|
| |
0.40%
|
| |
0.00%
|
| |
436
|
| |
436
|
| |
n.a.
|
Total Stock options
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
543
|
| |
38
|
free shares
|
| |
Share
price
(in euros)
|
| |
Exercise
price
(in euros)
|
| |
Volatility
|
| |
Maturity
(in years)
|
| |
Risk-free
rate
|
| |
Yield
|
| |
Value of
initial plan
(in thousands
of euros)
|
| |
Expense for
the year
ended
December 31,
2019
(in thousands
of euros)
|
| |
Expense
for the
year
ended
December 31,
2018
(in thousands
of euros)
|
AGA 2018-1
|
| |
12.87
|
| |
0.00
|
| |
n.a.
|
| |
n.a.
|
| |
0.00%
|
| |
0.00%
|
| |
4,951
|
| |
2,052
|
| |
1,891
|
AGA 2018-2
|
| |
12.87
|
| |
0.00
|
| |
n.a.
|
| |
n.a.
|
| |
0.00%
|
| |
0.00%
|
| |
75
|
| |
37
|
| |
16
|
AGA 2019-1
|
| |
10.90
|
| |
0.00
|
| |
n.a.
|
| |
n.a.
|
| |
0.19% / 0.141%
|
| |
0.00%
|
| |
4,776
|
| |
1,529
|
| |
n.a.
|
Total
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
n.a.
|
| |
3,618
|
| |
1,907
|
(in thousands of euros)
|
| |
BSPCE
|
| |
BSA
|
| |
OSA
|
| |
AGA
|
| |
Total
|
Expense for the year ended December 31, 2019
|
| |
175
|
| |
(16)
|
| |
543
|
| |
3,618
|
| |
4,320
|
(in thousands of euros)
|
| |
BSPCE
|
| |
BSA
|
| |
OSA
|
| |
AGA
|
| |
Total
|
Expense for the year ended December 31, 2018
|
| |
(39)
|
| |
(39)
|
| |
38
|
| |
1,907
|
| |
1,867
|
|
| |
For the year ended December 31,
|
|||
(in thousands of euros)
|
| |
2019
|
| |
2018
|
Income from cash and cash equivalents
|
| |
105
|
| |
34
|
Foreign exchange gains
|
| |
599
|
| |
1,051
|
Other financial income
|
| |
133
|
| |
87
|
Total financial income
|
| |
837
|
| |
1,172
|
Interest cost(1)
|
| |
(4,434)
|
| |
(847)
|
IFRS 16 related interests
|
| |
(359)
|
| |
—
|
Foreign exchange losses
|
| |
(176)
|
| |
(602)
|
Total financial expenses
|
| |
(4,970)
|
| |
(1,449)
|
Net financial income (loss)
|
| |
(4,133)
|
| |
(277)
|
(1)
|
Including €4.4 million of fixed and variable interests related to the EIB loan in 2019, as compared with €730 thousand in 2018
|
|
| |
For the year ended December 31
|
|||
(in thousands of euros)
|
| |
2019
|
| |
2018
|
Net loss
|
| |
(50,915)
|
| |
(30,345)
|
Effective tax expense
|
| |
3
|
| |
—
|
Recurring loss before tax
|
| |
(50,912)
|
| |
(30,345)
|
Theoretical tax rate (statutory rate in France)
|
| |
31.00%
|
| |
33.33%
|
Theoretical tax (benefit) expense
|
| |
(15,782)
|
| |
(10,115)
|
Share-based payment
|
| |
1,339
|
| |
622
|
Other permanent differences
|
| |
(1)
|
| |
(17)
|
Other non-taxable items
|
| |
(736)
|
| |
(1,084)
|
Unrecognized tax losses
|
| |
15,177
|
| |
10,593
|
Effective tax expense
|
| |
(3)
|
| |
—
|
Effective tax rate
|
| |
0.0%
|
| |
0.0%
|
|
| |
For the year ended December 31,
|
|||
|
| |
2019
|
| |
2018
|
Net loss for the period (in thousands of euros)
|
| |
(50,915)
|
| |
(30,345)
|
Weighted average number of shares
|
| |
21,631,514
|
| |
19,633,373
|
Basic loss per share (in euros)
|
| |
(2.35)
|
| |
(1.55)
|
Diluted loss per share (in euros)
|
| |
(2.35)
|
| |
(1.55)
|
−
|
One short term lease for an office by Nanobiotix Corp., of which the annual rent is $140 thousand; and
|
−
|
Leases related to low-value assets for Nanobiotix SA’s printers, of which the annual rent is approximately €10 thousand.
|
−
|
Commitment granted by the Company: the Company committed to maintain the patents mentioned by the concession agreement for 25 years.
|
−
|
Commitment granted to the Company: Malaysia Biotech Corp committed to use the patents mentioned above in fields outside of oncology.
|
|
| |
For the year ended December 31,
|
|||
(in thousands euros)
|
| |
2019
|
| |
2018
|
Salaries, wages and benefits
|
| |
1,306
|
| |
1,437
|
Share-based payments
|
| |
2,066
|
| |
1,068
|
Supervisory Board’s fees
|
| |
70
|
| |
70
|
Total compensation to related parties
|
| |
3,442
|
| |
2,575
|
⯀
|
On April 11, 2017, we issued an aggregate of 1,596,527 ordinary shares in a private placement, at an issue price of €15.75 per share, for a total subscription amount of €25,145,300.25. The offering was made to investors in the United States and Europe, as well as existing shareholders. Jefferies International Limited and Kempen & Co. N.V. acted as joint global coordinators, and together with Gilbert Dupont, as joint bookrunners.
|
⯀
|
On November 2, 2017, we issued an aggregate of 1,941,789 ordinary shares in a private placement, at an issue price of €14.00 per share, for a total subscription amount of €27,185,046. The offering was made to investors in the United States and Europe, as well as existing shareholders. Jefferies International Limited acted as sole global coordinator, and together with Cowen and Company, LLC and Gilbert Dupont, as joint bookrunners.
|
⯀
|
On April 9, 2019, we issued an aggregate of 2,566,666 ordinary shares in a private placement, at an issue price of €11.50 per share, for a total subscription amount of €29,516,659. The offering was made to investors in the United States and Europe. Jefferies International Limited acted as sole bookrunner.
|
⯀
|
On July 30, 2020, we issued an aggregate of 3,300,000 ordinary shares in a private placement, at an issue price of €6.10 per share, for a total subscription amount of €20,130,000. The offering was made to investors in the United States and Europe. Jefferies International Limited acted as sole global coordinator and joint bookrunner, and ODDO BHF SCA and Gilbert Dupont acted as the joint bookrunners.
|
⯀
|
Since January 1, 2017, we have granted:
|
⯀
|
289,400 founders’ warrants at an exercise price of €15.93 per warrant, none of which have been exercised and 108,550 of which have since become void. Therefore, of the founders’ warrants issued since January 1, 2017, 180,850 remain outstanding as of September 30, 2020;
|
⯀
|
87,820 warrants, consisting of 18,000 warrants at an exercise price of €15.76 per warrant, 28,000 warrants at an exercise price of €13.55 per warrant, 5,820 warrants at an exercise price of €16.102 per warrant, 18,000 warrants at an exercise price of €11.66 and 18,000 warrants at an exercise price of €6.59 per warrant. None of the warrants have been exercised or have become void. Therefore, all of the warrants issued since January 1, 2017 remain outstanding as of September 30, 2020;
|
⯀
|
1,015,322 stock options, consisting of 7,850 stock options at an exercise price of €14.97, 62,000 stock options at an exercise price of €12.87, 37,500 stock options at an exercise price of €11.08, 500,000 stock options at an exercise price of €6.41 and 407,972 stock options at an exercise price of €6.25. None of the stock options have been exercised and 32,062 have become void. Therefore, of the stock options issued since January 1, 2017, 983,260 remain outstanding as of September 30, 2020; and
|
⯀
|
890,500 free shares, of which 316,083 were definitively acquired on March 6, 2020 and 6,000 were definitively acquired on July 27, 2020 and 122,917 have since become void. Therefore, of the free shares granted as of January 1, 2017, 445,500 remain outstanding as of September 30, 2020.
|
⯀
|
In the same period:
|
⯀
|
340,785 founders’ warrants, granted before January 1, 2017, have been exercised, resulting in the issuance of 340,785 ordinary shares for aggregate proceeds to us of €2,064,027; and
|
⯀
|
4,000 stock options, granted before January 1, 2017, have been exercised, resulting in the issuance of 4,000 ordinary shares for aggregate proceeds to us of €52,200.
|
(a)
|
Exhibits.
|
Exhibit
Number
|
| |
Description of Exhibit
|
1.1#
|
| |
Form of Underwriting Agreement
|
| |
By-laws (status) of the registrant (English translation)
|
|
| |
Form of Deposit Agreement
|
|
| |
Form of American Depositary Receipt (included in Exhibit 4.1)
|
|
5.1#
|
| |
Opinion of Jones Day
|
8.1#
|
| |
Tax Opinion of Jones Day
|
| |
Exclusive License and Collaboration Agreement, by and between PharmaEngine, Inc. and Nanobiotix S.A., dated as of August 6, 2012
|
|
| |
Amendment #1 to the Exclusive License and Collaboration Agreement, by and between PharmaEngine, Inc. and Nanobiotix S.A., dated as of October 7, 2014
|
|
| |
Finance Contract, by and between the European Investment Bank and Nanobiotix S.A., dated as of July 26, 2018 (the “EIB Finance Contract”)
|
|
| |
Amendment to the EIB Finance Contract, by and between the European Investment Bank and Nanobiotix S.A., dated as of July 20, 2020
|
|
| |
Royalty Agreement, by and between the European Investment Bank and Nanobiotix S.A., dated as of July 26, 2018
|
|
| |
Amended and Restated Strategic Collaboration Agreement, by and between The University of Texas M.D. Anderson Cancer Center and Nanobiotix S.A., dated as of January 23, 2020
|
|
| |
Summary of BSA Plans
|
|
| |
Summary of BSPCE Plans
|
|
| |
2016 Stock Option Plan
|
|
| |
2016-2 Stock Option Plan
|
|
| |
2017 Stock Option Plan
|
|
| |
2018 Stock Option Plan
|
|
| |
2019 Stock Option Plan
|
|
| |
LLY 2019 Stock Option Plan
|
|
| |
Summary of Free Share Plans
|
|
| |
List of Subsidiaries of the Registrant
|
|
| |
Consent of Independent Registered Public Accounting Firm
|
|
23.2#
|
| |
Consent of Jones Day (included in Exhibits 5.1 and 8.1)
|
| | ||
| |
Summary of HSBC France Loan, by and between HSBC France and Nanobiotix S.A., dated as of June 22, 2020
|
|
| |
Summary of Bpifrance Loan, by and between Bpifrance Financement and Nanobiotix S.A., dated as of July 10, 2020
|
#
|
To be filed by amendment.
|
†
|
Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(10). The omitted information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
|
^
|
Certain exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the SEC.
|
(b)
|
Financial Statement Schedules.
|
(1)
|
For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
|
(2)
|
For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
|
|
| |
NANOBIOTIX S.A.
|
|||
|
| |
|
| |
|
|
| |
By:
|
| |
/s/ LAURENT LEVY
|
|
| |
|
| |
Laurent Levy, Ph.D.
|
|
| |
|
| |
Chief Executive Officer
|
Signature
|
| |
Title
|
| |
Date
|
|
| |
|
| |
|
/s/ LAURENT LEVY
|
| |
Chief Executive Officer and
Executive Board Chairman
(Principal Executive Officer)
|
| |
November 20, 2020
|
Laurent Levy, Ph.D.
|
| |||||
|
| |
|
| |
|
/s/ PHILIPPE MAUBERNA
|
| |
Chief Financial Officer and
Executive Board Member
(Principal Financial Officer
and Principal Accounting Officer)
|
| |
November 20, 2020
|
Philippe Mauberna
|
| |||||
|
| |||||
|
| |
|
| |
|
/s/ LAURENT CONDOMINE
|
| |
Supervisory Board Chairman
|
| |
November 20, 2020
|
Laurent Condomine
|
| |||||
|
| |
|
| |
|
/s/ ANNE-MARIE GRAFFIN
|
| |
Supervisory Board Deputy Chairman
|
| |
November 20, 2020
|
Anne-Marie Graffin
|
| |||||
|
| |||||
/s/ ALAIN HERRERA
|
| |
Supervisory Board Member
|
| |
November 20, 2020
|
Alain Herrera, M.D.
|
| |||||
|
| |
|
| |
|
/s/ ENNO SPILLNER
|
| |
Supervisory Board Member
|
| |
November 20, 2020
|
Enno Spillner
|
|
|
| |
NANOBIOTIX CORPORATION
|
||||||
|
| |
|
| |
|
| ||
|
| |
By:
|
| |
/s/ PHILIPPE MAUBERNA
|
|||
|
| |
|
| |
Name:
|
| |
Philippe Mauberna
|
|
| |
|
| |
Title:
|
| |
Treasurer and Authorized Signatory
|
-
|
research and development in physical and natural sciences;
|
-
|
the filing, study, acquisition, granting of any patents, licences, processes, trademarks and protection of specialised knowledge relating or referring in any way
to the areas or technologies covered by the corporate purpose;
|
-
|
the design, development, manufacture, distribution, import, export and operation by any means of medicinal products, pharmaceuticals, medical devices and other
healthcare products;
|
-
|
the creation, acquisition, rental, lease-management of any business, the leasing, setting up, operation of any establishments, businesses, factories, workshops,
relating to any of the specified activities;
|
-
|
the company’s participation through any means, in all operations that might relate to its purpose through the creation of new companies, subscription or purchase
of securities or corporate rights, merger or otherwise;
|
-
|
and, more generally all financial, commercial, industrial operations, security and real estate transactions that may relate directly or indirectly to the above
purpose or to any similar or related purposes, likely to promote its development or expansion.
|
8.1 |
Shares registered in accounts are freely transferable from one account to another through a wire, in accordance with applicable laws and regulations.
|
8.2 |
The company may also, subject to applicable laws and regulations, at its own expense, request from an authorized agency at any time, the name, or, in the case of a legal entity, the
corporate name, nationality, and address of holders of securities granting an immediate or future right to vote at its shareholders’ meetings, and the number of securities held by each of them and, if applicable, any restrictions to which
these securities may be subject.
|
- |
temporary appointment of members of the supervisory board as provided for in article L. 225-78 of the French commercial code;
|
- |
authorization of securities, endorsements and guarantees provided for in the last paragraph of article L. 225-68 of the French commercial code;
|
- |
decision taken pursuant to a delegation granted by the extraordinary shareholders’ meeting in accordance with the second paragraph of article L. 225-65 of the French commercial code to
amend the Bylaws in order to comply with applicable laws and regulations;
|
- |
convening shareholders' meetings; and
|
- |
transfer of the registered office within the same department (département).
|
19.1. |
Securities, endorsements and guarantees given by the company must be authorised by the supervisory board under the conditions provided for by law.
|
19.2. |
Any agreement to be entered into, whether directly or through an intermediary between the company and any member of the executive board or supervisory board, any shareholders holding
more than 10% of the voting rights or, in the case a legal entity being a shareholder, the company controlling it within the meaning of article L. 233-3 of the French commercial code, must be submitted for the prior approval of the
supervisory board.
|
-
|
to grant a proxy in accordance with applicable laws,
|
-
|
to vote by correspondence, or
|
-
|
to grant a proxy to the company without indicating any agent,
|
ARTICLE I DEFINITIONS |
1
|
|
Section 1.1 | “ADS Record Date” | 1 |
|
Section 1.2 | “Affiliate” | 1 |
|
Section 1.3 | “American Depositary Receipt(s)”, “ADR(s)” and “Receipt(s)” | 1 |
|
Section 1.4 | “American Depositary Share(s)” and “ADS(s)” | 2 |
|
Section 1.5 | [Intentionally Omitted]. | 2 |
|
Section 1.6 | “Beneficial Owner” | 2 |
|
Section 1.7 | “By-Laws” | 3 |
|
Section 1.8 | “Certificated ADS(s)” | 3 |
|
Section 1.9 | “Citibank” | 3 |
|
Section 1.10 | “Commission” | 3 |
|
Section 1.11 | “Company” | 3 |
|
Section 1.12 | “Custodian” | 3 |
|
Section 1.13 | “Deliver” and “Delivery” | 3 |
|
Section 1.14 | “Deposit Agreement” | 3 |
|
Section 1.15 | “Depositary” |
3
|
|
Section 1.16 | “Deposited Property” |
3
|
|
Section 1.17 | “Deposited Securities” | 4 |
|
Section 1.18 | “Dollars” and “$” | 4 |
|
Section 1.19 | “DTC” | 4 |
|
Section 1.20 | “DTC Participant” | 4 |
|
Section 1.21 | “Euro” and “€” | 4 |
|
Section 1.22 | “Euroclear” | 4 |
|
Section 1.23 | “Exchange Act” |
4
|
|
Section 1.24 | “Foreign Currency” |
4
|
|
Section 1.25 | “Form F-6” |
4
|
|
Section 1.26 | “Full Entitlement ADR(s)”, “Full Entitlement ADS(s)” and “Full Entitlement Share(s)” |
4
|
|
Section 1.27 | “Holder(s)” | 5 |
|
Section 1.28 |
“Partial Entitlement ADR(s)”, “Partial Entitlement ADS(s)” and “Partial Entitlement Share(s)”
|
5
|
|
Section 1.29 | “Principal Office” | 5 |
|
Section 1.30 | “Registrar” | 5 |
|
Section 1.31 | “Restricted Securities” | 5 |
|
Section 1.32 |
“Restricted ADR(s)”, “Restricted ADS(s)” and “Restricted Shares”
|
5
|
|
Section 1.33 | “Securities Act” |
5
|
|
Section 1.34 | “Share Registrar” | 6 |
|
Section 1.35 | “Shares” | 6 |
|
Section 1.36 | “Uncertificated ADS(s)” | 6 |
|
Section 1.37 | “United States” and “U.S.” | 6 |
ARTICLE II APPOINTMENT OF DEPOSITARY; FORM OF RECEIPTS; DEPOSIT OF SHARES; EXECUTION AND DELIVERY,
TRANSFER AND SURRENDER OF RECEIPTS
|
6
|
|
Section 2.1 | Appointment of Depositary | 6 |
|
Section 2.2 | Form and Transferability of ADSs. |
6
|
|
Section 2.3 | Deposit of Shares | 8 |
|
Section 2.4 | Registration and Safekeeping of Deposited Securities |
9
|
|
Section 2.5 | Issuance of ADSs | 10 |
|
Section 2.6 | Transfer, Combination and Split-up of ADRs. | 10 |
|
Section 2.7 | Surrender of ADSs and Withdrawal of Deposited Securities | 11 |
|
Section 2.8 |
Limitations on Execution and Delivery, Transfer, etc. of ADSs; Suspension of Delivery, Transfer, etc.
|
12
|
|
Section 2.9 | Lost ADRs, etc | 13 |
|
Section 2.10 |
Cancellation and Destruction of Surrendered ADRs; Maintenance of Records
|
13 |
|
Section 2.11 | Escheatment | 13 |
|
Section 2.12 | Partial Entitlement ADSs | 13 |
|
Section 2.13 | Certificated/Uncertificated ADSs | 14 |
|
Section 2.14 | Restricted ADSs | 15 |
ARTICLE III CERTAIN OBLIGATIONS OF HOLDERS AND BENEFICIAL OWNERS OF ADSS |
16
|
|
Section 3.1 | Proofs, Certificates and Other Information | 16 |
|
Section 3.2 | Liability for Taxes and Other Charges | 16 |
|
Section 3.3 | Representations and Warranties on Deposit of Shares | 17 |
|
Section 3.4 | Compliance with Information Requests |
17
|
|
Section 3.5 | Ownership Restrictions |
17
|
|
Section 3.6 | Reporting Obligations and Regulatory Approvals |
18
|
ARTICLE IV THE DEPOSITED SECURITIES |
18
|
|
Section 4.1 | Cash Distributions |
18
|
|
Section 4.2 | Distribution in Shares |
19
|
|
Section 4.3 | Elective Distributions in Cash or Shares | 20 |
|
Section 4.4 | Distribution of Rights to Purchase Additional ADSs. | 21 |
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Section 4.5 |
Distributions Other Than Cash, Shares or Rights to Purchase Shares.
|
22 |
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Section 4.6 |
Distributions with Respect to Deposited Securities in Bearer Form
|
23 |
|
Section 4.7 | Redemption | 23 |
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Section 4.8 | Conversion of Foreign Currency | 24 |
|
Section 4.9 | Fixing of ADS Record Date | 25 |
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Section 4.10 | Voting of Deposited Securities | 25 |
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Section 4.11 | Changes Affecting Deposited Securities |
28
|
|
Section 4.12 | Available Information |
29
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|
Section 4.13 | Reports |
29
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|
Section 4.14 | List of Holders |
29
|
|
Section 4.15 | Taxation |
29
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ARTICLE V THE DEPOSITARY, THE CUSTODIAN AND THE COMPANY |
30
|
|
Section 5.1 | Maintenance of Office and Transfer Books by the Registrar |
30
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Section 5.2 | Exoneration | 30 |
|
Section 5.3 |
Standard of Care
|
31 |
|
Section 5.4 |
Resignation and Removal of the Depositary; Appointment of Successor Depositary
|
32 |
|
Section 5.5 | The Custodian | 33 |
|
Section 5.6 | Notices and Reports | 33 |
|
Section 5.7 | Issuance of Additional Shares, ADSs etc | 34 |
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Section 5.8 | Indemnification | 35 |
|
Section 5.9 | ADS Fees and Charges |
36
|
|
Section 5.10 | Restricted Securities Owners |
37
|
ARTICLE VI AMENDMENT AND TERMINATION |
37
|
|
Section 6.1 | Amendment/Supplement |
37
|
|
Section 6.2 | Termination |
38
|
ARTICLE VII MISCELLANEOUS |
39
|
|
Section 7.1 | Counterparts |
39
|
|
Section 7.2 | No Third‑Party Beneficiaries / Acknowledgments |
39
|
|
Section 7.3 | Severability | 40 |
|
Section 7.4 |
Holders and Beneficial Owners as Parties; Binding Effect
|
40 |
|
Section 7.5 | Notices | 40 |
|
Section 7.6 | Governing Law and Jurisdiction | 41 |
|
Section 7.7 | Assignment | 43 |
|
Section 7.8 |
Compliance with, and No Disclaimer Under, U.S. Securities Laws
|
43 |
|
Section 7.9 | French Law References | 43 |
|
Section 7.10 | Titles and References. | 43 |
EXHIBITS
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|
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Form of ADR.
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A-1
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Fee Schedule.
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B-1
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NANOBIOTIX S.A.
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||
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By:
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Name:
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Title:
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CITIBANK, N.A.
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||
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By:
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Name:
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|
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Title:
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Number
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CUSIP NUMBER:
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(i) |
ADS Issuance Fee: by any person for whom ADSs are issued (e.g., an issuance upon a deposit of Shares, upon a change in the ADS(s)-to-Share(s) ratio, or for any other reason), excluding
issuances as a result of distributions described in paragraph (iv) below, a fee not in excess of U.S. $5.00 per 100 ADSs (or fraction thereof) issued under the terms of the Deposit Agreement;
|
|
(ii) |
ADS Cancellation Fee: by any person for whom ADSs are being cancelled (e.g., a cancellation of ADSs for Delivery of deposited shares, upon a change in the ADS(s)-to-Share(s) ratio, or for
any other reason), a fee not in excess of U.S. $5.00 per 100 ADSs (or fraction thereof) cancelled;
|
|
(iii) |
Cash Distribution Fee: by any Holder of ADSs, a fee not in excess of U.S. $5.00 per 100 ADSs (or fraction thereof) held for the distribution of cash dividends or other cash distributions (e.g.,
upon a sale of rights and other entitlements);
|
|
(iv) |
Stock Distribution /Rights Exercise Fee: by any Holder of ADS(s), a fee not in excess of U.S. $5.00 per 100 ADSs (or fraction thereof) held for the distribution of ADSs pursuant to (a) stock dividends or other free stock
distributions, or (b) an exercise of rights to purchase additional ADSs;
|
|
(v) |
Other Distribution Fee: by any Holder of ADS(s), a fee not in excess of U.S. $5.00 per 100 ADSs (or fraction thereof) held for the distribution of securities other than ADSs or rights to purchase additional ADSs (e.g., spin-off shares);
|
|
(vi) |
Depositary Services Fee: by any Holder of ADS(s) on the applicable record date(s) established by the Depositary, a fee not in excess of U.S. $5.00 per 100 ADSs (or fraction thereof) held on the applicable record date(s)
established by the Depositary;
|
|
(vii) |
Registration of ADS Transfer Fee: by any Holder of ADS(s) for whom ADS(s) are being transferred or by any person to whom ADSs are transferred, a fee not in excess of U.S. $5.00 per 100 ADSs (or fraction thereof) transferred; and
|
|
(viii) |
ADS Conversion Fee: by any Holder of ADS(s) for whom ADSs are being converted or by any person to whom the converted ADSs are delivered, a fee not in excess of U.S. $5.00 per 100 ADSs (or fraction thereof) converted from one ADS
series to another ADS series (e.g., upon conversion of Partial Entitlement ADSs for Full Entitlement ADSs, or upon conversion of Restricted ADSs into freely transferrable ADSs, and vice versa).
|
|
(a) |
taxes (including applicable interest and penalties) and other governmental charges;
|
|
(b) |
such registration fees as may from time to time be in effect for the registration of Shares or other Deposited Securities on the share register and applicable to transfers of Shares or other Deposited Securities to or from the name of
the Custodian, the Depositary or any nominees upon the making of deposits and withdrawals, respectively;
|
|
(c) |
such cable, telex and facsimile transmission and delivery expenses as are expressly provided in the Deposit Agreement to be at the expense of the person depositing Shares or withdrawing Deposited Securities or of the Holders and
Beneficial Owners of ADSs;
|
|
(d) |
in connection with the conversion of Foreign Currency, the fees, expenses, spreads, taxes and other charges of the Depositary and/or conversion service providers (which may be a division, branch or Affiliate of the Depositary). Such
fees, expenses, spreads, taxes and other charges shall be deducted from the Foreign Currency;
|
|
(e) |
any reasonable and customary out-of-pocket expenses incurred in such conversion and/or on behalf of the Holders and Beneficial Owners in complying with currency exchange control or other governmental requirements; and
|
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(f) |
the fees, charges, costs and expenses incurred by the Depositary, the Custodian, or any nominee in connection with the ADR program.
|
CITIBANK, N.A.
Transfer Agent and Registrar
|
CITIBANK, N.A.
as Depositary
|
|||
By:
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By:
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|||
|
Authorized Signatory |
|
Authorized Signatory |
II. |
Charges
|
(i) |
taxes (including applicable interest and penalties) and other governmental charges;
|
(ii) |
such registration fees as may from time to time be in effect for the registration of Shares or other Deposited Securities on the share register and applicable to transfers of Shares or other Deposited Securities to or from the name of the
Custodian, the Depositary or any nominees upon the making of deposits and withdrawals, respectively;
|
(iii) |
such cable, telex and facsimile transmission and delivery expenses as are expressly provided in the Deposit Agreement to be at the expense of the person depositing Shares or withdrawing Deposited Property or of the Holders and Beneficial
Owners of ADSs;
|
(iv) |
in connection with the conversion of Foreign Currency, the fees, expenses, spreads, taxes and other charges of the Depositary and/or conversion service providers (which may be a division, branch or Affiliate of the Depositary). Such fees,
expenses, spreads, taxes, and other charges shall be deducted from the Foreign Currency;
|
(v) |
any reasonable and customary out-of-pocket expenses incurred in such conversion and/or on behalf of the Holders and Beneficial Owners in complying with currency exchange control or other governmental requirements; and
|
(vi) |
the fees, charges, costs and expenses incurred by the Depositary, the Custodian, or any nominee in connection with the ADR program.
|
Clause
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Page
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1.
|
Definitions
|
3
|
2.
|
Grant and Scope of License
|
13
|
3.
|
Joint Steering Committee
|
18
|
4.
|
Development Obligations
|
23
|
5.
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Regulatory Activities
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26
|
6.
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Commercialization
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28
|
7.
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Payments
|
30
|
8.
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Manufacturing
|
39
|
9.
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Intellectual Property
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43
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10.
|
Exchange of Safety Information
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47
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11.
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Confidentiality
|
47
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12.
|
Warranties and Liabilities
|
49
|
13.
|
Indemnification and Insurance
|
53 |
14.
|
Term and Termination
|
55
|
15.
|
Consequences of Termination
|
57
|
16.
|
General Provisions
|
59
|
List of Exhibits
|
||
Exhibit 1:
|
Initial Development Plan PharmaEngine
|
64
|
Exhibit 2:
|
Licensor Know How
|
65
|
Exhibit 3:
|
Licensor Patent Rights
|
66
|
Exhibit 4:
|
Manufacturing Cost
|
68
|
Exhibit 5:
|
Licensing Benchmark
|
70
|
Exhibit 6:
|
Licensor Press Release
|
71
|
Exhibit 7:
|
Licensee Press Release PharmaEngine
|
73
|
Exhibit 8:
|
Manufacturing Process Flow Chart
|
75
|
(1) |
Nanobiotix S.A. a French joint-stock company having its registered office located at 60 Rue de Wattignies 75 012, Paris, France, Paris Companies’ Register No SIRET: RCS 447 521 600 (“Licensor”);
and
|
(2) |
PharmaEngine, Inc. a Taiwanese corporation having its registered office at 16F, 237 Sung-Chiang Road, Taipei 104, Taiwan, Republic of China, Companies’ Register Reg. No. 80264691, (“Licensee”).
|
(A) |
Licensor is a nanomedicine company that is focused on the development of NanoXray, its innovative oncology pipeline based on a physical mechanism of action to deposit high quantity of energy within the tumor cells.
|
(B) |
Licensee is a specialty pharmaceutical company specializing in the treatment of cancer and Asian prevalent diseases.
|
(C) |
Licensor is developing its proprietary nanoparticle NBTXR3 and intends to grant to Licensee an exclusive non-revertible license to develop and commercialize NBTXR3 for China (including Hong Kong and Macau) and Taiwan, and an exclusive
revertible license for certain other countries in Asia, Australia and New Zealand.
|
(D) |
Licensee is willing to further develop NBTXR3 in order to obtain regulatory approval, either as medicinal product or medical device, in all countries of the licensed territory, share any and all development data with Licensor and
Licensor’s other licensees and commercialize NBTXR3 in the licensed territory.
|
(E) |
NOW, THEREFORE, in consideration of the mutual covenants, agreements and stipulations set forth herein, the receipt and legal sufficiency of which are hereby mutually acknowledged, Licensor and Licensee hereby agree as follows:
|
1.1
|
“Affiliate” shall mean, with respect to a Party, an entity that, directly or indirectly through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party. In
this definition, “control” means: (i) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors; and (li) in the case
of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such entities.
|
1.2
|
“Agreement” shall mean this Exclusive License and Collaboration Agreement and all Exhibits attached hereto.
|
1.3
|
“Business Day” shall mean any day (other than Saturday or Sunday) on which banks are open for business in Taipei, Taiwan and Paris, France.
|
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1.4
|
“Calendar Quarter” shall mean each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1; provided that the first Calendar Quarter of the Term
shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term.
|
1.5
|
“Clinical Study” shall mean (i) any scientific study or any other test that is required by Laws and Regulations, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory
Approval of Licensed Product and (ii) any human clinical study or other test or study with respect to Licensed Product for an indication that is not required by Law and Regulations, or otherwise recommended by Regulatory Authorities, to
obtain or maintain Regulatory Approval for Licensed Product for such indication, including pharmacoeconomic studies, post-marketing surveillance studies and investigator sponsored studies, irrespective of the regulatory statuses of the
Licensed Product from country to country within the Territory (i.e. a medical device class III or medicinal product status). A Clinical Study is deemed to “Start” upon the first patient
receiving the first dose of Licensed Product in accordance with the relevant study protocol of such Clinical Study. A Clinical Study is deemed to be “Completed” upon lock of study database in accordance with the relevant study
protocol. “Clinical Studies” means more than one Clinical Study.
|
1.6
|
“CMC” shall mean “Chemistry, Manufacturing and Controls” and refers to the regulatory term under Laws and Regulations used in drug manufacturing and Development.
|
1.7
|
“CMO” shall mean a contract manufacturing organization performing manufacturing, packaging, or shipping services for drugs or medical devices.
|
1.8
|
“Combination Product” shall mean a product containing (i) a Licensed Product and (ii) one or more active ingredients that are not Licensed Products or a delivery device (whether such elements are
combined in a single formulation and/or package, as applicable, or formulated and/or packaged separately but sold together for a single price. The existence of a definition of “Combination Product” does not imply any right of
Licensee to modify the specifications of the Licensed Product other than in accordance with the rights expressly granted by this Agreement.
|
1.9
|
“Commercialization” shall mean any and all activities (whether occurring before or after Regulatory Approval) directed to the marketing, detailing and promotion of the Licensed Product after Regulatory
Approval for commercial sale has been obtained, and shall include marketing, promoting, detailing, marketing research, distributing, offering to commercially sell and commercially selling the Licensed Product, manufacturing in support of
any of the foregoing, importing, exporting or transporting the Licensed Product for commercial sale and regulatory affairs with respect to the foregoing. “Commercializing”, “Commercialize” and “Commercialized” shall
have corresponding meanings.
|
1.10
|
“Commercially Reasonable Efforts” shall mean, with respect to the Development, Commercialization or other Exploitation of Licensed Product, as the case may be, exerting such efforts and employing such
resources as would normally and objectively be exerted or employed by a similarly situated company for a product of similar market potential, profit potential and strategic value at a similar stage of its product life, taking into account
the competitiveness of the relevant marketplace, the patent, intellectual property and development positions of Third Parties, the applicable regulatory situation, the pricing/reimbursement situation, the commercial viability of the
product and other relevant development and commercialization factors based upon then-prevailing conditions.
|
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|
1.11
|
“Commercial Supply Agreement” shall mean the commercial supply agreement for the supply of Licensee with Nanoparticles as described in Section 8.6.
|
1.12
|
“Confidential Information” shall mean all Know How, including the Licensor Know How, the Know How within Licensee Technology, the Development Data, Nanoparticles and non-public information and
materials relating to the Licensed Product, or the business, affairs, research and development activities, results of pre-clinical and clinical trials, national and multinational regulatory proceedings and affairs, finances, plans,
contractual relationships and operations of the Parties that is treated by the applicable Party as confidential. All terms and conditions of this Agreement shall be considered Confidential Information of both Parties.
|
1.13
|
“Control” or “Controlled” shall mean, with respect to an item or right, the possession, whether by ownership or license (in each case other than pursuant to this Agreement), by a Party of the
right to grant to the other Party access to or a license to or under each such item or right as provided in this Agreement without violating any agreement or other arrangement with any Third Party.
|
1.14
|
“Debar”, “Debarred” or “Debarment” shall mean (i) being debarred, or being subject to a pending debarment, pursuant to section 306 of the FFDCA, 21 U.S.C. § 335a, (ii) being listed by any
federal and/or state agencies, excluded, debarred, suspended or otherwise made ineligible to participate in federal or state healthcare programs or federal procurement or non-procurement programs (as that term is defined in 42 U.S.C.
1320a-7b(f), or being subject to any pending process by which any such listing, exclusion, debarment, suspension or other ineligibility could occur, (iii) being disqualified by any government or regulatory agency from performing specific
services, or being subject to a pending disqualification proceeding, or (iv) being convicted of a criminal offense related to the provision of healthcare items or services or being subject to any pending criminal action related to the
provision of healthcare items or services.
|
1.15
|
“Development” shall mean all pre-clinical and other non-clinical testing and clinical research and development activities necessary to obtain Regulatory Approval for the Licensed Product. Development
shall include, but not be limited to, clinical testing, test method development and stability testing, toxicology, pharmacokinetics, pharmacoeconomic studies, mechanism studies, quality assurance, Clinical Studies, regulatory affairs and
activities, statistical analysis and report writing of submission documents. “Develop”, “Developed” and “Developing” shall have a corresponding meaning.
|
1.16
|
“Development Data” shall mean any results of experimentation and testing, processes, laboratory records, chemical, pharmacological, toxicological, clinical, analytical and quality control data,
pre-clinical, clinical and non-clinical trial data (including, but not limited to, data generated in Global Studies), study protocols, case report forms, trial master files, data analyses, reports, manufacturing data, techniques, processes
and summaries, other information contained in submissions to and information from ethics committees and Regulatory Authorities, health registration data, including but not limited to, registration dossiers, relating to the Licensed Product
and any updates thereof. Development Data shall include any Development Data generated by or on behalf of either Licensor or Licensee as well as Development Data generated by or on behalf of Licensor’s Other Licensees or Licensee’s
Sublicensees or any such Other Licensees’ or Sublicensees’ sublicensees.
|
1.17
|
“Development Plan” shall mean the plan to be established for the Development of the Licensed Product to obtain Regulatory Approval for the Field and for the Territory, as further defined in Section 4.3
hereof. An outline of the initial Development Plan is attached hereto as Exhibit 1.
|
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1.18
|
“Development Supply Agreement” shall mean the agreement for the supply of Licensee with Licensed Product for Development described in Section 8.6.
|
1.19
|
“Effective Date” of this Agreement shall mean the date of this Agreement as set forth in the Preamble.
|
1.20
|
“Electronic Data Platform” shall have the meaning set forth in Section 4.7.
|
1.21
|
“EMA” shall mean the European Medicines Agency or any successor entity having the same functions and responsibilities.
|
1.22
|
“European Union” shall mean the economic, scientific and political organization of member states as it may be constituted from time to time, which, as of the Effective Date, consists of Austria,
Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the
United Kingdom of Great Britain and Northern Ireland and that certain portion of Cyprus included in such organization.
|
1.23
|
“Exploit” shall mean to make, have made, import, use, sell or offer for sale, including with respect to Licensed Product, to Develop, Commercialize, obtain and maintain Regulatory Approval,
manufacture, have manufactured, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market or have sold or otherwise dispose of Licensed Product, and “Exploitation” shall mean the act
of Exploiting.
|
1.24
|
“FDA” shall mean the U.S. Food and Drug Administration or any successor entity having the same functions and responsibilities.
|
1.25
|
“FFDCA” shall mean the United States Food, Drug, and Cosmetic Act, as amended from time to time.
|
1.26
|
“FFF Manufacture” shall mean the steps of formulation, fill and finish (including but not limited to labeling) of the Nanoparticles to manufacture Licensed Products in accordance with Licensor’s
instructions and the Licensed Product’s current or future specifications [***].
|
1.27
|
“Field” shall mean the treatment of cancer in combination with radiotherapy.
|
1.28
|
“First Commercial Sale” shall mean the first sale in a country in the Territory of a Licensed Product to a Third Party by Licensee or its Related Parties for use in the Field and in the Territory,
after the applicable Licensed Product has obtained Regulatory Approval in such country. First Commercial Sale will not include a sale of a Licensed Product to a Related Party or sales of Licensed Products to be used for Clinical Studies.
|
1.29
|
“GCP” shall mean the current Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials, including without
limitation supranational, national and local legislation, regulations and official guidance, including but not limited to, as applicable, the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (E6), EU
Directive 2001/20/EC, EU clinical trial guidelines Volume X (EudraLex) and the FDA’s regulations and guidance documents for the conduct of clinical trials.
|
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|
1.30
|
“Generic Product” shall mean with respect to Licensed Product, on a country-by-country basis, a product (i) that contains Nanoparticles (or equivalent as determined by the relevant Regulatory
Authority); and (ii) that has received Regulatory Approval in such country through a regulatory approval process by which the sponsor or the regulatory agency references the Licensed Product or relies, in whole or in part, upon the data
supporting the Licensed Product and such product is considered a “generic” version of the Licensed Product (including any therapeutically equivalent or substitutable version of the Licensed Product and any extended-release version of the
Licensed Product). “Generic Product” shall not include any products sold or authorized for sale by a Party, its Affiliates or sublicensees, including through the granting of a Right of Reference or Use.
|
1.31
|
“Global Study” shall mean a global Clinical Study being or to be conducted by or on behalf of Licensor in the Field and within and outside the Territory. “Global Studies” means more than one
Global Study.
|
1.32
|
“GMP” shall mean all standards relating to current Good Manufacturing Practices for fine chemicals, API, intermediates, bulk products or finished pharmaceutical products, including without limitation,
as applicable, EU Good Manufacturing Practice Guidelines for Medicinal Products Volume IV (EudraLex), ICH Guidelines relating to the manufacture of API and finished pharmaceuticals, FDA current good manufacturing practice regulations and
guidance documents as well as Laws and Regulations promulgated by any governmental authority having jurisdiction over the manufacture of the Licensed Product or any components of either of the foregoing, or published guidance documents
(including advisory opinions, compliance policy guides and guidelines) promulgated by any Regulatory Authority having jurisdiction over the manufacture the Licensed Product, which guidance documents are being implemented within the
pharmaceutical manufacturing industry.
|
1.33
|
“Invention(s)” shall mean any and all inventions and discoveries, whether or not patentable or otherwise protectable under the Laws and Regulations of any country, which relate to the Licensed Product,
whether in the Field or not, and which are conceived, discovered or reduced to practice during the Term.
|
1.34
|
“Joint Steering Committee” or “JSC” shall mean Joint Steering Committee established by the Parties pursuant to Section 3.1.
|
1.35
|
“Joint Invention” shall have the meaning set forth Section 9.2(iii).
|
1.36
|
“Joint Patent Rights” shall have the meaning set forth Section 9.2(iii).
|
1.37
|
“Joint Technology” shall have the meaning set forth Section 9.2(iii).
|
1.38
|
“Know How” shall mean any and all data and information which is Confidential Information of either Party comprising or relating to concepts, discoveries, data, designs, formulae, ideas, Inventions,
improvements, materials, methods, models, research plans, procedures, designs for experiments and tests and results of experimentation and testing, processes, laboratory records, pre-clinical, clinical and non-clinical trial data, case
report forms, data analyses, reports, or summaries and information contained in submissions to and information from ethics committees and Regulatory Authorities. Know How includes documents containing know how, including but not limited to,
any rights including trade secrets, copyright, database or design rights protecting such know how.
|
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|
1.39
|
“Laws and Regulations” shall mean (i) all applicable laws, statutes, constitutions, treaties, rules, regulations, ordinances, codes of conduct, statutory guidance, codes and guidance having the force
of law, directives and regulations; and (ii) all applicable judicial, executive, legislative or administrative orders, directives, decrees, injunctions, judgments, permits, agreements, and other legal requirements applicable to the
Development, Commercialization and other Exploitation of the Licensed Product; and (iii) all applicable guidance documents and guidelines issued by Regulatory Authorities in its current version or as amended from time to time.
|
1.40
|
“License” shall have the meaning set out in Section 2.1.
|
1.41
|
“Licensed Product” shall mean NBTXR3 in any dose including, but not limited to, as part of a Combination Product.
|
1.42
|
“Licensee Net Sales” shall be calculated in accordance with international financial reporting standards (IFRS) and shall mean with respect to any Licensed Product, the gross sales of such Licensed
Product by Licensee or its Related Parties to Third Parties (other than a Sublicensee) in an arm lengths transaction, less the following amounts actually deducted or allowed:
|
(i)
|
discounts, credits, retroactive price reductions, rebates, refunds, chargebacks, allowances and adjustments granted to non-Sublicensee Third Parties, including Medicaid, managed care and similar types of
rebates, which are, in each case, imposed upon Licensee or its Related Parties by any Regulatory Authority or other entity with the authority to impose or demand such discounts, credits, retroactive price reductions, rebates, refunds,
chargebacks, allowances and adjustments;
|
(ii)
|
voluntary trade, quantity and cash discounts and rebates allowed or given, and customary fees paid to wholesale distributors, which are, in each case, consistent with Licensee’s customary past practice;
|
(iii)
|
sales, excise, turnover, inventory, value-added, and similar taxes assessed on the sale of the Licensed Product (other than income taxes of Licensee or its Related Parties), and import and customs duties
imposed upon and paid directly with respect to delivery, sale or use of Licensed Products;
|
(iv)
|
credits or allowances for damaged goods, returns or rejections actually paid on account of rejection or return of a Licensed Product; and
|
(v)
|
transportation, importation, shipping insurance, postage, freight and other handling expenses to the extent included in the price or otherwise paid by the Third Party.
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1.43
|
“Licensee Technology” shall mean the Patent Rights and related Know How Controlled by Licensee, its Affiliates and Sublicensees on or after the Effective Date that are necessary for the development,
commercialization or exploitation in the Field of products (including, but not limited to, the Licensed Product) that are primarily based on solid nanoparticle technology, including but not limited to, Licensee’s interest in any Joint
Technology that meets the requirements of this Section 1.43. Licensee Technology does not include Development Data generated by or for Licensee, Licensee’s Sublicensees or any sublicensee of any such Sublicensee.
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1.44
|
“Licensor Competitor” means (i) a Third Party that, at the time Licensee informs Licensor that it intends to enter into sublicensing discussions with such Third Party, is developing or commercializing,
or has publicly announced that it intends to develop or commercialize, a product that is primarily based on solid nanoparticle technology, or (ii) a person or entity that directly controls (as that term is used in Section 1.1) or is
directly controlled (as that term is used in Section 1.1) by a person or entity described in clause (i) of this Section 1.44.
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1.45
|
“Licensor Know How” shall mean the Know How that is Controlled by Licensor on or after the Effective Date that is necessary for the Development. Commercialization or Exploitation of the Licensed
Product in the Field and in the Territory including, but not limited to, Development Data and Licensor’s interest in any Joint Technology, except for Know How that consists of results of early research (prior to pre-clinical studies) and
CMC/manufacturing Know How not necessary to obtain or maintain Regulatory Approval in the Field and in the Territory. The Licensor Know How in existence on the Effective Date which Licensee will receive is described in more detail in Exhibit 2 hereto.
|
1.46
|
“Licensor Net Sales” shall be calculated in accordance with international financial reporting standards (IFRS) and shall mean with respect to any Licensed Product, the gross invoiced sales of such
Licensed Product by Licensor and its Related Parties to Third Parties in the Revertible Territory after exercise by Licensor of its right to terminate Licensee’s rights within the Revertible Territory in accordance with Section 2.4 in an
arm lengths transaction, less the following amounts actually deducted or allowed:
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(i)
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discounts, credits, retroactive price reductions, rebates, refunds, chargebacks, allowances and adjustments granted to non-Sublicensee Third Parties, including Medicaid, managed care and similar types of
rebates, which are, in each case, imposed upon Licensee or its Related Parties by any Regulatory Authority or other entity with the authority to impose or demand such discounts, credits, retroactive price reductions, rebates, refunds,
chargebacks, allowances and adjustments;;
|
(ii)
|
voluntary trade, quantity and cash discounts and rebates allowed or given, and customary fees paid to wholesale distributors, which are, in each case, consistent with Licensor’s customary past practice;
|
(iii)
|
sales, excise, turnover, inventory, value-added, and similar taxes assessed on the sale of the Licensed Product (other than income taxes of Licensor or its Related Parties), and import and customs duties
imposed upon and paid directly with respect to delivery, sale or use of Licensed Products;
|
(iv)
|
credits or allowances for damaged goods, returns or rejections actually paid on account of rejection or return of a Licensed Product; and;
|
(v)
|
transportation, importation, shipping insurance, postage, customs clearance, freight and other handling expenses to the extent included in the price or otherwise paid by the Third Party.
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1.47
|
“Licensor’s Other Licensees” shall mean any Third Party with whom Licensor has entered into a license agreement for Exploitation of the Licensed Product outside the Territory and within the Field.
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1.48
|
“Licensor Patent Rights” shall mean the Patent Rights that are Controlled by Licensor on or after the Effective Date within the Territory, including but not limited to, Licensor’s interest in any Joint
Patent Rights, which cover the Licensed Product. Without limiting the generality of the definition set forth in this Section 1.48, the Licensor Patent Rights on the Effective Date are listed in more detail in Exhibit 3 hereto.
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1.49
|
“Licensor Technology” shall mean, collectively, the Licensor Know How, the Licensor Patent Rights, and the Licensor Trademark.
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1.50
|
“Licensor Trademark” shall mean the trademark “NanoXray”, in any alphabetical characters.
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1.51
|
“Major Market Country” means China, India, Japan, South Korea or Taiwan.
|
1.52
|
“Manufacturing Cost” shall have the meaning set forth set forth on Exhibit 4.
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1.53
|
“Manufacturing Cost Cap” shall have the meaning set forth on Exhibit 4.
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1.54
|
“MRA Territory” means Australia and New Zealand.
|
1.55
|
“Nanoparticles” shall mean the crystalline hafnium oxide (HfO2) nanoparticles forming the basis of the Licensed Product.
|
1.56
|
“NBTXR3” shall mean Licensor’s product candidate NBTXR3, a pyrogen-free, sterile aqueous suspension of Nanoparticles with a biocompatible coating of hexamethylphosphate which provides a negative
surface charge to the Nanoparticles at neutral pH for intra-tumoral and intra-arterial injection.
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1.57
|
“Non-Releasing Party” shall have the meaning set forth in Section 16.11(ii).
|
1.58
|
“Non-Revertible Territory” shall mean China (including Hong Kong and Macau) and Taiwan.
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1.59
|
“Party” or “Parties” shall mean Licensee or Licensor, or Licensee and Licensor, as the context requires.
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1.60
|
“Patent Right(s)” shall mean any and all (i) patents, (ii) pending patent applications, including, without limitation, all provisional applications, substitutions, continuations, continuations-in-part,
divisions, renewals, and all patents granted thereon, (iii) all patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including, without limitation,
supplementary protection certificates or the equivalent thereof, and (iv) all foreign counterparts of any of the foregoing.
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1.61
|
“Phase I Study” shall mean a Clinical Study of a Licensed Product in human subjects in accordance with Laws and Regulations and GCP that generally meets the requirements of 21 C.F.R. § 312.21(a), as
amended (or its successor regulation or comparable laws in countries outside the United States).
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1.62
|
“Phase II Study” shall mean a Clinical Study of a Licensed Product in human subjects in accordance with Laws and Regulations and GCP that generally meets the requirements of 21 C.F.R. § 312.21(b), as
amended (or its successor regulation or comparable laws in countries outside the United States) that is intended to support a preliminary determination as to whether such Licensed Product is safe for its intended use, and to provide
preliminary information about such Licensed Product’s efficacy, in order to permit the design of further Clinical Study(ies), including Phase III Studies.
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1.63
|
“Phase III Study” shall mean a controlled Clinical Study in human subjects of the efficacy and safety of a Licensed Product, which is prospectively designed to demonstrate statistically whether such
Licensed Product is effective and safe for use in a particular indication in a manner sufficient to file an application to obtain Regulatory Approval to market such Licensed Product as further defined in 21 C.F.R. § 312.21(c) (or the
non-United States equivalent thereof).
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1.64
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“Pilot Study” shall mean an initial Clinical Study commonly referred to as a pilot or feasibility study to gain clinical experience in using the Licensed Product as a medical device prior initiating a
large-scale Clinical Study.
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1.65
|
“Pivotal Study” shall mean a Clinical Study in a sufficient number of human patients to collect the primary evidence of safety and effectiveness of the Licensed Product for the purpose of preparing and
submitting applications for or otherwise obtaining Regulatory Approval as a medical device.
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1.66
|
“Regulatory Approval” shall mean any and all approvals (including the approval by an applicable governmental authority in certain countries or territories with respect to the price at which a
pharmaceutical product or a medical device is sold and can be reimbursed by healthcare insurers), licenses, registrations or authorizations of any national, supra-national, regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity, necessary for the marketing and sale of a pharmaceutical product or a medical device in a given regulatory jurisdiction.
|
1.67
|
“Regulatory Authorities” shall mean any competent national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, ethics
committee or authority involved in the granting or controlling of Regulatory Approvals or otherwise exercising authority with respect to the Exploitation of the Licensed Product in the Territory.
|
1.68
|
“Related Parties” means a Party’s Affiliates and (i) in the case of Licensee, Licensee’s Sublicensees, and (ii) in the case of Licensor, Licensor’s Other Licensees.
|
1.69
|
“Releasing Party” shall have the meaning set forth in Section 16.11(ii).
|
1.70
|
“Right of Reference or Use” shall mean a “Right of Reference or Use” as that term is defined in 21 C.F.R. §314.3(b), and equivalent rights outside the United States.
|
1.71
|
“Revertible Territory” shall mean Bangladesh, Brunei, Burma, Cambodia, East Timor, India, Indonesia, Japan, Korea (including South Korea and North Korea), Laos. Malaysia, Mongolia, Pakistan, Papua New
Guinea, Philippines, Singapore, Thailand, and Vietnam.
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1.72
|
“Royalty Term” means, on a country-by-country and Licensed Product-by-Licensed Product basis, the period of time beginning upon the date of First Commercial Sale of a Licensed Product in that country,
and ending upon the later to occur of (i) the expiration of the last Valid Claim of a Licensor Patent Right covering such Licensed Product in such country, or (ii) ten (10) years from the First Commercial Sale of the Licensed Product in
such country.
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1.73
|
“Safety Data Exchange Agreement” or “SDEA” shall mean the agreement described in Section 10.2.
|
1.74
|
“Sublicensee” shall mean an entity to which Licensee grants a sublicense under Licensee’s License pursuant to Section 2.5; provided that “Sublicensee” does not include (i) any of Licensee’s Affiliates,
or (ii) wholesale distributors of Licensee or its Affiliates who, in each case, purchase Licensed Products from Licensee or its Affiliates
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1.75
|
“Supply Failure” shall have the meaning set forth in Section 8.7(iv).
|
1.76
|
“Term” shall have the meaning set forth in Section 14.1.
|
1.77
|
“Territory” shall mean, initially, the Non-Revertible Territory, the Revertible Territory and the MRA Territory. If Licensor exercises its right to terminate Licensee’s License with respect to the
Revertible Territory and/or the MRA Territory in accordance with Sections 2.3 and/or 2.4, the term “Territory” shall, as of the effective date of each such termination, no longer include such terminated portion(s) countries.
|
1.78
|
“Third Part(y/ies)” shall mean any party other than the Parties and their respective Affiliates.
|
1.79
|
“Third Party Agreement” shall have the meaning set forth in Section 12.2(iv).
|
1.80
|
“Valid Claim” shall mean
|
(i)
|
any claim of an issued and unexpired Licensor Patent Right, which has not been held unenforceable or invalid by a court or other governmental agency of competent jurisdiction in a decision that is not
appealed or cannot be appealed, and which has not been disclaimed or admitted to be invalid or unenforceable through reissue or otherwise; or
|
(ii)
|
a pending claim in a pending patent application within the Licensor Patent Rights. Notwithstanding the foregoing clause (i), in the event that a pending claim in a pending application does not issue as a
valid and enforceable claim in an issued patent within eight (8) years after the earliest date from which such patent application claims priority, such a pending claim will not be a Valid Claim, unless and until such pending claim
subsequently issues as a valid and enforceable claim in an issued patent, in which case such claim will be reinstated and be deemed to be a Valid Claim as of the date of issuance of such patent.
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2.1
|
Exclusive License Grant to Licensee. Subject to the terms of this Agreement, including but not limited to Section 2.2, Licensor hereby grants to Licensee as of the Effective Date and for the Term, and
Licensee hereby accepts, the exclusive (even as to Licensor), perpetual and irrevocable (subject to Sections 2.3, 2.4 and 14) license, with the right to sublicense (subject to Section 2.5) through multiple tiers under and to the Licensor
Technology in order to:
|
(i)
|
Exploit or have Exploited the Licensed Product in the Field and in the Territory; and
|
(ii)
|
use the Licensor Trademark in connection with the Exploitation of the Licensed Product in the Field and in the Territory,
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2.2
|
Exclusions from the License. The License set forth in Section 2.1 shall be restricted as follows:
|
(i)
|
Unless and until a Supply Failure occurs, Licensee’s right to make or have made Licensed Products shall be limited to using Nanoparticles supplied by Licensor for FFF Manufacture of the Licensed Product in
the Field and in the Territory. But, upon occurrence of a Supply Failure, Licensee’s License shall cover all rights to make or have made Licensed Products including, but not limited to, the right to make or have made Nanoparticles;
|
(ii)
|
The Parties agree that Licensee’s License to Develop the Licensed Product shall not include the right to modify the substance of the Licensed Product, in particular, Licensee shall not modify (i) the coating
of NBTXR3 and/or (ii) the Nanoparticle and Licensee shall not reverse engineer the Nanoparticle.
|
2.3
|
Termination by Licensor of MRA Territory. Licensor shall have the right to terminate the License with respect to the MRA Territory with immediate effect by giving written notice to Licensee. If
Licensor terminates the License with respect to the MRA Territory, then Licensee’s License shall lapse with respect to the MRA Territory.
|
2.4
|
Termination by Licensor of Revertible Territory.
|
(i)
|
Licensor shall have the right to terminate the License in the Revertible Territory by giving written notice to Licensee at any time after Licensee has Completed at least one (1) Phase I Study (in case of
medicinal product designation for Licensed Product) or Pilot Study (in case of medical device designation for Licensed Product) under the following conditions:
|
(1)
|
if Licensor is or has been acquired by a Third Party through merger or purchase of all or substantially all of Licensor’s stock or assets; or
|
(2)
|
If Licensor has entered into a license or similar agreement containing development and commercialization terms with a Third Party to Exploit the Licensed Product outside the Territory, and such Third Party
wishes to obtain an exclusive license to Exploit the Licensed Product in the Field in the Revertible Territory.
|
(ii)
|
If Licensor elects to terminate the License with respect to Revertible Territory, Licensor must send written notice to Licensee seeking to terminate the License for the entire Revertible Territory and not on
a country-by-country basis.
|
(iii)
|
Licensee shall have the right to refuse Licensor’s termination under Section 2.4(ii) on a country-by-country basis if Licensee:
|
(1)
|
is actively negotiating with a potential Sublicensee in good faith and has received a draft term sheet from such potential Sublicensee or has provided a draft term sheet to such potential Sublicensee; or
|
(2)
|
has granted a sublicense in accordance with Section 2.5 to a Sublicensee; or
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(3)
|
has, filed for Regulatory Approval of the Licensed Product in the applicable country.
|
(iv)
|
If Licensee refuses Licensor’s termination under Section 2.4(ii) as provided in Section 2.4(iii), then:
|
(1)
|
Licensee’s rights under the License will be terminated only in those countries within the Revertible Territory for which Licensee did not refuse Licensor’s termination;
|
(2)
|
Licensee’s rights under the License will continue in those countries within the Revertible Territory for which Licensee refused Licensor’s termination; and
|
(3)
|
Licensor will have, subject to Section 2.4(v), no further right under this Section 2.4 to terminate Licensee’s rights in those countries within the Revertible Territory for which Licensee refused Licensor’s
termination.
|
(v)
|
If Licensee refuses Licensor’s termination under Section 2.4(ii) as provided in Section 2.4(iii)(1), [***] then Licensor may, within [***] days after receipt of Licensee’s notice of the expiration of the
applicable period, inform Licensee with a written notice that Licensor wishes to re-exercise its right to terminate the License in the affected portion of the Revertible Territory. If Licensor so notifies Licensee, Licensee’s rights under
the License in the affected portion of the Revertible Territory will terminate and Licensor will have the same rights and obligations with regard to the affected portion of the Revertible Territory as it does for the other parts of the
Revertible Territory where Licensee’s rights were originally terminated including, but not limited to, the obligation to make all payments under Section 7.7. If Licensor does not wish to re-exercise its right to terminate the License in
such affected portion of the Revertible Territory, or if Licensor fails to provide Licensee with written notice that it wishes to re-exercise its right to terminate the License in such affected portion of the Revertible Territory within the
[***] day period set forth in this Section 2.4(v), then Licensor will have no further right to terminate Licensee’s rights in the affected portions of the Revertible Territory.
|
2.5
|
Sublicenses. Subject to the requirements of this Section 2.5, Licensee shall be entitled to sublicense any or all of its rights under this Agreement through multiple tiers:
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(i)
|
Licensee has informed Licensor of the discussions with such potential Sublicensee in accordance with Section 3.7; and
|
(ii)
|
Each sublicense granted by Licensee will be pursuant to a written agreement that imposes on such Sublicensee obligations that are at least as protective of Licensor’s rights as the relevant restrictions and
limitations set forth In this Agreement, including provisions regarding Commercially Reasonable Efforts, exclusions from the License, termination of the MRA Territory, development obligations (to the extent applicable), regulatory
activities (to the extent applicable), commercialization (to the extent applicable), confidentiality, sharing of Development Data, Joint Technology, audit, record-keeping and termination, including consequences of termination. Any such
sublicense agreement shall include provisions on warranties and liabilities, indemnification and insurance that are not inconsistent with those contained in this Agreement. If Licensee grants a sublicense to a Third Party as permitted by
this Section 2.5, then Licensee shall provide Licensor prompt written notice thereof. Licensee shall provide Licensor with an executed copy of any such sublicense agreement (redacted as Licensee may reasonably determine to protect
confidential or commercially sensitive information; provided that Licensee may not redact any information that is necessary for Licensor to determine whether such sublicense meets the requirements of this Agreement). Except as
otherwise agreed by the Parties in writing, Licensee shall be jointly and severally responsible with its Sublicensees to Licensor for failure by its Sublicensees to comply with this Agreement; and
|
(iii)
|
Licensee shall not grant without the prior written consent of Licensor a sublicense to (1) a Licensor Competitor; or (2) Licensee’s rights [***].
|
2.6
|
Licensor Know How Data Packages. In furtherance of the rights and licenses granted by Licensor to Licensee under this Agreement, Licensor shall furnish to Licensee all Licensor Know How which is
necessary and useful to Develop and Commercialize the Licensed Product in the Field and in the Territory. The Parties agree that Licensee will have access to an electronic copy of the Licensor Know How only, but Licensee will have the
ability to download and print such electronic copy. Licensee may use the Licensor Know How furnished by Licensor under this Section 2.6 solely to carry out its rights and comply with its obligations under this Agreement. In the event
Licensee reasonably believes that the Licensor Know How furnished by Licensor under this Section 2.6 is incomplete, Licensee shall provide written notice thereof to Licensor, and Licensor shall furnish such missing Licensor Know How, if
available, as quickly as possible, but in any event no more than thirty (30) days after receipt of Licensee’s written notice hereunder. Licensor shall use its reasonable endeavors to answer all questions received from Licensee regarding the
Licensor Know How as soon as reasonably possible after receipt. All such Licensor Know How shall be included in the Electronic Data Platform. For the period before the Electronic Data Platform is established, Licensor will continue to grant
Licensee access to the electronic data room of Licensor that was reviewed by Licensee during the due diligence phase leading up to this Agreement. In addition, Licensor will provide to Licensee a copy of the Licensor Know How in existence
on the Effective Date on a DVD-ROM or other appropriate media acceptable to Licensee at Licensor’s cost. In addition, if at any time the Electronic Data Platform is not functioning properly, each Party agrees to provide, at the request of
the other Party, updated Know How on a DVD-ROM or other appropriate media acceptable to the requesting Party.
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2.7
|
Documents and Declarations. Licensor shall execute all documents, give all declarations regarding the licenses granted hereunder and reasonably cooperate with Licensee at the costs of Licensee to the
extent such documents, declarations and/or cooperation are required for the recordation or registration of the License granted hereunder at competent patent offices in the Territory.
|
2.8
|
Retention of Rights. Except as expressly set forth therein, Licensor grants no other right or license under, and reserves all right, title and interest in and to the Licensor Technology. Licensor
reserves all rights not explicitly granted herein, including, but not limited to, (i) the exclusive right to Exploit the Licensed Product and/or the Licensor Technology outside of the Territory and outside the Field within the Territory,
(ii) the right to conduct Global Studies in the Territory subject to the terms of this Agreement; (iii) the right to terminate the License with respect to the MRA Territory and/or the Revertible Territory in accordance with Sections 2.3
and/or 2.4; (iv) the exclusive worldwide right to manufacture Nanoparticles subject to Section 8.7; (v) the exclusive worldwide right to modify the manufacturing process of Nanoparticles and Licensed Product subject to the provisions of
Section 8.5, and (vi) the right to use the Licensor Technology in the Territory to the extent required to perform its obligations to Licensee under this Agreement. Nothing herein shall be construed to grant Licensee the right to use
Nanoparticles, NBTXR3 and other Licensor Technology for any product other than the Licensed Product, for any use other than in the Field, and in any country other than a country in the Territory.
|
2.9
|
License Grant to Licensor.
|
(i)
|
Subject to the terms and conditions of this Agreement, Licensee hereby grants to Licensor a perpetual, non-exclusive, cost-free license, with the right to sublicense in multiple tiers (subject to Section
2.9(ii)), to the Licensee Technology (a) to the extent necessary for Licensor perform its obligations under this Agreement; (b) to Exploit the Licensed Product in any country outside the Territory and in the Field and (c) to develop,
manufacture, commercialize, exploit or otherwise use, in the Field anywhere in the world, products other than the Licensed Product that (i) are covered by a Valid Claim that is included in a Licensor Patent Right in existence as of the
Effective Date in the form such Valid Claim exists as of the Effective Date, (ii) are primarily based on solid nanoparticle technology, and (iii) do not compete with the Licensed Product.
|
(ii)
|
Each sublicense granted by Licensor will be pursuant to a written agreement that imposes on such sublicensee obligations that are at least as protective of the Licensee Technology as the relevant restrictions
and limitations set forth in this Agreement, including provisions regarding exclusion from the license, development obligations (to the extent that the sublicense relates to the Licensed Product), regulatory activities (to the extent that
the sublicense relates to the Licensed Product), commercialization (to the extent that the sublicense relates to the Licensed Product), confidentiality, sharing of Development Data (to the extent that the sublicense relates to the Licensed
Product), and termination, including consequences of termination. If Licensor grants a sublicense to a Third Party as permitted by this Section 2.9(ii), then Licensor shall provide Licensee prompt written notice thereof. Licensor shall
provide Licensee with an executed copy of any such sublicense agreement (redacted as Licensor may reasonably determine to protect confidential or commercially sensitive information; provided that Licensor may not redact any
information that is necessary for Licensee to determine whether such sublicense meets the requirements of this Agreement). Except as otherwise agreed by the Parties in writing. Licensor shall be jointly and severally responsible with its
sublicensees to Licensee for failure by its sublicensees to comply with this Agreement.
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2.10
|
Right of Licensor to Request Negotiations. Licensor may at any time request in writing that Licensee make the licenses granted Licensor under Section 2.9(i) exclusive (or, if appropriate, co-exclusive
with Licensee), and Licensee will consider such request in good faith. Licensee also agrees that, if it is considering granting a license to the Licensee Technology to a Third Party outside the context of a sublicense pursuant to Section
2.5, it will so inform Licensor and Licensor may request that Licensee offer such license to Licensor. Licensor acknowledges that any license granted by Licensee under this Section 2.10 will be subject to the terms of any licenses to the
Licensee Technology previously granted by Licensee to its Sublicensees or other licensees. If the Parties elect to negotiate a license as described in this Section 2.10, such negotiation will be in good faith, but nothing in this Section
2.10 shall require either Party to enter into negotiations with the other Party or conclude any license under this Section 2.10. Further, if Licensee elects to enter into negotiations with Licensor for a license as described in the second
sentence of this Section 2.10, nothing in this Section 2.10 will be deemed to limit in any way Licensee’s right to discuss a license covering the same subject matter with Third Parties.
|
2.11
|
Reservation of Rights. Except as expressly set forth in Section 2.9(i) and in Section 4.7(ii) with regard to Development Data, Licensee grants no other right or license under, and reserves all right,
title and interest in and to, (i) the Licensee Technology, (ii) the Development Data obtained by or for Licensee, Licensee’s Sublicensees or any sublicensees of such Sublicensees, and (iii) any other Patent Rights and Know How Controlled by
Licensee on or after the Effective Date.
|
3.1
|
Establishment of the JSC. Promptly after the Effective Date the Parties shall establish and during the Term the Parties shall operate a Joint Steering Committee (JSC), which shall have the primary role
in ensuring the overall success of the Development and Commercialization of the Licensed Product in the Field and in the Territory. The JSC shall be comprised of six (6) professionally and technically qualified representatives, three (3)
from each Party. The JSC shall meet at such time as the JSC shall agree from time to time, but at least once every six (6) months. Licensee shall designate the chairman of the JSC who shall be responsible to call the regular meetings and
Licensor shall designate the vice-chairman. JSC meetings may be conducted in person, by telephone or videoconference. Until the First Commercial Sale of a Licensed Product in the Field and in the Territory at least one (1) meeting per
calendar year shall be held in person. Each Party shall provide the other Party with written notice of its representatives for the JSC within ten (10) days after the Effective Date of this Agreement and, thereafter, immediately upon
replacement. Each Party may invite guests to the meetings, in order to discuss special scientific, non-clinical, clinical, technical or commercial topics. Prior to each meeting of the JSC the Parties will exchange an agenda and written
summaries of recent Development Data and other information, relating to their respective activities and the activities of Licensee’s Sublicensees or Licensor’s Other Licensees in accordance with Section 4.7 hereof. In addition to regular
scheduled meetings, either of the chairman or vice-chairman may convene a special meeting of the JSC with two (2) weeks’ written notice if such meeting is to be conducted in person, and with one (1) week’s written notice if such meeting is
to be conducted by teleconference, or such shorter period as the chairman and vice-chairman may agree;
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3.2
|
Responsibilities of the JSC. As described in more detail below, the Joint Steering Committee will supervise the Development, Commercialization and other Exploitation of the Licensed Product in the
Field and in the Territory. The expertise of the individuals acting as each Party’s JSC representatives shall reflect the Development stage of the Licensed Product. The tasks of the JSC shall include, subject to the terms of this Agreement:
|
(i)
|
review and approve drafts of the Development Plan and any amendments thereto submitted in accordance with Section 4.3 including, but not limited to any plans of Licensee to Develop or Commercialize a
Combination Product;
|
(ii)
|
oversee the pre-clinical, clinical and regulatory program for Licensed Product, consistent with the applicable Development Plan;
|
(iii)
|
review and approve the scientific integrity of all Clinical Studies (including, if applicable Global Studies);
|
(iv)
|
review and coordinate the statistical analysis plans and protocols (and any investigator’s brochures and revisions thereto) for each Clinical Study conducted in the Territory with respect to the Licensed
Product (including, if applicable Global Studies);
|
(v)
|
monitor the progress of all Clinical Studies (including, if applicable Global Studies) and other Development activities concerning the Licensed Product;
|
(vi)
|
determine whether to suspend any Clinical Studies (including, if applicable Global Studies) in accordance with Section 4.8;
|
(vii)
|
review and coordinate any publication and communication strategy of results of Clinical Studies;
|
(viii)
|
review and coordinate the proposed regulatory strategy and regulatory designation request of the Licensed Product for each country of the Territory;
|
(ix)
|
review the communication strategy with Regulatory Authorities and coordinate briefing documents to be used in meetings with Regulatory Authorities;
|
(x)
|
facilitate the exchange of all Development information and data relating to all research and studies including Clinical Studies for Licensed Product;
|
(xi)
|
oversee the development of a manufacturing strategy for supplies of Nanoparticles and Licensed Product for Clinical Studies (including, if applicable Global Studies) to ensure that such Licensed Product is
manufactured, packed
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(xii)
|
oversee the development of robust processes for Licensed Product manufacture that are capable of scale-up to commercial scale and can be validated and operated reliably to produce consistently product of the
required standard;
|
(xiii)
|
oversee the conduct of appropriate stability studies, using appropriate and validated analytical methods, according to current ICH guidelines;
|
(xiv)
|
review the needs and requirements for supplies of Nanoparticles and Licensed Product and the manufacture thereof;
|
(xv)
|
review and coordinate patent and other intellectual property strategy and, to the extent applicable, patent litigation strategy;
|
(xvi)
|
discuss the necessity and review new in-license agreements for Third Party licenses in accordance with Section 9.8(ii);
|
(xvii)
|
review and coordinate market and commercialization strategy within the bounds of applicable Laws and Regulations;
|
(xviii)
|
establish guidelines for operation and maintenance of the Electronic Data Platform as described in Section 4.7
|
(xix)
|
discuss and resolve any proposals by Licensor to exceed Manufacturing Cost Cap as described on Exhibit 4; and
|
(xx)
|
establish project teams and tasks for these teams on an “as-needed” basis.
|
3.3
|
First Right of Information. [***].
|
3.4
|
Decision Making; Casting Vote. Each Party shall have one (1) vote and, subject to the terms of this Section 3.4, all decisions will be made unanimously. In the event the JSC is unable to agree on any
matter after good faith attempts to resolve a disagreement in a commercially reasonable fashion then either Party may refer the disagreement to a one- to-one personal face-to-face meeting between the Chief Executive Officer of Licensee and
the Chief Executive Officer of Licensor which shall take place within fourteen (14) days of the date of the relevant referral. If the Chief Executive Officer of Licensee and the
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(i)
|
[***]
|
(ii)
|
[***]
|
(iii)
|
[***]
|
(iv)
|
[***]
|
(1)
|
[***]
|
(2)
|
[***]
|
(3)
|
[***]
|
(v)
|
[***]
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3.5
|
Expert Decision. Neither Party shall have final decision-making authority in the event the disputed topic concerns the following:
|
(i)
|
the determination whether a milestone has been successfully completed and whether a milestone becomes payable; or
|
(ii)
|
any amendment to the Development Plan which may lead to a delay of the Development or adversely affect the successful Development of the Licensed Product in the Field either within or outside the Territory;
|
(iii)
|
the determination of the reasonable Development costs incurred by Licensee and the market potential of the Licensed Product upon termination of the Revertible Territory (or parts thereof) in accordance with
Section 2.4; or
|
(iv)
|
the determination whether a request by Licensor to charge Manufacturing Cost in excess of the Manufacturing Cost Cap is justified, and the amount, if any, in excess of the Manufacturing Cost Cap that Licensee
is required to pay.
|
3.6
|
Limits on JSC Power. Except to the extent explicitly permitted in this Agreement, the JSC shall have no power to amend this Agreement.
|
3.7
|
Right of Information. Without limiting Licensor’s obligations and Licensee’s rights under Section 3.3, during the Term, each Party shall keep the JSC reasonably and regularly informed about its
Exploitation of Licensed Product. In particular, Licensor will keep Licensee reasonably informed about the development and commercialization of a Combination Product outside the Territory and in the Field. Further, (i) each Party shall
promptly inform the other Party of discussions with potential Third Party licensees or sublicensees with respect to the Exploitation of the Licensed Product in the Territory (inside the Field with respect to the Licensee and outside the
Field with respect to the Licensor) and (ii) Licensor shall promptly inform Licensee of discussions with potential licensees for development and commercialization of its products NBTX-IV and NBTX-TOPO inside the Territory, in both cases (i)
and (ii) once a binding confidentiality agreement has been signed with the applicable Third Party. In that case such Party shall provide the other Party with the name of the Third Party and the general scope of the proposed license. The
Parties shall ensure that such potential licensees or sublicensees agree to the disclosure in accordance with this Section 3.7. Both Parties will inform the (vice-) chairman of the other Party in between the meetings of the JSC in case of
important and material events concerning the Exploitation of the Licensed Product.
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3.8
|
Licensor Agreements with Third Parties. If and when Licensor exercises its right to enter into one or more agreements with Third Parties regarding Licensed Products or Nanoparticles outside of the
Territory or in the Territory but outside the Field, Licensor agrees that such agreements shall be consistent with, and not conflict with, Licensor’s obligations to Licensee under this Agreement.
|
4.1
|
Scope and Conduct of the Development. Licensee shall use Commercially Reasonable Efforts to Develop, at its cost, the Licensed Product in the Field in the Territory. The Development of the Licensed
Product in the Field and in the Territory shall be performed in accordance with the Development Plan, GCP, GMP and Laws and Regulations in order to obtain Regulatory Approval, either as medicinal product or a medical device, in the Field
throughout the Territory. The Parties expressly agree that any Development activities shall be performed in accordance with the Laws and Regulations throughout the Territory as well as Laws and Regulations and GCP applied by the EMA and the
FDA to the Licensed Product so that any Development Data generated by Licensee, its Affiliates or Sublicensees is usable to obtain Regulatory Approval for the Licensed Product in the European Union and the USA.
|
4.2
|
Studies. In particular, Licensee shall use Commercially Reasonable Efforts to conduct the Development within the timeframes set forth in the Development Plan. Licensee and Licensor explicitly
understand and agree that Licensee commits to use Commercially Reasonable Efforts to:
|
(i)
|
to Start a minimum of two (2) Phase I Studies (in case of medicinal product designation for Licensed Product)/Pilot Studies (in case of medical device designation for Licensed Product) in two (2) different
tumor indications within the Field and within the Territory. The timeline for the Start of these Clinical Studies shall be (a) eighteen (18) months after the Effective Date of this Agreement in case Licensee reasonably determines that
further pre-clinical studies are needed for a particular clinical indication based on information received from Regulatory Authorities or from qualified and experienced experts, such information to be shared with Licensor through the
Electronic Database and provided that such further pre-clinical studies are actually conducted; or (b) [***] months after the Effective Date in case no pre-clinical studies are needed for a particular clinical indication.
For the avoidance of doubt, Licensee’s commitment includes the obligation to conduct pre-clinical studies that are required to conduct the above Clinical Studies and to bear all related costs; and
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(ii)
|
to Start a third (3rd) Phase I Study (in case of medicinal product designation for Licensed Product)/Pilot Study in a third
indication (in case of medical device designation for Licensed Product) within thirty-six (36) months after the Effective Date of this Agreement or sooner, if feasible; provided that, it will not be a breach of this Agreement if
Licensee does not Start such third (3rd) Phase I Study sooner than thirty-six (36) months after the Effective Date of this Agreement. The estimated timeline
for the Start and the outline of this third Phase I Study (in case of medicinal product designation for Licensed Product)/Pilot Study (in case of medical device designation for Licensed Product) will be determined in the Development Plan.
|
4.3
|
Development Plan. An outline of the initial Development Plan as of the Effective Date is attached hereto as Exhibit 1. The Parties agree that certain changes to the outline of the initial Development
Plan may result from the outcome of meetings with the Regulatory Authorities. A detailed Development Plan based on the outline of the initial Development Plan in Exhibit 1 will be provided for review and approval by the Joint Steering
Committee no later than six (6) months after the Effective Date. Thereafter, the Development Plan will be updated from time to time by Licensee, but at least once a year, and shall be reviewed and approved by the Joint Steering Committee.
The Development Plan shall contain content that is similar to similar documents customarily used in the pharmaceutical industry and shall at a minimum set forth, inter alia, the activities to be performed under the Development Plan,
including but not limited to, the non-clinical and clinical development program, Licensee’s and Licensor’s manufacturing activities and the obtaining of Regulatory Approvals in the Field in the Territory; and projected non-binding timelines
for each activity and any Development milestone.
|
4.4
|
Global Studies.
|
(i)
|
Licensor may, from time to time, propose a Global Study by providing all relevant information about such proposed Global Study to Licensee through the JSC. Licensee may determine, in its sole discretion,
whether it wishes to participate in such Global Study in the Territory. The Parties will discuss Licensor’s proposal in good faith and Licensee will reasonably consider participating in such Global Study in the Territory.
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(ii)
|
If Licensee determines that it wishes to participate in such Global Study in the Territory, then Licensee shall conduct such Global Study as sponsor in the Territory in coordination with Licensor, who shall
be responsible for such Global Study outside the Territory, and the Parties shall discuss coordination of efforts and cost-sharing for such Global Study.
|
(iii)
|
If Licensee determines that it does not wish to participate in such Global Study performed in the Territory and Licensor continues to wish to conduct such Global Study in the Territory without Licensee’s
participation, then Licensor may request that Licensee permit Licensor to so conduct such Global Study in the Territory. Licensee will consider such proposal in good faith and will not arbitrarily refuse Licensor’s proposal, always
understood that Licensee shall have the final decision-making power with no veto right for Licensor. If Licensee elects to accept such proposal, (a) Licensee will cooperate in good faith with Licensor to execute such documents that are
reasonably required for Licensor to conduct the Global Study in the Territory, with reasonable and documented costs for the execution of such documents as well as applicable out-of-pocket expenses to be reimbursed by Licensor, and (b)
Licensor will share the Development Data arising from such Global Study pursuant to Section 4.7 to the same extent as for any other Clinical Trial conducted under this Agreement. If Licensee elects not to accept such proposal, then such
Global Study will not be conducted in the Territory.
|
4.5
|
Cooperation. To the extent that Licensor or an Affiliate or licensee of Licensor elects to carry on Development of the Licensed Product in the Territory but outside the Field, Licensor will reasonably
inform and consult with Licensee, through the JSC, in all regulatory matters relating to such Development in the Territory to avoid any steps that would adversely affect Licensee’s Development of the Licensed Product in the Field in the
Territory. Licensor shall bind its Affiliates and use commercially reasonable efforts to bind Licensor’s Other Licensees who may conduct Development of the Licensed Product in the Territory but outside the Field to cooperate with Licensee
in accordance with this Section 4.5. Nothing in the foregoing will limit Licensor’s obligations under this Section 4.5, regardless of whether Development is being conducted by Licensor, an Affiliate or a licensee.
|
4.6
|
Performance and Funding of the Development Obligations. As of the Effective Date, except as otherwise provided in this Agreement, Licensee shall bear all costs for the Development of the Licensed
Product in the Field and in the Territory, including but not limited to all pre-clinical or Clinical Studies required to obtain Regulatory Approval in the Field in the Territory.
|
4.7
|
Development Data; Electronic Data Platform.
|
(i)
|
The Parties will make available to each other copies of all Development Data generated resulting from their respective Development activities with regard to the Licensed Product. All Development Data and all
correspondence regarding Development Data shall be provided, as far as possible, in English language. In case a document is not in English but material for the Exploitation of the Licensed Product, then the Party that has prepared the
document shall prepare a non-certified translation into English. The exchange of Development Data shall be performed by establishing a secured electronic platform, e.g. an electronic data room (‘‘Electronic Data Platform”). The
Electronic Data Platform shall contain copies of all signed copies of reports or other quality documents that are reasonably necessary for the Development and Commercialization of the Licensed Product in compliance with Laws and
Regulations. The details of the Electronic Data Platform shall be determined by the JSC and it shall be the responsibility of the JSC to establish the Electronic Data Platform within three (3) months after the Effective Date of this
Agreement. The Parties will share the cost of the Electronic Data Platform equally. In case further parties are granted access to the Electronic Data Platform (e.g. Licensor’s Other Licensees or approved Sublicensees of Licensee) then the
Parties agree to re-negotiate the cost splitting in good faith.
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(ii)
|
Licensee and Licensee’s Sublicensees will share all Development Data obtained by or for them with Licensor free of charge, and Licensor is entitled to disclose, such Development Data, subject to the
requirements of Section 11, to its Affiliates and to Licensor’s Other Licensees (including sublicensees of Licensor’s Other Licensees) for Exploitation of the Licensed Product outside the Territory and in the Field. Licensor and Licensor’s
Other Licensees will share all Development Data obtained by or for them with Licensee free of charge, and Licensee is entitled to disclose such Development Data, subject to the requirements of Section 11, to its Affiliates and to Licensee’s
Sublicensees (including sublicensees of Licensee’s Sublicensees) for Exploitation of the Licensed Product inside the Field and in the Territory in accordance with the terms of this Agreement. The Parties shall ensure that Licensor’s
licensees, including, but not limited to. Licensor’s Other Licensees and Licensee’s Sublicensees agree to the disclosure of Development Data in accordance with this Section 4.7(ii). Such Development Data shall be treated as the Confidential
Information of the Disclosing Party. In no event shall a Party be obligated to disclose to the other Party protected patient information obtained in its Clinical Studies.
|
4.8
|
Suspension of Clinical Studies. If Licensor requests that Licensee suspend or terminate any Clinical Study due to concerns about patient safety or the efficacy of such Licensed Product, the JSC shall
decide whether to effect such requested suspension or termination no later than two (2) Business Days after Licensee receives notice of the request for suspension. If the JSC cannot, or does not, reach consensus on the request for
suspension or termination within such two (2) Business Day period, then the CEOs of both Parties shall attempt to resolve this requested suspension within four (4) Business Days after the day the JSC has not reached consensus. If the CEOs
cannot reach consensus then the issue shall be submitted to expert decision as provided in Section 3.5.
|
5.1
|
Regulatory Activities. Licensee shall use Commercially Reasonable Efforts to apply for and to obtain Regulatory Approval for the Licensed Product in the Field in all countries of the Territory. Where
applicable, Licensee shall coordinate its activities for obtaining marketing authorization for the Licensed Product in a country of the Territory with its activities for obtaining pricing or reimbursement approval in such country, including
relevant Development activities. [***].
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5.2
|
Responsibilities. Following the Effective Date, Licensor shall remain responsible, subject to Section 4.5, for all submissions to, and communications and interactions with, Regulatory Authorities
outside the Territory or inside the Territory but outside the Field with respect to the Licensed Product, and Licensee shall be responsible for submissions to, and communications and interactions with, Regulatory Authorities in the
Territory in the Field with respect to the Licensed Product. In connection therewith:
|
(i)
|
Licensee shall keep Licensor informed through the JSC and the Electronic Data Platform regarding Licensee’s (or its Affiliate’s or Sublicensee’s) regulatory strategy, planned regulatory submissions and
communications, including any changes to such strategy, submissions or communications, with Regulatory Authorities inside the Territory and inside the Field with respect to the Licensed Product. Licensee shall promptly provide, and cause
its Affiliates and Sublicensees to provide, through the Electronic Data Platform, Licensor with copies of regulatory submissions to, and communications with, any Regulatory Authorities inside the Territory (in English translation for
material submissions or communications). In addition, Licensee shall also promptly provide Licensor with a copy of all correspondence that Licensee (or its Affiliate or Sublicensee) receives from, or submits to, any Regulatory Authorities
inside the Territory including contact reports concerning conversations or substantive meetings, contact reports of all Regulatory Authority interactions concerning conversations or substantive meetings, all IND annual reports (including
any equivalent filings outside the United States), and cover letters of all agency submissions (it being understood that Licensor may request, and shall then receive, copies of all attachments to any such cover letters) relating to the
Licensed Product. Licensee shall also provide Licensor with any meeting minutes that Licensee prepares that reflect material communications with any Regulatory Authorities inside the Territory regarding the Licensed Product. Licensor shall
use the information and materials provided by Licensee pursuant to this Section 5.2(i) solely in the Development and Commercialization of the Licensed Product outside the Territory and in accordance with the provisions of this Agreement.
|
(ii)
|
Licensor shall keep Licensee informed through the JSC and the Electronic Data Platform regarding Licensor’s (or its Affiliate’s or Licensor’s Other Licensees’)) (a) regulatory strategy, planned regulatory
submissions and communications, including any changes to such strategy, submissions or communications, with Regulatory Authorities inside the Territory with respect to the Licensed Product outside the Field and (b) regulatory strategy,
planned material regulatory submissions and material communications, including any changes to such strategy, material submissions or material communications, with Regulatory Authorities in the USA, Germany, France, UK, Italy and Spain with
respect to the Licensed Product inside the Field; and (c) regulatory strategy, planned material regulatory submissions and material communications, including any changes to such strategy, material submissions or material communications with
Regulatory Authorities (other than USA, Germany, France, UK, Italy and Spain) with respect to the Licensed Product inside the Field outside the Territory that Licensor reasonably believes to have an material impact on the Exploitation of
the Licensed Product in Field in the Territory. Licensor shall promptly provide, and cause its Affiliates and Licensor’s Other Licensees to provide, through the Electronic Data Platform, Licensee with copies of regulatory submissions to and
communications with, any Regulatory Authorities as provided under (a), (b) or (c) (in English translation for material submissions or communications). In addition, Licensor shall also promptly provide Licensee through the Electronic Data
Platform with a copy of all correspondence that Licensor (or its Affiliate or any Licensor’s Other Licensee) receives from, or submits to, any Regulatory Authorities as provided under (a), (b) or (c), including contact reports concerning
conversations or substantive meetings, contact reports of all Regulatory Authority interactions concerning conversations or substantive meetings, all IND annual reports (including any equivalent filings outside the United States), and cover
letters of all agency submissions (it being understood that Licensee may request, and shall then receive, copies of all attachments to any such cover letters) relating to the Licensed Product Licensor shall also provide Licensee through the
Electronic Data Platform with any meeting minutes that Licensor prepares that reflect material communications with any Regulatory Authorities as provided under (a), (b) or (c). Licensee shall use the information and materials provided by
Licensor pursuant to this Section 5.2(ii) solely in the Development and Commercialization of the Licensed Product in the Field and in the Territory and in accordance with the provisions of this Agreement.
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5.3
|
Product Withdrawals and Recalls. If any Regulatory Authority (i) threatens, initiates or advises any action to remove the Licensed Product from the market in any country of the world, or (ii) requires
or advises either Party or such Party’s Affiliates, licensees or sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of the Licensed Product in any country of the world, then Licensor (if such action is outside
the Territory or in the Territory but outside the Field) or Licensee (if such action is in the Territory), as applicable, shall notify the other Party of such event within three (3) Business Days (or sooner if required by Laws and
Regulations) after such Party becomes aware of the action, threat, advice or requirement (as applicable). The JSC will discuss and attempt to agree upon whether to recall or withdraw the Licensed Product; provided, however, that if the
Parties fail to agree within an appropriate time period or if the matter involves a safety issue that, in order to protect patient safety, does not allow for sufficient time for a discussion at the JSC level, Licensor shall decide whether
to recall or withdraw the Licensed Product outside the Territory and shall undertake any such recall or withdrawal outside the Territory at its own cost and expense, and Licensee shall decide whether to recall or withdraw the Licensed
Product in the Territory and shall undertake any such recall or withdrawal in the Territory at its own cost and expense. Notwithstanding the foregoing, if any recall or withdrawal that was threatened, initiated or advised by a Regulatory
Authority results from (a) the negligence or willful misconduct of a Party and such Party is not the Party responsible for the costs of such recall or withdrawal under the immediately preceding two sentences, then such Party that acted
negligently or with willful misconduct shall be responsible for the costs of such recall or withdrawal to the extent that such negligence or willful misconduct directly caused such recall or withdrawal; or (b) any Nanoparticles manufactured
or quality controlled by or on behalf of Licensor which did not conform with the specifications with which such Nanoparticles were required to comply under the terms of the applicable supply agreement between Licensor and Licensee, then
Licensor shall be responsible for the costs of such recall or withdrawal to the extent that the non-conformity with the agreed specifications caused such recall or withdrawal.
|
6.1
|
Overview. Licensee shall use its Commercially Reasonable Efforts to Commercialize the Licensed Product throughout the Territory, whether by itself and its Affiliates or through Sublicensees, with the
aim to optimize the sales of the Licensed Product in a manner
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6.2
|
Responsibilities.
|
(i)
|
Licensor will have sole responsibility for the Commercialization of the Licensed Product outside the Territory or inside the Territory but outside the Field, including all costs and expenses relating thereto,
and for booking sales of the Licensed Product outside the Territory or inside the Territory but outside the Field.
|
(ii)
|
Licensee will have sole responsibility for the Commercialization of the Licensed Product in the Territory in the Field, including all costs and expenses relating thereto, and for booking sales of the Licensed
Product throughout the Territory in the Field.
|
6.3
|
Cooperation. To the extent that Licensor or an Affiliate or licensee of Licensor elects to Commercialize of the Licensed Product in the Territory but outside the Field, Licensor or such Affiliate or
licensee will reasonably inform and consult with Licensee, through the JSC and without violating any Laws and Regulations, in all matters relating to such Commercialization in the Territory to avoid any steps that would adversely affect
Licensee’s Commercialization of the Licensed Product in the Field in the Territory. Licensor shall bind its Affiliates and shall use commercially reasonable efforts to bind Licensor’s Other Licensees who may conduct Commercialization of the
Licensed Product in the Territory but outside the Field to cooperate with Licensee in accordance with this Section 4.5. Nothing in the foregoing will limit Licensor’s obligations under this Section 6.3, regardless of whether
Commercialization is being conducted by Licensor, an Affiliate or a licensee.
|
6.4
|
Complaints.
|
(i)
|
The Parties shall develop, implement, and abide by:
|
(1)
|
a customary policy for handling complaints that may be made, alleged or threatened by a Third Party with respect to the use of any promotional, advertising, patient information, communication and educational
materials by a Party relating to the Licensed Product; and
|
(2)
|
a customary policy for handling and investigating complaints made, alleged or threatened by a Third Party with respect to the manufacturing, handling or storage of the Licensed Product.
|
(ii)
|
Licensor shall be responsible for handling all complaints with respect to the Licensed Product outside the Territory or in the Territory but outside the Field, and all costs and expenses associated therewith.
Licensee shall be responsible for handling all complaints with respect to the Licensed Product in the Territory, and all costs and expenses associated therewith.
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6.5
|
Licensor Proposals. In case Licensee does not have its own Commercialization infrastructure in a particular country within the Territory to Commercialize the Licensed Product in a manner consistent
with Commercially Reasonable Efforts at least [***] months before an anticipated First Commercial Sale of the Licensed Product in the applicable country, then Licensee shall promptly inform Licensor through the JSC and Licensee shall give
commercial reasonable considerations to Licensor’s proposals in case Licensor can present a Commercialization solution or propose a qualified commercial partner for the applicable countries.
|
6.6
|
Marketing Plan. At least [***] months before an anticipated First Commercial Sale of the Licensed Product in the Territory, Licensee shall provide to Licensor a marketing plan outlining the planned
marketing activities to be performed by itself or by its Sublicensees. The marketing plan shall specify Licensed Products-related information on (i) the Licensed Product’s positioning; (li) non-binding sales projections, number of units
projections and marketing activities and support budgets; (iii) details on marketing support and sales force; (iv) Regulatory Approval and overall strategy; (v) competitors; and (vi) overall timelines and timetable.
|
6.7
|
Marketing Reporting. Licensee shall furnish Licensor, through the JSC, with annual summaries of Licensee’s or its Sublicensees’ marketing activities performed in the previous calendar year. In
addition, no more than once each calendar year, Licensor may request that Licensee furnish to Licensor one (1) additional interim report of Licensee’s or its Sublicensees’ marketing activities performed but not yet reported in a report
under the first sentence of this Section 6.7.
|
7.1
|
Upfront Payment. In consideration of the efforts expended by Licensor regarding the Development of the Licensed Product and for the rights and licenses granted hereunder, Licensee shall pay to Licensor
within ten (10) Business Days after the Effective Date an upfront payment in the amount of One Million US-Dollars (USD 1,000,000).
|
7.2
|
Milestone Payments. In addition to the upfront payment specified in Section 7.1 hereof and as further consideration for the Development efforts expended by Licensor regarding the Development of the
Licensed Product and for the rights and licenses granted hereunder, Licensee shall make the following Development milestone payments and sales milestone payments to Licensor:
|
(i)
|
Development Milestone Payments.
|
(1)
|
[***] regarding the Licensed Product in the Field in any country of the Territory:
|
(2)
|
[***] regarding the Licensed Product in the Field in any country of the Territory:
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(3)
|
[***] regarding the Licensed Product in the Field in any country of the Territory:
|
(4)
|
[***] regarding the Licensed Product in the Field in any country of the Territory; provided that, for purposes of this Section 7.2(i)(4) only, [***]:
|
(5)
|
[***] regarding the Licensed Product in the Field in any country of the Territory; provided that, for purposes of this Section 7.2(i)(5) only, [***]:
|
(ii)
|
Sales Milestone Payments.
|
(1)
|
[***]
|
(2)
|
[***]
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(3)
|
[***]
|
(4)
|
[***]
|
7.3
|
Upfront and Milestone Payments. Licensee shall inform Licensor of the occurrence of an event triggering a milestone payment as soon as possible, however, not later than within [***] Business Days after
becoming aware of such event. Milestone payments under Section 7.2(i) are payable within [***] days after Licensee’s receipt of an invoice issued by Licensor for such payments. Milestone payments under Section 7.2(ii) are payable within
[***] days after Licensee’s receipt of an invoice from Licensor; provided that, Licensee will have no obligation to make any such payment earlier than [***] days after Licensee’s notice to Licensor of the event triggering the
applicable milestone payment. In the event that the upfront payment under Section 7.1 and the first milestone under Section 7.2(i) ([***] regarding the Licensed Product in the Field in any country the Territory) would be due within [***]
months of each other, Licensee shall be entitled to pay the first milestone under Section 7.2(i) at the beginning of the [***] month after payment of the upfront payment (by way of example only, if Licensee paid the upfront payment in May,
then the first milestone will not be paid earlier than [***] of the next year).
|
7.4
|
Royalties.
|
Annual Licensee Net Sales
|
Royalty
|
|
The portion of aggregate annual Licensee Net Sales [***]
|
[***]
|
|
The portion of aggregate annual Licensee Net Sales [***]
|
[***]
|
|
The portion of aggregate annual Licensee Net Sales [***]
|
[***]
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7.5
|
Adjustments to Royalties.
|
(i)
|
Generic Competition. In the event that in a country in the Territory, one or more Generic Products with respect to Licensed Product are sold by any person or entity other than Licensee or its Related
Parties, then the applicable royalty rate set forth in Section 7.4 shall be reduced by [***] for that particular country. If the sales of such Generic Product in such country during a Calendar Quarter are in the aggregate (on a unit
equivalent basis) [***] in such country during such Calendar Quarter, then the applicable royalty rates shall be reduced by [***]. If the sales of such Generic Product in such country during a Calendar Quarter are in the aggregate (on a
unit equivalent basis) [***] in such country during such Calendar Quarter, then Licensee shall not be obliged to pay a royalty rate for that particular country.
|
(ii)
|
Third Party Royalties. If Licensee or its Affiliates obtains a license or similar right from any Third Party under any Third Party Patent Rights as provided in Section 9.8(iii) (i.e. the Parties
disagree on the necessity of such license, but Licensee has reasonably decided that such license is necessary), then the royalties due pursuant to Section 7.4 in the affected country will be reduced [***]
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(1)
|
[***]
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(2)
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[***]
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(iii)
|
Cumulative Adjustments. The provisions of Sections 7.5(i) through Section 7.5(ii) are cumulative and will be applied in the order that results [***].
|
7.6
|
Compensation Due Licensee for Termination of MRA Territory.
|
7.7
|
Termination and Royalty Payment for Termination of Revertible Territory. If Licensor exercises its right to terminate Licensee’s License in the Revertible Territory under Section 2.4:
|
(i)
|
[***]
|
(ii)
|
Commencing on the effective date of the termination, Licensor shall pay to Licensee running royalties on all Licensor Net Sales within the terminated Revertible Territory. The royalty rate shall depend on the
Development status of the Licensed Product as follows:
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(1)
|
Scenario A: If, on the effective date of termination, [***] Licensor shall pay to Licensee a running royalty on Licensor Net Sales in the terminated parts of the Revertible Territory as follows:
|
Annual Licensor Net Sales
|
Royalty
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
(2)
|
Scenario B: If, on the effective date of termination, [***] Licensor shall pay to Licensee a running royalty on Licensor Net Sales in the terminated parts of the Revertible Territory as follows:
|
Annual Licensor Net Sales
|
Royalty
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
(3)
|
Scenario C: If, on the effective date of termination, [***] Licensor shall pay to Licensee a running royalty on Licensor Net Sales in the terminated parts of the Revertible Territory as follows:
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Annual Licensor Net Sales
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Royalty
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
(4)
|
Scenario D: If, on the effective date of termination, [***] Licensor shall pay to Licensee a running royalty on Licensor Net Sales in the terminated parts of the Revertible Territory as follows:
|
Annual Licensor Net Sales
|
Royalty
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
7.8
|
Royalty Payments.
|
(i)
|
Running royalties payable by either Party under this Section 7 shall be payable on a quarterly basis, within [***] days after the end of each Calendar Quarter, based upon the aggregate Licensee Net Sales or
Licensor Net Sales (as applicable) during such Calendar Quarter. Only one royalty payment shall be due on Licensee Net Sales or Licensor Net Sales (as applicable) even though the sale or use of the Licensed Product may be covered by more
than one Patent Right or item of Know How in a country.
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(ii)
|
At the request of the Party obligated to pay royalties (the “paying party”), the Parties shall meet and confer in good faith with respect to which, if any, invoices shall be issued by the party entitled to
receive royalties (the “payment receiving party”) to the paying party in connection with payments owed by the paying party to the payment receiving party under this Section 7.
|
(iii)
|
Each royalty payment hereunder shall be accompanied by a statement in sufficient detail to allow for the calculation of royalties due hereunder, including by showing, to the extent possible, country-by
country and broken out by month (v) invoiced sales and Licensee Net Sales or Licensor Net Sales (as applicable), (w) the number of units of Licensed Product sold in such country during such Calendar Quarter and the country(ies) in which
such Licensed Product was Manufactured, (x) a detailed breakdown of any deductions from the invoiced sales to obtain Licensee Net Sales or Licensor Net Sales (as applicable) (y) the amount of royalties due on such Licensee Net Sales or
Licensor Net Sales (as applicable), and (z) for the entire applicable territory, the aggregated annual Licensee Net Sales or Licensor Net Sales (as applicable) to date.
|
7.9
|
Non-Refundable Payments. All payments to be made by one Party to the other under this Section 7 are fully-earned, non-refundable, non-creditable and non-cancelable upon expiry or termination of this
Agreement for any reason whatsoever. None of the payments to be made by Licensee to Licensor under Sections 7.1 and 7.2 may be credited against any of Licensee’s royalty obligations under Section 7.4, and the payment made by Licensor to
Licensee under Section 7.7(i) may not be credited against Licensor’s royalty obligations under Section 7.7(ii). Nothing in this Section 7.9 shall be deemed to limit either Party’s right to claim damages against the other Party in case of
breach of this Agreement or for other causes of action or inaction.
|
7.10
|
Payment Terms.
|
(i)
|
All payments by Licensee to Licensor under this Section 7 shall be made in Dollars to the following account, unless indicated otherwise on the invoice:
|
(ii)
|
All payments by Licensor to Licensee under this Section 7 shall be made in Dollars to the following account, unless indicated otherwise on the invoice:
|
(iii)
|
All payments by one Party to the other shall be made in full, without any deductions (subject to Section 7.10(vi) below), and are exclusive of value added taxes, which shall, if applicable, be invoiced
separately.
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(iv)
|
For purposes of calculating any currency conversion under this Agreement, all such amounts shall be first determined in the currency in which the amount was incurred, paid or received (as applicable) and then
converted into US Dollars based upon the arithmetic mean of the monthly rates as published by The Wall Street Journal (Eastern Edition, which are accessible as of the Effective Date at http://online.wsj.com/mdc/public/page/2_3021-forex-20120511.html?mod=mdc_pastcalendar)
applicable to each month in the Calendar Quarter for which Licensee Net Sales or Licensor Net Sales (as applicable) and royalties are being reported.
|
(v)
|
If the Party obligated to make a payment shall fail to make a timely payment pursuant to the terms of this Agreement, the Party entitled to such payment shall provide written notice of such failure to the
Party obligated to make the payment, and interest shall accrue on the past due amount starting on the date of such notice at the [***] per annum, computed for the actual number of days after the date of such notice that the payment was past
due and calculated on a daily basis.
|
(vi)
|
For all payments to be made under this Section 7, the paying Party shall withhold taxes and other duties payable under applicable Laws and Regulations and shall forward such retained payments to the competent
tax authorities, however, only if all of the following conditions are met:
|
(1)
|
the respective tax is an income tax and no use tax, franchise tax, sales tax or other tax; and
|
(2)
|
the Party entitled to such payment is the debtor of such income taxes under Laws and Regulations; and
|
(3)
|
the paying Party is required by Laws and Regulations to withhold the tax from the Party entitled to such payment and to forward such tax to the competent tax authorities; and
|
(4)
|
the paying Party provides to the Party entitled to such payment a tax certificate of withheld and paid taxes.
|
(vii)
|
All other taxes and duties payable hereunder shall be paid by Licensee.
|
7.11
|
Book Keeping and Auditing. Until the expiration such Party’s obligations to make payments under this Agreement and for a term of [***] years thereafter, each Party shall maintain complete and accurate
books and records of account, in accordance with generally accepted account principles, of all transactions and other business activities under this Agreement, sufficient to confirm the accuracy of all reports and payments furnished by such
Party to the other Party under this Section 7. Upon a Party’s reasonable written notice to the other Party, during normal business hours and not more than once every calendar year, a certified public accountant designated by the requesting
Party and reasonably acceptable to the Party being audited shall have the right to audit such books and records of account of such Party being audited (provided always that such certified public accountant enters into an appropriate
confidentiality agreement with the party being audited), in order to confirm the accuracy and completeness of all such reports and all such payments; provided that, the auditing Party may only audit transactions that occurred within
the three (3) years immediately prior to the date of the audit. Such certified public accountant may disclose to the requesting Party only whether such reports and payments are correct or incorrect and the specific details concerning any
discrepancies. No other information shall be provided to the requesting Party. The requesting Party shall bear all costs and expenses incurred in connection with any such audit; provided, however,
that if any such audit reveals a variance of [***] or more between the amount of payments actually due and the amount of payments made to the requesting Party in any Calendar Quarter, then, in addition to paying the full amount of such
underpayment, plus accrued interest, the Party being audited shall reimburse the requesting Party’s reasonable out-of-pocket costs and expenses incurred in conducting such audit. For avoidance of doubt, Licensee will have the rights set
forth in this Section 7.11 only if Licensor is required to make payments to Licensee as a result of Licensor’s exercise of its rights under Section 2.3 or 2.4.
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7.12
|
Blended Royalty Rates. The Parties acknowledge and agree that the Patent Rights and Know How licensed pursuant to this Agreement may justify royalty rates of differing amounts with respect to the sales
of Licensed Products, which rates could be applied separately to Licensed Products involving the exercise of such Patent Rights and/or the incorporation of such Know How, and that, if such royalties were calculated separately, royalties
relating to Patent Rights and royalties relating to Know How would last for different terms. Notwithstanding the foregoing, the Parties have determined, for reasons of convenience, that blended royalty rates for the Patent Rights and the
Know How licensed hereunder, as set forth above, will apply during a single Royalty Term. Further, the Parties acknowledge and agree that nothing in this Agreement (including any exhibits or attachments hereto) will be construed as
representing an estimate or projection of either (i) the number of Licensed Products that will or may be successfully Developed or Commercialized or (ii) anticipated sales or the actual value of any Licensed Product.
|
7.13
|
Third Party Agreements. Except as provided in Section 9.8(ii) Licensor will be solely liable for any payment obligations (including license fees, milestones or royalties) under any Third Party
Agreements.
|
8.1
|
Development Supply. Licensor will supply or have supplied Licensee with all quantities of Licensed Product required and used by Licensee for the Development of the Licensed Product in the Field and in
the Territory in accordance with the specifications then in force. The supply price for such Licensed Product shall be the Manufacturing Cost of the Licensed Product, unless the Licensed Product is used for agreed-upon, reasonable pre-
clinical studies, in which case it will be provided by Licensor at no cost to Licensee. Licensor or its CMO shall supply the Licensed Product to a maximum of two (2) warehouses designated by Licensee within the Territory (either DDP
(Delivered Duty Paid) or CIP (Carriage Insurance Paid), depending on the receiving countries, INCOTERMS 2010). Should Licensee require a specific format of the product (e.g. vial size, vial type, etc.) which is not used outside the
Territory, Licensee will bear the costs for the implementation of these specific requirements [***]. The Licensed Product supplied to Licensee by Licensor shall conform to the specifications, at that time and be manufactured by Licensor or
its CMO in accordance with Laws and Regulations and GMP.
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8.2
|
Manufacture of Licensed Product. To enable Licensee to perform FFF Manufacture of Licensed Product. Licensor will transfer the FFF Manufacture process to Licensee and its CMO for the purpose of
implementing the FFF Manufacture process only. [***].
|
8.3
|
Exclusive Supply of Nanoparticles.
|
(i)
|
Upon transfer of the manufacturing process to Licensee under Section 8.2 above, Licensor shall make or have made and supply to Licensee, and Licensee shall, until the occurrence of a Supply Failure, purchase
or procure exclusively from Licensor, all pre-formulated Nanoparticles required for the FFF Manufacture. For the avoidance of doubt, unless a Supply Failure occurs, Licensee’s License shall not comprise the right to manufacture
Nanoparticles.
|
(ii)
|
The supply price for pre-formulated Nanoparticles shall be the Manufacturing Cost.
|
(iii)
|
Licensor or its CMO shall supply pre-formulated Nanoparticles to a maximum of two (2) warehouses designated by Licensee within the Territory (either DDP or CIP, depending on the receiving countries, INCOTERMS
2010). Pre-formulated Nanoparticles supplied to Licensee by Licensor shall conform to the specifications and be manufactured by Licensor or its CMO in accordance with GMP.
|
8.4
|
Limited Use of Nanoparticles. Licensee shall use pre-formulated Nanoparticles for the FFF Manufacture only, it shall not use Nanoparticles or pre-formulated Nanoparticles for any other purpose,
including without limitation, for any commercial product or process or commercial product development effort other than a Licensed Product. Licensee shall not distribute pre-formulated Nanoparticles or Nanoparticles to any other party
including Affiliates of Licensee. Prior to the occurrence of a Supply Failure, Licensee shall not manufacture, reverse-engineer or modify Nanoparticles or pre-formulated Nanoparticles. Licensee undertakes to keep Nanoparticles and
pre-formulated Nanoparticles secure and safe from loss, theft, misuse or unauthorized access to the same extent as it or its CMO so protects other raw materials and to use Nanoparticles in accordance with Laws and Regulations.
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8.5
|
Changes of Licensed Product or Nanoparticles. Licensor will inform Licensee of all changes regarding Licensed Product or Nanoparticles or the manufacturing process for Licensed Product or
Nanoparticles. If Licensor intends to or has to materially change the composition, formulation or manufacturing process for Licensed Product or Nanoparticles in a manner that would require resubmission by Licensee of regulatory documents to
a Regulatory Authority (other than mere notifications) then, before implementing such change, Licensor will inform Licensee of all relevant information regarding such change and the Parties will discuss the implementation. If such material
change is required by Laws and Regulations or by any Regulatory Authority inside the Territory, Licensee shall assist Licensor in the implementation, file any resubmissions which are necessary and each Party shall bear the related costs
with respect to its Territory. Licensee may elect not to implement material changes with respect to the Territory if such material changes are not required by Laws and Regulations or by any Regulatory Authority inside the Territory, provided
that Licensee’s decision may result in higher Manufacturing Cost for Licensee.
|
8.6
|
Supply Agreements. Within ninety (90) days after the Effective Date, the Parties shall enter into the Development Supply Agreement for the supply by Licensor to Licensee of Licensed Product for
Development. The Parties shall in addition enter into the Commercial Supply Agreement for the supply by Licensor to Licensee of Nanoparticles for FFF Manufacture no later than [***], as applicable. The Development Supply Agreement and the
Commercial Supply Agreement, along with corresponding quality agreements, shall incorporate the key terms and principles set forth in Sections 8.1, 8.2 and 8.3, appropriate forecasting and ordering provisions, provisions permitting Licensee
to audit Licensor to determine whether the supply price has been accurately calculated, and other customary provisions agreed to by the Parties.
|
8.7
|
Supply Failure.
|
(i)
|
[***]
|
(ii)
|
[***]
|
(iii)
|
[***]
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(iv)
|
[***]
|
(v)
|
[***]
|
(vi)
|
[***]
|
(vii)
|
[***]
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9.1
|
Ownership. The Parties acknowledge and agree that, as between the Parties:
|
(i)
|
Licensor owns all right, title and interest in and to the Licensor Technology; and
|
(ii)
|
Licensee owns all right, title and interest in and to the Licensee Technology.
|
9.2
|
Inventions.
|
(i)
|
Inventorship of all Inventions will be determined in accordance with United States patent laws, to the extent permitted under local Laws and Regulations in the jurisdiction where such Invention was conceived
and reduced to practice. To the extent the application of United States patent laws is not permitted, inventorship of such Inventions will be determined in accordance with local Laws and Regulations in the jurisdiction where such Invention
was conceived and reduced to practice.
|
(ii)
|
Subject to the provisions of this Agreement, a Party shall own all Inventions and any other Know How (and all related Patent Rights) conceived and reduced to practice solely by employees, contractors or
agents of such Party or its Affiliates.
|
(iii)
|
Subject to the provisions of this Agreement, each Party shall own a fifty percent (50%) undivided interest with the other Party in any Invention conceived and reduced to practice jointly by employees of both
Parties or their Affiliates (“Joint Inventions”), any Patent Right filed as to a Joint Invention (“Joint Patent Rights”) and any other Know How made jointly by employees of both Parties (collectively the “Joint Technology”).
Either Party may exploit any Joint Technology without accounting to or obtaining consent from the other Party and is entitled to grant licenses to the Joint Technology inside and outside the Field; subject,
however, to Licensee’s exclusive License and other rights under this Agreement.
|
(iv)
|
In the event either Party engages a (sub)contractor for the Development of the Licensed Product, such Party shall ensure that it will become the owner or the exclusive licensee of all Inventions, (i.e., the (sub)contracting agreement shall provide for the assignment and transfer of all Inventions from the (sub)contractor to the respective Party or for an exclusive license to use such Inventions
for the Licensed Product in the Field and in the Territory), including the right to grant sublicenses.
|
9.3
|
Licensor Patent Rights and Licensor Trademark.
|
(i)
|
Licensee shall not register, or attempt to register, any of the Licensor Patent Rights and Licensor Trademark, or otherwise assert any ownership rights with respect to any of Licensor Patent Rights and
Licensor Trademark in the Territory.
|
(ii)
|
During the Term, Licensor shall have the first right to prosecute and maintain the Licensor Patent Rights and Licensor Trademark. Licensee shall at Licensor’s reasonable request and at Licensor’s cost take
such actions, and shall provide Licensor with such assistance, as Licensor shall reasonably request in order to protect, perfect, prosecute and maintain Licensor’s rights, title and interests in and to all of Licensor Patent Rights and
Licensor Trademark within the Territory. Licensor shall keep Licensee reasonably informed and shall consult with Licensee on an ongoing basis regarding prosecution and maintenance of the Licensor Patent Rights and Licensor Trademark and any
actions which require to be taken in relation thereto. Both Parties will indicate in writing within 30 (thirty) days after the Effective Date contact persons within their respective organization for the ongoing liaison according to this
Section 9.3(ii). Upon the first obtaining of Regulatory Approval in the Territory, Licensee shall furnish Licensor as soon as possible, however, not later than within fourteen (14) days following such grant, with a written notice to that
effect, in order to permit Licensor to take such action as Licensor, in its sole discretion, determines to be necessary or appropriate to protect and perfect Licensor’s rights, title and interests in and to all of Licensor Patent Rights in
the Territory.
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(iii)
|
If Licensor decides not to proceed with the filing, prosecution or maintenance of a Licensor Patent Right or a Licensor Trademark in any country in the Territory or if Licensee decides not to proceed with the
filing, prosecution or maintenance of a Patent Right that is part of the Licensee Technology in any country in or outside the Territory, such Party (the “Discontinuing Party”) will promptly notify (the “Prosecution Notice”)
the other Party (the “Continuing Party”) in sufficient time to enable the Continuing Party to timely meet any applicable deadline, and in any event not later than sixty (60) days before any relevant deadline relating to or any public
disclosure of the relevant Patent Right In such event, the Continuing Party may, in its sole discretion, file such patent application or continue prosecution or maintenance of such Patent Rights in such country at its own expense. If the
Continuing Party elects to file or continue such prosecution or maintenance, the Discontinuing Party shall assign to the Continuing Party its share in such Patent Right and shall execute such documents and perform such acts, at the
Continuing Party’s expense, as may be reasonably necessary to permit the Continuing Party to file such patent application, or to prosecute or maintain such Patent Rights in such country.
|
9.4
|
Patent Rights in Licensee Technology.
|
(i)
|
Licensor shall not register, or attempt to register, any of the Patent Rights within the Licensee Technology, or otherwise assert any ownership rights with respect to any of such Patent Rights.
|
(ii)
|
Licensee shall have the sole right to prosecute and maintain the all Patent Rights within the Licensee Technology. Licensor shall, at Licensee’s reasonable request and at Licensee’s cost take such actions,
and shall provide Licensee with such assistance, as Licensee shall reasonably request in order to protect, perfect, prosecute and maintain Licensee’s rights, title and interests in and to all Patent Rights within the Licensee Technology.
|
9.5
|
Joint Patent Rights. Notwithstanding anything to the contrary in this Agreement, the Parties’ respective rights with regard to the prosecution and maintenance of Joint Patent Rights and Joint
Inventions (including any such Joint Patent Rights and Joint Inventions that are part of the Licensor Patent Rights or the Licensee Technology) will be governed by the following:
|
(i)
|
In the event the Parties make any Joint Invention, the Parties - through the Joint Steering Committee - shall promptly meet to discuss and decide whether to seek patent protection. If the Parties decide to
seek patent protection on a Joint Invention, Licensor has the first right to prepare, file, prosecute and maintain a patent application on a Joint Invention and/or any Joint Patent Right throughout the world on behalf of both Parties. The
costs of such filing, prosecution and maintenance shall be equally shared between the Parties. Licensor shall give Licensee an opportunity to review and provide comments on the text of any application, including, without limitation, the
specifications, claims, and territorial scope, with respect to such Joint Invention before filing, shall consult with Licensee with respect thereto, if Licensee is not providing comments within fourteen (14) days after having received the
draft of the application Licensor may file the application without having received comments from Licensee. Licensor shall supply Licensee with a copy of the application as filed, together with notice of its filing date and serial number.
Licensor shall keep Licensee advised of the status of the actual and prospective patent filings.
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(ii)
|
If either Party elects not to file a patent application on a Joint Invention or to cease the prosecution and/or maintenance of any Joint Patent Right, such Party shall provide the other Party with written
notice promptly upon the decision not to file such application or continue the prosecution or maintenance of such Joint Patent Right, and in any event, not later than sixty (60) days before any relevant deadline relating to or any public
disclosure of the relevant Joint Patent Right. In such event, the discontinuing Party shall permit the other Party, at such other Party’s sole discretion, to file such patent application and/or continue prosecution and/or maintenance of
such Joint Patent Rights at such other Party’s own expense. If the other Party elects to file and/or continue such prosecution or maintenance, the discontinuing Party shall assign to the Continuing Party its interest in such Joint Invention
or Joint Patent Right, as the case may be, and shall execute such documents and perform such acts, at the Continuing Party’s expense, as may be reasonably necessary to permit the Continuing Party to file such patent application, and/or to
prosecute and/or maintain such Joint Patent Rights.
|
9.6
|
Enforcement of Patent Rights and Trademarks.
|
(i)
|
If either Licensee or Licensor becomes aware of any infringement of any issued patent within the Licensor Patent Rights, the Licensee Technology, or Joint Patent Rights or any infringement of the Licensor
Trademark in the Territory, it will promptly notify the other Party to that effect. Licensor shall at its costs have the first right to take actions, in the courts, administrative agencies, or otherwise, including a settlement, to prevent
or enjoin any and all such infringements and other unauthorized uses of the Licensor Patent Rights and/or Licensor Trademark in the Territory.
|
(ii)
|
Licensee shall take no action with respect to any such infringement or unauthorized use of Licensor Patent Rights and/or Licensor Trademark, without the prior written authorization of Licensor; provided, however, that Licensee shall provide at the reasonable request and at Licensor’s cost such assistance as Licensor shall reasonably request in connection with any action to prevent or enjoin any
such infringement or unauthorized use of any of Licensor Patent Rights and/or Licensor Trademark. In the event Licensor is unable or unwilling to sue the alleged infringer in the Territory within (i) one hundred twenty (120) days of the
date of notice of such infringement, or (ii) thirty (30) days before the time limit, if any, set forth in the Laws and Regulations for the filing of such actions, whichever comes first, Licensee may, but shall not be obligated to, take such
action as Licensee may deem appropriate to prevent, enjoin or otherwise address the alleged infringement or threatened infringement of a Licensor Patent Right in the Territory. In such event, Licensee shall act at its own expense, and
Licensor shall co-operate reasonably with Licensee, at the expense of Licensee in prosecuting such action, and Licensor agrees to be named as a party, if so required under Laws and Regulations. Any recovery obtained as a result of any
proceeding against a Third Party infringer in the Territory shall be allocated as follows:
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(1)
|
the recovery shall first be used to reimburse each Party for all litigation costs in connection with such litigation paid by that Party; and
|
(2)
|
each Party shall receive fifty percent (50%) of any recovery remaining after payment of the amounts specified in clause (i) above; provided that, if Licensor is unwilling or unable to prosecute such
action and Licensee elects to prosecute such action, Licensee shall receive one hundred percent (100%) of any recovery remaining after payment of the amounts specified in clause (i) above.
|
9.7
|
Information. Each Party shall promptly notify the other in writing (i) of any suspected or threatened infringement of a Licensor Patent Right or a Patent Right within the Licensee Technology by a Third
Party in the Territory, (ii) of any known or suspected unauthorized use or misappropriation by a Third Party of any Licensor Technology or Licensee Technology in the Territory, and (iii) of any assertion or claim of alleged patent
infringement by Licensee or its Sublicensees with respect to the Exploitation of the Licensed Product in the Territory, and shall provide the other Party with all evidence in its possession that tends to prove the Third Party infringement
or unauthorized use or misappropriation described in clauses (i) or (ii); or that tends to negate the alleged infringement described in clause (iii); in the case of each of clauses (i), (ii) and (iii), to the extent such Party becomes aware
of it. Licensor shall promptly advise Licensee of any events outside the Territory of which Licensor becomes aware that may have a material bearing on the validity or enforceability of the Licensor Patent Rights in the Territory and shall
inform Licensee of Licensor’s plan, if any, to commence proceedings or to take other appropriate action in response to such events. Licensor shall consider Licensee’s advice and comments in good faith.
|
9.8
|
Infringement and Third Party Licenses.
|
(i)
|
If the Development, Commercialization or other Exploitation of the Licensed Product is alleged by a Third Party to infringe a Third Party’s Patent Right in the Territory or in a certain country of the
Territory, the Party becoming aware of such allegation shall promptly notify the other Party. Additionally, if either Party determines that, based upon the review of a Third Party’s Patent Right, it may be desirable to obtain a license from
such Third Party with respect thereto, such Party shall promptly notify the other Party of such determination in writing giving detailed reasoning and discuss the necessity to obtain such Third Party’s license or whether such Third Party
Patent Right could be challenged.
|
(ii)
|
In the event the Parties agree that it is necessary for Licensee to seek or exercise a license from a Third Party as the practice of the Licensor Technology granted to Licensee hereunder would infringe such
Third Party’s intellectual property rights, Licensor shall have the first right, subject to Licensee’s consent to the terms, to reasonably negotiate and conclude such license for the Territory. Whichever Party negotiates such Third Party
license shall keep the other Party informed and shall take due account of the other Party’s interests, and such other Party shall provide any assistance reasonably requested. In the event the Parties agree that such Third Party license is
necessary, the costs for such licensing shall be shared by the Parties; provided that, Licensee shall bear the costs related to exercise of such license in the Field in the Territory, and Licensor shall bear the costs outside the
Territory and inside the Territory but outside the Field, until and unless the JSC decides otherwise.
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(iii)
|
In the event the Parties disagree whether it is necessary for Licensee to seek or exercise a license from a Third Party in the Territory or in a certain country of the Territory but Licensee has reasonably
determined, based on advice from patent counsel or the actions of the Third Party, that it would be less burdensome and more efficient to Develop and Commercialize the Licensed Product in the affected country(ies) to take the applicable
license, than Licensee shall have the right to negotiate and conclude such license in its own name, provided that Licensee shall bear the costs related to exercise of such license in the Field in the Territory, subject to Licensee’s
right to offset a certain portion of such expenses pursuant to Section 7.5(ii).
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11.1
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Disclosure of Confidential Information. All Confidential Information disclosed, revealed or otherwise made available by one Party (“Disclosing Party”) to the other Party (“Receiving Party”)
under, or as a result of, this Agreement is furnished to the Receiving Party solely to permit the Receiving Party to exercise its rights, and perform its obligations, under this Agreement. The Receiving Party shall not use any of the
Disclosing Party’s Confidential Information for any other purpose, and shall not disclose, reveal or otherwise make any of the Disclosing Party’s Confidential Information available to any Third Party, without the prior written authorization
of the Disclosing Party.
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11.2
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Obligation of Confidentiality. In furtherance of the Receiving Party’s obligations under Section 11.1 hereof, the Receiving Party shall take all reasonably appropriate steps, and shall implement all
reasonably appropriate safeguards, to prevent the unauthorized use or disclosure of any of the Disclosing Party’s Confidential Information. Without limiting the generality of this Section 11.2, the Receiving Party shall disclose any of the
Disclosing Party’s Confidential Information only to those of its and its Affiliates’ officers, employees, licensees (Licensor’s Other Licensees and Licensee’s Sublicensees), consultants and financial investors who have a need to know the
Disclosing Party’s Confidential Information, in order for the Receiving Party to exercise its rights and perform its obligations under this Agreement, and only if such officers, employees, licensees, consultants and financial investors are
bound by obligations of confidentiality effectively prohibiting the unauthorized use or disclosure of the Disclosing Party’s Confidential Information. The Receiving Party shall furnish the Disclosing Party with prompt written notice of any
material unauthorized use or disclosure of any of the Disclosing Party’s Confidential Information by any officer, employee, licensee, consultants or financial investors of the Receiving Party, and shall take appropriate actions in order to
prevent any further unauthorized use or disclosure of the Disclosing Party’s Confidential Information.
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11.3
|
Exclusions. The Receiving Party’s obligations under Sections 11.1 and 11.2 hereof shall not apply to any Confidential Information to the extent that the Receiving Party can prove by competent evidence
or testimony that such information:
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(i)
|
is in the public domain, or became generally available to the public through no fault of the Receiving Party;
|
(ii)
|
was known to the Receiving Party prior to disclosure hereunder by the Disclosing Party;
|
(iii)
|
was disclosed, revealed or otherwise made available to the Receiving Party by a Third Party that was under no obligation of non-disclosure and/or non-use to the Disclosing Party;
|
(iv)
|
was independently developed by the Receiving Party without use of or reference to the Disclosing Party’s Confidential Information; or
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(v)
|
is required to be disclosed under Laws and Regulations, including the filing requirements under securities laws, court orders, or in connection with any application by the Receiving Party for any Regulatory
Approvals; provided, however, that the Receiving Party shall furnish the Disclosing Party with as much prior written notice of such disclosure requirement as reasonably practicable, so as to permit
the Disclosing Party, in its sole discretion, to take appropriate action, including seeking a protective order, in order to prevent the Disclosing Party’s Confidential Information from passing into the public domain or becoming generally
available to the public.
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11.4
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Publications on Clinical Studies. The Parties recognize the desirability of publishing and publicly disclosing the results of Clinical Studies. Accordingly, subject to coordination through designated
representatives of each Party, each Party may publicly disclose the results of Clinical Studies involving the Licensed Product conducted by such Party in a manner consistent with best industry practices, subject to prior review and comment
by the other Party as provided in this Section 11.4. If a Party intends to publish an article in a scientific or medical journal or to make a presentation of the results of Clinical Studies involving the Licensed Product, including
abstracts, PowerPoint slides, posters (“Publication”), such Party shall provide the other Party (through its designated representatives) with such Publication at least thirty (30) days prior to the date of publication, if such
material is an article or manuscript, or ten (10) days before publication or presentation, if such material is a presentation or an abstract. The Party receiving such proposed Publication shall respond promptly through its designated
representative, and in any event no later than thirty (30) days after receipt of such proposed Publication, or such shorter period as may be required by the Publication, with any comments thereto. Each Party will give due regard to comments
furnished by the other Party and such comments shall not be unreasonably rejected. In the event that the non-publishing Party reasonably disagrees with the publishing Party’s rejection of its comments, the Parties shall promptly refer such
issue for resolution to the JSC; provided that if following such referral the Parties still fail to agree within a reasonable period of time, the publishing Party shall have the final say with respect to such Publication or
presentation. In addition, the publishing Party shall, at the other Party’s request, delay such publication for a reasonable period (not to exceed sixty (60) days) to permit filings for patent protection or to otherwise address issues of
Confidential Information or related competitive harm. Each Party shall be responsible to assure that its Affiliates and (sub-)licensees agree to equivalent undertakings in favor of the other Party. Notwithstanding anything to the contrary
herein, each Party shall be entitled to publish the results of Clinical Studies conducted by such Party in any clinical study database maintained by or on behalf of a Party in accordance with Laws and Regulations or best industry practices.
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11.5
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Return of Confidential Information. Upon the termination of this Agreement for any reason whatsoever, the Receiving Party shall take reasonable steps to return to the Disclosing Party, or destroy, as
the Disclosing Party shall specify in writing, all copies of all documents and other materials that contain or embody any of the Disclosing Party’s Confidential Information, except to the extent that the Receiving Party is required by Laws
and Regulations to retain such documents and materials and except to the extent the Receiving Party is permitted to use such Confidential Information pursuant to the terms of this Agreement.
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11.6
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Surviving Provisions. All of the Receiving Party’s obligations under Sections 11.1 and hereof, with respect to the protection of the Disclosing Party’s Confidential Information, shall survive for ten
(10) years after the termination or expiration of this Agreement for any reason whatsoever.
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12.1
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Representations, Warranties and Covenants of each Party. Each of Licensor and Licensee hereby represents, warrants and covenants to the other Party hereto as follows:
|
(i)
|
It is a company or corporation duly organized, validly existing and in good standing under the Laws and Regulations 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 transfer the rights granted hereunder.
|
(ii)
|
As of the Effective Date, (a) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (b) it has taken all necessary corporate action
on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (c) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal,
valid and binding obligation of such Party that is enforceable against it in accordance with its terms, subject to bankruptcy, insolvency, reorganization, arrangement, winding-up, moratorium, and similar laws of general application
affecting the enforcement of creditors’ rights generally, and subject to general equitable principles, including the fact that the availability of equitable remedies, such as injunctive relief or specific performance, is in the discretion
of the court.
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(iii)
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As of the Effective Date, it has not entered into, and it will not during the Term enter into, into any agreement with any Third Party that is in conflict with the rights granted to the other Party under this
Agreement or that would prevent such Party from fulfilling its obligations under this Agreement.
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12.2
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Additional Representations, Warranties and Covenants of Licensor. In addition to the representations, warranties and covenants made by Licensor elsewhere in this Agreement, Licensor hereby represents,
warrants and covenants as of the Effective Date that
|
(i)
|
The Licensor Technology constitutes all of the intellectual property owned or Controlled by Licensor that would, but for the rights granted to Licensee pursuant to this Agreement, be infringed or
misappropriated by the exercise by Licensee of its rights under this Agreement.
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(ii)
|
As of the Effective Date, (i) the Licensor Patent Rights exist and are not invalid or unenforceable, in whole or in part, (ii) Licensor is the sole and exclusive owner of all right, title and interest in and
to the Licensor Technology, and (iii) the Licensor Technology is free and clear of any liens, charges and encumbrances. As of the Effective Date Licensor has no knowledge of any claim made against it (x) asserting the invalidity, misuse,
unregisterability or unenforceability of any of the Licensor Patent Rights or (y) challenging Licensor’s Control of the Licensor Technology or making any adverse claim of ownership of the Licensor Technology.
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(iii)
|
As of the Effective Date, no regulatory activities related to the Licensed Product are being or have been undertaken by or on behalf of Licensor in the Territory.
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(iv)
|
As of the Effective Date there are no agreements between Licensor and Third Parties pursuant to which Licensor has rights and/or obligations with respect to any Licensor Technology that it is sublicensing to
Licensee under this Agreement (“Third Party Agreements”). If at any time during the Term Licensor enters into any Third Party Agreements, Licensor will ensure that it is able to grant, and will maintain the ability to grant
throughout the Term the License and other rights granted under this Agreement to all the Licensor Technology.
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(v)
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As of the Effective Date, (i) Licensor has no knowledge of any Patent Rights (other than the Licensor Patent Rights) that may be infringed by the manufacture, use or sale of Licensed Products, (ii) no claim
of infringement of the Patent Rights of any Third Party that has been made nor, to Licensor’s knowledge, is threatened against Licensor or any of its Affiliates with respect to the development, manufacture, sale or use of Licensed Products,
and (iii) Licensor has no knowledge of other claims, judgments or settlements against or owed by Licensor or to which Licensor is a party or pending or threatened claims or litigation, in either case relating to any Licensed Product. As of
the Effective Date, Licensor has no knowledge that Licensor or any of its Affiliates or their respective current or former employees has misappropriated any of the Licensor Know How from any Third Party, and Licensor has no knowledge of any
claim by a Third Party that such misappropriation has occurred.
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(vi)
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As of the Effective Date, Licensor has no knowledge of any activities by Third Parties that would constitute infringement or misappropriation of the Licensor Technology.
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(vii)
|
As of the Effective Date, and to Licensor’s knowledge, the Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates has been conducted in accordance with all applicable Laws and
Regulations in the past and Licensor will implement and comply with corporate policies so that all Exploitation of the Licensed Product by or on behalf of Licensor or its Affiliates in the Field outside the Territory or outside the Field
will be conducted in accordance with applicable Laws and Regulations in the future.
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(viii)
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Neither Licensor nor any of its Affiliates has been Debarred and, in the course of its research, development or manufacture of products, Licensor, its Affiliates, their respective officers, and any person or
entity engaged by Licensor or its Affiliates, have not used, and during the Term will not use in performing any activities pursuant to this Agreement, any person or entity who is or has been Debarred by the FDA or equivalent regulatory
authorities or who, to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is the subject of Debarment proceedings by the FDA or equivalent regulatory authorities. Licensor
agrees to notify Licensee in writing immediately if Licensor or its Affiliates, or any of their respective officers, or any person or entity used by Licensor or its Affiliates under this Agreement, is subject to any of the foregoing, or if
any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best knowledge of Licensor, its Affiliates or any such person or entity engaged by Licensor or its Affiliates, is threatened.
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(ix)
|
As of the Effective Date, to Licensor’s knowledge, Licensor and its Affiliates have the financial and organizational capabilities and experience to perform Licensor’s obligations under this Agreement and
Licensor and its Affiliates will maintain financial and organizational capabilities to perform Licensor’s obligations under this Agreement.
|
(x)
|
Licensor will grant sublicenses to the Licensee Technology in strict compliance with the provisions set forth in Section 2.9.
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12.3
|
Additional Representations, Warranties and Covenants of Licensee. In addition to the representations, warranties and covenants made by Licensee elsewhere in this Agreement, Licensee hereby represents,
warrants and covenants as of the Effective Date that
|
(i)
|
Licensee will implement and comply with corporate policies so that all Exploitation of the Licensed Product by or on behalf of Licensee or its Affiliates in the Field in the Territory will be conducted in
accordance with applicable Laws and Regulations.
|
(ii)
|
Neither Licensee nor any of its Affiliates has been Debarred and, in the course of its research, development or manufacture of products, Licensee, its Affiliates, their respective officers, and any person or
entity engaged by Licensee or its Affiliates, have not used, and during the Term will not use in performing any activities pursuant to this Agreement, any person or entity who is or has been Debarred by the FDA or equivalent regulatory
authorities or who, to the best knowledge of Licensee, its Affiliates or any such person or entity engaged by Licensee or its Affiliates, is the subject of Debarment proceedings by the FDA or equivalent regulatory authorities. Licensee
agrees to notify Licensor in writing promptly if Licensee or its Affiliates, or any of their respective officers, or any person or entity used by Licensee or its Affiliates under this Agreement, is subject to any of the foregoing, or if any
action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best knowledge of Licensee, its Affiliates or any such person or entity engaged by Licensee or its Affiliates, is threatened.
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(iii)
|
As of the Effective Date, to Licensee’s knowledge, Licensee and its Affiliates have the financial and organizational capabilities and experience to perform Licensee’s obligations under this Agreement and
Licensee and its Affiliates will maintain financial and organizational capabilities to perform Licensee’s obligations under this Agreement.
|
(iv)
|
Licensee will grant sublicenses to the Licensor Technology in strict compliance with the provisions set forth in Section 2.5.
|
12.4
|
Disclaimer. THE EXPRESS REPRESENTATIONS AND WARRANTIES STATED IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS. EACH PARTY HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE DEVELOPMENT. MANUFACTURE OR
COMMERCIALIZATION OF ANY LICENSED PRODUCT PURSUANT TO THIS AGREEMENT WILL BE SUCCESSFUL OR THAT ANY PARTICULAR SALES LEVEL WITH RESPECT TO A LICENSED PRODUCT WILL BE ACHIEVED. NOTHING IN THIS SECTION 12.4 IS INTENDED TO LIMIT OR RESTRICT
LICENSEE’S OBLIGATIONS TO USE COMMERCIALLY REASONABLE EFFORTS TO EXPLOIT THE LICENSED PRODUCT IN ACCORDANCE WITH ITS EXPRESS OBLIGATIONS UNDER THIS AGREEMENT.
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12.5
|
LIMITATION OF LIABILITY. NEITHER PARTY WILL BE LIABLE UNDER ANY LEGAL THEORY (WHETHER TORT. CONTRACT OR OTHERWISE) FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING OUT OF OR RELATED
TO THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES, EXCEPT AS A RESULT OF SUCH PARTY’S GROSS NEGLIGENCE OR
WILLFUL MISCONDUCT OR A MATERIAL BREACH OF THE CONFIDENTIALITY AND NON-USE OBLIGATIONS IN SECTION 11. NOTHING IN THIS SECTION 12.5 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY.
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13.1
|
Licensor’s Obligation to Indemnify. Licensor shall defend, indemnify and hold Licensee, its Affiliates or Sublicensees, and their respective directors, officers, employees, consultants and other
representatives harmless against any Third Party claims, suits, actions, proceedings, losses, liabilities, damages, costs and expenses (collectively “Claims and Liabilities”) arising from, related to, or attributable to:
|
(i)
|
any claim by any Third Party with respect to the Licensed Product Exploitation, sale or other use by Licensor, its Affiliates, or Sublicensees outside the Territory or in the Territory but outside the Field,
regardless of whether such claim is based on contract, breach of warranty, any form of tort, strict liability, or otherwise;
|
(ii)
|
any allegation that the Licensed Product Exploitation, sale or other use by Licensor, its Affiliates, or Sublicensees outside the Territory or in the Territory but outside the Field fails to conform with the
requirements of any Laws and Regulations and/or any applicable Regulatory Approvals, including, but not limited to, the failure by Licensor to obtain any required Regulatory Approvals outside the Territory or in the Territory but outside
the Field;
|
(iii)
|
any breach of any of Licensor’s representations, warranties or covenants set forth in this Agreement and
|
(iv)
|
any other grossly negligent, willful or intentionally wrongful act, error or omission on the part of Licensor, or any officer, director, employee, agent or representative of Licensor in their performance of
this Agreement.
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13.2
|
Exclusions of Licensor’s Obligation to Indemnify. Licensor’s obligations under Section 13.1 hereof shall not apply to the extent any such Claims and Liabilities arise from or relate to (i) Licensee’s
use of Licensor Patent Rights and/or Licensor Know How in violation of the terms and conditions of this Agreement; (ii) Licensee’s grossly negligent act, error or omission; (iii) any modification, adaptation or application of Licensor Know
How made by Licensee without the prior authorization of Licensor; (iv) any combination of the Licensed Product with any other products or materials without Licensor’s consent if such combination was not permitted under this Agreement; (v)
any modification of the Licensed Product/ Nanoparticles specifications without the prior authorization of Licensor; (vi) FFF Manufacture by or on behalf of Licensee other than in accordance with processes or specifications provided by
Licensor; or (vii) any other matter for which Licensee is obligated to indemnify Licensor under Section 13.3.
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13.3
|
Licensee’s Obligation to Indemnify. Licensee shall defend, indemnify and hold Licensor or its Affiliates, and their respective directors, officers, employees, consultants and other representatives
harmless against any and all Claims and Liabilities arising from, related to, or attributable to:
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(i)
|
any claim by any Third Party with respect to the Licensed Product Exploitation, sale or other use by Licensee, its Affiliates, or Sublicensees in the Territory in the Field, regardless of whether such claim
is based on contract, breach of warranty, any form of tort, strict liability, or otherwise, except to the extent such claim is solely based on Licensor Technology;
|
(ii)
|
any allegation that the Licensed Product Exploitation, sale or other use by Licensee in the Territory in the Field fails to conform with the requirements of any Laws and Regulations and/or any applicable
Regulatory Approvals, including, but not limited to, the failure by Licensee to obtain any required Regulatory Approvals in the Territory in the Field;
|
(iii)
|
any breach of any of Licensee’s representations, warranties or covenants set forth in this Agreement; or
|
(iv)
|
any other grossly negligent, willful or intentionally wrongful act, error or omission on the part of Licensee, or any officer, director, employee, agent, consultant or representative of Licensee in their
performance of this Agreement.
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13.4
|
Exclusions of Licensee’s Obligation to Indemnify. Licensee’s obligations under Section 13.3 hereof shall not apply to the extent that any such Claims and Liabilities arise from or relate to (i)
Licensor’s gross negligent or willful act, error or omission, (ii) Licensor’s breach of any of its representations, warranties or covenants under this Agreement, (iii) Licensor’s manufacture of Licensed Product or Nanoparticles not
conforming with the specifications with which such Licensed Product or Nanoparticles were required to comply under the terms of the applicable supply agreement between Licensor and licensee, or (iv) any other matter for which Licensor is
obligated to indemnify Licensee under Section 13.1.
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13.5
|
Insurance of Licensee. Licensee shall, at its sole cost and expense, and shall cause its Sublicensees and Affiliates to, obtain no later than on the date of first clinical trial, and shall maintain in
full force and effect during the continuance of this Agreement and for three (3) years thereafter, (i) commercial general liability insurance amounting to [***] per incident and in the annual aggregate, (ii) insurance covering the use of
the Licensed Product in Clinical Studies with Licensee as sponsor as required by statute, and (iii) product liability coverage amounting to [***] per incident and in the annual aggregate; provided that, Licensee will not be required
to obtain the insurance described in this clause (iii) of this Section 13.5 until the earliest to occur of the First Commercial Sale of the Licensed Product inside the Territory. Upon Licensor’s request, Licensee will promptly provide
Licensor with certificates of insurance evidencing such coverages. The certificates shall specify the dates such coverage expires. Licensee hereby specifically acknowledges and agrees that the insurance coverage limits set forth in this
Section 13.5 shall not be construed to create any limit on Licensee’s liability hereunder and/or indemnification obligation under Section 13.3 hereof.
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13.6
|
Insurance of Licensor. Licensor shall, at its sole cost and expense, and shall cause Licensor’s Other Licensees and Affiliates to, obtain no later than on the date of the first Clinical Study of a
Licensed Product anywhere in the world, and shall maintain in full force and effect during the continuance of this Agreement and for three (3) years thereafter, (i) commercial general liability insurance amounting to [***] per incident and
in the annual aggregate, (ii) insurance covering the use of the Licensed Product in Clinical Studies with Licensor as sponsor as required by statute, and (iii) product liability insurance amounting to [***] per incident and in the annual
aggregate; provided that, Licensor will not be required to obtain the insurance described in this clause (iii) of this Section 13.6 until the earliest to occur of the first commercial sale of the Licensed Product, NBTX-IV or
NBTX-TOPO anywhere in the world. Upon Licensee’s request, Licensor will promptly provide Licensee with certificates of insurance evidencing such coverages. The certificates shall specify the dates such coverage expires. Licensor hereby
specifically acknowledges and agrees that the insurance coverage limits set forth in this Section 13.6 shall not be construed to create any limit on Licensor’s liability hereunder and/or indemnification obligation under Section 13.1 hereof.
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14.1
|
Expiry. This Agreement will become effective on the Effective Date and will remain in effect unless terminated pursuant to this Section 14 (the “Term”).
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14.2
|
Termination for Breach. In the event that either Party (the “Breaching Party”) commits a material breach or default of any of its obligations hereunder, the other Party hereto (the “Non-Breaching
Party”) may give the Breaching Party written notice of such material breach or default, and shall request that such material breach or default be cured as soon as reasonably practicable. In the event that the Breaching Party fails to
cure such breach or default within ninety (90) days after the date of the Non-Breaching Party’s notice thereof (in the event of default of payment within thirty (30) days after the date of the Non-Breaching Party’s notice), the
Non-Breaching Party may terminate this Agreement with immediate effect: provided that, if Licensor elects to terminate this Agreement for Licensee’s material breach of its obligation to apply Commercially Reasonable Efforts under
Sections 4, 5, or 6, such termination will be limited to those countries in the Territory where Licensee has failed to use Commercially Reasonable Efforts as required by the applicable Section(s) unless such material breach relates to a
Major Market Country, in which case Licensor may terminate this Agreement in its entirety. Termination of this Agreement in accordance with this Section 14.2 shall not affect or impair the Non-Breaching Party’s right to pursue any legal
remedy, including, but not limited to, the right to recover damages, for any harm suffered or incurred by the Non-Breaching Party as a result of such breach or default.
|
14.3
|
Termination for Non-Launch. If Licensee or its Sublicensees do not launch the Licensed Product within two (2) years after all required Regulatory Approvals have been granted for a country within the
Territory, Licensor shall be entitled to terminate Licensee’s License with respect to such country with immediate effect by giving written notice to Licensee after having discussed the matter in the JSC.
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14.4
|
Termination for Non-Conduct of Clinical Studies. If Licensee does not Start Clinical Studies in accordance with Section 4.2 plus an additional twelve (12) months, unless the JSC determined otherwise by
mutual vote, Licensor shall be entitled to terminate this Agreement with immediate effect by giving written notice to Licensee.
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14.5
|
Termination for Insolvency
|
(i)
|
Termination in case of insolvency of Licensor. Licensee shall have the right, subject to mandatory public policy rules, to terminate this Agreement immediately by written notice to Licensor, if
Licensor becomes subject to insolvency (redressement judiciaire) or liquidation (liquidation judiciaire) proceedings under the laws of France.
|
(ii)
|
Termination in case of insolvency of Licensee. This Agreement may be terminated by Licensor, subject to mandatory public policy rules, upon Licensee becoming subject to bankruptcy, reorganization,
liquidation or receivership proceedings under the laws of the Republic of China; provided, however, that in the event of any involuntary bankruptcy or receivership proceeding, such right to terminate will only become
effective if the Licensee consents to the involuntary bankruptcy or receivership or such proceeding is not dismissed within [***] days after the filing of such bankruptcy or receivership.
|
(iii)
|
To the extent that any bankruptcy of Licensor is adjudicated under the United States Bankruptcy Code (the “Bankruptcy Code”), all licenses and rights to licenses granted under or pursuant to this
Agreement by Licensor to Licensee are, and will otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. The
Parties agree that Licensee, as a licensee of such rights under this Agreement, will retain and may fully exercise all of its rights and elections under the Bankruptcy Code. The Parties further agree that that upon commencement of a
bankruptcy proceeding by or against Licensor under the Bankruptcy Code, Licensee will be entitled to a complete duplicate of, or complete access to (as Licensee deems appropriate), all such intellectual property and all embodiments of such
intellectual property. Such intellectual property and all embodiments of such intellectual property will be promptly delivered to Licensee (i) upon any such commencement of a bankruptcy proceeding and upon written request by Licensee,
unless Licensor elects to continue to perform all of its obligations under this Agreement, or (ii) if not delivered under (i) above, upon the rejection of this Agreement by or on behalf of Licensor and upon written request by the Licensee.
Licensor (in any capacity, including debtor-in-possession) and its successors and assigns (including any trustee) agrees not to interfere with the exercise by Licensee or its Affiliates of its rights and licenses to such intellectual
property and such embodiments of intellectual property in accordance with this Agreement, and agrees to assist Licensee and its Affiliates in obtaining such intellectual property and such embodiments of intellectual property in the
possession or control of Third Parties as reasonably necessary or desirable for Licensee to exercise such rights and licenses in accordance with this Agreement. The foregoing provisions are without prejudice to any rights Licensee may have
arising under the Bankruptcy Code or other applicable Laws and Regulations.
|
(iv)
|
To the extent that any bankruptcy, insolvency, reorganization, liquidation, receivership or similar proceeding of Licensor is adjudicated under Laws and Regulations other than the Bankruptcy Code, then the
Parties intend that Licensee shall be entitled in such proceeding to the rights granted to Licensee under Section 14.5(iii) to the greatest extent permitted or possible under the applicable Laws and Regulations.
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15.1
|
Termination By Licensor. Upon termination by Licensor for Licensee’s breach under Section 14.2 through Section 14.5:
|
(i)
|
Licensee’s License shall immediately lapse with respect to the Territory or, if Licensor’s termination is limited to certain country(ies), with respect to the portions of the Territory affected by such
termination, subject to Section 15.1(ii). If Licensor’s termination is limited to certain country(ies). Licensee’s rights in the portions of the Territory not affected by such termination will remain unchanged and in full force and effect.
|
(ii)
|
Immediately upon the termination of this Agreement, Licensee shall cease all Development, Commercialization and sale of the Licensed Product under the License granted hereunder in the Territory or, if
Licensor’s termination is limited to certain country(ies), in the portions of the Territory affected by such termination; provided, however, that, Licensee shall have the right to distribute and
sell its existing inventory of the Licensed Product in the Field and in the Territory or, if Licensor’s termination is limited to certain country(ies), in the portions of the Territory affected by such termination for a period of not more
than six (6) months following the date of termination hereof, subject to Licensee’s continuing obligation to pay royalties with respect to the Licensee Net Sales derived from the distribution and sale of such existing inventory of the
Licensed Product.
|
(iii)
|
Licensor’s obligation to share Development Data with Licensee shall immediately lapse, but Licensor and its Related Parties may continue to freely use all the Development Data generated by Licensee, its
Affiliates or Sublicensees at no cost.
|
(iv)
|
Licensor shall have the right to request and Licensee will provide the following:
|
(1)
|
(a) the transfer and assignment to Licensor or to a Third Party designated by Licensor of all Regulatory Approvals that are in the name of Licensee or any of its Affiliates in the Territory or, if Licensor’s
termination is limited to certain country(ies), in the portions of the Territory affected by such termination, or (b) cooperation from Licensee in seeking to have Licensor or a Third Party designated by Licensor “step in” as applicant for
any pending but not yet issued Regulatory Approvals in the Territory or, if Licensor’s termination is limited to certain country(ies), in the portions of the Territory affected by such termination, including, as applicable, notifying the
competent Regulatory Authorities thereof and supplying Licensor with all documents already prepared by Licensee or its Affiliates and not previously provided to Licensor for the filing of applications for such Regulatory Approvals; and
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(2)
|
the grant, subject to any prior grants of licenses to Sublicensees and to all terms of this Agreement, of a non-exclusive license, in the Field in the Territory or, if Licensor’s termination is limited to
certain country(ies), in the
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(3)
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In consideration of the transfer and assignment under Section 15.1(iv)(1) and the grant of the license under Section 15.1 (iv)(2), Licensor shall pay to Licensee running royalties on all Licensor Net Sales
within the terminated portions of the Territory in accordance with Section 7.7(ii) as if such terminated Territory were part of the Revertible Territory after termination by Licensor under Section 2.4, except that such royalties shall be
reduced by [***].
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(v)
|
In the event that the License granted to Licensee under this Agreement is terminated, any granted sublicenses will remain in full force and effect; provided that the Sublicensee is not then in breach
of its sublicense agreement and the Sublicensee agrees to be bound to Licensor as a licensor under the terms and conditions of the sublicense agreement and that Licensor shall not be bound to perform any duties or obligations set forth in
any sublicenses that extend beyond the duties and obligations of Licensor set forth in this Agreement. Licensor will enter into appropriate agreements or amendments to the sublicense agreement to substitute itself for Licensee as the
licensor thereunder, subject to the provisions of this subsection (v).
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(vi)
|
All amounts payable by Licensor under Section 7 after the effective date of termination in the Territory or, if Licensor’s termination is limited to certain country(ies), in the portions of the Territory
affected by such termination will be reduced by [***] other than the amount set forth in Section 7.7(i).
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15.2
|
Termination By Licensee. Upon termination by Licensee for Licensor’s breach under Section 14.2 or Section 14.5:
|
(i)
|
The license granted under Section 2.9 shall immediately lapse.
|
(ii)
|
Licensee’s obligation to share Development Data with Licensor shall immediately lapse, but the obligation of Licensor and Licensor’s Other Licensees to share Development Data under this Agreement will
continue.
|
(iii)
|
All amounts payable by Licensee under Section 7 after the effective date of termination will be reduced by [***].
|
15.3
|
Accrued Payment Claims. Expiry or termination of this Agreement for any reason whatsoever shall not relieve either Party of its obligations to pay all royalties and other amounts payable to the other
Party which have accrued prior to, but remain unpaid as of, the date of expiry or termination hereof, or which accrue thereafter, in accordance with Section 15.4.
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15.4
|
Survival. Sections 1, 2.8, 2.11 (except that the references in such Section 2.11 to Sections 2.9(i) and 4.7(ii) will survive only the extent such Sections survive), 7.6, through 7.13, 9.1, 9.2, 9.4,
9.5, 11, 12, 13, 15 and 16 shall survive any termination of this Agreement. In addition, (i) Sections 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 4.1, 4.6, 4.7 (with regard to Licensor’s and its licensees’ obligation to share Development Data only),
5, 6, 7.1 through 7.5, 7.13, 9.3, 9.6, 9.7, 9.8 and 10 will survive termination of this Agreement by Licensee for Licensor’s breach under Section 14.2 or Section 14.5; and (ii) Section 2.9 and 2.10 will survive termination of this Agreement
by Licensor for Licensee’s breach under Section 14.2 through Section 14.5.
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16.1
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Government Approvals. Licensee and Licensor will cooperate and use respectively all reasonable efforts to make all registrations, filings and applications, to give all notices and to obtain as soon as
practicable all governmental or other consents, transfers, approvals, orders, qualifications, authorizations, permits and waivers, if any, and to do all other things necessary or desirable for the consummation of the transactions as
contemplated hereby.
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16.2
|
Assignment. Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other Party, except that, subject to Section 16.3, a
Party may make such an assignment or transfer without the other Party’s consent (i) to the assigning Party’s Affiliates or (ii) to the successor to all or substantially all of the business or assets of such Party to which this Agreement
relates (whether by merger, sale of stock, sale of assets or other transaction). Any permitted successor or assignee of rights and/or obligations hereunder will, in a writing to the other Party, expressly assume performance of such rights
and/or obligations but, if such permitted successor or assignee of rights and/or obligations hereunder fails to provide such an express assumption, the assigning Party will remain primarily liable and responsible for the performance of all
of its obligations under this Agreement and for causing its assignees to act in a manner consistent herewith. Any permitted assignment will be binding on the successors of the assigning Party. Any assignment or attempted assignment by
either Party in violation of the terms of this Section 16.2 will be null and void.
|
16.3
|
Delegation and Performance by Affiliates. Each of Licensor and Licensee acknowledge that their obligations under this Agreement may be delegated to and performed by their respective Affiliates.
Notwithstanding any delegation of obligations under this Agreement by a Party to an Affiliate, each Party will remain primarily liable and responsible for the performance of all of its obligations under this Agreement and for causing its
Affiliates to act in a manner consistent herewith. Wherever in this Agreement the Parties delegate responsibility to Affiliates or local operating entities, the Parties agree that such entities will not make decisions inconsistent with this
Agreement, amend the terms of this Agreement or act contrary to its terms in any way.
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16.4
|
Force Majeure. If the performance of any part of this Agreement by either Party, or any obligation under this Agreement, is prevented, restricted, interfered with or delayed by reason of any cause
beyond the reasonable control of the Party liable to perform, unless conclusive evidence to the contrary is provided, the Party so affected shall, upon giving written notice to the other Party, be excused from such performance or obligation
to the extent of such prevention, restriction, interference or delay, provided that the affected Party shall use its reasonable efforts to avoid or remove such causes of non-performance and shall continue performance with the utmost
dispatch whenever such causes are removed. When such circumstances arise, the Parties shall discuss what, if any, modification of the terms of this Agreement may be required in order to arrive at an equitable solution. Notwithstanding
anything to the contrary in the foregoing, if a condition covered by this Section 16.4 results in a delay by Licensor in supplying Licensed Product or Nanoparticles to Licensee in accordance with the terms of this Agreement, and such delay
lasts for seven (7) months or more, then the procedure set forth in Section 8.7 shall apply accordingly.
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16.5
|
Notices. All notices, reports and other communications between the Parties under this Agreement shall be sent by registered air mail, postage prepaid and return receipt requested, by international air
courier, or by facsimile, with a confirmation copy sent by registered air mail or international air courier, addressed as follows:
|
Attention: |
[***]
[***] |
|
Attention: |
[***]
[***] |
16.6
|
Governing Law. This Agreement shall be governed by, and interpreted in accordance with the laws of the State of New York, without reference to any conflicts of laws principles that would result in the
application of the laws of any other jurisdiction, with the exception of intellectual property matters which shall be determined in accordance with the intellectual property laws applicable to the intellectual property in question.
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16.7
|
Dispute Resolution. Except as otherwise expressly stated in this Agreement, any dispute relating to the validity, performance, construction or interpretation of this Agreement, which cannot be resolved
amicably between the Parties, shall be determined by arbitration administered by the American Arbitration Association (AAA). The decision of the arbitrators shall be final and binding upon the Parties and enforceable in any court of
competent jurisdiction. Place of arbitration is New York City, New York USA. The number of arbitrators is three (3). The language of the arbitration proceeding is English. Judgment upon any award made by the arbitrators may be entered in
any court having jurisdiction thereof notwithstanding the provisions of this Section 16.7, each Party shall have the right to seek preliminary and permanent injunctive relief in any court of competent jurisdiction, in order to prevent or
enjoin any misappropriation, misuse, unauthorized disclosure or infringement of any of Patent Rights and/or the Confidential Information of either Party.
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16.8
|
Severability. If any provision of this Agreement is determined by any court or administrative tribunal of competent jurisdiction to be invalid or unenforceable, the Parties shall negotiate in good
faith a replacement provision that is commercially equivalent, to the maximum extent permitted by Laws and Regulations, to such invalid or unenforceable provision. The invalidity or unenforceability of any provision of this Agreement shall
not affect the validity or enforceability of the other provisions of this Agreement.
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16.9
|
Entire Agreement and Amendments. This Agreement constitutes the entire agreement between the Parties, and supersedes all prior agreements (including, but not limited to, the Confidentiality Agreement
dated as of November 8, 2011), understandings and communications between the Parties, with respect to the subject matter hereof. No modification or amendment of this Agreement shall be binding upon the Parties unless executed in writing by
the duly authorized representative of each of the Parties; this shall also apply to any change of this clause.
|
16.10
|
Waivers. The failure by either Party hereto to assert any of its rights hereunder, including, but not limited to, the right to terminate this Agreement due to a breach or default by the other Party
hereto, shall not be deemed to constitute a waiver by that Party of its right thereafter to enforce each and every provision of this Agreement in accordance with its terms.
|
16.11
|
Press Releases.
|
(i)
|
Initial Press Release. Upon execution of this Agreement, the Parties shall each separately issue a press release announcing the execution of this Agreement, substantially in the form of Exhibit 6 or Exhibit 7 attached hereto, as applicable, and Licensor and Licensee may also separately issue a translation in the French of the form of press release
attached as Exhibit 6 and in Chinese of the form of press release attached as Exhibit 7. Notwithstanding anything to the contrary in the foregoing, if either
Party is restricted by applicable Laws and Regulations (including, but not limited to, applicable securities laws) from making a press release as described in this Section 16.11(i), then such Party will be deemed to have fulfilled its
obligations under this Section 16.11(i) by making such public statement, if any, as is permitted under such applicable Law and Regulations.
|
(ii)
|
Subsequent Disclosure. After such initial press release, except as otherwise provided in this Section 16.11(ii), neither Licensor nor Licensee (the “Releasing Party”) may issue a press release
or public announcement relating to this Agreement without the prior written approval of the other Party (the “Non-Releasing Party”), which approval shall not be unreasonably withheld, conditioned or delayed, except that the Releasing
Party may:
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(a)
|
issue such press release or public announcement if the contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by the Releasing
Party;
|
(b)
|
issue such a press release or public announcement if required by applicable Laws and Regulations, including by the rules or regulations of the Taiwan OTC, the French securities authorities or similar
regulatory agency in a country other than Taiwan or France; and
|
(c)
|
issue such a press release or public announcement regarding:
|
(1)
|
the commencement, completion or “top-line” results of preclinical and clinical studies of the Licensed Product;
|
(2)
|
the completion of subject enrollments for clinical studies of the Licensed Product;
|
(3)
|
the filing or receipt of Regulatory Approval with respect to the Licensed Product; and
|
(4)
|
such Party’s Commercialization activities with respect to the Licensed Product hereunder, including the development of sales, marketing and medical infrastructure and management changes to support Development
and Commercialization activities;
|
(5)
|
receipt of milestone payments;
|
16.12
|
Clinical Trial Registry and Results Databank. Each of Licensor and Licensee shall have the obligation to the extent required by applicable Laws and Regulations to publish registration information and
summaries of data and results from any Clinical Trials conducted by such Party under this Agreement on the applicable clinical trials registry or on a government-sponsored database without requiring the consent of the other Party. The
content of such publication shall be submitted to the JSC for prior approval.
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Licensor
|
Licensee
|
|||||
/s/ Laurent Levy
|
/s/ C. Grace Yeh
|
|||||
Name
|
: | Dr. Laurent Levy |
Name
|
:
|
C. Grace Yeh, Ph.D. | |
Title
|
:
|
Chief Executive Officer |
Title
|
:
|
President and Chief Executive Officer | |
Nanobiotix S.A.
|
PharmaEngine, Inc.
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Exhibit 2:
|
Licensor Know How
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Exhibit 3:
|
Licensor Patent Rights
|
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Exhibit 4:
|
Manufacturing Cost
|
1. |
Manufacturing Cost for the Licensed Product
|
|
(A) |
The Manufacturing Cost per vial of Licensed Product shall be calculated by the following equation:
|
|
(B) |
As used in the equation above, Production Cost for the Licensed Product shall be the actual out-of-pocket fees, paid by Licensor to subcontractors for:
|
|
i. |
raw materials: including [***]
|
|
ii. |
processing: manufacture, fill and finish
|
|
iii. |
quality control: regular characterization and analysis
|
|
iv. |
packaging: including the primary packaging material and the secondary packaging material
|
|
v. |
Miscellaneous: including production consumables
|
|
vi. |
Maintenance of the equipment: based on the purchasing price of the equipment at the rate of [***] per year
|
|
vii. |
Depreciation of the equipment: the depreciation of facilities and equipment purchased and owned by Licensor and used by Licensor’s subcontractors in manufacturing Licensed Product for Licensee.
|
|
(C) |
Except as otherwise provided in this Paragraph C, under no circumstances may the per-vial Manufacturing Cost payable by Licensee for Licensed Product exceed [***] (the “Manufacturing Cost Cap”). If Licensor learns that the
per-vial Manufacturing Cost as calculated pursuant to Paragraph A for any batch or other quantity of the Licensed Product exceeds or is anticipated to exceed the Manufacturing Cost Cap, then Licensor will inform Licensee as soon as it
becomes aware of such situation. Licensor must promptly present information to the JSC justifying such excess, and the JSC will determine as expeditiously as possible under Section 3.4 and, if applicable, Section 3.5, whether Licensee is
required to pay any amount in excess of the Manufacturing Cost Cap.
|
2. |
Manufacturing Cost for the Nanoparticles
|
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Exhibit 5:
|
Licensing Benchmark
|
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Exhibit 6:
|
Licensor Press Release
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Exhibit 7:
|
Licensee Press Release PharmaEngine
|
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Exhibit 8:
|
Manufacturing Process Flow Chart
|
Exclusive License and Collaboration Agreement PharmaEngine – NanoBiotix
Confidential |
(1) |
Nanobiotix S.A. a French joint-stock company having its registered office located at 60 Rue de Wattignies 75 012, Paris, France, Paris Companies’ Register No SIRET: RCS 447 521 600 (“Licensor”);
and
|
(2) |
PharmaEngine, Inc. a Taiwanese corporation having its registered office at 16F, 237 Sung-Chiang Road, Taipei 104, Taiwan, Republic of China, Companies’ Register Reg. No. 80264691, (“Licensee”).
|
(A) |
Licensor and Licensee have entered into an Exclusive License and Collaboration Agreement as of August 06, 2014 (the “License Agreement”);
|
(B) |
In order to expedite the development of NBTXR3 in the Territory, Licensee intends to join the global pivotal study of soft tissue sarcoma initiated by Licensor (the “First Global Study”) in the Territory, including the MRA Territory in
accordance with Section 4.4 of the License Agreement and the terms of this Amendment #1;
|
(C) |
Licensee has also agreed, in accordance with the terms of this Amendment # 1, to make an advance milestone payment to Licensor although such payment is not yet required under the License Agreement; and
|
1. |
Development Milestone Payments. Although such payment is not yet due under the License Agreement, Licensee will pay to
Licensor the milestone due under Section 7.2(i)(1) of the License Agreement in the amount of One Million US-Dollars (USD 1,000,000) no later than October 30, 2014. Such payment shall be treated for purposes of the License Agreement in the
same way as if Licensee had reached the applicable milestone and had made the required milestone payment. Without limiting the generality of the foregoing, Licensee shall have no obligation to make such milestone payment again should
Licensee later achieve the milestone set forth in Section 7.2(i)(1) of the License Agreement.
|
2. |
Global Study Support
|
2.1 |
Licensee will provide support in conducting the First Global Study in the Territory, including the MRA Territory, as more fully described in Exhibit A attached to this Amendment #1.
|
2.2 |
Licensor acknowledges that the support provided by Licensee under Section 2.1 of this Amendment #1 and the early payment of the milestone under Section 1 of this Amendment #1 are linked to activities that have and will be performed by
Licensee in the MRA Territory. Therefore, in accordance with Section 7.6 of the License Agreement, Licensor will be obligated to compensate Licensee in accordance with
|
3.
|
Press Releases
|
4. |
Miscellaneous
|
5. |
Exhibits
|
Licensor
|
Licensee
|
|
/s/ Bernd Mühlenweg
|
/s/ C. Grace Yeh
|
|
Name: Bernd Mühlenweg
|
Name: C. Grace Yeh, Ph.D.
|
|
Title: Chief Business Officer
|
Title: President and Chief Executive Officer
|
|
Nanobiotix S.A.
|
PharmaEngine, Inc.
|
1. |
Background
|
|
(1) |
Nanobiotix has initiated a pivotal study entitled “A MULTICENTER RANDOMIZED, OPEN-LABEL PHASE ll/lll STUDY, TO COMPARE THE EFFICACY OF NBTXR3, IMPLANTED AS INTRATUMOR INJECTION AND ACTIVATED BY RADIOTHERAPY, VERSUS RADIOTHERAPY ALONE IN
PATIENTS WITH LOCALLY ADVANCED SOFT TISSUE SARCOMA OF THE EXTREMITY AND TRUNK WALL” (the “Study,” also known as “Study NBTXR3-301”). The protocol for the Study as of the Effective Date (as amended from time to time, the “Protocol”) is
attached hereto as Schedule 1; and
|
|
(2) |
In accordance with Section 4.4(ii) of the License Agreement, PharmaEngine wishes to participate in such Study as sponsor in the Territory in coordination with Nanobiotix, who shall be responsible for such Study outside the Territory.
|
|
(3) |
The Parties shall discuss coordination of efforts for the Study and shall agree on cost-sharing for certain costs for the Study that are not clearly attributable solely to either the Territory or the areas outside the Territory.
|
|
(4) |
This Memorandum outlines the general and also some detailed principles on which the parties agree in respect to the conduct of the Study.
|
2. |
Relationship between Parties.
|
|
(1) |
Nanobiotix will be the Sponsor of the Study outside the Territory and PharmaEngine will be the Sponsor of the Study in the Territory in accordance with Section 4.4(ii) of the License Agreement. The demarcation of responsibilities of each
Party with respect to the management of the Study is attached hereto as Schedule 2. Each Party shall cooperate with the other party with regard to the Study as required under the License Agreement and agrees to fulfil its obligations and
responsibilities in accordance with this Memorandum.
|
|
(2) |
Nanobiotix shall be solely responsible for all submissions to, communications and interactions with Regulatory Authorities outside the Territory regarding the Study, and PharmaEngine shall be responsible for submissions to, communications
and interactions with Regulatory Authorities in the Territory regarding the Study. Notwithstanding anything to the contrary in the foregoing, the Parties agree that PharmaEngine together with its designated CRO will prepare the regulatory
documentation for use in the Territory. Prior to the initial submission to Regulatory Authorities, PharmaEngine will provide to Nanobiotix for review any significant documents that are to be filed with Regulatory Authorities that are created
by PharmaEngine (as opposed to documents that are provided by Nanobiotix to PharmaEngine and unchanged versions are used by PharmaEngine for filing purposes, such as, for example only, investigator’s brochure, Study protocol, ICF, application
forms and their translated versions). Nanobiotix shall review such documentation and provide PharmaEngine with its feedback within three (3) business days unless a shorter timeline is required in accordance with applicable law. PharmaEngine
shall consider any comments from Nanobiotix on such documents in good faith, but PharmaEngine will have final decision-making authority regarding all such documents. The submission to the Regulatory Authorities in the Territory will be done
by the CRO on behalf of PharmaEngine. The final version of submission documentation and the related correspondence incurred after the initial submission will be part of the electronic trial master file of the Study. It is therefore
explicitly agreed between PharmaEngine and Nanobiotix that these documents do not need to be uploaded to the Electronic Data Platform by PharmaEngine. Nanobiotix shall assist PharmaEngine as required under the License Agreement in the
regulatory documentation and submission if requested by PharmaEngine.
|
|
(3) |
The Parties shall implement the Study in accordance with the Protocol as approved by the applicable Regulatory Authorities and with any subsequent amendments approved by the applicable Regulatory Authorities, and in compliance with the ISO
14155, the Guideline for Good Clinical Practice set forth by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (as amended and/or restated from time to time, “GCP”) and
any applicable laws, regulations, guidelines and rules. Without limiting the foregoing, PharmaEngine shall ensure that all activities in the Territory comply materially with the applicable requirements for medical devices, including the risk
management based on the last updated version of ISO 14971.
|
|
(4) |
PharmaEngine is responsible for selecting the countries, investigators, hospitals and CRO who will be responsible for regulatory submissions and clinical monitoring in the countries where PharmaEngine is the sponsor of the Study.
PharmaEngine will inform Nanobiotix through the regular project calls (see clause 5(3)) of its decisions regarding such countries, investigators, hospitals and CROs. Such selections and decisions will be discussed in such project calls, if
necessary, but PEI shall have final decision-making authority with regard to such matters.
|
|
(5) |
Quality assurance of the Study will be performed on a global basis and will be coordinated by Nanobiotix. Nanobiotix shall provide such quality assurance plan for PharmaEngine’s review and comments. PharmaEngine shall bear the costs for
the quality assurance auditing activities in the Territory. The auditing activities shall be delineated in the quality assurance plan.
|
|
(6) |
PharmaEngine is responsible for the implementation of its own quality management system in accordance with ISO 13485.
|
|
(7) |
Each Party shall be responsible for negotiating, executing and entering into Study Agreements (“SAs”) with the investigators and hospitals in the countries where it is the sponsor. Each Party shall be responsible for the performance of
all of its obligations under such SAs.
|
|
(8) |
Each Party shall procure reasonable and customary clinical trial insurance with respect to the conduct of the Study in the countries where it is the sponsor in accordance with all applicable laws, regulations and rules.
|
|
(9) |
Neither Party shall bear any responsibility or liability for any payment, expenses or damages under any SA signed by the other Party.
|
|
(10) |
In performing their respective responsibilities, the Parties shall at all times comply with all applicable terms and conditions of the License Agreement and the SAs and this Memorandum. For the avoidance of doubt, nothing in this
Memorandum shall be construed to relieve either Party of any of its obligations under the License Agreement.
|
|
(11) |
The Parties agree to follow Nanobiotix’s standard operating procedures (SOPs) in the conduct of the Study in the Territory, including such SOPs for Pre-study site visit (Site selection visit), Initiation visit, Monitoring visit, Closeout
visit, Trial Master File, Investigation Site File and Audit visit as well as all other appropriate documents needed to conduct the Study in the Territory.
|
|
(12) |
Both Nanobiotix and PharmaEngine shall have the right to access eCRF database without the prior consent of the other party. The Parties will discuss the exact privileges to access the eCRF database to be granted to their respective
employees and agents, but such privileges shall include, at a minimum, PharmaEngine’s project manager having the same access rights and operational permits to such eCRF database for data collected in the Territory as the Nanobiotix project
manager for data collected outside the Territory, and PharmaEngine having appropriate access to create reports that include data collected outside the Territory.
|
|
(13) |
In case there is an aspect of the collaboration between the Parties needed for the conduct of the Study that is not covered by this Memorandum, then the Parties agree to reasonably and cooperatively work together on that aspect in a way
that is in the best interest of the conduct of the Study on a global level.
|
|
(14) |
The parties shall update the study status and the project plan in the Territory with each other in the scheduled global project calls during all phases of the conduct of the Study and provide the required documentation and updates, if any,
before such calls. During these calls the details of the global Study (inside and outside the Territory) shall be discussed, and PharmaEngine’s CRO shall participate in such calls as well. The topics shall further include, but not be
limited to, (a) status of each country, (b) questions from the investigators or site staff, (c) change of design of the Study, (d) change of timeline affecting the sites, (e) requests from any of the Regulatory Authorities of the Study (f)
requests from any other Regulatory Authorities that might reasonably impact the Study and (g) responses by Nanobiotix or PharmaEngine to the requests referenced in clauses (e) and (f).
|
3. |
Clinical Supply of the Licensed Product
|
|
(1) |
Nanobiotix shall supply PharmaEngine with the Licensed Product for the conduct of the Study in accordance with the Development Supply Agreement signed by the parties on August 06, 2013 (the “Supply Agreement”). In addition to the
activities described in the Supply Agreement Nanobiotix shall be responsible for the secondary packaging and labeling of the Licensed Product for use in the Study in compliance with applicable laws and regulations, the License Agreement and
the Supply Agreement. PharmaEngine shall pay Nanobiotix for such secondary packaging and labeling a price equal to [***].
|
|
(2) |
PharmaEngine shall provide Nanobiotix with the label content required by the countries in the Territory to perform the labelling of the Licensed Product promptly upon selection of a particular jurisdiction for conduct of the Study and in a
timely manner to prevent delays in the timelines of submissions to Regulatory Authorities.
|
|
(3) |
Nanobiotix is responsible for the pharmaceutical release (CMC portion) and shipment of the Licensed Product to the warehouse(s) designated by PharmaEngine. Subsequently PharmaEngine is responsible for the clinical release of the Licensed
Product and the transfer from the warehouse to the clinical sites in the Territory.
|
4. |
Responsibilities of Nanobiotix
|
|
(1) |
Nanobiotix shall provide PharmaEngine with all documents required for Study regulatory submissions in English, including but not limited to the Protocol and any subsequent amendments, Investigator’s brochures, electronic case report forms
(paper copy of the electronic version), master informed consent form, statistical analysis plan, data monitoring plan, data verification plan and central laboratories information. PharmaEngine shall be responsible for any necessary
translation of any such documents for the sites in the Territory and for the specific adaptation of the documents required for the submission in the Territory. Nanobiotix shall provide all such documentation to PharmaEngine in a timely
manner to prevent delays in the timelines of submissions to Regulatory Authorities in the Territory.
|
|
(2) |
Nanobiotix shall be responsible for the pharmacovigilance, data management, central image review, body kinetics study, statistics and IWRS, quality of the study conduct, as well as final Study report writing. The following CROs have been
selected by Nanobiotix to provide such services. Nanobiotix will use commercial reasonable efforts to obtain the consent from its CROs to share the CRO agreements and potential amendments with PharmaEngine.
|
|
● |
[***]
|
|
● |
[***]
|
|
● |
[***]
|
|
● |
[***]
|
|
● |
[***]
|
|
● |
[***]
|
|
(3) |
Nanobiotix shall provide PharmaEngine with all the relevant SOPs in Section 2(10) of this Memorandum, and all templates for reports and forms for the Study.
|
|
(4) |
Prior to making any material change in the design of the Study Nanobiotix and PharmaEngine will discuss such suggested material change via either email or telephone. Nanobiotix shall provide PharmaEngine with a full description of all
proposed changes after such discussion. PharmaEngine shall review and provide comments to Nanobiotix within ten (10) days after receiving all information relating to the changes in case these material study changes are of strategic nature,
e.g. to increase the enrollment rate. In case the material study changes are an emergency, e.g. to react on side effects, then PharmaEngine shall review and provide comments to Nanobiotix within three (3) days after receiving all information
relating to the changes. Nanobiotix will have final decision-making authority regarding all such documents. Nanobiotix shall reasonably consider PharmaEngine’s comments and modifications regarding such proposed changes. Nanobiotix shall
provide PharmaEngine with all the relevant instructions for the Study including, but not limited to, injection instructions, EDC instructions, lab manuals, Investigator Site File filing manual, and the paper and electronic versions of the
trial master file.
|
|
(5) |
PharmaEngine will invite Prof. Sylvie Bonvalot (or any other investigator skilled to perform the intratumoral injection) to attend the first regional Investigators’ meeting in the Territory at PharmaEngine’s expense. Nanobiotix will
support PharmaEngine in making the contact to Prof. Sylvie Bonvalot or any other skilled investigator. Furthermore, PharmaEngine may, but shall not be required to, send investigators from the Territory for training at Prof. Bonvalot’s
center, also at PharmaEngine’s expense. The contractual relationship to accomplish these tasks between Prof. Sylvie Bonvalot or any other skilled investigator or their respective employers is the sole responsibility of PharmaEngine.
Additionally, either Party may elect to participate in the other Party’s meetings with investigators at the expense of the Party that is not holding the meeting.
|
5. |
Responsibilities of PharmaEngine
|
|
(1) |
PharmaEngine shall establish a project plan, which shall be updated during the regular project calls.
|
|
(2) |
PharmaEngine shall cooperate with the CROs which have been contracted by Nanobiotix as described in Section 4(2) of this Memorandum.
|
|
(3) |
PharmaEngine plans, but does not guarantee to recruit, approximately [***] subjects to be randomized in this Study, representing roughly [***] of all subjects recruited.
|
6. |
Cost Sharing
|
|
(1) |
Subject to clauses 6(2) of this Memorandum, each party shall separately bear all the costs and expenses incurred as a result of the activities performed in the countries where it is the Sponsor for the Study, including CRO services,
clinical trial insurance, clinical monitoring in its Territory, delivery of samples, (including, but not limited to, samples collected at the investigational sites to the central lab for body kinetics analysis).
|
|
(2) |
Notwithstanding anything to the contrary in Clause 6(1) above, PharmaEngine shall initially be responsible for [***] of the fees and expenses incurred for the CRO services as identified in Section 4(2) of this Memorandum. After the Study
has been completed, the Parties will calculate the actual percentage of randomized subjects enrolled by PharmaEngine in the Study in the Territory out of the total number of randomized subjects enrolled in the entire Study. PharmaEngine’s
share of the fees and expenses incurred for the CRO services in identified in Section 4(2) of this Memorandum shall then be adjusted to reflect the actual percentage of the total number of subjects enrolled in the Study that were enrolled by
PharmaEngine in the Study in the Territory. For example, in case 170 subjects were randomized in the entire Study and PharmaEngine contributed 20 subjects, then PharmaEngine shall pay 11.8% of the applicable costs. PharmaEngine’s cost
contribution shall not drop below [***] even in case PharmaEngine has enrolled less than [***] of the patients in the Study.
|
|
(3) |
PharmaEngine will pay all costs for which it is responsible under Section 6(2) to Cmed (or any successor CRO identified by Nanobiotix), regardless of whether such costs relate to activities conducted by Cmed or another CRO. As long as
PharmaEngine makes its required payments to Cmed, PharmaEngine shall have no liability to Nanobiotix or any third party for any further payments. PharmaEngine and Nanobiotix will enter into a three-way agreement with CMed (or any successor
CRO identified by Nanobiotix) to reflect this payment arrangement.
|
7. |
Intellectual Property
|
8. |
Miscellaneous
|
|
(1) |
Except as expressly stated in this Memorandum, In the event of any inconsistency between this Memorandum and the License Agreement, the License Agreement shall prevail.
|
|
(2) |
All capitalized terms used in this Memorandum and not otherwise defined in this Memorandum have the meanings assigned them in the License Agreement.
|
|
(3) |
Schedules
|
|
|
Schedule 1 – Study Protocol
|
|
|
Schedule 2 – Roles and Responsibilities in the Territory
|
/s/ B. Mϋhlenweg | /s/ Grace Yeh. | |
Name: Dr. Bernd Mühlenweg
|
Name: C. Grace Yeh, Ph.D.
|
|
Title: Chief Business Officer
|
Title: President and Chief Executive Officer
|
|
Nanobiotix S.A.
|
PharmaEngine, Inc.
|
ARTICLE 9
|
25
|
|
9.1
|
RIGHT TO DEMAND REPAYMENT
|
25
|
9.2
|
OTHER RIGHTS AT LAW
|
27
|
9.3
|
PREPAYMENT FEE
|
27
|
9.4
|
NON-WAIVER
|
27
|
9.5
|
NO HARDSHIP
|
27
|
ARTICLE 10
|
27
|
|
10.1
|
GOVERNING LAW
|
27
|
10.2
|
JURISDICTION
|
27
|
10.3
|
PLACE OF PERFORMANCE
|
27
|
10.4
|
EVIDENCE OF SUMS DUE
|
27
|
10.5
|
ENTIRE AGREEMENT
|
27
|
10.6
|
INVALIDITY
|
28
|
10.7
|
AMENDMENTS
|
28
|
ARTICLE 11
|
28
|
|
11.1
|
NOTICES
|
28
|
11.2
|
ENGLISH LANGUAGE
|
29
|
SCHEDULE A
|
31
|
|
INVESTMENT SPECIFICATION AND REPORTING
|
31
|
|
SCHEDULE B
|
34
|
|
DEFINITION OF EURIBOR
|
34
|
|
SCHEDULE C
|
35.
|
|
FORM OF DISBURSEMENT OFFER/ACCEPTANCE
|
35
|
|
SCHEDULE D
|
37
|
|
FORM OF CERTIFICATE (ARTICLE 2.5.5)
|
37
|
|
SCHEDULE E
|
38
|
|
INITIAL DOCUMENTARY CONDITIONS PRECEDENT
|
38
|
|
SCHEDULE F
|
39
|
|
REPRESENTATIONS AND WARRANTIES
|
39
|
|
SCHEDULE G
|
42
|
|
EXISTING INDEBTEDNESS AND EXISTING OFF BALANCE SHEETS COMMITMENTS
|
42
|
|
SCHEDULE H
|
43
|
|
GENERAL UNDERTAKINGS
|
43
|
|
SCHEDULE I
|
52
|
|
INFORMATION AND VISITS
|
52
|
The European Investment Bank having its seat at 100 blvd Konrad Adenauer, Luxembourg, L-2950 Luxembourg, represented by Barbara Boos (Head of Division ) and Charlotte Hill (Legal Officer)
|
(the "Bank")
|
|
and
|
||
Nanobiotix, a company incorporated in France, having its registered office at 60 rue de Wattignies, 75012 Paris, and registered under number 447 521 600 RCS Paris, represented by Philippe Mauberna (Chief Financial Officer)
|
(the "Borrower")
|
|
(a) |
The Borrower has stated that it is undertaking a research and development project relating to activities required to bring NBTXR3 (a nanoparticle radio-enhancer product) to the market as more particularly described in the technical
description (the "Technical Description") set out in Schedule A (the "Investment"). The total cost of the Investment, as estimated by the Bank, is EUR
94,700,000.
|
|
(b) |
The Bank, considering that the financing of the Investment falls within the scope of its functions, agreed to provide the Borrower with a credit in an amount of EUR 40,000,000 under this Finance Contract (the "Contract") to finance the Investment; provided that the amount of the loan hereunder shall not, in any case, exceed 50% of the cost of the Investment.
|
|
(c) |
This operation benefits from a guarantee from the European Union under the European Fund for Strategic Investments ("EFSI").
|
|
(d) |
The statute of the Bank provides that the Bank shall ensure that its funds are used as rationally as possible in the interests of the European Union; and, accordingly, the terms and conditions of the Bank's loan operations must be
consistent with relevant policies of the European Union.
|
|
(e) |
The Bank considers that access to information plays an essential role in the reduction of environmental and social risks, including human rights violations, linked to the projects it finances and has therefore established its
Transparency Policy, the purpose of which is to enhance the accountability of the EIB group towards its stakeholders and the citizens of the European Union in general.
|
|
(f) |
The processing of personal data shall be carried out by the Bank in accordance with applicable European Union legislation on the protection of individuals with regard to the processing of personal data by the European Union
institutions and bodies and on the free movement of such data.
|
|
(g) |
The EIB places great emphasis on integrity and good governance and has therefore established policies and procedures to avoid misuse of its funds for purposes of tax fraud, tax evasion, money laundering and financing of terrorism, and
with a view to protect against its operations financing artificial arrangements aimed at tax avoidance. Such policies and procedures are designed to be in line with the principles and standards of applicable EU Law, and European Union or
internationally agreed tax standards on transparency and exchange of information.
|
1.1 |
Interpretation
|
|
(a) |
references to Articles, Recitals, Schedules and Paragraphs are, save if explicitly stipulated otherwise, references respectively to articles of, and recitals, schedules and paragraphs of schedules to, this Contract. All Recitals and
Schedules form part of this Contract;
|
|
(b) |
references to “law" or “laws” mean (a) any applicable law and any applicable treaty, constitution, statute, legislation, decree, normative act, rule, regulation, judgement, order, writ, injunction, determination, award or other
legislative or administrative measure or judicial or arbitral decision in any jurisdiction which is binding or applicable case law, and (b) EU Law;
|
|
(c) |
references to applicable law, applicable laws or applicable jurisdiction means (a) a law or jurisdiction applicable to the Borrower, its rights and/or obligations (in each case arising out of or in connection with the Finance
Documents), its capacity and/or assets and/or the Investment; and/or, as applicable, (b) a law or jurisdiction (including in each case the Bank’s Statute) applicable to the Bank, its rights, obligations, capacity and/or assets;
|
|
(d) |
references to a provision of law are references to that provision as amended or re-enacted;
|
|
(e) |
references to any other agreement or instrument are references to that other agreement or instrument as amended, novated, supplemented, extended or restated; and
|
|
(f) |
words and expressions in plural shall include singular and vice versa.
|
1.2 |
Definitions
|
|
(a) |
any person or group of persons acting in concert gains control of the Borrower or of any entity directly or ultimately controlling the Borrower; or
|
|
(b) |
Laurent Levy ceases to hold at least the Minimum Shareholding in the Borrower.
|
|
(a) |
a material disruption to those payment or communications systems or to those financial markets which are, in each case, required to operate in order for payments to be made in connection with this Contract; or
|
|
(b) |
the occurrence of any other event which results in a disruption (of a technical or systems-related nature) to the treasury or payments operations of either the Bank or the Borrower, preventing that party from:
|
|
(i) |
performing its payment obligations under this Contract; or
|
|
(ii) |
communicating with other parties in accordance with the terms of this Contract,
|
|
(a) |
fauna and flora;
|
|
(b) |
soil, water, air, climate and the landscape; and
|
|
(c) |
cultural heritage and the built environment,
|
|
(a) |
in relation to the Second Tranche, 5% (five per cent); and
|
|
(b) |
in relation to the Third Tranche, 4% (four per cent).
|
|
(a) |
obligations for borrowed money;
|
|
(b) |
indebtedness under any acceptance credit;
|
|
(c) |
indebtedness under any bond, debenture, note or similar instrument;
|
|
(d) |
instrument under any bill of exchange;
|
|
(e) |
indebtedness in respect of any interest rate or currency swap or forward currency sale or purchase or other form of interest or currency hedging transaction (including without limit caps, collars and floors);
|
|
(f) |
indebtedness under any Finance Lease;
|
|
(g) |
indebtedness (actual or contingent) under any guarantee, bond security, indemnity or other agreement;
|
|
(h) |
indebtedness (actual or contingent) under any instrument entered into for the purpose of raising finance;
|
|
(i) |
indebtedness in respect of a liability to reimburse a purchaser of any receivables sold or discounted in the event that any amount of those receivables is not paid;
|
|
(j) |
indebtedness arising under a securitisation; or
|
|
(k) |
other transaction which has the commercial effect of borrowing.
|
|
(a) |
the ability of the Borrower or the Group taken as a whole to perform its obligations under the Finance Documents;
|
|
(b) |
the business, operations, property, condition (financial or otherwise) or prospects of the Borrower or the Group as a whole; or
|
|
(c) |
the legality, validity or enforceability of, the rights or remedies of the Bank under the Finance Documents.
|
|
(a) |
for the First Tranche, the sole Repayment Date of that Tranche as specified in the relevant Disbursement Offer, being the date falling 5 (five) years from the Disbursement Date of that Tranche;
|
|
(b) |
for the Second Tranche and the Third Tranche, the last Repayment Date of that Tranche as specified in the relevant Disbursement Offer, being the date falling 5 (five) years from the Disbursement Date of the relevant Tranche.
|
|
(a) |
a fee of 5% of the Prepayment Amount if the Prepayment Date is after the relevant Disbursement Date but before or on the first anniversary of such Disbursement Date;
|
|
(b) |
a fee of 4% of the Prepayment Amount if the Prepayment Date is after the first anniversary of the relevant Disbursement Date but before or on the second anniversary of such Disbursement Date;
|
|
(c) |
a fee of 3% of the Prepayment Amount if the Prepayment Date is after the second anniversary of the relevant Disbursement Date but before or on the third anniversary of such Disbursement Date;
|
|
(d) |
a fee of 2% of the Prepayment Amount if the Prepayment Date is after the third anniversary of the relevant Disbursement Date but before or on the Maturity Date,
|
|
(a) |
such prepayment is not made within a revolving credit facility (save for the cancellation of the revolving credit facility); or
|
|
(b) |
such prepayment is not made out of the proceeds of a loan or other indebtedness having a term at least equal to the unexpired term of the Non-EIB Financing prepaid.
|
2.1 |
Amount of Credit
|
2.2 |
Disbursement procedure
|
2.2.1 |
Tranches
|
|
(a) |
The first Tranche shall be EUR 16,000,000 (sixteen million euros) (the "First Tranche");
|
|
(b) |
The second Tranche shall be EUR 14,000,000 (fourteen million euros) (the "Second Tranche");
|
|
(c) |
The third Tranche shall be EUR 10,000,000 (ten million euros) (the "Third Tranche");
|
2.2.2 |
Disbursement Offer
|
|
(a) |
whether the Tranche is the First Tranche, the Second Tranche or the Third Tranche;
|
|
(b) |
the amount of the Tranche;
|
|
(c) |
the Disbursement Date, which shall be a Relevant Business Day, falling at least 10 (ten) days after the date of the Disbursement Offer and on or before the Final Availability Date;
|
|
(d) |
the interest rate basis of the Tranche, namely:
|
|
(i) |
in respect of the First Tranche, the PIK Interest Rate; and
|
|
(ii) |
in respect of the Second Tranche and the Third Tranche, the Fixed Rate applicable to such Tranche; and
|
|
(e) |
the Payment Dates and interest periods;
|
|
(f) |
the terms and frequency for repayment of principal;
|
|
(g) |
first Repayment Date and/or Maturity Date;
|
|
(h) |
the Disbursement Acceptance Deadline.
|
2.2.3 |
Disbursement Acceptance
|
|
(a) |
The Borrower may accept a Disbursement Offer by delivering a Disbursement Acceptance to the Bank no later than the Disbursement Acceptance Deadline. The Disbursement Acceptance shall be signed by an Authorised Signatory with individual
representation right or two or more Authorised Signatories with joint representation right and shall specify the Disbursement Account to which disbursement of the Tranche should be made in accordance with Article 2.3 (Disbursement Account);
|
|
(b) |
If a Disbursement Offer is duly accepted by the Borrower in accordance with its terms on or before the Disbursement Acceptance Deadline, and provided the conditions in Article 2.5.6 are met, the Bank shall make the Accepted Tranche
available to the Borrower in accordance with the relevant Disbursement Offer and subject to the terms and conditions of this Contract.
|
|
(c) |
The Borrower shall be deemed to have refused any Disbursement Offer which has not been duly accepted in accordance with its terms on or before the Disbursement Acceptance Deadline, in which case the Tranche shall not be made available
to the Borrower by the Bank, and the Credit shall not be affected.
|
2.3 |
Disbursement Account
|
|
(a) |
Disbursement shall be made to the Disbursement Account specified in the relevant Disbursement Acceptance, provided that such Disbursement Account is acceptable to the Bank.
|
|
(b) |
Only one Disbursement Account may be specified for each Tranche.
|
2.4 |
Currency of disbursement
|
2.5 |
Conditions of Disbursement
|
2.5.1 |
Initial Documentary Conditions Precedent
|
2.5.2 |
First Tranche – Documentary Conditions Precedent
|
2.5.3 |
Second Tranche – Documentary Conditions Precedent
|
|
(a) |
the First Tranche has been fully disbursed; and
|
|
(b) |
the Bank has confirmed that it has received, in form and substance satisfactory to it, evidence of a positive Clinical Evaluation Assessment Report (as defined in MEDDEV 2.7/1 revision 4) from Laboratoire National de Métrologie et
d’Essais for the CE mark application for NBTXR3 and the successful identification of the dosage for the use of NBTXR3 in Head and Neck clinical studies.
|
2.5.4 |
Third Tranche – Documentary Conditions Precedent
|
|
(a) |
the Second Tranche has been fully disbursed; and
|
|
(b) |
the Bank has confirmed that it has received, in form and substance satisfactory to it:
|
|
(i) |
evidence, that the CE mark for NBTXR3 has been obtained and that the primary clinical endpoint of the pivotal phase III trial for the use of NBTXR3 in the treatment of Head and Neck cancer has been achieved;
|
|
(ii) |
evidence that the Borrower has received a fully paid capital increase of at least EUR 20,000,000 (twenty million euros) in new equity financing.
|
2.5.5 |
All Tranches - Documentary Conditions Precedent
|
|
(a) |
a certificate from the Borrower in the form of Schedule D, signed by an authorised representative of the Borrower and dated no earlier than the date falling 10 (ten) days before the Disbursement Date; and
|
|
(b) |
A progress report in relation to the Investment in the form as set out in Part 0 of Schedule A.
|
2.5.6 |
All Tranches – Other Conditions
|
|
(b) |
the representations and warranties which are repeated pursuant to Article 7(b) are correct in all respects; and
|
|
(c) |
no event or circumstance has occurred and is continuing which constitutes or would with the expiry of a grace period and/or the giving of notice under this Contract constitute:
|
|
(i) |
an Event of Default; or
|
|
(ii) |
a Prepayment Event other than pursuant to Article 5.3.1 (Cost Reduction),
|
2.5.7 |
Conditions precedent for the sole benefit of the Bank
|
2.6 |
Cancellation
|
|
(a) |
The Borrower may send a written notice to the Bank requesting the cancellation of the undisbursed portion of the Credit. The written notice:
|
|
(i) |
must specify whether the Borrower would like to cancel the undisbursed portion of the Credit in whole or in part and, if in part, the amount of the Credit the Borrower would like to cancel; and
|
|
(ii) |
must not relate to an Accepted Tranche which has a Disbursement Date falling within 5 (five) Business Days of the date of the written notice.
|
|
(b) |
At any time upon the occurrence of the following events, the Bank may notify the Borrower in writing that the undisbursed portion of the Credit shall be cancelled in whole or in part:
|
|
(i) |
a Prepayment Event;
|
|
(ii) |
an Event of Default;
|
|
(iii) |
an event or circumstance which would with the passage of time or giving of notice under this Contract constitute a Prepayment Event other than pursuant to Article 5.3.1 (Cost reduction) or an
Event of Default; or
|
|
(iv) |
by an amount equal to the amount by which it is entitled to cancel the Credit pursuant to Article 5.3.1 (Cost reduction).
|
2.7 |
Fee for cancellation of an Accepted Tranche
|
|
(a) |
If pursuant to Article 2.6(a) the Borrower cancels an Accepted Tranche, the Borrower shall pay to the Bank the Cancellation Fee.
|
|
(b) |
If the Bank cancels an Accepted Tranche upon an Event of Default, the Borrower shall pay to the Bank the Cancellation Fee.
|
|
(c) |
If an Accepted Tranche is not disbursed on the Disbursement Date because the conditions precedent set out in Article 2.5.6 (All Tranches – Other Conditions) are not satisfied on such date, such
Tranche shall be cancelled and the Borrower shall pay to the Bank the relevant Cancellation Fee.
|
2.8 |
Cancellation after expiry of the Credit
|
2.9 |
Non-utilisation fee
|
|
(a) |
The Borrower shall pay to the Bank a non-utilisation fee for an amount of 1% of the Credit if no disbursement has occurred under the Contract within 6 (six) months of the date of signature of the Contract.
|
|
(b) |
If the date on which the non-utilisation fee is due to be paid is not a Relevant Business Day, payment shall be made on the next day, if any, of that calendar month that is a Relevant Business Day or, failing that, the nearest
preceding day that is a Relevant Business Day.
|
2.10 |
Sums due under Article 2
|
3.1 |
Amount of Loan
|
3.2 |
Currency of repayment, interest and other charges
|
|
(a) |
Interest, repayments and other charges payable in respect of each Tranche shall be made by the Borrower in EUR.
|
|
(b) |
Any other payment shall be made in the currency specified by the Bank having regard to the currency of the expenditure to be reimbursed by means of that payment.
|
4.1 |
First Tranche Interest
|
4.2 |
Second and Third Tranches Interest
|
4.3 |
Royalty Agreement
|
4.4 |
Interest on overdue sums
|
|
(a) |
for overdue sums related to the First Tranche, the higher of (a) the applicable PIK Interest Rate, plus 2% (200 basis points) or (b) EURIBOR plus 2% (200 basis points);
|
|
(b) |
for overdue sums related to the Second Tranche and the Third Tranche, the higher of (a) the applicable Fixed Rate plus 2% (200 basis points) or (b) EURIBOR plus 2% (200 basis points);
|
|
(c) |
for overdue sums other than under Article 4.4(a) above, the EURIBOR plus 2% (200 basis points),
|
4.5 |
Effective global rate
|
5.1 |
Normal repayment
|
5.1.1 |
First Tranche
|
5.1.2 |
Second Tranche
|
5.1.3 |
Third Tranche
|
5.2 |
Voluntary prepayment
|
5.2.1 |
Prepayment option
|
|
(a) |
Subject to Articles 5.2.2 and 5.4 (General), the Borrower may prepay all or part of any Tranche, together with accrued interest (including any interest under Article 4.1 and 4.2), any Prepayment
Fee, upon giving a Prepayment Request with at least 30 (thirty) calendar days prior notice specifying
|
|
(i) |
the Prepayment Amount;
|
|
(ii) |
the Prepayment Date;
|
|
(iii) |
if applicable, the choice of application method of the Prepayment Amount in line with paragraph (a)(i) of Article 6.5.3; and
|
|
(iv) |
the Contract Number.
|
|
(b) |
The Prepayment Request shall be irrevocable.
|
5.2.2 |
Prepayment Fee
|
5.2.3 |
Prepayment mechanics
|
5.3 |
Compulsory prepayment
|
5.3.1 |
Cost Reduction
|
5.3.2 |
Pari passu to Non-EIB Financing
|
5.3.3 |
Change Events
|
|
(a) |
a Change-of-Control Event has occurred or is likely to occur in respect of itself ;
|
|
(b) |
a Change-of-Law Event has occurred or is likely to occur; or
|
|
(c) |
a Senior Management Change has occurred or is likely to occur.
|
5.3.4 |
Illegality
|
5.3.5 |
Disposals
|
5.3.6 |
Prepayment Fee
|
5.3.7 |
Prepayment mechanics
|
5.4 |
General
|
|
(a) |
A repaid or prepaid amount may not be reborrowed.
|
|
(b) |
If the Borrower prepays a Tranche on a date other than a relevant Payment Date, or if the Bank exceptionally accepts, solely upon the Bank’s discretion, a Prepayment Request with prior notice of less than 30 (thirty) calendar days, the
Borrower shall pay to the Bank an administrative fee in such an amount as the Bank shall notify to the Borrower.
|
6.1 |
Day count convention
|
6.2 |
Time and place of payment
|
|
(a) |
If neither this Contract nor the Bank's demand specifies a due date, all sums other than sums of interest, indemnity and principal are payable within 15 (fifteen) days of the Borrower's receipt of the Bank's demand.
|
|
(b) |
Each sum payable by the Borrower under this Contract shall be paid to the following account:
|
Bank:
|
European Investment Bank
|
|
City:
|
Luxembourg
|
|
Account number:
|
LU92 9980 0000 0000 0001
|
|
SWIFT Code/BIC:
|
BEILLULLXXX
|
|
Remark:
|
/RT or direct via TARGET2 (DVT),
|
|
(c) |
The Borrower shall provide the Contract Number as a reference for each payment made under this Contract.
|
|
(d) |
Any disbursements by and payments to the Bank under this Contract shall be made using account(s) acceptable to the Bank. Any account in the name of the Borrower held with a duly authorised financial institution in the jurisdiction
where the Borrower is incorporated or where the Investment is undertaken is deemed acceptable to the Bank.
|
6.3 |
No set-off by the Borrower
|
6.4 |
Disruption to Payment Systems
|
|
(a) |
the Bank may, and shall if requested to do so by the Borrower, consult with the Borrower with a view to agreeing with the Borrower such changes to the operation or administration of the Contract as the Bank may deem necessary in the
circumstances;
|
|
(b) |
the Bank shall not be obliged to consult with the Borrower in relation to any changes mentioned in Article 6.4(a) above if, in its opinion, it is not practicable to do so in the circumstances and, in any event, shall have no obligation
to agree to such changes; and
|
|
(c) |
the Bank shall not be liable for any damages, costs or losses whatsoever arising as a result of a Disruption Event or for taking or not taking any action pursuant to or in connection with this Article 6.4.
|
6.5 |
Application of sums received
|
6.5.1 |
General
|
6.5.2 |
Partial payments
|
|
(a) |
first, any unpaid fees, costs, indemnities and expenses due under this Contract;
|
|
(b) |
secondly, any accrued interest due but unpaid under this Contract;
|
|
(c) |
thirdly, any principal due but unpaid under this Contract; and
|
|
(d) |
fourthly, any other sum due but unpaid under this Contract.
|
6.5.3 |
Allocation of sums related to Tranches
|
|
(a) |
In case of:
|
|
(i) |
a partial voluntary prepayment of a Tranche that is subject to a repayment in several instalments, the Prepayment Amount shall be applied pro rata to each outstanding instalment, or, at the
request of the Borrower, in inverse order of maturity,
|
|
(ii) |
a partial compulsory prepayment of a Tranche that is subject to a repayment in several instalments, the amount prepaid shall be applied in reduction of the outstanding instalments in inverse order of maturity.
|
|
(b) |
Sums received by the Bank following a demand under Article 9.1 (Right to demand repayment) and applied to a Tranche, shall reduce the outstanding instalments in inverse order of maturity. The
Bank may apply sums received between Tranches at its discretion.
|
|
(c) |
In case of receipt of sums which cannot be identified as applicable to a specific Tranche, and on which there is no agreement between the Bank and the Borrower on their application, the Bank may apply these between Tranches at its
discretion.
|
|
(a) |
The Borrower makes the representations and warranties set out in Schedule F (Representations and Warranties) to the Bank on the date of this Agreement.
|
|
(b) |
The Repeating Representations are deemed to be made by the Borrower on the date of each Disbursement Acceptance, each Disbursement Date and each Payment Date by reference to the facts and circumstances then existing.
|
|
(c) |
The undertakings in Schedule H (General Undertakings) and Schedule I (Information and Visits) remain in force from the date of this Contract for so long
as any amount is outstanding under this Contract or the Credit is available.
|
8.1 |
Taxes, duties and fees
|
8.2 |
Other charges
|
8.3 |
Increased costs, indemnity and set-off
|
|
(a) |
The Borrower shall pay to the Bank any costs or expenses incurred or suffered by the Bank as a consequence of the introduction of or any change in (or in the interpretation, administration or application of) any law or regulation or
compliance with any law or regulation which occurs after the date of signature of this Contract, in accordance with or as a result of which (i) the Bank is obliged to incur additional costs in order to fund or perform its obligations
under this Contract, or (ii) any amount owed to the Bank under this Contract or the financial income resulting from the granting of the Credit or the Loan by the Bank to the Borrower is reduced or eliminated.
|
|
(b) |
Without prejudice to any other rights of the Bank under this Contract or under any applicable law, the Borrower shall indemnify and hold the Bank harmless from and against any loss incurred as a result of any full or partial discharge
that takes place in a manner other than as expressly set out in this Contract.
|
|
(c) |
The Bank may set off any matured obligation due from the Borrower under this Contract (to the extent beneficially owned by the Bank) against any obligation (whether or not matured) owed by the Bank to the Borrower regardless of the
place of payment, booking branch or currency of either obligation. If the obligations are in different currencies, the Bank may convert either obligation at a market rate of exchange in its usual course of business for the purpose of the
set-off. If either obligation is unliquidated or unascertained, the Bank may set off in an amount estimated by it in good faith to be the amount of that obligation.
|
9.1 |
Right to demand repayment
|
|
(a) |
any amount payable pursuant to this Contract is not paid on the due date at the place and in the currency in which it is expressed to be payable, unless (i) its failure to pay is caused by an administrative or technical error or a
Disruption Event and (ii) payment is made within 3 (three) Business Days of its due date;
|
|
(b) |
any information or document given to the Bank by or on behalf of any Obligor or any representation, warranty or statement made or deemed to be made by the Borrower in or pursuant to this Contract is or proves to have been incorrect,
incomplete or misleading in any material respect;
|
|
(c) |
following any default of any Obligor in relation to any loan, or any obligation arising out of any financial transaction, other than the Loan,
|
|
(i) |
such Obligor is required or is capable of being required or will, following expiry of any applicable contractual grace period, be required or be capable of being required to prepay, discharge, close out or terminate ahead of maturity
such other loan or obligation; or
|
|
(ii) |
any financial commitment for such other loan or obligation is cancelled or suspended;
|
|
(d) |
any Obligor is unable to pay its debts as they fall due, or suspends its debts, or makes or seeks to make a composition with its creditors including a moratorium, or commences negotiations with one or more of its creditors with a view
to rescheduling any of its financial indebtedness;
|
|
(e) |
any corporate action, legal proceedings or other procedure or step is taken in relation to the suspension of payments, a moratorium of any indebtedness, dissolution, administration or reorganisation (by way of voluntary arrangement,
scheme of arrangement or otherwise) or an order is made or an effective resolution is passed for the winding up of any Obligor, or if any Obligor takes steps towards a substantial reduction in its capital, is declared insolvent or ceases
or resolves to cease to carry on the whole or any substantial part of its business or activities or any situation similar to any of the above occurs under any applicable law;
|
|
(f) |
if any of the following events occur:
|
|
(i) |
any Obligor and/or any other Group Company is unable to pay its debts as they fall due, or suspends its debts, or makes or seeks to make a composition with its creditors;
|
|
(ii) |
any Obligor and/or any other Group Company is subject to difficulties which, although it has not ceased to make payments, it is not in a position to overcome as set out in article L. 620 of the French Commercial Code (Code de commerce) or has ceased to make payments as set out in article L. 631-1 of the French Commercial Code (Code de commerce) or article L. 613-26 of the
French Monetary and Financial Code (Code monétaire et financier);
|
|
(iii) |
the appointment, in respect of any Obligor and/or any other Group Company, of a mandataire ad hoc pursuant to article L. 611-3 of the French Commercial Code (Code
de commerce) or the commencement, in respect of the Borrower or any other member of the Group, of a compromise procedure (procédure de conciliation) pursuant to article L. 611-4 of the
French Commercial Code (Code de commerce);
|
|
(iv) |
any Obligor and/or any other Group Company is subject to any judgment opening proceedings for safeguard (sauvegarde) (including accelerated safeguard (sauvegarde
accélérée) and accelerated financial safeguard (sauvegarde financiere accélérée)), judicial recovery proceedings (redressement judiciaire) or
judicial liquidation (liquidation judiciaire) or to a total or partial asset transfer plan (plan de cession totale ou partielle) or any other measure for
preventing or resolving crises provided for in parts 4 and 5 of article L. 613-31-16 I of the French Monetary and Financial Code (Code monétaire et financier);
|
|
(v) |
any Obligor and/or any other Group Company is subject to any measure, procedure or judgment which is similar to, or has equivalent effects to, those referred to in paragraphs (i), (ii), (iii) and (iv) above, in France or in any other
country;
|
|
(g) |
an encumbrancer takes possession of, or a receiver, liquidator, administrator, administrative receiver or similar officer is appointed, whether by a court of competent jurisdiction or by any competent administrative authority or by any
person, of or over, any part of the business or assets of any Obligor or any property forming part of the Investment, unless the proceedings are frivolous or vexatious;
|
|
(h) |
any Obligor defaults in the performance of any obligation in respect of any other loan granted by the Bank or financial instrument entered into with the Bank;
|
|
(i) |
any Obligor defaults in the performance of any obligation in respect of any other loan made to it from the resources of the Bank or the European Union;
|
|
(j) |
any distress, execution, sequestration or other process is levied or enforced upon the property of any Obligor or any property forming part of the Investment and is not discharged or stayed within 14 (fourteen) days, unless the
proceedings are frivolous or vexatious;
|
|
(k) |
a Material Adverse Change occurs, as compared with the position at the date of this Contract;
|
|
(l) |
it is or becomes unlawful for any Obligor to perform any of its obligations under the Finance Documents, or the Finance Documents are not effective in accordance with its terms or is alleged by any Obligor to be ineffective in
accordance with its terms; or
|
|
(m) |
any Obligor fails to comply with any other provision under the Finance Documents, unless the non-compliance or circumstance giving rise to the non-compliance is capable of remedy and is remedied within 20 Business Days from the earlier
of the Borrower becoming aware of the non-compliance and a notice served by the Bank on the Borrower.
|
9.2 |
Other rights at law
|
9.3 |
Prepayment Fee
|
9.4 |
Non-Waiver
|
9.5 |
No hardship
|
10.1 |
Governing Law
|
10.2 |
Jurisdiction
|
10.3 |
Place of performance
|
10.4 |
Evidence of sums due
|
10.5 |
Entire Agreement
|
10.6 |
Invalidity
|
|
(a) |
the legality, validity or enforceability in that jurisdiction of any other term of this Contract or the effectiveness in any other respect of this Contract in that jurisdiction; or
|
|
(b) |
the legality, validity or enforceability in other jurisdictions of that or any other term of this Contract or the effectiveness of this Contract under the laws of such other jurisdictions.
|
10.7 |
Amendments
|
11.1 |
Notices
|
11.1.1 |
Form of notice
|
|
(a) |
Any notice or other communication given under this Contract must be in writing and, unless otherwise stated, may be made by letter or electronic mail.
|
|
(b) |
Notices and other communications for which fixed periods are laid down in this Contract or which themselves fix periods binding on the addressee, may be made by hand delivery, registered letter, or by electronic mail. Such notices and
communications shall be deemed to have been received by the other party:
|
|
(i) |
on the date of delivery in relation to a hand-delivered or registered letter;
|
|
(ii) |
in the case of any electronic mail sent by the Borrower to the Bank, only when actually received in readable form and only if it is addressed in such a manner as the Bank shall specify for this purpose, or
|
|
(iii) |
in the case of any electronic mail sent by the Bank to the Borrower, when the electronic mail is sent.
|
|
(c) |
Any notice provided by the Borrower to the Bank by e-mail shall:
|
|
(i) |
mention the Contract Number in the subject line; and
|
|
(ii) |
be in the form of a non-editable electronic image (pdf, tif or other common non-editable file format agreed between the parties) of the notice signed by one or more Authorised Signatories of the Borrower as appropriate, attached to the
e-mail.
|
|
(d) |
Notices issued by the Borrower pursuant to any provision of this Contract shall, where required by the Bank, be delivered to the Bank together with satisfactory evidence of the authority of the person or persons authorised to sign such
notice on behalf of the Borrower and the authenticated specimen signature of such person or persons.
|
|
(e) |
Without affecting the validity of electronic mail or communication made in accordance with this Article 12.1, the following notices, communications and documents shall also be sent by registered letter to the relevant party at the
latest on the immediately following Business Day:
|
|
(i) |
disbursement Acceptance;
|
|
(ii) |
any notices and communication in respect of the cancellation of a disbursement of any Tranche, Prepayment Request, Prepayment Notice, Event of Default, any demand for prepayment, and
|
|
(iii) |
any other notice, communication or document required by the Bank.
|
|
(f) |
The parties agree that any above communication (including via electronic mail) is an accepted form of communication, shall constitute admissible evidence in court and shall have the same evidential value as an agreement under hand
(sous seing privé).
|
11.1.2 |
Addresses
|
11.1.3 |
Demand after notice to remedy
|
11.2 |
English language
|
|
(a) |
Any notice or communication given under or in connection with this Contract must be in English.
|
|
(b) |
All other documents provided under or in connection with this Contract must be:
|
|
(i) |
in English; or
|
|
(ii) |
if not in English, and if so required by the Bank, accompanied by a certified English translation and, in this case, the English translation will prevail.
|
Signed for and on behalf of
EUROPEAN INVESTMENT BANK
|
Signed for and on behalf of
NANOBIOTIX
|
/s/ Barbara Boos
|
/s/ Charlotte Hill
|
/s/ Philippe Mauberna
|
|||
Barbara Boos
|
Charlotte Hill
|
Philippe Mauberna
|
|||
Head of Division
|
Legal Officer
|
CFO
|
|
(a) |
in respect of a relevant period of less than one month, the Screen Rate (as defined below) for a term of one month;
|
|
(b) |
in respect of a relevant period of one or more months for which a Screen Rate is available, the applicable Screen Rate for a term for the corresponding number of months; and
|
|
(c) |
in respect of a relevant period of more than one month for which a Screen Rate is not available, the rate resulting from a linear interpolation by reference to two Screen Rates, one of which is applicable for a period next shorter and
the other for a period next longer than the length of the relevant period,
|
|
(a) |
All percentages resulting from any calculations referred to in this Schedule will be rounded, if necessary, to the nearest one thousandth of a percentage point, with halves being rounded up.
|
|
(b) |
The Bank shall inform the Borrower without delay of the quotations received by the Bank.
|
|
(c) |
If any of the foregoing provisions becomes inconsistent with provisions adopted under the aegis of EMMI and EURIBOR ACI (or any successor to that function of EMMI and EURIBOR ACI as determined by the Bank), the Bank may by notice to
the Borrower amend the provision to bring it into line with such other provisions.
|
|
1. |
Authorisations and Binding Obligations
|
|
(a) |
It is duly incorporated and validly existing as a company with limited liability under the laws of France.
|
|
(b) |
It has the power to carry on its business as it is now being conducted and to own its property and other assets, and to execute, deliver and perform its obligations under the Finance Documents.
|
|
(c) |
It has obtained all necessary Authorisations in connection with the execution, delivery and performance of the Finance Documents and in order to lawfully comply with its obligations thereunder, and in respect of the Investment, and all
such Authorisations are in full force and effect and admissible in evidence.
|
|
(d) |
The execution and delivery of, the performance of its obligations under and compliance with the provisions of the Finance Documents do not and will not contravene or conflict with:
|
|
(i) |
any applicable law, statute, rule or regulation, or any judgement, decree or permit to which it is subject;
|
|
(ii) |
any agreement or other instrument binding upon it which might reasonably be expected to have a material adverse effect on its ability to perform its obligations under the Finance Documents; or
|
|
(iii) |
any provision of its constitutional documents.
|
|
(e) |
The obligations expressed to be assumed by each Obligor in each Finance Document to which it is a party are legal, valid, binding and enforceable obligations.
|
|
2. |
No default or other adverse event
|
|
(a) |
There has been no Material Adverse Change since 20 July 2018. (Non-repeating)
|
|
(b) |
No event or circumstance which constitutes an Event of Default has occurred and is continuing unremedied or unwaived.
|
|
3. |
No proceedings
|
|
(a) |
No litigation, arbitration, administrative proceedings or investigation is current or to its knowledge is threatened or pending before any court, arbitral body or agency which has resulted or if adversely determined is reasonably
likely to result in a Material Adverse Change, nor is there subsisting against it or any of its subsidiaries any unsatisfied judgement or award.
|
|
(b) |
To the best of its knowledge and belief (having made due and careful enquiry) no material Environmental Claim has been commenced or is threatened against it. (Non-repeating)
|
|
(c) |
As at the date of this Contract, the Borrower has not taken any action to commence proceedings for, nor have any other steps been taken or legal proceedings commenced or, so far as the Borrower is aware, threatened against it for its
insolvency, winding up or dissolution, or for the Borrower to enter into any arrangement or compositions for the benefit of creditors, or for the appointment of an administrator, receiver, administrative receiver, examiner, trustee or
similar officer. (Non-repeating)
|
|
4. |
Security
|
|
5. |
Ranking
|
|
(a) |
Its payment obligations under this Contract rank not less than pari passu in right of payment with all other present and future unsecured and unsubordinated obligations under any of its debt
instruments except for obligations mandatorily preferred by law applying to companies generally.
|
|
(b) |
No financial covenants have been concluded with any other creditor of the Borrower.
|
|
(c) |
No Voluntary Non EIB Prepayment has occurred.
|
|
6. |
Anti-Corruption
|
|
(a) |
It is in compliance with all applicable European Union and France legislation, including any applicable anti-corruption legislation.
|
|
(b) |
To the best of its knowledge, no funds invested in the Investment by the Borrower or by its controlling entities or any Group Company are of illicit origin, including products of money laundering or linked to the financing of
terrorism.
|
|
(c) |
It is not engaged in any Illegal Activities and to the best of its knowledge no Illegal Activities have occurred in connection with the Investment.
|
|
7. |
Accounting and Tax
|
|
(a) |
The latest available consolidated audited accounts of the Borrower and the other Obligors have been prepared on a basis consistent with previous years and have been approved by its auditors as representing a true and fair view of the
results of its operations for that year and accurately disclose or reserve against all the liabilities (actual or contingent) of the Borrower and the other Obligors, as relevant.
|
|
(b) |
The Accounting Reference Date of the Borrower is 31 December.
|
|
(c) |
It is not required to make any deduction for or on account of any Tax from any payment it may make under the Finance Documents. (Non-repeating)
|
|
(d) |
All Tax returns required to have been filed by it or on its behalf under any applicable law have been filed when due and contain the information required by applicable law to be contained in them.
|
|
(e) |
It has paid when due all Taxes payable by it under applicable law except to the extent that it is contesting payment in good faith and by appropriate means.
|
|
(f) |
With respect to Taxes which have not fallen due or which it is contesting, it is maintaining reserves adequate for their payment and in accordance, where applicable, with GAAP.
|
|
(g) |
Under the laws of France it is not necessary that the Finance Documents be filed, recorded or enrolled with any court or other authority in France or that any stamp, registration or similar tax be paid on or in relation to the Finance
Documents, or the transactions contemplated by the Finance Documents. (Non-repeating).
|
|
8. |
Information provided
|
|
(a) |
Any factual information provided by the Borrower for the purposes of entering into this Contract and any related documentation was true and accurate in all material respects as at the date it was provided or as at the date (if any) at
which it is stated and continues to be true and accurate in all material respect as at the date of the signature of this Contract. (Non-repeating)
|
|
(b) |
The Group structure chart is true, complete and accurate in all material respects and represents the complete corporate structure of the Group as at the date of this Contract, and other than as set out therein the Borrower owns no
other equity and/or shares in any other business entity. (Non-repeating)
|
|
9. |
No indebtedness
|
|
10. |
No Immunity
|
|
11. |
Pensions
|
|
1. |
Use of Loan
|
|
2. |
Completion of Investment
|
|
3. |
Procurement procedure
|
|
4. |
Compliance with laws
|
|
5. |
Environment
|
|
(a) |
The Borrower shall:
|
|
(i) |
implement and operate the Investment in compliance with Environmental Law;
|
|
(ii) |
obtain, maintain and comply with requisite Environmental Approvals for the Investment,
|
|
(i) |
the Borrower shall promptly notify the Bank;
|
|
(ii) |
the Borrower and the Bank will consult for up to 15 Business Days from the date of notification with a view to agreeing the manner in which the breach should be rectified; and
|
|
(iii) |
the Borrower shall remedy the breach within 30 Business Days of the end of the consultation period.
|
|
6. |
Integrity
|
|
7. |
Integrity Audit Rights
|
|
(a) |
the requirement that the relevant contractor promptly informs the Bank of a genuine allegation, complaint or information with regard to Criminal Offences related to the Investment;
|
|
(b) |
the requirement that the relevant contractor keeps books and records of all financial transactions and expenditures in connection with the Investment; and
|
|
(c) |
the Bank’s right, in relation to an alleged Criminal Offence, to review the books and records of the relevant contractor in relation to the Investment and to take copies of documents to the extent permitted by law.
|
|
8. |
Disposal of assets
|
|
(a) |
Except as provided below, the Borrower shall not, and shall procure that no Group Company shall, either in a single transaction or in a series of transactions whether related or not and whether voluntarily or involuntarily dispose of
all or any part of any Group Company's business, undertaking or assets (including any shares or security of any entity or a business or undertaking, or any interest in any of them).
|
|
(b) |
Paragraph (a) above does not apply to any such disposal:
|
|
(i) |
made with the prior written consent of the Bank, provided always that if the Borrower requests the consent of the Bank pursuant to this provision, the Bank shall review the anticipated transaction, the anticipated synergies and will
give due consideration to the request for consent of the Borrower;
|
|
(ii) |
made on arm's length terms in the ordinary course of business of a Group Company;
|
|
(iii) |
made on arm's length terms and at fair market value for cash, which is reinvested in assets of comparable or superior type, value and quality;
|
|
(iv) |
made on arm's length terms in exchange for other assets comparable or superior as to type, value and quality;
|
|
(v) |
by one Obligor to another Obligor or by a Group Company to another Group Company subject to the Group Company receiving the asset(s) simultaneously becoming a Guarantor;
|
|
(vi) |
constituted by a licence of Intellectual Property Rights;
|
|
(vii) |
made in relation to non-material assets which have depreciated to less than 25% of their initial value or which are obsolete;
|
|
(viii) |
excluding any disposal otherwise permitted under (ii) to (vii) above, disposals where the higher of the market value or consideration receivable for such disposals does not exceed (x) 10% of total assets during any financial year, and
(y) 25% of total assets during the term of the Credit; or
|
|
(ix) |
arising as a result of Permitted Security,
|
|
9. |
Maintenance of assets
|
|
10. |
Insurances
|
|
11. |
Change in business
|
|
12. |
Merger
|
|
(a) |
with the prior written consent of the Bank; or
|
|
(b) |
the solvent liquidation or reorganisation of a Group Company which is not an Obligor so long as any payments or assets distributed as a result of such liquidation or reorganisation are distributed to other Group Companies;
|
|
(c) |
such amalgamation, demerger, merger or corporate reconstruction does not result in a Material Adverse Change and is on a solvent basis, and provided that:
|
|
(i) |
only Group Companies are involved provided that if the Borrower is a party to such merger, the Borrower shall survive such merger and there shall be no adverse financial consequences resulting from such merger;
|
|
(ii) |
the resulting entity will not be incorporated or located in a country which is in a jurisdiction that is blacklisted by any Lead Organisation in connection with activities such as money laundering, financing of terrorism, tax fraud and
tax evasion or harmful tax practices as such blacklist may be amended from time to time; and
|
|
(iii) |
if the Borrower is involved, (i) the rights and obligations of the Borrower under this Contract will remain with the Borrower, (ii) the surviving entity will be the Borrower and the statutory seat of the Borrower would not as a result
of such merger be transferred to a different jurisdiction, (iii) the merger will not have an effect on the validity, legality or enforceability of the Borrower's obligations under this Contract; and (iv) all of the business and assets of
the Borrower are retained by it.
|
|
13. |
Books and records
|
|
14. |
Ownership
|
|
(a) |
The Borrower shall maintain not less than 51% of the share capital, directly or indirectly, of each of its Material Subsidiaries, unless a prior written consent of the Bank is received by the Borrower.
|
|
(b) |
The Borrower shall in aggregate maintain not less than 100% of the share capital, directly or indirectly, of each Guarantor, unless prior written consent of the Bank is received by the Borrower.
|
|
(c) |
The Borrower shall immediately notify the Bank in the event of a new entity becoming a majority owned subsidiary of the Borrower (meaning ownership of more than 50%) through any means, including but not limited to acquisition, creation
and spin-off.
|
|
(d) |
The undertakings in Paragraphs (a) and (b) above shall be calculated in accordance with GAAP as applied by the Borrower on the date of this Contract and as GAAP is amended from time to time and tested annually.
|
|
15. |
Acquisitions
|
|
(a) |
with the prior written consent of the Bank, provided always that if the Borrower requests the consent of the Bank pursuant to this provision, the Bank shall review the anticipated transaction, the anticipated synergies and will give
due consideration to the request for consent of the Borrower;
|
|
(b) |
by one Obligor of an asset sold, leased, transferred or otherwise disposed of by another Obligor;
|
|
(c) |
by a Group Company of all the shares or other ownership interests in any limited liability company or corporation, limited liability partnership or any equivalent company, provided that:
|
|
(i) |
such entity has not yet commenced commercial operations;
|
|
(ii) |
such entity is incorporated in a country that is a member of either or both of the European Union or the Organisation of Economic Co-Operation and Development; and
|
|
(iii) |
no Event of Default is continuing on the date the relevant acquisition agreement is entered into or would occur as a result of the acquisition; or
|
|
(d) |
of shares or other ownership interests in any limited liability company or corporation, limited liability partnership or any equivalent company, the consideration for which:
|
|
(i) |
if in cash, does not exceed an aggregate amount of EUR 1,500,000 during any financial year and EUR 4,000,000 during the term of the Credit; or
|
|
(ii) |
consists of shares in the Borrower only, up to a maximum value of 8% of the average of the market capitalisation of the Borrower in the three months up to the date of the acquisition,
|
|
(i) |
no Event of Default is continuing on the date the relevant acquisition agreement is entered into or would occur as a result of the acquisition;
|
|
(ii) |
the acquired entity is engaged in a business similar or complementary to the business carried on by the Group as at the date of this Contract;
|
|
(iii) |
the acquired entity is not incorporated or located in a jurisdiction that is blacklisted by any Lead Organisation in connection with activities such as money laundering, financing of terrorism, tax fraud and tax evasion or harmful tax
practices as such blacklist may be amended from time to time; and
|
|
16. |
Indebtedness
|
|
(a) |
with the prior written consent of the Bank;
|
|
(b) |
Existing Indebtedness;
|
|
(c) |
Existing Off Balance Sheet Commitments;
|
|
(d) |
under this Contract;
|
|
(e) |
under any finance or capital leases of equipment if the aggregate liability in respect of the equipment leases does not at any time exceed EUR 2,000,000 (or its equivalent in another currency or currencies);
|
|
(f) |
under Permitted Hedging;
|
|
(g) |
under any letters of credit provided that such Indebtedness does not, singularly or in aggregate, exceed EUR 2,000,000 (or its equivalent in another currency or currencies);
|
|
(h) |
in respect of a Permitted Guarantee; or
|
|
(i) |
not permitted by the preceding paragraphs and the outstanding amount of which does not exceed EUR 1,000,000 (or its equivalent) in aggregate for the Group at any time.
|
|
17. |
Guarantees
|
|
(a) |
The Borrower shall not, and shall procure that no other Group Company shall, issue or allow to remain outstanding any guarantees in respect of any liability or obligation of any person save for:
|
|
(i) |
with the prior written consent of the Bank;
|
|
(ii) |
Existing Off Balance Sheet Commitments; or
|
|
(iii) |
guarantees issued in the ordinary course of trade by any Group Company under or in connection with:
|
|
(1) |
under the Guarantee Agreement;
|
|
(2) |
under any negotiable instruments;
|
|
(3) |
in connection with any performance bond;
|
|
(4) |
in connection with any Permitted Indebtedness; or
|
|
(5) |
issued by one Obligor to another Obligor.
|
|
(b) |
The Borrower shall procure that each Material Subsidiary accedes to the Guarantee Agreement as a Guarantor.
|
|
18. |
Hedging
|
|
(a) |
any derivative transaction by a Group Company to hedge actual or projected exposure arising in the ordinary course of trading and not for speculative purposes; and
|
|
(b) |
any derivative instrument of a Group Company which is accounted for on a hedge accounting basis but is not entered into for speculative purposes.
|
|
19. |
Restrictions on distributions
|
|
(a) |
with the prior written consent of the Bank;
|
|
(b) |
payments to a Group Company as a result of a solvent liquidation or reorganisation of a Group Company which is not an Obligor;
|
|
(c) |
any dividend payments made by any subsidiary of the Borrower;
|
|
(d) |
dividend payments or share repurchases by a Group Company provided that:
|
|
(i) |
such dividends and repurchases are made in compliance with applicable corporate law and other mandatory regulatory restrictions;
|
|
(ii) |
no Default has occurred and is continuing;
|
|
(iii) |
such dividends or repurchases do not exceed in aggregate 50% of the net earnings for the Group as reported in the annual, audited, consolidated accounts for the preceding financial year;
|
|
(iv) |
the First Tranche and the Second Tranche have been fully repaid; and
|
|
(v) |
the amount of the Net Cash position of the Borrower is in excess of EUR 30,000,000.
|
|
20. |
Restrictions on intercompany loans
|
|
(a) |
with the prior written consent of the Bank;
|
|
(b) |
where the lender of the intercompany loan is the Borrower or an Obligor; or
|
|
(c) |
the payments to a Group Company as a result of a solvent liquidation or reorganisation of a Group Company which is not an Obligor.
|
|
21. |
Intellectual Property Rights
|
|
22. |
Maintenance of Status
|
|
23. |
Negative pledge
|
|
(a) |
The Borrower shall not (and shall procure that no other Group Company shall) create or permit to subsist any Security over any of its assets.
|
|
(b) |
For the purposes of this Paragraph 23, the term Security shall also include any arrangement or transaction on assets or receivables or money (such as the sale, transfer or other disposal of assets on terms whereby they are or may be
leased to or re-acquired by any Group Company, the sale, transfer or other disposal of any receivables on recourse terms or any arrangement under which money or the benefit of a bank account or other account may be applied or set off or
any preferential arrangement having a similar effect) in circumstances where the arrangement or transaction is entered into primarily as a method of raising credit or of financing the acquisition of an asset.
|
|
(c) |
Paragraph (a) above does not apply to any Security, listed below:
|
|
(i) |
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;
|
|
(ii) |
any payment or close out netting or set-off arrangement pursuant to any Permitted Hedging, but excluding any Security under a credit support arrangement in relation to a hedging transaction;
|
|
(iii) |
any lien arising by operation of law and in the ordinary course of trading;
|
|
(iv) |
any Security over or affecting any asset acquired by Group Company after the date of this Contract if:
|
|
(1) |
the Security was not created in contemplation of the acquisition of that asset by a Group Company;
|
|
(2) |
the principal amount secured has not been increased in contemplation of or since the acquisition of that asset by a Group Company; and
|
|
(3) |
the Security is removed or discharged within 3 months of the date of acquisition of such asset;
|
|
(v) |
any Security over or affecting any asset of any company which becomes a Group Company after the date of this Contract, where the Security is created prior to the date on which that company becomes a Group Company, if:
|
|
(1) |
the Security was not created in contemplation of the acquisition of that company;
|
|
(2) |
the principal amount secured has not increased in contemplation of or since the acquisition of that company; and
|
|
(3) |
the Security is removed or discharged within 3 months of that company becoming a Group Company;
|
|
(vi) |
any Security entered into pursuant to this Contract;
|
|
(vii) |
any Security arising under any retention of title, hire purchase or conditional sale arrangement or arrangements having similar effect in respect of goods supplied to a Group Company in the ordinary course of trading and on the
supplier's standard or usual terms and not arising as a result of any default or omission by any Group Company; or
|
|
(viii) |
any Security securing indebtedness the principal amount of which (when aggregated with the principal amount of any other indebtedness which has the benefit of Security given by a Group Company other than any permitted under Paragraphs
(i) to (viii) above) does not exceed EUR 500,000 (or its equivalent in another currency or currencies).
|
|
24. |
Most Favoured Nation Clause
|
|
1. |
Information concerning the Investment
|
|
(a) |
The Borrower shall deliver to the Bank:
|
|
(i) |
the information in content and in form, and at the times, specified in Part 0 of Schedule A or otherwise as agreed from time to time by the parties to this Contract;
|
|
(ii) |
semi-annually after the Final Availability Date, a progress report in relation to the Investment;
|
|
(iii) |
any such information or further document concerning the Investment as the Bank may require to comply with its obligations under the EFSI Regulation; and
|
|
(iv) |
any such information or further document concerning the financing, procurement, implementation, operation and environmental matters of or for the Investment as the Bank may reasonably require within a reasonable time;
|
|
(b) |
The Borrower shall submit for the approval of the Bank without delay any material changes to the Investment, also taking into account the disclosures made to the Bank in connection with the Investment prior to the signing of this
Contract, in respect of, inter alia, the total cost, plans, timetable or to the expenditure programme or financing plan for the Investment.
|
|
(c) |
The Borrower shall promptly inform the Bank of:
|
|
(i) |
any action initiated or any objection raised by any third party or any genuine complaint received by the Borrower or any Environmental Claim that is to its knowledge commenced, pending or threatened against it with regard to
environmental or other matters affecting the Investment; and
|
|
(ii) |
any fact or event known to the Borrower, which may substantially prejudice or affect the Borrower's ability to execute the Investment;
|
|
(iii) |
a genuine allegation, complaint or information with regard to Illegal Activities related to the Loan and/or the Investment; and
|
|
(iv) |
any non-compliance by it with any applicable Environmental Law; and
|
|
(v) |
any suspension, revocation or modification of any Environmental Approval,
|
|
(d) |
If the total cost of the Investment exceeds the estimated figure set out in Recital (A), the Borrower shall notify the Bank without delay and shall inform the Bank of its plans to fund the increased costs.
|
|
(e) |
The Borrower shall, and shall procure that each other Group Company shall, promptly inform the Bank if at any time it becomes aware of the illicit origin (including products of money laundering or linked to the financing of terrorism)
of any funds invested in the Investment by the Borrower or by its controlling entities or another Group Company.
|
|
(f) |
The Borrower shall provide to the Bank, if so requested:
|
|
(i) |
a certificate of its insurers showing that all assets required in order to carry out the Investment are insured with first class insurance companies in accordance with the most comprehensive relevant industry practice;
|
|
(ii) |
annually, a list of policies in force covering any aspect of the Investment, together with confirmation of payment of the current premiums.
|
|
2. |
Information concerning the Borrower
|
|
(a) |
The Borrower shall deliver to the Bank:
|
|
(i) |
as soon as they become available but in any event within 90 days after the end of each of its financial years (and for the financial year ending on 31 December 2019, 120 days after the end of this financial year) its audited
consolidated and unconsolidated annual report, balance sheet, cash flow statement, profit and loss account and auditors report for that financial year; and
|
|
(ii) |
as soon as they become available but in any event within 60 days after the end of each of the relevant accounting periods its interim consolidated and unconsolidated semi-annual report, balance sheet, profit and loss account and cash
flow statement for the first half-year of each of its financial years;
|
|
(iii) |
from time to time, such further information, evidence or document concerning its general financial situation or such certificates of compliance with the undertakings of Article 7 (Borrower undertakings
and representations) the factual information or documents provided to the Bank for the purposes of entering into this Contract as the Bank may deem necessary or may reasonably require to be provided within a reasonable time; and
|
|
(iv) |
any such information or further document concerning customer due diligence matters of, or for, the Borrower to comply with “Know your customer” (KYC) or similar identification procedures as the Bank may deem necessary or may reasonably
require to be provided within a time;
|
|
(b) |
The Borrower shall inform the Bank immediately of:
|
|
(i) |
any Event of Default having occurred or being threatened or anticipated;
|
|
(ii) |
to the extent permitted by law, any material litigation, arbitration, administrative proceedings or investigation carried out by a court, administration or similar public authority, which, to the best of its knowledge and belief is
current, threatened or pending:
|
|
(1) |
against the Borrower or its controlling entities or members of the Borrower's management bodies in connection with Illegal Activities related to the Loan or the Investment; or
|
|
(2) |
which might if adversely determined result in a Material Adverse Change;
|
|
(iii) |
any measure taken by the Borrower pursuant to Paragraph 6 (Integrity) of Schedule H.
|
|
3. |
Visits by the Bank
|
|
(a) |
The Borrower shall allow persons designated by the Bank and, when either required by the relevant mandatory provisions of EU law or pursuant to the EFSI Regulation, the competent EU institutions including the European Court of
Auditors, the Commission, the European Anti-Fraud Office, as well as persons designated by the foregoing:
|
|
(i) |
to visit the sites, installations and works comprising the Investment;
|
|
(ii) |
to interview representatives of the Borrower, and not obstruct contacts with any other person involved in or affected by the Investment; and
|
|
(iii) |
to conduct such on the spot audits and checks as they may wish and review the Borrower's books and records in relation to the execution of the Investment and to be able to take copies of related documents to the extent not prohibited
by the law.
|
|
(b) |
The Borrower shall provide the Bank, or ensure that the Bank is provided, with all necessary assistance for the purposes described in this Article.
|
|
(c) |
In the case of a genuine allegation, complaint or information with regard to Illegal Activities related to the Loan and/or the Investment, the Borrower shall consult with the Bank in good faith regarding appropriate actions. In
particular, if it is proven that a third party committed Illegal Activities in connection with the Loan and/or the Investment with the result that the Loan or the EFSI financing were misapplied, the Bank may, without prejudice to the
other provisions of this Contract, inform the Borrower if, in its view, the Borrower should take appropriate recovery measures against such third party. In any such case, the Borrower shall in good faith consider the Bank's views and keep
the Bank informed.
|
|
4. |
Disclosure and publication
|
|
(a) |
The Borrower acknowledges and agrees that:
|
|
(i) |
the Bank may be obliged to communicate information relating to the Borrower and the Investment to any competent institution or body of the European Union in accordance with the relevant mandatory provisions of European Union law or
pursuant to the EFSI Regulation; and
|
|
(ii) |
the Bank may publish in its website or produce press releases containing information related to the financing provided pursuant to this Contract with support of the EFSI, including the name, address and country of establishment of the
Borrower, the purpose of the financing, and the type and amount of financial support received under this Contract.
|
|
(b) |
The Borrower agrees to cooperate with the Bank to ensure that any press releases or publications made by the Borrower regarding the financing and the Investment include an appropriate acknowledgement of the financial support provided
by EIB with the backing of the European Union through EFSI.
|
|
(c) |
If requested by the Bank, the Borrower undertakes to refer to this financing and other EIB financings in its public communications, if appropriate, during the availability period, and in connection with any drawdowns, and
communications on major corporate events.
|
To: |
Nanobiotix (the “Borrower”)
60 rue de Wattignies 75012 Paris France Attention: Finance Department and Nanobiotix Corp. (the “Guarantor”) 210 Broadway, NGIN 2nd floor, Cambridge, Massachusetts, United States Attention: Philippe Mauberna, Treasurer |
Subject: |
NANOBIOTIX (EGFF) SERAPIS 2018-0245, Fl 89427 AND 89987
|
Ref: |
Finance Contract dated 26 July 2018 between the Borrower and the Bank (the “Finance Contract”), Royalty Agreement dated 26 July 2018
between the Borrower and the Bank (the “Royalty Agreement”) and Guarantee dated on or about the date of this Letter between the Guarantor and the Bank (the “Guarantee”)
|
|
(1) |
Consent to the Borrower entering into the PGE Loan Agreements (as defined below): and
|
|
(2) |
Amendments to the Finance Contract to: (i) insert definitions of “PGE Loan Agreement” (ii) insert an undertaking whereby the Borrower shall request an extension of the repayment
schedule of the loans under the PGE Loan Agreements (as defined below) and (iii) modify the Final Availability Date.
|
1.
|
REFERENCE
|
1.1
|
Reference is made to:
|
(a)
|
the Finance Contract, the Guarantee and the Royalty Agreement;
|
(b)
|
a loan agreement dated 10 July 2020 between the Borrower and BPlfrance Financement for an amount of EUR 5,000,000 (five million euros) benefiting from a 90%
guarantee by the French state (the “BPI PGE Loan Agreement”);
|
(c)
|
a loan agreement dated 22 June 2020 between the Borrower and HSBC France for an amount of EUR 5,000,000 (five million euros) and benefiting from a 90% guarantee by
the French (the “HSBC PGE Loan Agreement”) (referred together with the BPI PGE Loan Agreement as the “PGE Loan Agreements”).
|
1.2
|
The Borrower has notified the Bank that it has entered into the PGE Loan Agreements without the prior written consent of the Bank (the “Notified Event”). Pursuant to Schedule H (General Undertakings), paragraph 16 of the Finance Contract, the prior consent of the Bank was required to the entry into the Indebtedness
constituted by the PGE Loan Agreements and the breach of this undertaking constituted by the Notified Event entitles the Bank to cancel the undisbursed portion of the Credit and demand prepayment of the Loan. The Borrower has requested the
Bank to waive and amend certain provisions of the Finance Contract.
|
2.
|
DEFINITIONS AND INTERPRETATION
|
(a)
|
a PDF copy of this Letter duly countersigned on behalf of the Borrower and the Guarantor;
|
(b)
|
a copy of any authorisation necessary for the Borrower and the Guarantor to enter into this Letter and perform any obligation thereunder as well as any evidence of
the powers of signature of the Borrower’s and the Guarantor’s signatories; and
|
(c)
|
the payment of a consent and amendment fee equal to EUR 5,000. The consent and amendment fee, once paid is non-refundable and non-creditable against any other fees
payable to the Bank.
|
3.
|
WAIVER AND CONSENT
|
3.1
|
From the Effective Date, the Bank waives its rights to cancel the undisbursed portion of the Credit and demand the prepayment of the Loan pursuant to the breach of
Schedule H (General Undertakings), paragraph 16 arising from the occurrence of the Notified Event.
|
3.2
|
For the purpose of Schedule H (General Undertakings), paragraph 16 (a) of the Finance Contract and as from the Effective
Date, the Bank retroactively consents to the Borrower entering into the PGE Loan Agreements representing an additional aggregate indebtedness of EUR 10,000,000 (ten million euros).
|
4.
|
AMENDMENTS
|
4.1
|
The definition of Final Availability Date shall be deleted and replaced by the following definition in Article 1.2 (Definitions) of the Finance Contract:
|
4.2
|
A new definition of PGE Loan Agreement shall be inserted in Article 1.2 (Definitions) of the Finance Contract:
|
(a)
|
the EUR 5,000,000 loan agreement entered into between the Borrower and BP/trance Financement benefiting from a 90% guarantee by the French
state; and
|
(b)
|
the EUR 5,000,000 loan agreement entered into between the Borrower and HSBC France benefiting from a 90% guarantee by the French state.
|
4.3
|
A new Article 2.9A shall be inserted in the Finance Contract as follows:
|
(a)
|
The Borrower shall pay to the Bank a commitment fee calculated on the daily undrawn and uncancelled balance of the Credit from 26 July 2020 until the Final
Availability Date at a rate of 0.1% (10 basis points) per annum (the “Commitment Fee”).
|
(b)
|
The accrued Commitment Fee shall be payable by the Borrower:
|
(i)
|
on the Final Availability Date; or
|
(ii)
|
if any part of the Credit is cancelled under Article 2.6 (Cancellation) prior to the Final Availability Date, on the
payment date mentioned under (a) above; or
|
(iii)
|
in case there is a voluntary prepayment under Article 5.2 (Voluntary Prepayment) or a compulsory prepayment under Article
5.3 (Compulsory Prepayment) on the Prepayment Date.
|
(c)
|
The Commitment Fee will be calculated using the day count convention of a year of 360 (three hundred and sixty) days and the number of days elapsed.
|
(d)
|
If the date on which the Commitment Fee is due to be paid is not a Relevant Business Day, payment shall be made on the next day, if any, of that calendar month that
is a Relevant Business Day or, failing that, the nearest preceding day that is a Relevant Business Day, in all cases with a corresponding adjustment to the amount of Commitment Fee due.”
|
4.4
|
A new paragraph 25 shall be inserted in Schedule H (General undertakings) of the Finance Contract:
|
5.
|
CONTINUITY• AFFIRMATION
|
5.1
|
Nothing in this Letter shall be deemed to be an amendment to the terms of the Finance Contract except, as from the Effective Date, as set out in clause 4 above.
Save as set out in paragraph 3, nothing in this Letter shall be deemed to be a waiver or consent by us to any breach or potential breach (present or future) of any provision of the Finance Contract or any waiver of any default which arises
on or after the date of this Letter. Nothing in this Letter shall prejudice our rights under the Finance Contract.
|
5.2
|
This Letter is delivered without prejudice to any rights which the Bank may have at any time now or in the future in relation to any breach, any Event of Default,
Prepayment Event or any other circumstances or matters other than as specifically referred to in this Letter (and whether subsisting at the date of this Letter or otherwise), which rights shall remain in full force and effect.
|
6.
|
DESIGNATION
|
6.1
|
In accordance with the Finance Contract, the Borrower and the Bank designate this Letter as a Finance Document.
|
6.2
|
With effect on and from the Effective Date, the Finance Contract and this Letter shall be read and construed as one document.
|
7.
|
REPRESENTATION AND WARRANTIES
|
8.
|
GOVERNING LAW AND JURISDICTION
|
/s/ Andéol du Trémolet de Lacheisserie
|
/s/ Guy Abehsera
|
|
Andéol du Trémolet de Lacheisserie,
Head of Division |
Guy Abehsera,
Counsel |
/s/ Philippe Mauberna
|
||
Name:
|
Philippe Mauberna
|
|
Title: |
CFO
|
|
Date: | 20/07/2020 |
/s/ Philippe Mauberna
|
||
Name: |
Philippe Mauberna
|
|
Title: |
Treasurer
|
|
Date: | 20/07/2020 |
Dated
|
2018 | ||
Contract number (FI No): 89427
Contract number (FI No): 89987
Serapis No: 2018-0245
|
|||
European Investment Bank
(the Bank)
|
|||
- and -
|
|||
Nanobiotix
(the Company)
|
|||
Royalty Agreement
|
|
||
Matter ref 1M0186.000509
PAARB/1864409
|
||
Hogan Lovells (Paris) LLP
17 avenue Matignon, 75008 Paris
|
||
Clause |
Page
|
1. | Definition and Interpretation | 1 |
2. | Royalties | 3 |
3. | Interest on overdue sums | 4 |
4. | Payments | 5 |
5. | Charges and expenses | 6 |
6. | Further Assurance | 6 |
7. | Termination | 6 |
8. | Notices | 6 |
9. | English language |
7
|
10. | No hardship | 8 |
11. | Obligations' survival | 8 |
12. | Governing Law and Jurisdiction, Miscellaneous | 8 |
Schedule 1 Compliance Certificate
|
9
|
(1)
|
The European Investment Bank having its seat at 100 boulevard Konrad Adenauer, L-2950 Luxembourg (the "Bank").
|
|
|
(2)
|
Nanobiotix, a company incorporated under the laws of France whose registered office is at 60 rue de Wattignies, 75012 Paris and registered under the commercial register
of Paris under number 447 521 600 (the "Company").
|
|
|
(A)
|
The Company has stated that it is undertaking a research and development project relating to activities required to bring NBTXR3 (a nanoparticle radio-enhancer product) to the market (the "Investment"). The total cost of the Investment, as estimated by the Bank, is EUR 94,700,000.
|
|
|
(B)
|
The Bank, considering that the financing of the Investment falls within the scope of its functions and that it is in a position to take some risks on this project, agreed to provide the Company with a credit
in an amount of EUR 40,000,000 under a Finance Contract dated on the date hereof (the "Finance Contract") to finance the Investment.
|
|
|
(C)
|
In consideration of this interest, the Company intends to account to the Bank for royalties on the income generated from the exploitation of the projects of the Company, including the Investment, which is the
subject matter of this agreement (the "Agreement").
|
|
|
1.
|
Definition and Interpretation
|
|
|
1.1
|
The following definitions and rules of interpretation in this clause apply in this Agreement.
|
|
|
(a)
|
a material disruption to those payment or communications systems or to those financial markets which are, in each case, required to operate in order for payments to be made in connection with this Agreement;
or
|
|
|
(b)
|
the occurrence of any other event which results in a disruption (of a technical or systems-related nature) to the treasury or payments operations of either the Bank or the Company, preventing that party:
|
|
|
(i)
|
from performing its payment obligations under this Agreement; or
|
|
|
(ii)
|
from communicating with other parties in accordance with the terms of this Agreement,
|
|
|
(a)
|
that the Company has served a notice to prepay a Tranche in accordance with article 5.2.1 of the Finance Contract; or
|
|
|
(b)
|
that a Prepayment Event has occurred and the Bank has demanded prepayment of the Loan in accordance with articles 5.3 of the Finance Contract;
|
|
|
(c)
|
a Change-of-Control Event has occurred after the Final Maturity Date but prior to the Termination Date; or
|
|
|
(d)
|
an event of default has occurred pursuant to article 9.1 of the Finance Contract and the Bank has requested the immediate repayment of all sums due under the Finance Contract.
|
|
|
1.2
|
In this Agreement:
|
|
|
(a)
|
References to Articles, Recitals, Schedules and Paragraphs are, save if explicitly stipulated otherwise, references respectively to articles of, and recitals, schedules and paragraphs of schedules to, this
Agreement. All Recitals and Schedules form part of this Agreement.
|
|
|
(b)
|
References to a provision of law are references to that provision as amended or re-enacted.
|
|
|
(c)
|
References to any other agreement or instrument are references to that other agreement or instrument as amended, novated, supplemented, extended or restated.
|
2.
|
Royalties
|
|
|
2.1
|
Payment
|
|
|
(a)
|
In the event the First Tranche has been made available to the Company, the Company shall pay to the Bank in respect of each financial year during the Royalty Calculation Period, a royalty fee equal to an
amount determined, on the basis of the audited consolidated financial statements of the Group for the relevant financial year (the "Royalty Fee") as follows:
|
|
|
(i)
|
[***] of the Group’s annual turnover applying on the portion of turnover of less than [***] ;
|
|
|
(ii)
|
[***] of the Group’s annual turnover applying on the portion of turnover between [***] and [***] ; and
|
|
|
(iii)
|
[***] of the Group’s annual turnover applying on the portion of turnover exceeding [***] .
|
|
|
(b)
|
In the event the Second Tranche has been made available to the Company, the Royalty Fee will be calculated, in respect of each financial year during the Royalty Calculation Period, on the basis of the audited
consolidated financial statements of the Group for the relevant financial year, as follows:
|
|
|
(i)
|
[***] of the Group’s annual turnover applying on the portion of turnover of less than [***] ;
|
|
|
(ii)
|
[***] of the Group’s annual turnover applying on the portion of turnover between [***] and [***] ; and
|
|
|
(iii)
|
[***] of the Group’s annual turnover applying on the portion of turnover exceeding [***] .
|
|
|
(c)
|
The Royalty Fee shall be paid on each Payment Date until the Termination Date.
|
|
|
2.2
|
Prepayment under the Finance Contract
|
|
|
(a)
|
In the event there is a Royalty Prepayment Event, the Bank may exercise its right to request the prepayment of the Royalty Fees by serving a Prepayment Notice to the Company.
|
|
|
(b)
|
Such Prepayment Notice shall include the amount to be prepaid by the Company in relation to the Royalty Fees, as the higher of:
|
|
|
(i)
|
the present value as of the Prepayment Date of all future Royalty Fees which is expected by the Bank to fall due under this Contract where the said present value shall be calculated at a discount rate
determined by an Independent Expert; and
|
|
|
(ii)
|
the amount, as determined by the Bank, required in order for the Bank to realise an internal rate of return on the Loan of 20%; and
|
|
|
(iii)
|
an amount equal to EUR 35,000,000.
|
|
|
(c)
|
The Royalty Fee Prepayment Amount shall be determined as required in accordance with paragraph (b)(i) above by an Independent Expert to be appointed by the Company and the Bank. The Company, the Bank and the
Independent Expert will execute together the terms of engagement of such Independent Expert.
|
|
|
(d)
|
The parties agree to cooperate with each other in relation to the appointment of the Independent Expert and agree not to withhold or delay unreasonably their consent to such appointment.
|
|
|
(e)
|
The Independent Expert shall decide on the procedure and timetable to be followed in the determination of the Royalty Fee Prepayment Amount and shall require the parties to provide each other with or with
access to the relevant information and documents.
|
|
|
(f)
|
When providing its determination, the Independent Expert shall not be obliged to give reasons for its determination and its determination (including any calculation, statement or other information) shall,
save in the case of fraud or manifest error, be final and binding on the Company and the Bank. The Independent Expert shall deliver its determination and any calculation, statement or other information required to be provided by it by this
Agreement to the parties in English in writing on or before the date falling thirty (30) Business Days after the date of its appointment.
|
|
|
(g)
|
The costs and expenses of the Independent Expert shall be borne by the Company.
|
|
|
(h)
|
If the Independent Expert is unable for whatever reason to act, or does not deliver the decision within the time required, the Company and the Bank shall ensure that a replacement expert is appointed in
accordance with the terms of this clause 3.2.
|
|
|
2.3
|
Information
|
|
|
(a)
|
The Company shall supply to the Bank, as soon as they become available but in any event within 90 days after the end of each of its financial years its audited consolidated (if any) and unconsolidated annual
report, balance sheet, profit and loss account and auditors report for that financial year together with a Compliance Certificate signed by the legal representative of the Company.
|
|
|
(b)
|
Not more than once in any year subject to reasonable notice, the Bank may appoint an accountant to inspect the relevant parts of the Company's books and records in order to verify the accounts. Any audit
shall be at the usual place of business of the Company during normal business hours and shall be at the sole expense of the Company. The Bank may not inspect the books or records in respect of royalty accounts rendered more than three (3)
years previously.
|
|
|
3.
|
Interest on overdue sums
|
|
|
3.1
|
If the Company fails to pay any amount payable by it under this Agreement on its due date, interest shall accrue on any such overdue amount from the due date to the date of actual payment at an annual rate
equal to 2% (200 basis points) and shall be payable in accordance with the demand of the Bank.
|
|
|
3.2
|
Default interest (if unpaid) arising on an overdue amount will be compounded with the overdue amount only if, within the meaning of article 1343-2 of the French Code civil, such interest is due for a period
of at least one year, but will remain immediately due and payable.
|
4.
|
Payments
|
|
|
4.1
|
Day count convention
|
|
|
4.2
|
Time and place of payment
|
|
|
(a)
|
If neither this Agreement nor the Bank's demand specifies a due date, all sums other than sums of interest, indemnity and royalty are payable within fifteen (15) days of the Company's receipt of the Bank's
demand.
|
|
|
(b)
|
Each sum payable by the Company under this Agreement shall be paid to the following account:
|
|
|
(c)
|
The Company shall provide the Serapis Number and the FI numbers listed at the front of this Agreement as a reference for each payment made under this Agreement.
|
|
|
(d)
|
Any disbursements by and payments to the Bank under this Agreement shall be made using account(s) acceptable to the Bank. Any account in the name of the Company held with a duly authorised financial
institution in the jurisdiction where the Company is incorporated or where the Investment is undertaken is deemed acceptable to the Bank.
|
|
|
4.3
|
No set-off by the Company
|
|
|
4.4
|
Disruption to Payment Systems
|
|
|
(a)
|
the Bank may, and shall if requested to do so by the Company, consult with the Company with a view to agreeing with the Company such changes to the operation or administration of this Agreement as the Bank
may deem necessary in the circumstances;
|
|
|
(b)
|
the Bank shall not be obliged to consult with the Company in relation to any changes mentioned in paragraph (a) above if, in its opinion, it is not practicable to do so in the circumstances and, in any event,
shall have no obligation to agree to such changes; and
|
|
|
(c)
|
the Bank shall not be liable for any damages, costs or losses whatsoever arising as a result of a Disruption Event or for taking or not taking any action pursuant to or in connection with this Article 4.4.
|
4.5
|
Application of sums received
|
|
|
5.
|
Charges and expenses
|
|
|
5.1
|
Taxes, duties and fees
|
|
|
5.2
|
Other charges
|
|
|
6.
|
Further Assurance
|
|
|
7.
|
Termination
|
|
|
8.
|
Notices
|
|
|
8.1
|
Notices to each party
|
|
|
8.2
|
Form of notice
|
|
|
(a)
|
Any notice or other communication given under this Agreement must be in writing.
|
|
|
(b)
|
Notices and other communications, for which fixed periods are laid down in this Agreement or which themselves fix periods binding on the addressee, may be made by hand delivery, registered letter or e-mail.
Such notices and communications shall be deemed to have been received by the other party on the date of delivery in relation to a hand-delivered or registered letter, on the date when the e-mail is sent in relation to an e-mail message sent
by the Bank or when confirmed by return e-mail by an authorised officer of the Bank to have been received in readable form, in the case of an email sent to the Bank.
|
|
|
(c)
|
Other notices and communications may be made by hand delivery, registered letter or e-mail.
|
|
|
(d)
|
Without affecting the validity of any notice delivered by e-mail according to the paragraphs above, a copy of each notice delivered by e-mail as applicable shall also be sent by letter to the relevant party
on the next following Business Day at the latest.
|
|
|
(e)
|
Notices issued by the Company pursuant to any provision of this Agreement shall, where required by the Bank, be delivered to the Bank together with satisfactory evidence of the authority of the person or
persons authorised to sign such notice on behalf of the Company and the authenticated specimen signature of such person or persons.
|
|
|
(f)
|
Any notice provided by the Company to the Bank by e-mail shall mention the Agreement Number in the subject line and shall be in the form of a non-editable electronic image (pdf, tif or other common
non-editable file format agreed between the parties) of the notice signed by one or more authorised signatories of the Company as appropriate, attached to the e-mail.
|
|
|
(g)
|
The Bank and the Company agree that communications sent in accordance with this Article shall constitute admissible evidence in Court.
|
|
|
9.
|
English language
|
|
|
(a)
|
Any notice or communication given under or in connection with this Agreement must be in English.
|
|
|
(b)
|
All other documents provided under or in connection with this Agreement must be:
|
|
|
(i)
|
in English; or
|
|
|
(ii)
|
if not in English, and if so required by the Bank, accompanied by a certified English translation and, in this case, the English translation will prevail.
|
10.
|
No hardship
|
|
|
11.
|
Obligations' survival
|
|
|
12.
|
Governing Law and Jurisdiction, Miscellaneous
|
|
|
12.1
|
Governing law
|
|
|
12.2
|
Jurisdiction
|
|
|
12.3
|
Place of performance
|
|
|
12.4
|
Evidence of sums due
|
|
|
12.5
|
Entire Agreement
|
|
|
12.6
|
Invalidity
|
|
|
(a)
|
the legality, validity or enforceability in that jurisdiction of any other term of this Agreement or the effectiveness in any other respect of this Agreement in that jurisdiction; or
|
|
|
(b)
|
the legality, validity or enforceability in other jurisdictions of that or any other term of this Agreement or the effectiveness of this Agreement under the laws of such other jurisdictions.
|
|
|
12.7
|
Amendments
|
|
|
Effective Date
|
$
|
963,534.00
|
||
January 1, 2020
|
$
|
963,534.00
|
||
[***] − End of enrollment*
|
$ Up to [***]
|
|||
Completion of all Studies**
|
$
|
[***]
|
First FDA approval
is granted in
|
Payment of*
|
[***]
|
$2,222,120
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
$16,434,467
|
|
(i) |
review, determine and approve the priority of Studies, including review and approve change of priority for a certain Study;
|
|
(ii) |
unless already determined by applicable law, review, determine and approve the responsibility as “sponsor”, including IND filing and monitoring, for each Study;
|
|
(iii) |
review and approve the design, time schedule, protocol, including draft protocols, and scientific integrity of any Studies;
|
|
(iv) |
discuss the strategy and implications with respect to Studies involving any of Nanobiotix’s products in combination with third party products (other than standard chemotherapy);
|
|
(v) |
review the personnel, facilities, and resources envisaged by MD Anderson for a specific Study;
|
|
(vi) |
oversee the conduct of each Study under the Collaboration;
|
|
(vii) |
provide technical, scientific clinical, and regulatory guidance to the Studies;
|
|
(viii) |
monitor the progress of the Studies;
|
|
(ix) |
discuss whether to suspend any Studies;
|
|
(x) |
review Data of the Studies and coordinate the sharing of Data between the Parties;
|
|
(xi) |
review information discovered during site monitoring visit, or Study results that may adversely affect the safety, well-being, or medical care of the Study subjects, or that may affect the willingness of Study subjects to continue
participation in a Study, influence the conduct of the Study, or that may alter the IRB’s approval to continue the Study, including discussion of notification of such events to the IRB and written communication about such results to Study
subjects;
|
|
(xii) |
discuss and approve a replacement of a terminated Study with a new study of similar scope that is of mutual scientific interest to the Parties;
|
|
(xiii) |
review and coordinate any publication and communication of results of any Studies;
|
|
(xiv) |
if required, review, approve and coordinate the patent strategy and the filing of patents; and
|
|
(xv) |
coordinate the resolution of issues arising in the Studies or in the Collaboration as a whole.
|
The University of Texas M. D. Anderson Cancer
|
Nanobiotix S.A.
|
|
Date:
|
Date: 24/01/20
|
|
/s/ Ben Melson
|
/s/ Philippe Mauberna
|
|
Name: Ben Melson
|
Name: Philippe MAUBERNA
|
|
Title: Sr. Vice President
and Chief Financial Officer
|
Title: Chief Financial Officer
|
◾ |
the term of the founders’ warrants granted on May 4, 2012 was seven years from the date of grant;
|
◾ |
neither the founders’ warrants granted on May 4, 2012, nor those granted on April 28, 2013, are subject to continuous employment; and
|
◾ |
on July 23, 2019, the executive board decided to lift, for two of our employees and for Mr. Bernd Muehlenweg, a former member of the executive board, the continued service condition and, where applicable, the performance conditions to
which the exercise of certain founders’ warrants was subject, notwithstanding the termination of their employment agreement or corporate office.
|
◾ |
for founders’ warrants granted on May 4, 2012, Liquidity Events are limited to the filing of a tender offer for our shares – in such event, the number of shares that may be exercised by holders is subject to the price per share offered
in the tender offer; and
|
◾ |
the founders’ warrants granted on April 10, 2013 do not to include any right of acceleration in the event of a change in control.
|
Exhibit 10.9
NANOBIOTIX
2016 STOCK OPTION PLAN
summary
Page | ||||
1. | Purposes of the Plan | 1 | ||
2. | Definitions | 1 | ||
3. | Shares Subject to the Plan | 5 | ||
4. | Administration of the Plan | 5 | ||
(a) | Procedure | 5 | ||
(b) | Powers of the Administrator | 5 | ||
(c) | Effect of Administrator’s Decision | 6 | ||
5. | Limitations | 6 | ||
6. | Term of Plan | 7 | ||
7. | Term of Options | 7 | ||
8. | Options Exercise Price and Consideration | 7 | ||
(a) | Subscription or Purchase Price | 7 | ||
(b) | Exercise Dates | 8 | ||
(c) | Form of Consideration | 8 | ||
9. | Exercise of Options | 8 | ||
(a) | Procedure for Exercise; Rights as a Shareholder | 8 | ||
(b) | Termination of the Optionee’s Continuous Status as Beneficiary | 9 | ||
(c) | Disability of Optionee | 9 | ||
(d) | Death of Optionee | 9 | ||
10. | Non-Transferability of Options | 10 | ||
11. | Adjustments Upon Changes in Capitalization, Dissolution | 10 | ||
(a) | Changes in capitalization | 10 | ||
(b) | Dissolution or Liquidation | 10 | ||
(c) | Change in Control | 10 | ||
12. | Grant | 11 | ||
13. | Amendment and Termination of the Plan | 11 | ||
(a) | Amendment and Termination | 11 | ||
(b) | Shareholders’ approval | 11 | ||
(c) | Effect of amendment or termination | 12 | ||
14. | Conditions Upon Issuance of Shares | 12 | ||
(a) | Legal Compliance | 12 | ||
(b) | Investment Representations | 12 | ||
15. | Liability of Company | 12 | ||
16. | Shareholders’ Approval | 12 |
summary
(continued)
Page | ||||
17. | Law, Jurisdiction | 12 |
Exhibit - Stock Option Grant Agreement
Part I - Notice of stock option grant
Part 11 - Terms and conditions
Exercise notice
NANOBIOTIX
2016 STOCK OPTION PLAN
1. | Purposes of the Plan |
According to the authorization granted by the extraordinary shareholders’ general meeting of June 25, 2015, the management board decided on February 2, 2016, in compliance with the provisions of articles L. 225-177 et. seq. of the French Commercial Code, to adopt the 2016 stock option plan of NANOBIOTIX, the terms and conditions of which are set out below.
The purposes of the Plan are:
- | to attract and retain the best available personnel for positions of substantial responsibility; |
- | to provide additional incentive to Beneficiaries; and |
- | to promote the success of the Company’s business. |
Options granted under the Plan to U.S. Beneficiaries are intended to be Incentive Stock Options or Non-Statutory Stock Options, as determined by the Administrator at the time of grant of an Option, and shall comply in all respects with US Applicable Laws in order that U.S. Beneficiaries may benefit from available tax advantages.
2. | Definitions |
(a) | “Administrator” means the management board of the Company which shall administer the Plan in accordance with Section 4 of the Plan. |
(b) | “Affiliated Company” means a company which conforms with the criteria set forth in article L. 225- 180 of the Commercial Code as follows: |
- | companies of which at least ten per cent (10%) of the share capital or voting rights is held directly or indirectly by the Company; |
- | companies which own directly or indirectly at least ten per cent (10%) of the share capital or voting rights of the Company; and |
- | companies of which at least fifty per cent (50%) of the share capital or voting rights is held directly or indirectly by a company which owns directly or indirectly at least fifty percent (50%) of the share capital or voting rights of the Company, |
(c) | “Applicable Laws” means for the US the legal requirements relating to the administration of stock option plans under state corporate and securities laws and the Code in force in the United States of America. |
(d) | “Beneficiary” means the president and the members of the management board (président et membres du directoire) or, as the case may be, the president of the board of directors (président du conseil d’administration), the general manager (directeur général) and the deputy general managers (directeurs généraux délégués) of the Company as well as any individual employed by the Company or by any Affiliated Company under the terms and conditions of an employment contract, it being specified that a term of office of member of the supervisory board of the Company or director of an Affiliated Company (remunerated or not) shall not be deemed to constitute an employment relationship. |
(e) | “Board” means the management board of the Company. |
(f) | “Code” means the United States Internal Revenue Code of 1986, as amended. |
(g) | “Commercial Code” means the French Commercial Code. |
(h) | “Company” means NANOBIOTIX, a corporation organized under the laws of the Republic of France. |
(i) | “Continuous Status as a Beneficiary” means as regards the president and the members of the management board or, as the case may be, the president of the board of directors, the general manager, the deputy general manager(s), that the term of their office has not been terminated and, as regards an employee that the employment relationship between the Beneficiary and the Company or any Affiliated Company is not terminated. Continuous Status as a Beneficiary shall not be considered terminated in the case of (i) any leave of absence having received a prior approval from the Company or requiring no prior approval under U.S. laws, or (ii) transfers between locations of the Company or between the Company or any Affiliated Company or the contrary or also from an Affiliated Company to another Affiliated Company. Leaves of absence which must receive a prior approval from the Company for the non-termination of the Continuous Status as a Beneficiary shall include leaves of more than three (3) months for illnesses or conditions about which the employee has advance knowledge, military leave, or any other personal leave. For purposes of U.S. Beneficiaries and Incentive Stock Options, no such leave may exceed ninety (90) days, unless reemployment upon expiration of such leave is guaranteed by statute contract or Company policies. If reemployment upon expiration of a leave of absence approved by the Company is not so guaranteed, on the 91st day of such leave any Incentive Stock Option held by a U.S. Beneficiary shall cease to be treated as an Incentive Stock Option and shall be treated for U.S. tax purposes as a Non-Statutory Stock Option. |
(j) | “Date of Grant” means the date of the decision of the Board to grant the Options. |
(k) | “Disability” means a disability declared further to a medical examination provided for in article L. 4624-21 of the French Labour Code or pursuant to any similar provision applicable to a foreign Affiliated Company. |
(l) | “Exchange Act” means the United States Securities Exchange Act of 1934, as amended. |
(m) | “Fair Market Value” means the value for one Share as determined in good faith by the Administrator, according to the following provisions, as provided in the Shareholder Authorization: |
(i) the Board may determine the subscription or purchase price of a share in compliance with the provisions of the law. However, the purchase or subscription price shall in no case be less than ninety five per cent (95%) of the average of the closing sales price for a share as quoted on stock exchange market during the twenty market trading days prior to the day of the Board’s decision to grant the Options,
(ii) for US Beneficiaries, the subscription or purchase price shall not be less than the fair market value of the Shares on the Date of Grant, determined as follows (a) if the Shares are listed or quoted for trading on an exchange, the value will be deemed to be the closing or last offer price, as applicable, of the Shares on the principal exchange upon which such securities are traded or quoted on such date, provided, if such date is not a trading day, on the last market trading day prior to such date; and (b) if the Shares are not listed or quoted for trading on an exchange, the fair market value of the Shares as determined by the Board, consistent with the requirements of Sections 422 with respect to Incentive Stock Options, and 409A of the Code with respect to Options not intended to be Incentive Stock Options,
it being specified that, when an Option entitles the holder to purchase shares previously repurchased by the Company, the exercise price, notwithstanding the above provisions and in accordance with applicable law, may not be less than 80% of the average purchase price paid by the Company for all shares so previously repurchased.
This price settled for the subscription or purchase of Shares shall not be modified during the period in which the Option may be exercised. However, if the Company makes one of the operations mentioned in article L. 225-181 of the French Commercial Code, it must take all necessary measures to protect Optionee’s interests in the conditions provided for by article L 228- 99 of the French Commercial Code. In case of issuance of securities granting the common stock access, as well as in case of Company’s merger or scission, the Board may decide, for a limited period of time, to suspend the exercisability of the Options.
(n) | “Incentive Stock Option” means an Option intended to qualify as an incentive stock option within the meaning of Section 422 of the Code and the regulations promulgated thereunder. |
(o) | “Non-Statutory Stock Option” means an Option which does not qualify as an Incentive Stock Option. |
(p) | “Notice of Grant” means a written notice evidencing the main terms and conditions of an individual Option grant. The Notice of Grant is part of the Option Agreement. |
(q) | “Option” means an option to purchase or subscribe Shares granted pursuant to the Plan. |
(r) | “Optionee” means a Beneficiary who holds at least one outstanding Option. |
(s) | “Option Agreement” means a written agreement entered into between the Company and an Optionee evidencing the terms and conditions of an individual Option grant. The Option Agreement is subject to the terms and conditions of the Plan. |
(t) | “Option Exchange Program” means a program whereby outstanding Options are surrendered in exchange for Options with different exercise conditions. |
(u) | “Parent” means a “parent corporation”, whether now or hereafter existing, as defined in Section 424(e) of the Code. |
(v) | “Plan” means the 2016 Stock Option Plan as approved by the Board on February 2, 2016. |
(w) | “Share” means a share of common stock (action ordinaire) of the Company |
(x) | “Shareholders Authorization” means the authorization given by the shareholders of the Company in the extraordinary general meeting held on June 25, 2015 as increased or amended from time to time by a further general meeting of the shareholders permitting the Board to grant Stock Options. |
(y) | “Share Capital” means the issued and paid up capital of the Company. |
(z) | “Subsidiary” means a “subsidiary corporation”, whether now or hereafter existing, as defined in Section 424(f) of the Code. |
(aa) | “U.S. Beneficiary” means a Beneficiary of the Company or an Affiliated Company residing in the United States or otherwise subject to United States’ laws, regulations or taxation. |
(bb) | “U.S. Optionee” means an Optionee residing in the United States or otherwise subject to United States’ laws, regulations or taxation. |
3. | Shares Subject to the Plan |
Subject to the provisions of Section 11 of the Plan and pursuant to the Shareholder Authorization, the maximum aggregate number of Shares which may be optioned and issued under the Plan is equal to 450,000. For “Incentive Stock Options”, the maximum number of Shares which may be optioned and issued is equal to 450,000. The Shares optioned and issued under the Plan may be newly issued Shares, treasury Shares or Shares purchased on the open market.
Should the Option expire or become unexercisable for any reason without having been exercised in full, the unsubscribed Shares which were subject thereto shall, unless the Plan shall have been terminated, become available again for future grant under the Plan.
4. | Administration of the Plan |
(a) | Procedure |
The Plan shall be administered by the Administrator.
(b) | Powers of the Administrator . |
Subject to the provisions of the Commercial Code, the Shareholders Authorization, the Plan, and the Applicable Laws, the Administrator shall have the authority, in its discretion:
(i) | to determine the Fair Market Value of the Shares, in accordance with Section 2(m) of the Plan; |
(ii) | to determine the Beneficiaries to whom Options may be granted hereunder; |
(iii) | to select the Beneficiaries and determine whether and to what extent Options are granted hereunder; |
(iv) | to approve or amend forms of agreement for use under the Plan; |
(v) | to determine the terms and conditions of any Options granted hereunder. Such terms and conditions include, but are not limited to, the exercise price, the time or times when Options may be exercised (which may be based on performance criteria), any vesting acceleration or waiver of forfeiture restrictions, and any restriction or limitation regarding any Option or the Shares relating thereto, based in each case on such factors as the Administrator, in its sole discretion, shall determine with the exception of the exercise price; it being specified that the Administrator’s discretion remains subject to the rules and limitations set forth in this Plan and in the Commercial Code; |
(vi) | to construe and interpret the terms of the Plan and Options granted pursuant to the Plan; |
(vii) | to prescribe, amend and rescind rules and regulations relating to the Plan, including rules and regulations relating to sub-plans established for the purpose of qualifying for preferred tax treatment under foreign tax laws; |
(viii) | to modify or amend each Option (subject to the provisions of Section 13(c) of the Plan), including the discretionary authority to extend the post-termination exercise period of Options after the termination of the employment agreement or the end of the term of office, longer than is otherwise provided for in the Plan; |
(ix) | to authorize any person to execute on behalf of the Company any instrument required to effect the grant of an Option previously granted by the Administrator; |
(x) | to implement an Option Exchange Program; |
(xi) | to determine the terms and restrictions applicable to Options; and |
(xii) | to make all other determinations deemed necessary or appropriate for administering the Plan. |
(c) | Effect of Administrator’s Decision. |
The Administrator’s decisions, determinations and interpretations shall be final and binding on all Optionees.
5. | Limitations |
(a) In the case of U.S. Beneficiaries, each Option shall be designated in the Notice of Grant either as an “Incentive Stock Option” or as a “Non-Statutory Stock Option”. Incentive Stock Options may only be granted to Beneficiaries of the Company or a Subsidiary who meet the definition of “employees” under Section 3401(c) of the Code.
Nevertheless, the aggregate Fair Market Value of the Shares covered by Incentive Stock Options granted under the Plan or any other stock option program of the Company (or any Parent or subsidiary of the Company) that become exercisable for the first time in any calendar year shall not exceed U.S. $100,000: to the extent the aggregate Fair Market Value of such Shares exceeds U.S. $100,000, the Options covering those Shares the Fair Market Values of which causes the aggregate Fair Market Value of all such Shares to be in excess of U.S. $100,000 shall be treated as Non-Statutory Options. Incentive Stock Options shall be taken into account in the order in which they were granted, and the aggregate Fair Market Value of the Shares shall be determined as of the Date of the Grant.
(b) The Options are governed by articles L. 225-177 and following of the Commercial Code. They are not part of the employment agreement or of the office which has allowed the Optionee to be granted the Option. Neither do they constitute an element of the Optionee’s remuneration.
Neither the Plan nor any Option shall confer upon an Optionee any right with respect to continuing the Optionee’s employment or his term of office with the Company or any Affiliated Company, nor shall they interfere in any way with the Optionee’s right or the Company’s or Affiliated Company’s right, as the case may be, to terminate such employment or such term of office at any time, with or without cause.
(c) Other than as expressly provided hereunder, no member of the board of directors of the Company or of the supervisory board (in the event of change of management formula of the Company) or of an equivalent management body of an Affiliated Company shall be as such eligible to receive Options under the Plan.
6. | Term of Plan |
Subject to the approval of the shareholders of the Company in accordance with Section 16 of the Plan, the Plan shall be effective and Options may be granted as of February 2, 2016. The Plan has been adopted by the Board on February 2, 2016. Options may be granted hereunder until August 25, 2018. It shall continue in effect until the date of termination of the last Option in force, unless terminated earlier under Section 13 of the Plan.
7. | Term of Options |
The term of each Option shall be stated in the Notice of Grant as ten (10) years from the Date of Grant, in accordance with the Shareholders Authorization or, in case of death or Disability of the Optionee during such 10-year period, six (6) months from the death or Disability of the Optionee in accordance with French law, it being however specified, for the avoidance of doubt, that no Option granted to any U.S. Optionee shall be exercised after the 10th anniversary of the Date of Grant.
8. | Options Exercise Price and Consideration |
(a) | Subscription or Purchase Price |
The per Share subscription or purchase price for the Shares to be issued or sold pursuant to exercise of an Option shall be determined by the Administrator on the basis of the Fair Market Value.
(i) In the case of an “Incentive Stock Option” granted to a U.S. Beneficiary who, at the time the Incentive Stock Option is granted, owns stock representing more than ten percent (10%) of the voting rights of all classes of stock of the Company or any Parent or Subsidiary of the Company and, to the extent such Beneficiary is permitted by the Commercial Code to receive Option grants, the per Share subscription or purchase price shall be no less than 110% of the Fair Market Value per Share on the Date of Grant as defined in Section 2(m)(iii);
(ii) In the case of a “Non-Statutory Stock Option” or “Incentive Stock Option”, not covered by Section 8(a) above, granted to any U.S. Beneficiary, the per Share subscription or purchase price shall be no less than 100% of the Fair Market Value per Share on the Date of Grant as defined in Section 2(m)(iii).
(b) | Exercise Dates |
At the time an Option is granted, the Administrator shall fix the period within which the Option may be exercised and shall determine any conditions which must be satisfied before the Option may be exercised. In so doing, the Administrator may specify that an Option may not be exercised until the completion of a service period in the Company or an Affiliated Company.
(c) | Form of Consideration |
The consideration to be paid for the Shares to be issued or purchased upon exercise of Options, including the method of payment, shall be determined by the Administrator. Such consideration shall consist entirely of an amount in Euro corresponding to the exercise price which shall be paid by wire transfer. Where the exercise of an Option would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and the Optionee provides the Company with either the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
9. | Exercise of Options |
(a) | Procedure for Exercise; Rights as a Shareholder |
Any Option granted hereunder shall be exercisable according to the terms of the Plan and at such times and under such conditions as determined by the Administrator and set forth in the Option Agreement.
An Option may not be exercised for a fraction of a Share.
An Option shall be deemed exercised when the Company receives: (i) written notice of exercise (in accordance with the provisions of the Option Agreement) together with a share subscription or purchase form (bulletin de souscription ou d’achat) duly executed by the person entitled to exercise the Option, and (ii) full payment for the Shares with respect to which the Option is exercised. Full payment may consist of any consideration and method of payment authorized by the Administrator and permitted by the Option Agreement and the Plan.
Where the exercise of an Option would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and the Optionee provides the Company with either the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
Upon exercise of an Option, the Shares issued or sold to the Optionee shall be assimilated with all other Shares of the Company of the same class and shall be entitled to dividends once the Shares are issued for the fiscal year during which the Option is exercised.
In the event that a Beneficiary infringes one of the above mentioned commitments, such Beneficiary shall be liable for any consequences resulting from such infringement for the Company and undertakes to indemnify the Company in respect of all amounts payable by the Company in connection with such infringement.
Granting of an Option in any manner shall result in a decrease in the number of Shares which thereafter may be available for purposes of the Plan, by the number of Shares as to which the Option may be exercised.
(b) | Termination of the Optionee’s Continuous Status as Beneficiary |
Upon termination of an Optionee’s Continuous Status as a Beneficiary, other than upon the Optionee’s death or Disability, the Optionee may exercise his or her Options, but only within such period of time as is specified in the Notice of Grant, and only for the part of the Options that the Optionee was entitled to exercise at the date of termination (but in no event later than the expiration of the term of such Options as set forth in the Notice of Grant). Unless a longer period is specified in the Notice of Grant or otherwise resolved by the Board, an Option shall remain exercisable for six (6) months following the Optionee’s termination of Continuous Status as a Beneficiary. In the case of an “Incentive Stock Option”, such a period cannot exceed three (3) months following the Optionee’s termination of Continuous Status as a Beneficiary. If, at the date of termination, the Optionee is not entitled to exercise all his or her Options, the Shares covered by the unexercisable portion of Options shall revert to the Plan. If, after termination, the Optionee does not exercise all of his or her Options within the time specified by the Administrator, the Options shall terminate, and the Shares covered by such Options shall revert to the Plan.
(c) | Disability of Optionee |
In the event that an Optionee’s Continuous Status as a Beneficiary terminates as a result of the Optionee’s Disability, unless otherwise resolved by the Board, the Optionee may exercise his or her Options at any time within six (6) months from the date of such termination, but only to the extent these Options are exercisable at the time of termination (but in no event later than the expiration of the term of such Options as set forth in the Notice of Grant). If, at the date of termination, the Optionee is not entitled to exercise all of his or her Options, the Shares covered by the unexercised portion of Options shall revert to the Plan. If, after termination, the Optionee does not exercise all of his or her Options within the time specified herein, the Options shall terminate, and the Shares covered by such Options shall revert to the Plan.
(d) | Death of Optionee |
In the event of the death of an Optionee during the term of the Options, unless otherwise resolved by the Board, the Options may be exercised at any time within six
(6) months following the date of death, by the Optionee’s estate or by a person who acquired the right to exercise the Option by bequest or inheritance, but only to the extent these Options are exercisable at the time of death. If, at the time of
death, the Optionee was not entitled to exercise all of his or her Options, the Shares
covered by the unexercised portion of Options shall immediately revert to the Plan. If, after death, the Optionee’s estate or a person who acquired the right to exercise the Options by bequest or inheritance does not exercise the Options within the time specified herein, the Options shall terminate, and the Shares covered by such Options shall revert to the Plan.
10. | Non-Transferability of Options |
An Option may not be sold, pledged, assigned, hypothecated, transferred or disposed of in any manner other than by will or by laws of descent or distribution and may be exercised, during the lifetime of the Optionee, only by the Optionee.
11. | Adjustments Upon Changes in Capitalization, Dissolution |
(a) | Changes in capitalization |
In the event of the carrying out by the Company of any of the financial operations pursuant to article L. 225-181 of the Commercial Code as follows:
- | amortization or reduction of the share capital, |
- | amendment of the allocation of profits, |
- | distribution of free shares, |
- | capitalization of reserves, profits, issuance premiums, |
- | the issuance of shares or securities giving right to shares to be subscribed for in cash or by set-off of existing indebtedness offered exclusively to the shareholders; |
the Company shall take the required measures to protect the interest of the Optionees in the conditions set forth in article L. 228-99 of the Commercial Code.
(b) | Dissolution or Liquidation |
In the event of the proposed dissolution or liquidation of the Company, to the extent that an Option has not been previously exercised, it will terminate immediately prior to the consummation of such proposed action. The Administrator may, in the exercise of its sole discretion in such instances, declare that any Option shall terminate as of a date determined by the Administrator and give each Optionee the right to exercise his or her Options as to Shares for which the Options would not otherwise be exercisable.
(c) | Change in Control |
No later than immediately prior to the completion of the relevant Liquidity Event (as defined below):
- |
in the event of a merger of the Company into another corporation or of the sale by one or several shareholders, acting alone or in concert, of the Company to one or
|
several third parties of a number of Shares resulting in a transfer of more than fifty per cent (50%) of the Shares of the Company to said third parties (a “Liquidity Event”), the Optionee’s right to exercise the Options will be accelerated so that the Optionee may exercise all of them with effect immediately prior to the completion of the relevant Liquidity Event; | ||
- | the Options that may be exercised shall have to be exercised no later than immediately prior to the completion of the relevant Liquidity Event, it being specified that the Company shall inform the Optionee of any proposed Liquidity Event at least 15 days prior to the completion thereof; and |
- | any Options not exercised for any reason on or prior to the date of completion of a Liquidity Event will automatically lapse. |
******
For Incentive Stock Options, all assumptions, substitutions and adjustments shall be determined in accordance with Sections 422 and 424 of the Code and the regulations promulgated thereunder and for Non Statutory Options for US Beneficiaries in accordance with the Section 424 of the Code.
12. | Grant |
12.1. The Date of Grant of an Option shall be, for all purposes, the date on which the Administrator decides to grant such Option. A notice of the grant shall be provided to each Optionee within a reasonable time after the Date of Grant.
12.2. In the event of any tax liability arising on account of the grant of the Options, the liability to pay such taxes shall be that of the Beneficiary alone.
The Beneficiary shall enter into such agreements of indemnity and execute any and all documents as the Company may specify for this purpose, if so required at the Date of Grant and at any other time at the discretion of the Company, on such terms and conditions as the Company may think fit, for recovery of the tax due, from the Beneficiary.
13. | Amendment and Termination of the Plan |
(a) | Amendment and Termination |
The Administrator may at any time amend, alter, suspend or terminate the Plan.
(b) | Shareholders’ approval |
The Company shall obtain shareholders’ approval of any Plan amendment to the extent necessary and desirable to comply with Applicable Laws (including the requirements of any exchange or quotation system on which Shares may then be listed or quoted). Such shareholders’ approval, if required, shall be obtained in such a manner and to such a degree as is required by the applicable law, rule or regulation.
(c) | Effect of amendment or termination |
No amendment, alteration, suspension or termination of the Plan shall impair the rights of any Optionee, unless mutually agreed otherwise between the Optionee and the Administrator, which agreement must be in writing and signed by the Optionee and the Company.
14. | Conditions Upon Issuance of Shares |
(a) | Legal Compliance |
Shares held by a US Beneficiary shall not be sold or issued pursuant to the exercise of an Option unless the exercise of such Option, and the issuance or sale and delivery of such Shares shall comply with all relevant provisions of law including, without limitation, the Commercial Code, the “Securities Act” of 1933, as amended, the “Exchange Act”, the rules and regulations promulgated thereunder, Applicable Laws and the requirements of any stock exchange or quotation system upon which the Shares may then be listed or quoted.
(b) | Investment Representations |
As a condition to the exercise of an Option by a US Beneficiary, the Company may require the person exercising such Option to represent and warrant at the time of any such exercise that the Shares are being subscribed or purchased only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a representation is required.
15. | Liability of Company |
15.1. The inability of the Company to obtain authority from any regulatory body having jurisdiction, which authority is deemed by any counsel to the Company to be necessary to the lawful issuance or sale of any Shares hereunder, shall relieve the Company of any liability in respect of the failure to issue or sell such Shares as to which such requisite authority shall not have been obtained.
15.2. The Company and its Affiliated Companies may not be held responsible in any way if the Beneficiary for any reason not attributable to the Company or its Affiliated Companies was not able to exercise the Options or acquire the Shares.
16. | Shareholders’ Approval |
The Plan shall be subject to approval by the shareholders of the Company within twelve (12) months of the date the Plan is adopted by the Board. Such shareholder approval shall be obtained in the manner and to the degree required under the Commercial Code and Applicable Laws.
17. | Law, Jurisdiction |
This Plan shall be governed by and construed in accordance with the laws of France.
The relevant court of the registered office of the Company shall be exclusively competent to determine any claim or dispute arising in connection herewith.
The grant of Options under this Plan shall entitle the Company to require the Beneficiary to comply with such requirements of law as may be necessary in the Options of the Company from time to time.
Stock Option Plan 2016
Exhibit
NANOBIOTIX
STOCK OPTION GRANT AGREEMENT
Part I
NOTICE OF STOCK OPTION GRANT
[Optionee’s Name and Address]
You have been granted Options to subscribe ordinary Shares of the Company, subject to the terms and conditions of the 2016 Stock Option Plan (the “Plan”) and this Option Agreement. Options are governed by articles L. 225-177 and following of the French Commercial Code. They are not part of the employment agreement or of the office which has allowed the Optionee to be granted the Options. Neither do they constitute an element of the Optionee’s remuneration. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Option Agreement.
Date of Grant1: | ____________________ |
Vesting Commencement Date2 : | ____________________ |
Exercise Price per Share: | EUR ________________ |
Total Number of Shares Granted: | ____________________ |
Total Exercise Price: | EUR ________________ |
Type of Options3: |
[Incentive Stock Option]
subject to provisions of article 5 (b) of the Plan |
[Non-Statutory Stock Option] |
|
Term/Expiration Date4: | ____________________ |
Where the exercise of an Option, as described under Article 9.(a) of the Plan, would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and the Optionee provides the Company with either the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
In the event that you infringe the above mentioned commitment, you shall be liable for any consequences resulting from such infringement for the Company and undertake to indemnify
1 date of the board meeting having allocated the Option.
2 date chosen by the Board as the Vesting Commencement Date; failing that, Date of Grant.
3 for U.S. Beneficiaries only.
4 date of termination of the Option (article 7 of the Plan), which shall not exceed 5 years for an ISO granted to a 10% owner and 10 years for a U.S. Optionee.
the Company in respect of all amounts payable by the Company in connection with such infringement.
Validity of the Options :
The Options will be valid as from the Date of Grant.
Vesting Schedule:
Unless otherwise determined or adapted by the Board, the Options may be exercised by the Optionee on the basis of the following initial vesting schedule subject to the condition precedent that the Optionee shall have previously returned to the Company the documents referred to under section 2. of Part II of the Stock Option Grant Agreement duly initialed and signed:
(i) Incentive Stock Option could be vested as follow :
- | By a third of them at the end of each year starting today, i.e. February, 2nd 2017, and |
- | At the latest within ten (10) years from the Date of Grant, knowing that all options that will not be vested during this period will become void automatically, |
(ii) Non-Statutory Stock Options could be vested anytime depending of the following conditions:
- | 15 % of them could be vested if and when the number of treated patients is equal or above 200, |
- | 15 % additional could be vested if and when the number of treated patients is equal or above 300, |
- | 30 % additional could be vested if and when the number of treated patients is equal or above 400, |
- | 40 % additional could be vested if and when the number of treated patients is equal or above 500. |
- | at the latest within ten (10) years as from the Date of Grant or in case of death or Disability of the Optionee during such then (10) year period, six (6) months as from the death or Disability of the Optionee (it being however specified, for the avoidance of doubt, that no Option granted to any U.S. Optionee shall be exercised after the 10th anniversary of the Date of Grant). |
The number of Options that could be exercised pursuant to the above vesting schedule will always be rounded down to the nearest full number.
If the Optionee fails to exercise the Options in whole or in part within the said period of ten (10) years (as may be extended to six (6) months from the death or Disability of the Optionee, the Options will lapse automatically.
Termination Period:
Unless otherwise decided by the Board, in case of termination of the Optionee’s Continuous Status as a Beneficiary, the Options exercisable at the time of termination may be exercised for six (6) months after such termination, being specified that all other Options shall automatically expire at the time of termination.
Unless otherwise decided by the Board, upon the death or Disability of the Optionee, the Options may be exercised during a period of six (6) months as provided in the Plan.
Save as provided in the Plan, in no event shall the Options be exercised later than the Term/Expiration Date as provided above. Should the Options expire or become unexercisable for any reason without having been exercised in full, the unsubscribed Shares which were subject thereto shall, unless the Plan shall have been terminated, become available for future grant under the Plan.
By his signature and the signature of the Company’s representative below, the Optionee and the Company agree that the Options are granted under and governed by the terms and conditions of the Plan and this Option Agreement. The Optionee has reviewed the Plan and this Option Agreement in their entirely, has had the opportunity to obtain the advice of counsel prior to executing this Option Agreement and fully understands all provisions of the Plan and Option Agreement. The Optionee hereby agrees to accept as binding, conclusive and final all decisions or interpretations of the Administrator upon any questions relating to the Plan and Option Agreement. The Optionee further agrees to notify the Company upon any change in the residence address indicated below.
NANOBIOTIX
STOCK OPTION GRANT AGREEMENT
Part II
TERMS AND CONDITIONS
1. Grant of Options.
1.1. The Administrator of the Company hereby grants to the Optionee named in the Notice of Grant attached as Part I of this Agreement (the “Optionee”), [ · ] options (the “Options”) to subscribe the number of ordinary Shares, as set forth in the Notice of Grant, at the exercise price per Share set forth in the Notice of Grant (the “Exercise Price”), subject to the terms and conditions of the Plan, which is incorporated herein by reference.
In the event of a conflict between the terms and conditions of the Plan and the terms and conditions of this Option Agreement, the terms and conditions of the Plan shall prevail.
If designated in the Notice of Grant as an Incentive Stock Option, this Option is intended to qualify as an Incentive Stock Option under Section 422 of the Code although the Company makes no representation as to the tax status of the Option. However, if this Option is intended to be an Incentive Stock Option, to the extent that it exceeds the U.S.$100,000 rule of Code Section 422(d) the excess shall be treated as a Non-Statutory Stock Option
1.2. An Option will be valid as from the Date of Grant.
1.3. In the event of any tax liability arising on account of the Grant of the Options, the liability to pay such taxes shall be that of the Beneficiary alone. The Beneficiary shall enter into such agreements of indemnity and execute any and all documents as the Company may specify for this purpose, if so required at the time of the Grant and at any other time at the discretion of the Company, on such terms and conditions as the Company may think fit, for recovery of the tax due, from the Beneficiary.
2. Exercise of Options
(a) Right to Exercise. An Option is exercisable during its term in accordance with the Vesting Schedule set out in the Notice of Grant and the applicable provisions of the Plan and this Option Agreement, subject to the condition precedent that the Optionee shall have previously returned to the Company, by electronic delivery under the conditions set forth in Article 10 below:
- Part I and Part II of the Stock Option Grant Agreement (Exhibit), duly initialed (all pages but for the signature page) and signed (signature page).
In the event of Optionee’s death, Disability or other termination of Optionee’s Continuous Status as a Beneficiary, the exercisability of an Option is governed by the applicable provisions of the Plan and this Option Agreement.
(b) Method of Exercise. An Option is exercisable by delivery of an exercise notice, in the form attached hereto (the “Exercise Notice”) stating the election to exercise the Option, the number of Shares in respect of which the Option is being exercised (the “Exercised Shares”), and such other
representations and agreements as may be required by the Company pursuant to the provisions of the Plan. The Exercise Notice shall be signed by the Optionee and shall be delivered in person or by certified mail to the Company or its designated representative or by facsimile message to be immediately confirmed by certified mail to the Company. The Exercise Notice shall be accompanied by payment of the aggregate Exercise Price as to all Exercised Shares. An Option shall be deemed to be exercised upon receipt by the Company of such fully executed Exercise Notice accompanied by the proof of payment of such aggregate Exercise Price.
No Share shall be issued pursuant to the exercise of an Option unless such issuance and exercise complies with all relevant provisions of law as set out under Section 14(a) of the Plan.
Upon exercise of an Option, the Shares issued to the Optionee shall be assimilated with all other Shares of the Company and shall be entitled to dividends for the fiscal year in course during which the Option is exercised.
3. Method of Payment. Payment of the aggregate Exercise Price shall be made by wire transfer with the execution of the corresponding exchange contract.
Where the exercise of an Option would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when (a) the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and (b) the Optionee provides the Company with either (i) the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, (ii) the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
The Company and its Affiliated Companies may not be held responsible in any way if the Beneficiary for any reason not attributable to the Company or its Affiliated Companies was not able to exercise the Option or purchase the Shares. The payment for the purchase of the shares shall be made by the Optionee under his/her own responsibility according to these Terms and Conditions.
4. Non-Transferability of Option. An Option may not be transferred in any manner otherwise than by will or by the laws of descent or distribution and may be exercised during the lifetime of the Optionee only by the Optionee. The terms of the Plan and this Option Agreement shall be binding upon the executors, administrators, heirs, successors and assigns of the Optionee.
5. Term of Options. Subject as provided in the Plan, an Option may be exercised only within the term set out in the Notice of Grant, and may be exercised during such term only in accordance with the Plan and the terms of this Option Agreement.
6. Entire Agreement - Governing Law. The Plan is incorporated herein by reference. The Plan and this Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and Optionee with respect to the subject matter hereof, and may not be modified adversely to the Optionee’s interest except by means of a writing signed by the Company and Optionee. This agreement is governed by the laws of the Republic of France.
Any claim or dispute arising under the Plan or this Agreement shall be subject to the exclusive jurisdiction of the court competent for the place of the registered office of the Company.
7. Tax Obligations. Regardless of any action the Company or Optionee’s employer (the “Employer”) takes with respect to any or all income tax, social insurance, payroll tax, or other tax-related withholding (“Tax-Related Items”), Optionee acknowledges that the ultimate liability for all Tax-Related Items legally due by Optionee is and remains Optionee’s responsibility and that the Company and/or the Employer (1) make no representations or undertakings regarding the treatment of any Tax-Related Items in connection with any aspect of the Option grant, including the grant, vesting or exercise of the Option, the subsequent sale of shares of common stock acquired pursuant to such exercise and the receipt of any dividends; and (2) do not commit to structure the terms of the grant or any aspect of the Option to reduce or eliminate Optionee’s liability for Tax-Related Items.
Prior to exercise of the Option, Optionee will pay or make adequate arrangements satisfactory to the Company and/or the Employer to satisfy all withholding obligations of the Company and/or the Employer, if any. In this regard, Optionee authorizes the Company and/or the Employer to withhold all applicable Tax-Related Items legally payable by Optionee from Optionee’s compensation paid to Optionee by the Company and/or Employer or from proceeds of the sale of Shares. Alternatively, or in addition, if permissible under local law, the Company may sell or arrange for the sale of Shares that Optionee acquires to meet the withholding obligation for Tax-Related Items. Finally, Optionee will pay to the Company or the Employer any amount of Tax-Related Items that the Company or the Employer may be required to withhold as a result of Optionee’s participation in the Plan or Optionee’s purchase of Shares that cannot be satisfied by the means previously described. The Company may refuse to honor the exercise and refuse to deliver the Shares issuable upon exercise of the Options if Optionee fails to comply with Optionee’s obligations in connection with the Tax-Related Items as described in this section.
8. Nature of Grant. In accepting the grant, Optionee acknowledges that:
(a) the Plan is established voluntarily by the Company, it is discretionary in nature and it may be modified, amended, suspended or terminated by the Company at any time, unless otherwise provided in the Plan and this Agreement;
(b) the grant of the Option is voluntary and occasional and does not create any contractual or other right to receive future grants of options, or benefits in lieu of options, even if options have been granted repeatedly in the past;
(c) all decisions with respect to future option grants, if any, will be at the sole discretion of the Company;
(d) Optionee’s participation in the Plan shall not create a right to further employment with the employer and shall not interfere with the ability of the Employer to terminate Optionee’s employment relationship at any time with or without cause;
(e) Optionee is voluntarily participating in the Plan;
(f) the Option is an extraordinary item that does not constitute compensation of any kind for services of any kind rendered to the Company or the Employer, and which is outside the scope of Optionee’s employment contract, if any;
(g) the Option is not part of normal or expected compensation or salary for any purpose, including, but not limited to, calculating any severance, resignation, termination, redundancy, end of service payments, bonuses, long service awards, pension or retirement benefits or similar payments and in no event should be considered as compensation for, or relating in any way to, past services for the Company or the Employer;
(h) the Option grant will not be interpreted to form an employment contract with the Company, the Employer or any Subsidiary or affiliate of the Company;
(i) the future value of the underlying Shares is unknown and cannot be predicted with certainty;
(j) if the underlying Shares do not increase in value, the Option will have no value;
(k) if Optionee exercises Optionee’s Option and obtains Shares, the value of those Shares acquired upon exercise may increase or decrease in value, even below the exercise price;
(l) in consideration of the grant of the Option, no claim or entitlement to compensation or damages shall arise from termination of the Option or diminution in value of the Option or Shares purchased through exercise of the Option resulting from termination of Optionee’s employment the Company or the Employer (for any reason whatsoever) and Optionee irrevocably releases the Company and the Employer from any such claim that may arise; if, notwithstanding the foregoing, any such claim is found by a court of competent jurisdiction to have arisen, then, by signing this Agreement, Optionee shall be deemed irrevocably to have waived Optionee’s entitlement to pursue such claim; and
(m) in the event of termination of Optionee’s employment, Optionee’s right to receive the Option and vest in the Option under the Plan, if any, will terminate effective as of the date that Optionee receives notice of termination regardless of when such termination is effective; furthermore, in the event of termination of employment, Optionee’s right to exercise the Option after termination of employment, if any, will be measured by the date on which the Optionee receives notice of termination; the Company shall have the exclusive discretion to determine when Optionee is no longer actively employed for purposes of Optionee’s Option grant. In addition, any period of notice or compensation in lieu of such notice, that is given or ought to have been given under any contract, statute, common law or civil law shall be excluded.
9. Data Privacy. Optionee hereby explicitly and unambiguously consents to the collection, use and transfer, in electronic or other form, of Optionee’s personal data as described in this document by and among, as applicable, the Employer, the Company and its subsidiaries and affiliates for the exclusive purpose of implementing, administering and managing Optionee’s participation in the Plan.
Optionee understands that the Company and the Employer may hold certain personal information about Optionee, including, but not limited to, Optionee’s name, home address and telephone number, date of birth, social insurance number or other identification number, salary, nationality, job title, any shares of stock or directorships held in the Company, details of all options or any other entitlement to shares of stock awarded, canceled, exercised, vested, unvested or outstanding in Optionee’s favor, for the exclusive purpose of implementing, administering and managing the Plan (“Data”).
Optionee understands that the recipients of the Data may be located in the United States or elsewhere including outside the EEA, and that the recipients’ country (e.g., the United States) may have different data privacy laws and protections than Optionee’s country. Optionee understands that Optionee may request a list with the names and addresses of any potential recipients of the Data by contacting Optionee’s local human resources representative. Optionee authorizes the Company and any other possible recipients which may assist the Company (presently or in the future) with implementing, administering and managing the Plan to receive, possess, use, retain and transfer the Data, in electronic or other form, for the sole purpose of implementing, administering and managing Optionee’s participation in the Plan. Optionee understands that Data will be held only as long as is necessary to implement, administer and manage Optionee’s participation in the Plan. Optionee understands that Optionee may, at any time, view the Data, request additional information about the storage processing of the Data, require any necessary amendments to Data or refuse or withdraw the consents herein, in any case without cost, by contacting in writing Optionee’s local human resources representative. Optionee understands, however, that refusing or withdrawing Optionee’s consent may affect Optionee’s ability to participate in the Plan. For more information on the consequences of Optionee’s refusal to consent or withdrawa of consent, Optionee understands that Optionee may contact Optionee’s local human resources representative.
10. Electronic Delivery. The Company may, in its sole discretion, decide to deliver any documents related to the Option and participation in the Plan or future options that may be granted under the Plan by electronic means or to request Optionee’s consent to participate in the Plan by electronic means. Optionee hereby consents to receive such documents by electronic delivery and, if requested, to agree to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.
11. Severability. The provisions of this Agreement are severable and if any one or more provisions are determined to be illegal or otherwise unenforceable, in whole or in part, the remaining provisions shall nevertheless be binding and enforceable.
OPTIONEE: | NANOBIOTIX | |||
|
By: | |||
Signature | ||||
Title: | ||||
Print Name |
Residence Address |
NANOBIOTIX
Société Anonyme á directoire et conseil de surveillance having a share capital of EUR. [ ]
Registered office : [ ]
[ o ] R.C.S. [ ]
2016 STOCK OPTION PLAN
EXERCISE NOTICE
(Share subscription form)
NANOBIOTIX
[ ]
[ ]
France
[ ], [ ]
Attention: [ ]
1. Exercise of Options. Effective as of today, _______________, __, the undersigned (“Optionee”) hereby elects to subscribe ___________________ (_____) ordinary shares (the “Shares”) of the Common Stock of NANOBIOTIX (the “Company”) under and pursuant to the Company’s 2016 Stock Option Plan (the “Plan”) adopted by the board on February 2, 2016 and the Stock Option Agreement dated __________, __ (the “Option Agreement”). The subscription price for the Shares shall be EUR. _________, as required by the Option Agreement.
2. Delivery of Payment. Optionee herewith delivers to the Company the full subscription price for the Shares.
3. Representations of Optionee. The Optionee acknowledges that Optionee has received, read and understood the Plan and the Option Agreement and agrees to abide by and be bound by their terms and conditions.
4. Rights as Shareholder. Until the issuance (as evidenced by the appropriate entry on the books of the Company) of the Shares, the Optionee shall have, as an Optionee, no right to vote or receive dividends or any other rights as a shareholder shall exist with respect to the Optioned Stock, except those the Optionee may have as a shareholder of the Company. No adjustment will be made for rights in respect of which the record date is prior to the issuance date for the Shares, except as provided in Section 11 of the Plan.
5. Tax consultation. The Optionee understands that Optionee may suffer adverse tax consequences as a result of Optionee’s subscription or disposition of the Shares. Optionee represents that Optionee has consulted with any tax consultants Optionee deems advisable in connection with the subscription or disposition of the Shares. The Optionee is not relying on the Company for any tax advice.
6. Entire Agreement - Governing Law. The Plan and Option Agreement are incorporated herein by reference. This Exercise Notice, the Plan and the Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and Optionee with respect to the subject
matter hereof, and may not be modified adversely to the Optionee’s interest except by means of a writing signed by the Company and Optionee. This agreement is governed by the laws of the Republic of France.
*
* *
This Exercise notice is delivered in two originals one of which shall be returned to the Optionee.
Submitted by:
OPTIONEE (*) |
Accepted by:
NANOBIOTIX |
||
Signature | Signature | ||
Its: | |||
Print Name | |||
Address: | |||
* The signature of the Optionee must be preceded by the following manuscript mention “accepted for format and irrevocable subscription of [__________] ordinary Shares”.
Exhibit 10.10
NANOBIOTIX
2016-2 STOCK OPTION PLAN
SUMMARY
Page | ||||
1. | Purposes of the Plan | 1 | ||
2. | Definitions | 1 | ||
3. | Shares Subject to the Plan | 5 | ||
4. | Administration of the Plan | 5 | ||
(a) | Procedure | 5 | ||
(b) | Powers of the Administrator | 5 | ||
(c) | Effect of Administrator’s Decision | 6 | ||
5. | Limitations | 6 | ||
6. | Term of Plan | 7 | ||
7. | Term of Options | 7 | ||
8. | Options Exercise Price and Consideration | 7 | ||
(a) | Subscription or Purchase Price | 7 | ||
(b) | Exercise Dates | 8 | ||
(c) | Form of Consideration | 8 | ||
9. | Exercise of Options | 8 | ||
(a) | Procedure for Exercise; Rights as a Shareholder | 8 | ||
(b) | Termination of the Optionee’s Continuous Status as Beneficiary | 9 | ||
(c) | Disability of Optionee | 9 | ||
(d) | Death of Optionee | 9 | ||
10. | Non-Transferability of Options | 10 | ||
11. | Adjustments Upon Changes in Capitalization, Dissolution | 10 | ||
(a) | Changes in capitalization | 10 | ||
(b) | Dissolution or Liquidation | 10 | ||
(c) | Change in Control | 10 | ||
12. | Grant | 11 | ||
13. | Amendment and Termination of the Plan | 11 | ||
(a) | Amendment and Termination | 11 | ||
(b) | Shareholders’ approval | 11 | ||
(c) | Effect of amendment or termination | 12 | ||
14. | Conditions Upon Issuance of Shares | 12 | ||
(a) | Legal Compliance | 12 | ||
(b) | Investment Representations | 12 | ||
15. | Liability of Company | 12 | ||
16. | Shareholders’ Approval |
12
|
SUMMARY
(continued)
Page | |||
17. | Law, Jurisdiction | 12 | |
Exhibit - Stock Option Grant Agreement | |||
Part I - Notice of stock option grant | |||
Part 11 - Terms and conditions | |||
Exercise notice |
NANOBIOTIX
2016-2 STOCK OPTION PLAN
1. | Purposes of the Plan |
According to the authorization granted by the extraordinary shareholders’ general meeting of June 23, 2016, the management board decided on November 3rd, 2016, in compliance with the provisions of articles L. 225-177 et. seq. of the French Commercial Code, to adopt the 2016 stock option plan of NANOBIOTIX, the terms and conditions of which are set out below.
The purposes of the Plan are:
– | to attract and retain the best available personnel for positions of substantial responsibility; |
– | to provide additional incentive to Beneficiaries; and |
– | to promote the success of the Company’s business. |
Options granted under the Plan to U.S. Beneficiaries are intended to be Incentive Stock Options or Non-Statutory Stock Options, as determined by the Administrator at the time of grant of an Option, and shall comply in all respects with US Applicable Laws in order that U.S. Beneficiaries may benefit from available tax advantages.
2. | Definitions |
(a) | “Administrator” means the management board of the Company which shall administer the Plan in accordance with Section 4 of the Plan. |
(b) | “Affiliated Company” means a company which conforms with the criteria set forth in article L. 225- 180 of the Commercial Code as follows: |
– | companies of which at least ten per cent (10%) of the share capital or voting rights is held directly or indirectly by the Company; |
– | companies which own directly or indirectly at least ten per cent (10%) of the share capital or voting rights of the Company; and |
– | companies of which at least fifty per cent (50%) of the share capital or voting rights is held directly or indirectly by a company which owns directly or indirectly at least fifty percent (50%) of the share capital or voting rights of the Company, |
(c) | “Applicable Laws” means for the US the legal requirements relating to the administration of stock option plans under state corporate and securities laws and the Code in force in the United States of America. |
(d) | “Beneficiary” means the president and the members of the management board (président et membres du directoire) or, as the case may be, the president of the board of directors (président du conseil d’administration), the general manager (directeur général) and the deputy general managers (directeurs généraux délégués) of the Company as well as any individual employed by the Company or by any Affiliated Company under the terms and conditions of an employment contract, it being specified that a term of office of member of the supervisory board of the Company or director of an Affiliated Company (remunerated or not) shall not be deemed to constitute an employment relationship. |
(e) | “Board” means the management board of the Company. |
(f) | “Code” means the United States Internal Revenue Code of 1986, as amended. |
(g) | “Commercial Code” means the French Commercial Code. |
(h) | “Company” means NANOBIOTIX, a corporation organized under the laws of the Republic of France. |
(i) | “Continuous Status as a Beneficiary” means as regards the president and the members of the management board or, as the case may be, the president of the board of directors, the general manager, the deputy general manager(s), that the term of their office has not been terminated and, as regards an employee that the employment relationship between the Beneficiary and the Company or any Affiliated Company is not terminated. Continuous Status as a Beneficiary shall not be considered terminated in the case of (i) any leave of absence having received a prior approval from the Company or requiring no prior approval under U.S. laws, or (ii) transfers between locations of the Company or between the Company or any Affiliated Company or the contrary or also from an Affiliated Company to another Affiliated Company. Leaves of absence which must receive a prior approval from the Company for the non-termination of the Continuous Status as a Beneficiary shall include leaves of more than three (3) months for illnesses or conditions about which the employee has advance knowledge, military leave, or any other personal leave. For purposes of U.S. Beneficiaries and Incentive Stock Options, no such leave may exceed ninety (90) days, unless reemployment upon expiration of such leave is guaranteed by statute contract or Company policies. If reemployment upon expiration of a leave of absence approved by the Company is not so guaranteed, on the 91st day of such leave any Incentive Stock Option held by a U.S. Beneficiary shall cease to be treated as an Incentive Stock Option and shall be treated for U.S. tax purposes as a Non-Statutory Stock Option. |
(j) | “Date of Grant” means the date of the decision of the Board to grant the Options. |
(k) | “Disability” means a disability declared further to a medical examination provided for in article L. 4624-21 of the French Labour Code or pursuant to any similar provision applicable to a foreign Affiliated Company. |
(l) | “Exchange Act” means the United States Securities Exchange Act of 1934, as amended. |
(m) | “Fair Market Value” means the value for one Share as determined in good faith by the Administrator, according to the following provisions, as provided in the Shareholder Authorization: |
(i) the Board may determine the subscription or purchase price of a share in compliance with the provisions of the law. However, the purchase or subscription price shall in no case be less than ninety five per cent (95%) of the average of the closing sales price for a share as quoted on stock exchange market during the twenty market trading days prior to the day of the Board’s decision to grant the Options,
(ii) for US Beneficiaries, the subscription or purchase price shall not be less than the fair market value of the Shares on the Date of Grant, determined as follows (a) if the Shares are listed or quoted for trading on an exchange, the value will be deemed to be the closing or last offer price, as applicable, of the Shares on the principal exchange upon which such securities are traded or quoted on such date, provided, if such date is not a trading day, on the last market trading day prior to such date; and (b) if the Shares are not listed or quoted for trading on an exchange, the fair market value of the Shares as determined by the Board, consistent with the requirements of Sections 422 with respect to Incentive Stock Options, and 409A of the Code with respect to Options not intended to be Incentive Stock Options,
it being specified that, when an Option entitles the holder to purchase shares previously repurchased by the Company, the exercise price, notwithstanding the above provisions and in accordance with applicable law, may not be less than 80% of the average purchase price paid by the Company for all shares so previously repurchased.
This price settled for the subscription or purchase of Shares shall not be modified during the period in which the Option may be exercised. However, if the Company makes one of the operations mentioned in article L. 225-181 of the French Commercial Code, it must take all necessary measures to protect Optionee’s interests in the conditions provided for by article L 228- 99 of the French Commercial Code. In case of issuance of securities granting the common stock access, as well as in case of Company’s merger or scission, the Board may decide, for a limited period of time, to suspend the exercisability of the Options.
(n) | “Incentive Stock Option” means an Option intended to qualify as an incentive stock option within the meaning of Section 422 of the Code and the regulations promulgated thereunder. |
(o) | “Non-Statutory Stock Option” means an Option which does not qualify as an Incentive Stock Option. |
(p) | “Notice of Grant” means a written notice evidencing the main terms and conditions of an individual Option grant. The Notice of Grant is part of the Option Agreement. |
(q) | “Option” means an option to purchase or subscribe Shares granted pursuant to the Plan. |
(r) | “Optionee” means a Beneficiary who holds at least one outstanding Option. |
(s) | “Option Agreement” means a written agreement entered into between the Company and an Optionee evidencing the terms and conditions of an individual Option grant. The Option Agreement is subject to the terms and conditions of the Plan. |
(t) | “Option Exchange Program” means a program whereby outstanding Options are surrendered in exchange for Options with different exercise conditions. |
(u) | “Parent” means a “parent corporation”, whether now or hereafter existing, as defined in Section 424(e) of the Code. |
(v) | “Plan” means the 2016-2 Stock Option Plan as approved by the Board on November 3rd, 2016. |
(w) | “Share” means a share of common stock (action ordinaire) of the Company |
(x) | “Shareholders Authorization” means the authorization given by the shareholders of the Company in the extraordinary general meeting held on June 23, 2016 as increased or amended from time to time by a further general meeting of the shareholders permitting the Board to grant Stock Options. |
(y) | “Share Capital” means the issued and paid up capital of the Company. |
(z) | “Subsidiary” means a “subsidiary corporation”, whether now or hereafter existing, as defined in Section 424(f) of the Code. |
(aa) | “U.S. Beneficiary” means a Beneficiary of the Company or an Affiliated Company residing in the United States or otherwise subject to United States’ laws, regulations or taxation. |
(bb) | “U.S. Optionee” means an Optionee residing in the United States or otherwise subject to United States’ laws, regulations or taxation. |
3. | Shares Subject to the Plan |
Subject to the provisions of Section 11 of the Plan and pursuant to the Shareholder Authorization, the maximum aggregate number of Shares which may be optioned and issued under the Plan is equal to 450,000. For “Incentive Stock Options”, the maximum number of Shares which may be optioned and issued is equal to 450,000. The Shares optioned and issued under the Plan may be newly issued Shares, treasury Shares or Shares purchased on the open market.
Should the Option expire or become unexercisable for any reason without having been exercised in full, the unsubscribed Shares which were subject thereto shall, unless the Plan shall have been terminated, become available again for future grant under the Plan.
4. | Administration of the Plan |
(a) | Procedure |
The Plan shall be administered by the Administrator.
(b) | Powers of the Administrator . |
Subject to the provisions of the Commercial Code, the Shareholders Authorization, the Plan, and the Applicable Laws, the Administrator shall have the authority, in its discretion:
(i) | to determine the Fair Market Value of the Shares, in accordance with Section 2(m) of the Plan; |
(ii) | to determine the Beneficiaries to whom Options may be granted hereunder; |
(iii) | to select the Beneficiaries and determine whether and to what extent Options are granted hereunder; |
(iv) | to approve or amend forms of agreement for use under the Plan; |
(v) | to determine the terms and conditions of any Options granted hereunder. Such terms and conditions include, but are not limited to, the exercise price, the time or times when Options may be exercised (which may be based on performance criteria), any vesting acceleration or waiver of forfeiture restrictions, and any restriction or limitation regarding any Option or the Shares relating thereto, based in each case on such factors as the Administrator, in its sole discretion, shall determine with the exception of the exercise price; it being specified that the Administrator’s discretion remains subject to the rules and limitations set forth in this Plan and in the Commercial Code; |
(vi) | to construe and interpret the terms of the Plan and Options granted pursuant to the Plan; |
(vii) | to prescribe, amend and rescind rules and regulations relating to the Plan, including rules and regulations relating to sub-plans established for the purpose of qualifying for preferred tax treatment under foreign tax laws; |
(viii) | to modify or amend each Option (subject to the provisions of Section 13(c) of the Plan), including the discretionary authority to extend the post-termination exercise period of Options after the termination of the employment agreement or the end of the term of office, longer than is otherwise provided for in the Plan; |
(ix) | to authorize any person to execute on behalf of the Company any instrument required to effect the grant of an Option previously granted by the Administrator; |
(x) | to implement an Option Exchange Program; |
(xi) | to determine the terms and restrictions applicable to Options; and |
(xii) | to make all other determinations deemed necessary or appropriate for administering the Plan. |
(c) | Effect of Administrator’s Decision. |
The Administrator’s decisions, determinations and interpretations shall be final and binding on all Optionees.
5. | Limitations |
(a) In the case of U.S. Beneficiaries, each Option shall be designated in the Notice of Grant either as an “Incentive Stock Option” or as a “Non-Statutory Stock Option”. Incentive Stock Options may only be granted to Beneficiaries of the Company or a Subsidiary who meet the definition of “employees” under Section 3401(c) of the Code.
Nevertheless, the aggregate Fair Market Value of the Shares covered by Incentive Stock Options granted under the Plan or any other stock option program of the Company (or any Parent or subsidiary of the Company) that become exercisable for the first time in any calendar year shall not exceed U.S. $100,000: to the extent the aggregate Fair Market Value of such Shares exceeds U.S. $100,000, the Options covering those Shares the Fair Market Values of which causes the aggregate Fair Market Value of all such Shares to be in excess of U.S. $100,000 shall be treated as Non-Statutory Options. Incentive Stock Options shall be taken into account in the order in which they were granted, and the aggregate Fair Market Value of the Shares shall be determined as of the Date of the Grant.
(b) The Options are governed by articles L. 225-177 and following of the Commercial Code. They are not part of the employment agreement or of the office which has allowed the Optionee to be granted the Option. Neither do they constitute an element of the Optionee’s remuneration.
Neither the Plan nor any Option shall confer upon an Optionee any right with respect to continuing the Optionee’s employment or his term of office with the Company or any Affiliated Company, nor shall they interfere in any way with the Optionee’s right or the Company’s or Affiliated Company’s right, as the case may be, to terminate such employment or such term of office at any time, with or without cause.
(c) Other than as expressly provided hereunder, no member of the board of directors of the Company or of the supervisory board (in the event of change of management formula of the Company) or of an equivalent management body of an Affiliated Company shall be as such eligible to receive Options under the Plan.
6. | Term of Plan |
Subject to the approval of the shareholders of the Company in accordance with Section 16 of the Plan, the Plan shall be effective and Options may be granted as of November 3rd, 2016. The Plan has been adopted by the Board on November 3rd, 2016. Options may be granted hereunder until August 23, 2019. It shall continue in effect until the date of termination of the last Option in force, unless terminated earlier under Section 13 of the Plan.
7. | Term of Options |
The term of each Option shall be stated in the Notice of Grant as ten (10) years from the Date of Grant, in accordance with the Shareholders Authorization or, in case of death or Disability of the Optionee during such 10-year period, six (6) months from the death or Disability of the Optionee in accordance with French law, it being however specified, for the avoidance of doubt, that no Option granted to any U.S. Optionee shall be exercised after the 10th anniversary of the Date of Grant.
8. | Options Exercise Price and Consideration |
(a) | Subscription or Purchase Price |
The per Share subscription or purchase price for the Shares to be issued or sold pursuant to exercise of an Option shall be determined by the Administrator on the basis of the Fair Market Value.
(i) In the case of an “Incentive Stock Option” granted to a U.S. Beneficiary who, at the time the Incentive Stock Option is granted, owns stock representing more than ten percent (10%) of the voting rights of all classes of stock of the Company or any Parent or Subsidiary of the Company and, to the extent such Beneficiary is permitted by the Commercial Code to receive Option grants, the per Share subscription or purchase price shall be no less than 110% of the Fair Market Value per Share on the Date of Grant as defined in Section 2(m)(iii);
(ii) In the case of a “Non-Statutory Stock Option” or “Incentive Stock Option”, not covered by Section 8(a) above, granted to any U.S. Beneficiary, the per Share subscription or purchase price shall be no less than 100% of the Fair Market Value per Share on the Date of Grant as defined in Section 2(m)(iii).
(b) | Exercise Dates |
At the time an Option is granted, the Administrator shall fix the period within which the Option may be exercised and shall determine any conditions which must be satisfied before the Option may be exercised. In so doing, the Administrator may specify that an Option may not be exercised until the completion of a service period in the Company or an Affiliated Company.
(c) | Form of Consideration |
The consideration to be paid for the Shares to be issued or purchased upon exercise of Options, including the method of payment, shall be determined by the Administrator. Such consideration shall consist entirely of an amount in Euro corresponding to the exercise price which shall be paid by wire transfer. Where the exercise of an Option would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and the Optionee provides the Company with either the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
9. | Exercise of Options |
(a) | Procedure for Exercise; Rights as a Shareholder |
Any Option granted hereunder shall be exercisable according to the terms of the Plan and at such times and under such conditions as determined by the Administrator and set forth in the Option Agreement.
An Option may not be exercised for a fraction of a Share.
An Option shall be deemed exercised when the Company receives: (i) written notice of exercise (in accordance with the provisions of the Option Agreement) together with a share subscription or purchase form (bulletin de souscription ou d’achat) duly executed by the person entitled to exercise the Option, and (ii) full payment for the Shares with respect to which the Option is exercised. Full payment may consist of any consideration and method of payment authorized by the Administrator and permitted by the Option Agreement and the Plan.
Where the exercise of an Option would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and the Optionee provides the Company with either the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
Upon exercise of an Option, the Shares issued or sold to the Optionee shall be assimilated with all other Shares of the Company of the same class and shall be entitled to dividends once the Shares are issued for the fiscal year during which the Option is exercised.
In the event that a Beneficiary infringes one of the above mentioned commitments, such Beneficiary shall be liable for any consequences resulting from such infringement for the Company and undertakes to indemnify the Company in respect of all amounts payable by the Company in connection with such infringement.
Granting of an Option in any manner shall result in a decrease in the number of Shares which thereafter may be available for purposes of the Plan, by the number of Shares as to which the Option may be exercised.
(b) | Termination of the Optionee’s Continuous Status as Beneficiary |
Upon termination of an Optionee’s Continuous Status as a Beneficiary, other than upon the Optionee’s death or Disability, the Optionee may exercise his or her Options, but only within such period of time as is specified in the Notice of Grant, and only for the part of the Options that the Optionee was entitled to exercise at the date of termination (but in no event later than the expiration of the term of such Options as set forth in the Notice of Grant). Unless a longer period is specified in the Notice of Grant or otherwise resolved by the Board, an Option shall remain exercisable for six (6) months following the Optionee’s termination of Continuous Status as a Beneficiary. In the case of an “Incentive Stock Option”, such a period cannot exceed three (3) months following the Optionee’s termination of Continuous Status as a Beneficiary. If, at the date of termination, the Optionee is not entitled to exercise all his or her Options, the Shares covered by the unexercisable portion of Options shall revert to the Plan. If, after termination, the Optionee does not exercise all of his or her Options within the time specified by the Administrator, the Options shall terminate, and the Shares covered by such Options shall revert to the Plan.
(c) | Disability of Optionee |
In the event that an Optionee’s Continuous Status as a Beneficiary terminates as a result of the Optionee’s Disability, unless otherwise resolved by the Board, the Optionee may exercise his or her Options at any time within six (6) months from the date of such termination, but only to the extent these Options are exercisable at the time of termination (but in no event later than the expiration of the term of such Options as set forth in the Notice of Grant). If, at the date of termination, the Optionee is not entitled to exercise all of his or her Options, the Shares covered by the unexercised portion of Options shall revert to the Plan. If, after termination, the Optionee does not exercise all of his or her Options within the time specified herein, the Options shall terminate, and the Shares covered by such Options shall revert to the Plan.
(d) | Death of Optionee |
In the event of the death of an Optionee during the term of the Options, unless otherwise resolved by the Board, the Options may be exercised at any time within six (6) months following the date of death, by the Optionee’s estate or by a person who acquired the right to exercise the Option by bequest or inheritance, but only to the extent these Options are exercisable at the time
of death. If, at the time of death, the Optionee was not entitled to exercise all of his or her Options, the Shares covered by the unexercised portion of Options shall immediately revert to the Plan. If, after death, the Optionee’s estate or a person who acquired the right to exercise the Options by bequest or inheritance does not exercise the Options within the time specified herein, the Options shall terminate, and the Shares covered by such Options shall revert to the Plan.
10. | Non-Transferability of Options |
An Option may not be sold, pledged, assigned, hypothecated, transferred or disposed of in any manner other than by will or by laws of descent or distribution and may be exercised, during the lifetime of the Optionee, only by the Optionee.
11. | Adjustments Upon Changes in Capitalization, Dissolution |
(a) | Changes in capitalization |
In the event of the carrying out by the Company of any of the financial operations pursuant to article L. 225-181 of the Commercial Code as follows:
– | amortization or reduction of the share capital, |
– | amendment of the allocation of profits, |
– | distribution of free shares, |
– | capitalization of reserves, profits, issuance premiums, |
– | the issuance of shares or securities giving right to shares to be subscribed for in cash or by set-off of existing indebtedness offered exclusively to the shareholders; |
the Company shall take the required measures to protect the interest of the Optionees in the conditions set forth in article L. 228-99 of the Commercial Code.
(b) | Dissolution or Liquidation |
In the event of the proposed dissolution or liquidation of the Company, to the extent that an Option has not been previously exercised, it will terminate immediately prior to the consummation of such proposed action. The Administrator may, in the exercise of its sole discretion in such instances, declare that any Option shall terminate as of a date determined by the Administrator and give each Optionee the right to exercise his or her Options as to Shares for which the Options would not otherwise be exercisable.
(c) | Change in Control |
No later than immediately prior to the completion of the relevant Liquidity Event (as defined below):
– | in the event of a merger of the Company into another corporation or of the sale by one or several shareholders, acting alone or in concert, of the Company to one or several third parties of a number of Shares resulting in a transfer of more than fifty per cent (50%) of the Shares of the Company to said third parties (a “Liquidity Event”), the Optionee’s right to exercise the Options will be accelerated so that the Optionee may exercise all of them with effect immediately prior to the completion of the relevant Liquidity Event; |
– | the Options that may be exercised shall have to be exercised no later than immediately prior to the completion of the relevant Liquidity Event, it being specified that the Company shall inform the Optionee of any proposed Liquidity Event at least 15 days prior to the completion thereof; and |
– | any Options not exercised for any reason on or prior to the date of completion of a Liquidity Event will automatically lapse. |
******
For Incentive Stock Options, all assumptions, substitutions and adjustments shall be determined in accordance with Sections 422 and 424 of the Code and the regulations promulgated thereunder and for Non Statutory Options for Beneficiaries in accordance with the Section 424 of the US Code.
12. | Grant |
12.1. The Date of Grant of an Option shall be, for all purposes, the date on which the Administrator decides to grant such Option. A notice of the grant shall be provided to each Optionee within a reasonable time after the Date of Grant.
12.2. In the event of any tax liability arising on account of the grant of the Options, the liability to pay such taxes shall be that of the Beneficiary alone.
The Beneficiary shall enter into such agreements of indemnity and execute any and all documents as the Company may specify for this purpose, if so required at the Date of Grant and at any other time at the discretion of the Company, on such terms and conditions as the Company may think fit, for recovery of the tax due, from the Beneficiary.
13. | Amendment and Termination of the Plan |
(a) | Amendment and Termination |
The Administrator may at any time amend, alter, suspend or terminate the Plan.
(b) | Shareholders’ approval |
The Company shall obtain shareholders’ approval of any Plan amendment to the extent necessary and desirable to comply with Applicable Laws (including the requirements of any exchange or quotation system on which Shares may then be listed or quoted). Such shareholders’
approval, if required, shall be obtained in such a manner and to such a degree as is required by the applicable law, rule or regulation.
(c) | Effect of amendment or termination |
No amendment, alteration, suspension or termination of the Plan shall impair the rights of any Optionee, unless mutually agreed otherwise between the Optionee and the Administrator, which agreement must be in writing and signed by the Optionee and the Company.
14. | Conditions Upon Issuance of Shares |
(a) | Legal Compliance |
Shares held by a US Beneficiary shall not be sold or issued pursuant to the exercise of an Option unless the exercise of such Option, and the issuance or sale and delivery of such Shares shall comply with all relevant provisions of law including, without limitation, the Commercial Code, the “Securities Act” of 1933, as amended, the “Exchange Act”, the rules and regulations promulgated thereunder, Applicable Laws and the requirements of any stock exchange or quotation system upon which the Shares may then be listed or quoted.
(b) | Investment Representations |
As a condition to the exercise of an Option by a US Beneficiary, the Company may require the person exercising such Option to represent and warrant at the time of any such exercise that the Shares are being subscribed or purchased only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a representation is required.
15. | Liability of Company |
15.1. The inability of the Company to obtain authority from any regulatory body having jurisdiction, which authority is deemed by any counsel to the Company to be necessary to the lawful issuance or sale of any Shares hereunder, shall relieve the Company of any liability in respect of the failure to issue or sell such Shares as to which such requisite authority shall not have been obtained.
15.2. The Company and its Affiliated Companies may not be held responsible in any way if the Beneficiary for any reason not attributable to the Company or its Affiliated Companies was not able to exercise the Options or acquire the Shares.
16. | Shareholders’ Approval |
The Plan shall be subject to approval by the shareholders of the Company within twelve (12) months of the date the Plan is adopted by the Board. Such shareholder approval shall be obtained in the manner and to the degree required under the Commercial Code and Applicable Laws.
17. | Law, Jurisdiction |
This Plan shall be governed by and construed in accordance with the laws of France.
The relevant court of the registered office of the Company shall be exclusively competent to determine any claim or dispute arising in connection herewith.
The grant of Options under this Plan shall entitle the Company to require the Beneficiary to comply with such requirements of law as may be necessary in the Options of the Company from time to time.
Exhibit
NANOBIOTIX
STOCK OPTION GRANT AGREEMENT
Part I
NOTICE OF STOCK OPTION GRANT
Noël Kurdi
You have been granted Options to subscribe ordinary Shares of the Company, subject to the terms and conditions of the 2016-2 Stock Option Plan (the “Plan”) and this Option Agreement. Options are governed by articles L. 225-177 and following of the French Commercial Code. They are not part of the employment agreement or of the office which has allowed the Optionee to be granted the Options. Neither do they constitute an element of the Optionee’s remuneration. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Option Agreement.
Date of Grant1: | Nov. 3rd 2016 | |
Vesting Commencement Date2 : | Nov. 3rd 2016 | |
Exercise Price per Share: | EUR 14.26€ | |
Total Number of Shares Granted: | 4.000 | |
Total Exercise Price: | EUR 57.040€ | |
Type of Options3: |
[Incentive Stock Option]
subject to provisions of article 5 (b) of the Plan |
|
Term/Expiration Date4: | Nov. 4th, 2026 |
Where the exercise of an Option, as described under Article 9.(a) of the Plan, would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and the Optionee provides the Company with either the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, the full payment , under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
In the event that you infringe the above mentioned commitment, you shall be liable for any consequences resulting from such infringement for the Company and undertake to indemnify the Company in respect of all amounts payable by the Company in connection with such infringement.
1 date of the board meeting having allocated the Option.
2 date chosen by the Board as the Vesting Commencement Date; failing that, Date of Grant.
3 for U.S. Beneficiaries only.
4 date of termination of the Option (article 7 of the Plan), which shall not exceed 5 years for an ISO granted to a 10% owner and 10 years for a U.S. Optionee.
Validity of the Options :
The Options will be valid as from the Date of Grant.
Vesting Schedule:
Unless otherwise determined or adapted by the Board, the Options may be exercised by the Optionee on the basis of the following initial vesting schedule subject to the condition precedent that the Optionee shall have previously returned to the Company the documents referred to under section 2. of Part II of the Stock Option Grant Agreement duly initialed and signed:
– | at the latest within ten (10) years as from the Date of Grant or in case of death or Disability of the Optionee during such then (10) year period, six (6) months as from the death or Disability of the Optionee (it being however specified, for the avoidance of doubt, that no Option granted to any U.S. Optionee shall be exercised after the 10th anniversary of the Date of Grant). |
The number of Options that could be exercised pursuant to the above vesting schedule will always be rounded down to the nearest full number.
If the Optionee fails to exercise the Options in whole or in part within the said period of ten (10) years (as may be extended to six (6) months from the death or Disability of the Optionee, the Options will lapse automatically.
Termination Period:
Unless otherwise decided by the Board, in case of termination of the Optionee’s Continuous Status as a Beneficiary, the Options exercisable at the time of termination may be exercised for six (6) months, three (3) months for Incentive Stock Options after such termination, being specified that all other Options shall automatically expire at the time of termination.
Unless otherwise decided by the Board, upon the death or Disability of the Optionee, the Options may be exercised during a period of six (6) months as provided in the Plan.
Save as provided in the Plan, in no event shall the Options be exercised later than the Term/Expiration Date as provided above. Should the Options expire or become unexercisable for any reason without having been exercised in full, the unsubscribed Shares which were subject thereto shall, unless the Plan shall have been terminated, become available for future grant under the Plan.
By his signature and the signature of the Company’s representative below, the Optionee and the Company agree that the Options are granted under and governed by the terms and conditions of the Plan and this Option Agreement. The Optionee has reviewed the Plan and this Option Agreement in their entirely, has had the opportunity to obtain the advice of counsel prior to executing this Option Agreement and fully understands all provisions of the Plan and Option Agreement. The Optionee hereby agrees to accept as binding, conclusive and final all decisions or interpretations of the Administrator upon any questions relating to the Plan and Option
Agreement. The Optionee further agrees to notify the Company upon any change in the residence address indicated below.
NANOBIOTIX
STOCK OPTION GRANT AGREEMENT
Part II
TERMS AND CONDITIONS
1. Grant of Options.
1.1. The Administrator of the Company hereby grants to the Optionee named in the Notice of Grant attached as Part I of this Agreement (the “Optionee”), 4.000 options (the “Options”) to subscribe the number of ordinary Shares, as set forth in the Notice of Grant, at the exercise price per Share set forth in the Notice of Grant (the “Exercise Price”), subject to the terms and conditions of the Plan, which is incorporated herein by reference.
In the event of a conflict between the terms and conditions of the Plan and the terms and conditions of this Option Agreement, the terms and conditions of the Plan shall prevail.
If designated in the Notice of Grant as an Incentive Stock Option, this Option is intended to qualify as an Incentive Stock Option under Section 422 of the Code although the Company makes no representation as to the tax status of the Option. However, if this Option is intended to be an Incentive Stock Option, to the extent that it exceeds the U.S.$ 100,000 rule of Code Section 422(d) the excess shall be treated as a Non-Statutory Stock Option
1.2. An Option will be valid as from the Date of Grant.
1.3. In the event of any tax liability arising on account of the Grant of the Options, the liability to pay such taxes shall be that of the Beneficiary alone. The Beneficiary shall enter into such agreements of indemnity and execute any and all documents as the Company may specify for this purpose, if so required at the time of the Grant and at any other time at the discretion of the Company, on such terms and conditions as the Company may think fit, for recovery of the tax due, from the Beneficiary.
2. Exercise of Options
(a) Right to Exercise. An Option is exercisable during its term in accordance with the Vesting Schedule set out in the Notice of Grant and the applicable provisions of the Plan and this Option Agreement, subject to the condition precedent that the Optionee shall have previously returned to the Company, by electronic delivery under the conditions set forth in Article 10 below:
- Part I and Part II of the Stock Option Grant Agreement (Exhibit), duly initialed (all pages but for the signature page) and signed (signature page).
In the event of Optionee’s death, Disability or other termination of Optionee’s Continuous Status as a Beneficiary, the exercisability of an Option is governed by the applicable provisions of the Plan and this Option Agreement.
(b) Method of Exercise. An Option is exercisable by delivery of an exercise notice, in the form attached hereto (the “Exercise Notice”) stating the election to exercise the Option, the
number of Shares in respect of which the Option is being exercised (the “Exercised Shares”), and such other representations and agreements as may be required by the Company pursuant to the provisions of the Plan. The Exercise Notice shall be signed by the Optionee and shall be delivered in person or by certified mail to the Company or its designated representative or by facsimile message to be immediately confirmed by certified mail to the Company. The Exercise Notice shall be accompanied by payment of the aggregate Exercise Price as to all Exercised Shares. An Option shall be deemed to be exercised upon receipt by the Company of such fully executed Exercise Notice accompanied by the proof of payment of such aggregate Exercise Price.
No Share shall be issued pursuant to the exercise of an Option unless such issuance and exercise complies with all relevant provisions of law as set out under Section 14(a) of the Plan.
Upon exercise of an Option, the Shares issued to the Optionee shall be assimilated with all other Shares of the Company and shall be entitled to dividends for the fiscal year in course during which the Option is exercised.
3. Method of Payment. Payment of the aggregate Exercise Price shall be made by wire transfer with the execution of the corresponding exchange contract.
Where the exercise of an Option would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when (a) the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and (b) the Optionee provides the Company with either (i) the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, (ii) the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
The Company and its Affiliated Companies may not be held responsible in any way if the Beneficiary for any reason not attributable to the Company or its Affiliated Companies was not able to exercise the Option or purchase the Shares. The payment for the purchase of the shares shall be made by the Optionee under his/her own responsibility according to these Terms and Conditions.
4. Non-Transferability of Option. An Option may not be transferred in any manner otherwise than by will or by the laws of descent or distribution and may be exercised during the lifetime of the Optionee only by the Optionee. The terms of the Plan and this Option Agreement shall be binding upon the executors, administrators, heirs, successors and assigns of the Optionee.
5. Term of Options. Subject as provided in the Plan, an Option may be exercised only within the term set out in the Notice of Grant, and may be exercised during such term only in accordance with the Plan and the terms of this Option Agreement.
6. Entire Agreement - Governing Law. The Plan is incorporated herein by reference. The Plan and this Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and
agreements of the Company and Optionee with respect to the subject matter hereof, and may not be modified adversely to the Optionee’s interest except by means of a writing signed by the Company and Optionee. This agreement is governed by the laws of the Republic of France.
Any claim or dispute arising under the Plan or this Agreement shall be subject to the exclusive jurisdiction of the court competent for the place of the registered office of the Company.
7. Tax Obligations. Regardless of any action the Company or Optionee’s employer (the “Employer”) takes with respect to any or all income tax, social insurance, payroll tax, or other tax-related withholding (“Tax-Related Items”), Optionee acknowledges that the ultimate liability for all Tax-Related Items legally due by Optionee is and remains Optionee’s responsibility and that the Company and/or the Employer (1) make no representations or undertakings regarding the treatment of any Tax-Related Items in connection with any aspect of the Option grant, including the grant, vesting or exercise of the Option, the subsequent sale of shares of common stock acquired pursuant to such exercise and the receipt of any dividends; and (2) do not commit to structure the terms of the grant or any aspect of the Option to reduce or eliminate Optionee’s liability for Tax-Related Items.
Prior to exercise of the Option, Optionee will pay or make adequate arrangements satisfactory to the Company and/or the Employer to satisfy all withholding obligations of the Company and/or the Employer, if any. In this regard, Optionee authorizes the Company and/or the Employer to withhold all applicable Tax-Related Items legally payable by Optionee from Optionee’s compensation paid to Optionee by the Company and/or Employer or from proceeds of the sale of Shares. Alternatively, or in addition, if permissible under local law, the Company may sell or arrange for the sale of Shares that Optionee acquires to meet the withholding obligation for Tax-Related Items. Finally, Optionee will pay to the Company or the Employer any amount of Tax-Related Items that the Company or the Employer may be required to withhold as a result of Optionee’s participation in the Plan or Optionee’s purchase of Shares that cannot be satisfied by the means previously described. The Company may refuse to honor the exercise and refuse to deliver the Shares issuable upon exercise of the Options if Optionee fails to comply with Optionee’s obligations in connection with the Tax-Related Items as described in this section.
8. Nature of Grant. In accepting the grant, Optionee acknowledges that:
(a) the Plan is established voluntarily by the Company, it is discretionary in nature and it may be modified, amended, suspended or terminated by the Company at any time, unless otherwise provided in the Plan and this Agreement;
(b) the grant of the Option is voluntary and occasional and does not create any contractual or other right to receive future grants of options, or benefits in lieu of options, even if options have been granted repeatedly in the past;
(c) all decisions with respect to future option grants, if any, will be at the sole discretion of the Company;
(d) Optionee’s participation in the Plan shall not create a right to further employment with the employer and shall not interfere with the ability of the Employer to terminate Optionee’s employment relationship at any time with or without cause;
(e) Optionee is voluntarily participating in the Plan;
(f) the Option is an extraordinary item that does not constitute compensation of any kind for services of any kind rendered to the Company or the Employer, and which is outside the scope of Optionee’s employment contract, if any;
(g) the Option is not part of normal or expected compensation or salary for any purpose, including, but not limited to, calculating any severance, resignation, termination, redundancy, end of service payments, bonuses, long service awards, pension or retirement benefits or similar payments and in no event should be considered as compensation for, or relating in any way to, past services for the Company or the Employer;
(h) the Option grant will not be interpreted to form an employment contract with the Company, the Employer or any Subsidiary or affiliate of the Company;
(i) the future value of the underlying Shares is unknown and cannot be predicted with certainty;
(j) if the underlying Shares do not increase in value, the Option will have no value;
(k) if Optionee exercises Optionee’s Option and obtains Shares, the value of those Shares acquired upon exercise may increase or decrease in value, even below the exercise price;
(l) in consideration of the grant of the Option, no claim or entitlement to compensation or damages shall arise from termination of the Option or diminution in value of the Option or Shares purchased through exercise of the Option resulting from termination of Optionee’s employment the Company or the Employer (for any reason whatsoever) and Optionee irrevocably releases the Company and the Employer from any such claim that may arise; if, notwithstanding the foregoing, any such claim is found by a court of competent jurisdiction to have arisen, then, by signing this Agreement, Optionee shall be deemed irrevocably to have waived Optionee’s entitlement to pursue such claim; and
(m) in the event of termination of Optionee’s employment, Optionee’s right to receive the Option and vest in the Option under the Plan, if any, will terminate effective as of the date that Optionee receives notice of termination regardless of when such termination is effective; furthermore, in the event of termination of employment, Optionee’s right to exercise the Option after termination of employment, if any, will be measured by the date on which the Optionee receives notice of termination; the Company shall have the exclusive discretion to determine when Optionee is no longer actively employed for purposes of Optionee’s Option grant. In addition, any period of notice or compensation in lieu of such notice, that is given or ought to have been given under any contract, statute, common law or civil law shall be excluded.
9. Data Privacy. Optionee hereby explicitly and unambiguously consents to the collection, use and transfer, in electronic or other form, of Optionee’s personal data as described in this document by and among, as applicable, the Employer, the Company and its subsidiaries and affiliates for the exclusive purpose of implementing, administering and managing Optionee’s participation in the Plan.
Optionee understands that the Company and the Employer may hold certain personal information about Optionee, including, but not limited to, Optionee’s name, home address and telephone number, date of birth, social insurance number or other identification number, salary, nationality, job title, any shares of stock or directorships held in the Company, details of all options or any other entitlement to shares of stock awarded, canceled, exercised, vested, unvested or outstanding in Optionee’s favor, for the exclusive purpose of implementing, administering and managing the Plan (“Data”).
Optionee understands that the recipients of the Data may be located in the United States or elsewhere including outside the EEA, and that the recipients’ country (e.g., the United States) may have different data privacy laws and protections than Optionee’s country. Optionee understands that Optionee may request a list with the names and addresses of any potential recipients of the Data by contacting Optionee’s local human resources representative. Optionee authorizes the Company and any other possible recipients which may assist the Company (presently or in the future) with implementing, administering and managing the Plan to receive, possess, use, retain and transfer the Data, in electronic or other form, for the sole purpose of implementing, administering and managing Optionee’s participation in the Plan. Optionee understands that Data will be held only as long as is necessary to implement, administer and manage Optionee’s participation in the Plan. Optionee understands that Optionee may, at any time, view the Data, request additional information about the storage processing of the Data, require any necessary amendments to Data or refuse or withdraw the consents herein, in any case without cost, by contacting in writing Optionee’s local human resources representative. Optionee understands, however, that refusing or withdrawing Optionee’s consent may affect Optionee’s ability to participate in the Plan. For more information on the consequences of Optionee’s refusal to consent or withdrawal of consent, Optionee understands that Optionee may contact Optionee’s local human resources representative.
10. Electronic Delivery. The Company may, in its sole discretion, decide to deliver any documents related to the Option and participation in the Plan or future options that may be granted under the Plan by electronic means or to request Optionee’s consent to participate in the Plan by electronic means. Optionee hereby consents to receive such documents by electronic delivery and, if requested, to agree to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.
11. Severability. The provisions of this Agreement are severable and if any one or more provisions are determined to be illegal or otherwise unenforceable, in whole or in part, the remaining provisions shall nevertheless be binding and enforceable.
OPTIONEE: | NANOBIOTIX | |||
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By: | |||
Signature | ||||
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Title: | |||
Print Name | ||||
Residence Address |
NANOBIOTIX
Société Anonyme á directoire et conseil de surveillance having a share capital of EUR. [ ]
Registered office : [__]
[ o ] R.C.S. [__]
2016-2 STOCK OPTION PLAN
EXERCISE NOTICE
(Share subscription form)
NANOBIOTIX
[__]
[__]
France
[_______], [__]
Attention: [______]
1. Exercise of Options. Effective as of today, _______________, __ , the undersigned (“Optionee”) hereby elects to subscribe ___________________ (_____) ordinary shares (the “Shares”) of the Common Stock of NANOBIOTIX (the “Company”) under and pursuant to the Company’s 2016-2 Stock Option Plan (the “Plan”) adopted by the board on November [ o ], 2016 and the Stock Option Agreement dated __________, __ (the “Option Agreement”). The subscription price for the Shares shall be EUR. _________, as required by the Option Agreement.
2. Delivery of Payment. Optionee herewith delivers to the Company the full subscription price for the Shares.
3. Representations of Optionee. The Optionee acknowledges that Optionee has received, read and understood the Plan and the Option Agreement and agrees to abide by and be bound by their terms and conditions.
4. Rights as Shareholder. Until the issuance (as evidenced by the appropriate entry on the books of the Company) of the Shares, the Optionee shall have, as an Optionee, no right to vote or receive dividends or any other rights as a shareholder shall exist with respect to the Optioned Stock, except those the Optionee may have as a shareholder of the Company. No adjustment will be made for rights in respect of which the record date is prior to the issuance date for the Shares, except as provided in Section 11 of the Plan.
5. Tax consultation. The Optionee understands that Optionee may suffer adverse tax consequences as a result of Optionee’s subscription or disposition of the Shares. Optionee represents that Optionee has consulted with any tax consultants Optionee deems advisable in connection with the subscription or disposition of the Shares. The Optionee is not relying on the Company for any tax advice.
6. Entire Agreement - Governing Law. The Plan and Option Agreement are incorporated herein by reference. This Exercise Notice, the Plan and the Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their
entirety all prior undertakings and agreements of the Company and Optionee with respect to the subject matter hereof, and may not be modified adversely to the Optionee’s interest except by means of a writing signed by the Company and Optionee. This agreement is governed by the laws of the Republic of France.
*
* *
This Exercise notice is delivered in two originals one of which shall be returned to the Optionee.
Submitted by: | Accepted by: | ||
OPTIONEE (*) | NANOBIOTIX | ||
Signature | Signature | ||
Its: | |||
Print Name | |||
Address: | |||
* The signature of the Optionee must be preceded by the following manuscript mention “accepted for format and irrevocable subscription of [__________] ordinary Shares”.
SUMMARY
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Page
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Purposes of the Plan
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1
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2.
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Definitions
|
1
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3.
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Shares Subject to the Plan
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4
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4.
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Administration of the Plan
|
5
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|
(a)
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Procedure
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5
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(b)
|
Powers of the Administrator
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5
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(c)
|
Effect of Administrator’s Decision
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6
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5.
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Limitations
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6
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6.
|
Term of Plan
|
7
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7.
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Term of Options
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7
|
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8.
|
Options Exercise Price and Consideration
|
7
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|
(a)
|
Subscription or Purchase Price
|
7
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(b)
|
Exercise Dates
|
7
|
|
(c)
|
Form of Consideration
|
8
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9.
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Exercise of Options
|
8
|
|
(a)
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Procedure for Exercise; Rights as a Shareholder
|
8
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|
(b)
|
Termination of the Optionee’s Continuous Status as Beneficiary
|
9
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|
(c)
|
Disability of Optionee
|
9
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|
(d)
|
Death of Optionee
|
9
|
|
10.
|
Non-Transferability of Options
|
10
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|
11.
|
Adjustments Upon Changes in Capitalization, Dissolution
|
10
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(a)
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Changes in capitalization
|
10
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(b)
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Dissolution or Liquidation
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10
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(c)
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Change in Control
|
10
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12.
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Grant
|
11
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13.
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Amendment and Termination of the Plan
|
11
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(a)
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Amendment and Termination
|
11
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|
(b)
|
Shareholders’ approval
|
11
|
|
(c)
|
Effect of amendment or termination
|
11
|
|
14.
|
Conditions Upon Issuance of Shares
|
||
(a)
|
Legal Compliance
|
12
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(b)
|
Investment Representations
|
12
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15.
|
Liability of Company
|
12
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16.
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Shareholders’ Approval
|
12
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SUMMARY
|
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(continued)
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Page
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17.
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Law, Jurisdiction
|
12
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Exhibit -
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Stock Option Grant Agreement
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Part I -
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Notice of stock option grant
|
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Part 11 -
|
Terms and conditions
|
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Exercise notice
|
1. |
Purposes of the Plan
|
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− |
to attract and retain the best available personnel for positions of substantial responsibility;
|
|
− |
to provide additional incentive to Beneficiaries; and
|
|
− |
to promote the success of the Company’s business.
|
2. |
Definitions
|
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(a) |
“Administrator” means the management board of the Company which shall administer the Plan in accordance with Section 4 of
the Plan.
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(b) |
“Affiliated Company” means a company which conforms with the criteria set forth in article L. 225-180 of the Commercial
Code as follows:
|
|
− |
companies of which at least ten per cent (10%) of the share capital or voting rights is held directly or indirectly by the Company;
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|
− |
companies which own directly or indirectly at least ten per cent (10%) of the share capital or voting rights of the Company; and
|
|
− |
companies of which at least fifty per cent (50%) of the share capital or voting rights is held directly or indirectly by a company which owns directly or indirectly at least fifty percent (50%) of the share capital or voting rights of
the Company,
|
|
(c) |
“Beneficiary” means the president and the members of the management board (president et
membres du directoire) or, as the case may be, the president of the board of directors (président du conseil d’administration), the general manager (directeur
general) and the deputy general managers (directeurs généraux délégués) of the Company as well as any individual employed by the Company or by any Affiliated Company under the terms and
conditions of an employment contract, it being specified that a term of office of member of the supersivory board of the Company or director of an Affiliated Company (remunerated or not) shall not be deemed to constitute an employment
relationship.
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(d) |
“Board” means the management board of the Company.
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(e) |
“Commercial Code” means the French Commercial Code.
|
|
(f) |
“Company” means NANOBIOTIX, a corporation organized under the laws of the Republic of France.
|
|
(g) |
“Continuous Status as a Beneficiary” means as regards the president and the members of the management board or, as the case
may be, the president of the board of directors, the general manager, the deputy general manager(s), that the term of their office has not been terminated and, as regards an employee that the employment relationship between the
Beneficiary and the Company or any Affiliated Company is not terminated. Continuous Status as a Beneficiary shall not be considered terminated in the case of (i) any leave of absence having received a prior approval from the Company or
requiring no prior approval under U.S. laws, or (ii) transfers between locations of the Company or between the Company or any Affiliated Company or the contrary or also from an Affiliated Company to another Affiliated Company. Leaves of
absence which must receive a prior approval from the Company for the non-termination of the Continuous Status as a Beneficiary shall include leaves of more than three (3) months for illnesses or conditions about which the employee has
advance knowledge, military leave, or any other personal leave. For purposes of U.S. Beneficiaries and Incentive Stock Options, no such leave may exceed ninety (90) days, unless reemployment upon expiration of such leave is guaranteed by
statute contract or Company policies. If reemployment upon expiration of a leave of absence approved by the Company is not so guaranteed, on the 91st day of such leave any Incentive Stock Option held by a U.S. Beneficiary shall cease to
be treated as an Incentive Stock Option and shall be treated for U.S. tax purposes as a Non-Statutory Stock Option.
|
|
(h) |
“Date of Grant” means the date of the decision of the Board to grant the Options.
|
|
(i) |
“Disability” means a disability declared further to a medical examination provided for in article L. 4624-1 of the French
Labour Code or pursuant to any similar provision applicable to a foreign Affiliated Company.
|
|
(j) |
“Exchange Act” means the United States Securities Exchange Act of 1934, as amended.
|
|
(k) |
“Fair Market Value” means the value for one Share as determined in good faith by the Administrator, according to the
following provisions, as provided in the Shareholder Authorization:
|
|
This price settled for the subscription or purchase of Shares shall not be modified during the period in which the Option may be exercised. However, if the Company makes one of the operations mentioned in
article L. 225-181 of the French Commercial Code, it must take all necessary measures to protect Optionee’s interests in the conditions provided for by article L 228- 99 of the French Commercial
Code. In case of issuance of securities granting the common stock access, as well as in case of Company’s merger or scission, the Board may decide, for a limited period of time, to suspend the exercisability of the Options.
|
|
(l) |
“Incentive Stock Option” means an Option intended to qualify as an incentive stock option within the meaning of Section 422
of the US Code and the regulations promulgated thereunder.
|
|
(m) |
“Non-Statutory Stock Option” means an Option which does not qualify as an Incentive Stock Option.
|
|
(n) |
“Notice of Grant” means a written notice evidencing the main terms and conditions of an individual Option grant. The Notice
of Grant is part of the Option Agreement.
|
|
(o) |
“Option” means an option to purchase or subscribe Shares granted pursuant to the Plan.
|
|
(p) |
“Optionee” means a Beneficiary who holds at least one outstanding Option.
|
|
(q) |
“Option Agreement” means a written agreement entered into between the Company and an Optionee evidencing the terms and
conditions of an individual Option grant. The Option Agreement is subject to the terms and conditions of the Plan.
|
|
(r) |
“Option Exchange Program” means a program whereby outstanding Options are surrendered in exchange for Options with
different exercise conditions.
|
|
(s) |
“Parent” means a “parent corporation”, whether now or hereafter existing, as defined in Section 424(e) of the US Code.
|
|
(t) |
“Plan” means the 2017 Stock Option Plan as approved by the Board on January, 22nd, 2018.
|
|
(u) |
“Share” means a share of common stock (action ordinaire) of the Company.
|
|
(v) |
“Shareholders Authorization” means the authorization given by the shareholders of the Company in the extraordinary general
meeting held on June 14, 2017 as increased or amended from time to time by a further general meeting of the shareholders permitting the Board to grant Stock Options.
|
|
(w) |
“Share Capital” means the issued and paid up capital of the Company.
|
|
(x) |
“Subsidiary” means a “subsidiary corporation”, whether now or hereafter existing, as defined in Section 424(f) of the US
Code.
|
|
(y) |
“US Applicable Laws” means for the US the legal requirements relating to the administration of stock option plans under
state corporate and securities laws and the US Code in force in the United States of America.
|
|
(z) |
“U.S. Beneficiary” means a Beneficiary of the Company or an Affiliated Company residing in the United States or otherwise
subject to United States’ laws, regulations or taxation.
|
|
(aa) |
“US Code” means the United States Internal Revenue Code of 1986, as amended.
|
|
(bb) |
“U.S. Optionee” means an Optionee residing in the United States or otherwise subject to United States’ laws, regulations or
taxation.
|
3. |
Shares Subject to the Plan
|
4. |
Administration of the Plan
|
|
(a) |
Procedure
|
|
(b) |
Powers of the Administrator.
|
|
(i) |
to determine the Fair Market Value of the Shares, in accordance with Section 2(k) of the Plan;
|
|
(ii) |
to determine the Beneficiaries to whom Options may be granted hereunder;
|
|
(iii) |
to select the Beneficiaries and determine whether and to what extent Options are granted hereunder;
|
|
(iv) |
to approve or amend forms of agreement for use under the Plan;
|
|
(v) |
to determine the terms and conditions of any Options granted hereunder. Such terms and conditions include, but are not limited to, the exercise price, the time or times when Options may be exercised (which may be based on performance
criteria), any vesting acceleration or waiver of forfeiture restrictions, and any restriction or limitation regarding any Option or the Shares relating thereto, based in each case on such factors as the Administrator, in its sole
discretion, shall determine with the exception of the exercise price; it being specified that the Administrator’s discretion remains subject to the rules and limitations set forth in this Plan and in the Commercial Code;
|
|
(vi) |
to construe and interpret the terms of the Plan and Options granted pursuant to the Plan;
|
|
(vii) |
to prescribe, amend and rescind rules and regulations relating to the Plan, including rules and regulations relating to sub-plans established for the purpose of qualifying for preferred tax treatment under foreign tax laws;
|
|
(viii) |
to modify or amend each Option (subject to the provisions of Section 13(c) of the Plan), including the discretionary authority to extend the post-termination exercise period of Options after the termination of the employment agreement or
the end of the term of office, longer than is otherwise provided for in the Plan;
|
|
(ix) |
to authorize any person to execute on behalf of the Company any instrument required to effect the grant of an Option previously granted by the Administrator;
|
|
(x) |
to implement an Option Exchange Program;
|
|
(xi) |
to determine the terms and restrictions applicable to Options; and
|
|
(xii) |
to make all other determinations deemed necessary or appropriate for administering the Plan.
|
|
(c) |
Effect of Administrator’s Decision.
|
5. |
Limitations
|
6. |
Term of Plan
|
7. |
Term of Options
|
8. |
Options Exercise Price and Consideration
|
|
(a) |
Subscription or Purchase Price
|
|
(b) |
Exercise Dates
|
|
(c) |
Form of Consideration
|
9. |
Exercise of Options
|
|
(a) |
Procedure for Exercise; Rights as a Shareholder
|
|
(b) |
Termination of the Optionee’s Continuous Status as Beneficiary
|
|
(c) |
Disability of Optionee
|
|
(d) |
Death of Optionee
|
10. |
Non-Transferability of Options
|
11. |
Adjustments Upon Changes in Capitalization, Dissolution
|
|
(a) |
Changes in capitalization
|
|
− |
amortization or reduction of the share capital,
|
|
− |
amendment of the allocation of profits,
|
|
− |
distribution of free shares,
|
|
− |
capitalization of reserves, profits, issuance premiums,
|
|
− |
the issuance of shares or securities giving right to shares to be subscribed for in cash or by set-off of existing indebtedness offered exclusively to the shareholders;
|
|
(b) |
Dissolution or Liquidation
|
|
(c) |
Change in Control
|
|
− |
in the event of a merger of the Company into another corporation or of the sale by one or several shareholders, acting alone or in concert, of the Company to one or several third parties of a number of Shares resulting in a transfer of
more than fifty per cent (50%) of the Shares of the Company to said third parties (a “Liquidity Event”), the Optionee’s right to exercise the Options will be accelerated so that the Optionee may exercise all of them with effect immediately
prior to the completion of the relevant Liquidity Event;
|
|
− |
the Options that may be exercised shall have to be exercised no later than immediately prior to the completion of the relevant Liquidity Event, it being specified that the Company shall inform the Optionee of any proposed Liquidity
Event at least 15 days prior to the completion thereof; and
|
|
− |
any Options not exercised for any reason on or prior to the date of completion of a Liquidity Event will automatically lapse.
|
12. |
Grant
|
13. |
Amendment and Termination of the Plan
|
|
(a) |
Amendment and Termination
|
|
(b) |
Shareholders’ approval
|
|
(c) |
Effect of amendment or termination
|
14. |
Conditions Upon Issuance of Shares
|
|
(a) |
Legal Compliance
|
|
(b) |
Investment Representations
|
15. |
Liability of Company
|
16. |
Shareholders’ Approval
|
17. |
Law, Jurisdiction
|
Date of Grant1:
|
March 6, 2018
|
Vesting Commencement Date2 :
|
March 6, 2018
|
Exercise Price per Share:
|
EUR 12.87
|
Total Number of Shares Granted:
|
[ o ]
|
Total Exercise Price:
|
EUR [ o ]
|
Type of Options3:
|
Incentive Stock Option subject to provisions of article 5 (b) of the Plan
|
Term/Expiration Date4:
|
March 5, 2028
|
− |
up to two thirds of the Options, as March 7, 2019,
|
− |
then up to one third of the Options, as of March 7, 2020, and
|
− |
at the latest within ten (10) years as from the Date of Grant or in case of death or Disability of the Optionee during such then (10) year period, six (6) months as from the death or Disability of the Optionee (it being however
specified, for the avoidance of doubt, that no Option granted to any U.S. Optionee shall be exercised after the 10th anniversary of the Date of Grant).
|
− |
up to one third of the Options, as March 7, 2019,
|
− |
then up to an additional tranche equal to one third of the Options, as of each elapsed as from March 7, 2019, i.e. as of March 7, 2020 for one third and as of March 7, 2021 for the last third, and
|
− |
at the latest within ten (10) years as from the Date of Grant or in case of death or Disability of the Optionee during such then (10) year period, six (6) months as from the death or Disability of the Optionee (it being however
specified, for the avoidance of doubt, that no Option granted to any U.S. Optionee shall be exercised after the 10th anniversary of the Date of Grant).
|
OPTIONEE:
|
NANOBIOTIX
|
|||
Signature
|
By:
|
|||
Print Name
|
Title:
|
|||
Residence Address
|
|
|||
Submitted by:
|
Accepted by:
|
||
OPTIONEE (*)
|
NANOBIOTIX
|
||
Signature
|
Signature
|
||
Print Name
|
Its:
|
||
Address:
|
|||
Exhibit 10.12
NANOBIOTIX
2018 STOCK OPTION PLAN
SUMMARY
Page | |||
1. | PURPOSES OF THE PLAN | 1 | |
2. | DEFINITIONS | 1 | |
3. | SHARES SUBJECT JO THE PLAN | 4 | |
4. | ADMINISTRATION OF THE PLAN | 5 | |
(a) | Procedure | 5 | |
(b) | Powers of the Administrator | 5 | |
(c) | Effect of Administrator’s Decision | 6 | |
5. | LIMITATIONS | 6 | |
6. | TERM OF PLAN | 7 | |
7. | TERM OF OPTIONS | 7 | |
8. | OPTIONS EXERCISE PRICE AND CONSIDERATION | 7 | |
(a) | Subscription or purchase Price | 7 | |
(b) | Exercise Dates | 7 | |
(c) | Form of Consideration | 7 | |
9. | EXERCISE OF OPTIONS | 8 | |
(a) | Procedure for Exercise; Rights as a Shareholder | 8 | |
(b) | Termination of the Optionee’s Continuous Status as Beneficiary | 9 | |
(c) | Disability of Optionee | 9 | |
(d) | Death of Optionee | 9 | |
10. | NON-TRANSFERABILITY OF OPTIONS | 10 | |
11. | ADJUSTMENTS UPON CHANGES IN CAPITALIZATION, DISSOLUTION | 10 | |
(a) | Changes in capitalization | 10 | |
(b) | Dissolution or Liquidation | 10 | |
(c) | Change in Control | 10 | |
12. | GRANT | 11 | |
13. | AMENDMENT AND TERMINATION OF THE PLAN | 11 | |
(a) | Amendment and Termination | 11 | |
(b) | Shareholders’ approval | 11 | |
(c) | Effect of amendment or termination | 11 | |
14. | CONDITIONS UPON ISSUANCE OF SHARES | 11 |
SUMMARY
(continued)
Page | |||
(a) | Legal Compliance | 11 | |
(b) | Investment Representations | 12 | |
15. | LIABILITY OF COMPANY | 12 | |
16. | SHAREHOLDERS’ APPROVAL | 12 | |
17. | LAW | 12 |
Exhibit – Stock Option Grant Agreement
Part I – Notice of Stock option grant
Part II – Terms and conditions
Exercise notice
NANOBIOTIX
2018 STOCK OPTION PLAN
1. | Purposes of the Plan |
According to the authorization granted by by the extraordinary shareholders’ general meeting of May 23, 2018, the management board decided on February 5, 2019, in compliance with the provisions of articles L. 225-177 et. seq. of the French Commercial Code, to adopt the 2018 stock option plan of NANOBIOTIX, the terms and conditions of which are set out below.
The purposes of the Plan are:
- | to attract and retain the best available personnel for positions of substantial responsibility; |
- | to provide additional incentive to Beneficiaries; and |
- | to promote the success of the Company’s business. |
Options granted under the Plan to U.S. Beneficiaries are intended to be Incentive Stock Options or Non-Statutory Stock Options, as determined by the Administrator at the time of grant of an Option, and shall comply in all respects with US Applicable Laws in order that U.S. Beneficiaries may benefit from available tax advantages.
2. | Definitions. |
(a) | “Administrator” means the management board of the Company which shall administer the Plan in accordance with Section 4 of the Plan. |
(b) | “Affiliated Company” means a company which conforms with the criteria set forth in article L. 225-180 of the Commercial Code as follows: |
- | companies of which at least ten per cent (10%) of the share capital or voting rights is held directly or indirectly by the Company; |
- | companies which own directly or indirectly at least ten per cent (10%) of the share capital or voting rights of the Company; and |
- | companies of which at least fifty per cent (50%) of the share capital or voting rights is held directly or indirectly by a company which owns directly or indirectly at least fifty percent (50%) of the share capital or voting rights of the Company, |
(c) | “Beneficiary” means the president and the members of the management board (président et membres du directoire) or, as the case may be, the president of the board of directors (président du conseil d’administration), the general manager (directeur général) and the deputy general managers (directeurs généraux délégués) of the Company as well as any individual employed by the Company or by any Affiliated Company under the terms and |
conditions of an employment contract, it being specified that a term of office of member of the supersivory board of the Company or director of an Affiliated Company (remunerated or not) shall not be deemed to constitute an employment relationship. |
(d) | “Board” means the management board of the Company. |
(e) | “Commercial Code” means the French Commercial Code. |
(f) | “Company” means NANOBIOTIX, a corporation organized under the laws of the Republic of France. |
(g) | “Continuous Status as a Beneficiary” means as regards the president and the members of the management board or, as the case may be, the president of the board of directors, the general manager, the deputy general manager(s), that the term of their office has not been terminated and, as regards an employee that the employment relationship between the Beneficiary and the Company or any Affiliated Company is not terminated. Continuous Status as a Beneficiary shall not be considered terminated in the case of (i) any leave of absence having received a prior approval from the Company or requiring no prior approval under U.S. laws, or (ii) transfers between locations of the Company or between the Company or any Affiliated Company or the contrary or also from an Affiliated Company to another Affiliated Company. Leaves of absence which must receive a prior approval from the Company for the non-termination of the Continuous Status as a Beneficiary shall include leaves of more than three (3) months for illnesses or conditions about which the employee has advance knowledge, military leave, or any other personal leave. For purposes of U.S. Beneficiaries and Incentive Stock Options, no such leave may exceed ninety (90) days, unless reemployment upon expiration of such leave is guaranteed by statute contract or Company policies. If reemployment upon expiration of a leave of absence approved by the Company is not so guaranteed, on the 91st day of such leave any Incentive Stock Option held by a U.S. Beneficiary shall cease to be treated as an Incentive Stock Option and shall be treated for U.S. tax purposes as a Non-Statutory Stock Option. |
(h) | “Date of Grant” means the date of the decision of the Board to grant the Options. |
(i) | “Disability” means a disability declared further to a medical examination provided for in article L. 4624-1 of the French Labour Code or pursuant to any similar provision applicable to a foreign Affiliated Company. |
(j) | “Exchange Act” means the United States Securities Exchange Act of 1934, as amended. |
(k) | “Fair Market Value” means the value for one Share as determined in good faith by the Administrator, according to the following provisions, as provided in the Shareholder Authorization: |
(i) | the Board may determine the subscription or purchase price of a share in compliance with the provisions of the law. However, the purchase or subscription price shall in no case be less than ninety five per cent (95%) of the average of the closing sales price for a share as quoted on stock |
exchange market during the twenty market trading days prior to the day of the Board’s decision to grant the Options, |
(ii) | for US Beneficaries, the subscription or purchase price shall not be less than the fair market value of the Shares on the Date of Grant, determined as follows (a) if the Shares are listed or quoted for trading on an exchange, the value will be deemed to be the closing or last offer price, as applicable, of the Shares on the principal exchange upon which such securities are traded or quoted on such date, provided, if such date is not a trading day, on the last market trading day prior to such date; and (b) if the Shares are not listed or quoted for trading on an exchange, the fair market value of the Shares as determined by the Board, consistent with the requirements of Sections 422 with respect to Incentive Stock Options, and 409A of the US Code with respect to Options not intended to be Incentive Stock Options, it being specified that, when an Option entitles the holder to purchase shares previously repurchased by the Company, the exercise price, notwithstanding the above provisions and in accordance with applicable law, may not be less than 80% of the average purchase price paid by the Company for all shares so previously repurchased. |
This price settled for the subscription or purchase of Shares shall not be modified during the period in which the Option may be exercised. However, if the Company makes one of the operations mentioned in article L 225-181 of the French Commercial Code, it must take all necessary measures to protect Optionee’s interests in the conditions provided for by article L 228-99 of the French Commercial Code. In case of issuance of securities granting the common stock access, as well as in case of Company’s merger or scission, the Board may decide, for a limited period of time, to suspend the exercisability of the Options.
(l) | “Incentive Stock Option” means an Option intended to qualify as an incentive stock option within the meaning of Section 422 of the US Code and the regulations promulgated thereunder. |
(m) | “Non-Statutory Stock Option” means an Option which does not qualify as an Incentive Stock Option. |
(n) | “Notice of Grant” means a written notice evidencing the main terms and conditions of an individual Option grant. The Notice of Grant is part of the Option Agreement. |
(o) | “Option” means an option to purchase or subscribe Shares granted pursuant to the Plan. |
(p) | “Optionee” means a Beneficiary who holds at least one outstanding Option. |
(q) | “Option Agreement” means a written agreement entered into between the Company and an Optionee evidencing the terms and conditions of an individual Option grant. The Option Agreement is subject to the terms and conditions of the Plan. |
(r) | “Option Exchange Program” means a program whereby outstanding Options are surrendered in exchange for Options with different exercise conditions. |
(s) | “Parent” means a “parent corporation”, whether now or hereafter existing, as defined in Section 424(e) of the US Code. |
(t) | “Plan” means the 2018 Stock Option Plan as approved by the Board on February 5, 2019. |
(u) | “Share” means a share of common stock (action ordinaire) of the Company |
(v) | “Shareholders Authorization” means the authorization given by the shareholders of the Company in the extraordinary general meeting held on May 23, 2018 as increased or amended from time to time by a further general meeting of the shareholders permitting the Board to grant Stock Options. |
(w) | “Share Capital” means the issued and paid up capital of the Company. |
(x) | “Subsidiary” means a “subsidiary corporation”, whether now or hereafter existing, as defined in Section 424(f) of the US Code. |
(y) | “US Applicable Laws” means for the US the legal requirements relating to the administration of stock option plans under state corporate and securities laws and the US Code in force in the United States of America. |
(z) | “U.S. Beneficiary” means a Beneficiary of the Company or an Affiliated Company residing in the United States or otherwise subject to United States’ laws, regulations or taxation. |
(aa) | “US Code” means the United States Internal Revenue Code of 1986, as amended. |
(bb) | “U.S. Optionee” means an Optionee residing in the United States or otherwise subject to United States’ laws, regulations or taxation. |
3. | Shares Subject to the Plan |
Subject to the provisions of Section 11 of the Plan and pursuant to the Shareholder Authorization, the maximum aggregate number of Shares which may be optioned and issued under the Plan is equal to 648,000 For “Incentive Stock Options”, the maximum number of Shares which may be optioned and issued is equal to 648,000. The Shares optioned and issued under the Plan may be newly issued Shares, treasury Shares or Shares purchased on the open market.
Should the Option expire or become unexercisable for any reason without having been exercised in full, the unsubscribed Shares which were subject thereto shall, unless the Plan shall have been terminated, become available again for future grant under the Plan.
4. | Administration of the Plan |
(a) | Procedure |
The Plan shall be administered by the Administrator.
(b) | Powers of the Administrator . |
Subject to the provisions of the Commercial Code, the Shareholders Authorization, the Plan, and the US Applicable Laws, the Administrator shall have the authority, in its discretion:
(i) | to determine the Fair Market Value of the Shares, in accordance with Section 2(k) of the Plan; |
(ii) | to determine the Beneficiaries to whom Options may be granted hereunder; |
(iii) | to select the Beneficiaries and determine whether and to what extent Options are granted hereunder; |
(iv) | to approve or amend forms of agreement for use under the Plan; |
(v) | to determine the terms and conditions of any Options granted hereunder. Such terms and conditions include, but are not limited to, the exercise price, the time or times when Options may be exercised (which may be based on performance criteria), any vesting acceleration or waiver of forfeiture restrictions, and any restriction or limitation regarding any Option or the Shares relating thereto, based in each case on such factors as the Administrator, in its sole discretion, shall determine with the exception of the exercise price; it being specified that the Administrator’s discretion remains subject to the rules and limitations set forth in this Plan and in the Commercial Code; |
(vi) | to construe and interpret the terms of the Plan and Options granted pursuant to the Plan; |
(vii) | to prescribe, amend and rescind rules and regulations relating to the Plan, including rules and regulations relating to sub-plans established for the purpose of qualifying for preferred tax treatment under foreign tax laws; |
(viii) | to modify or amend each Option (subject to the provisions of Section 13(c) of the Plan), including the discretionary authority to extend the post-termination exercise period of Options after the termination of the employment agreement or the end of the term of office, longer than is otherwise provided for in the Plan; |
(ix) | to authorize any person to execute on behalf of the Company any instrument required to effect the grant of an Option previously granted by the Administrator; |
(x) | to implement an Option Exchange Program; |
(xi) | to determine the terms and restrictions applicable to Options; and |
(xii) | to make all other determinations deemed necessary or appropriate for administering the Plan. |
(c) | Effect of Administrator’s Decision. |
The Administrator’s decisions, determinations and interpretations shall be final and binding on all Optionees.
5. | Limitations |
(a) In the case of U.S. Beneficiaries, each Option shall be designated in the Notice of Grant either as an “Incentive Stock Option” or as a “Non-Statutory Stock Option”. Incentive Stock Options may only be granted to Beneficiaries of the Company or a Subsidiary who meet the definition of “employees” under Section 3401(c) of the US Code.
Nevertheless, the aggregate Fair Market Value of the Shares covered by Incentive Stock Options granted under the Plan or any other stock option program of the Company (or any Parent or subsidiary of the Company) that become exercisable for the first time in any calendar year shall not exceed U.S. $100,000: to the extent the aggregate Fair Market Value of such Shares exceeds U.S. $100,000, the Options covering those Shares the Fair Market Values of which causes the aggregate Fair Market Value of all such Shares to be in excess of U.S. $100,000 shall be treated as Non-Statutory Options. Incentive Stock Options shall be taken into account in the order in which they were granted, and the aggregate Fair Market Value of the Shares shall be determined as of the Date of the Grant.
(b) The Options are governed by articles L. 225-177 and following of the Commercial Code. They are not part of the employment agreement or of the office which has allowed the Optionee to be granted the Option. Neither do they constitute an element of the Optionee’s remuneration.
Neither the Plan nor any Option shall confer upon an Optionee any right with respect to continuing the Optionee’s employment or his term of office with the Company or any Affiliated Company, nor shall they interfere in any way with the Optionee’s right or the Company’s or Affiliated Company’s right, as the case may be, to terminate such employment or such term of office at any time, with or without cause.
(c) Other than as expressly provided hereunder, no member of the board of directors of the Company or of the supervisory board (in the event of change of management formula of the Company) or of an equivalent management body of an Affiliated Company shall be as such eligible to receive Options under the Plan.
6. | Term of Plan |
Subject to the approval of the shareholders of the Company in accordance with Section 16 of the Plan, the Plan shall be effective and Options may be granted as of February 5, 2019; date of its adoption by the Board. Options may be granted hereunder until July 23, 2021. It shall continue in effect until the date of termination of the last Option in force, unless terminated earlier under Section 13 of the Plan.
7. | Term of Options |
The term of each Option shall be stated in the Notice of Grant as ten (10) years from the Date of Grant, in accordance with the Shareholders Authorization or, in case of death or Disability of the Optionee during such 10-year period, six (6) months from the death or Disability of the Optionee in accordance with French law, it being however specified, for the avoidance of doubt, that no Option granted to any U.S. Optionee shall be exercised after the 10th anniversary of the Date of Grant.
8. | Options Exercise Price and Consideration |
(a) | Subscription or purchase Price |
The per Share subscription or purchase price for the Shares to be issued or sold pursuant to exercise of an Option shall be determined by the Administrator on the basis of the Fair Market Value.
(i) In the case of an “Incentive Stock Option” granted to a U.S. Beneficiary who, at the time the Incentive Stock Option is granted, owns stock representing more than ten percent (10%) of the voting rights of all classes of stock of the Company or any Parent or Subsidiary of the Company and, to the extent such Beneficiary is permitted by the Commercial Code to receive Option grants, (x) the per Share subscription or purchase price shall be no less than 110% of the Fair Market Value per Share on the Date of Grant as defined in Section 2(k)(ii) and (y) the date of termination of the Option shall not exceed 5 years;
(ii) In the case of a “Non-Statutory Stock Option” or “Incentive Stock Option”, not covered by Section B(a)(i) above, granted to any U.S. Beneficiary, the per Share subscription or purchase price shall be no less than 100% of the Fair Market Value per Share on the Date of Grant as defined in Section 2(k)(ii).
(b) | Exercise Dates |
At the time an Option is granted, the Administrator shall fix the period within which the Option may be exercised and shall determine any conditions which must be satisfied before the Option may be exercised. In so doing, the Administrator may specify that an Option may not be exercised until the completion of a service period in the Company or an Affiliated Company.
(c) | Form of Consideration |
The consideration to be paid for the Shares to be issued or purchased upon exercise of Options, including the method of payment, shall be determined by the Administrator. Such consideration shall consist entirely of an amount in Euro corresponding to the exercise price which shall be paid by wire transfer.
Where the exercise of an Option would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and the Optionee provides the Company with either the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
9. | Exercise of Options |
(a) | Procedure for Exercise; Rights as a Shareholder |
Any Option granted hereunder shall be exercisable according to the terms of the Plan and at such times and under such conditions as determined by the Administrator and set forth in the Option Agreement.
An Option may not be exercised for a fraction of a Share.
An Option shall be deemed exercised when the Company receives: (i) written notice of exercise (in accordance with the provisions of the Option Agreement) together with a share subscription or purchase form (bulletin de souscription ou d’achat) duly executed by the person entitled to exercise the Option, and (ii) full payment for the Shares with respect to which the Option is exercised. Full payment may consist of any consideration and method of payment authorized by the Administrator and permitted by the Option Agreement and the Plan.
Where the exercise of an Option would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and the Optionee provides the Company with either the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
Upon exercise of an Option, the Shares issued or sold to the Optionee shall be assimilated with all other Shares of the Company of the same class and shall be entitled to dividends once the Shares are issued for the fiscal year during which the Option is exercised.
In the event that a Beneficiary infringes one of the above mentioned commitments, such Beneficiary shall be liable for any consequences resulting from such infringement for the Company and undertakes to indemnify the Company in respect of all amounts payable by the Company in connection with such infringement.
Granting of an Option in any manner shall result in a decrease in the number of Shares which thereafter may be available for purposes of the Plan, by the number of Shares as to which the Option may be exercised.
(b) | Termination of the Optionee’s Continuous Status as Beneficiary |
Upon termination of an Optionee’s Continuous Status as a Beneficiary, other than upon the Optionee’s death or Disability, the Optionee may exercise his or her Options, but only within such period of time as is specified in the Notice of Grant, and only for the part of the Options that the Optionee was entitled to exercise at the date of termination (but in no event later than the expiration of the term of such Options as set forth in the Notice of Grant). Unless a longer period is specified in the Notice of Grant or otherwise resolved by the Board, an Option shall remain exercisable for six (6) months following the Optionee’s termination of Continuous Status as a Beneficiary. In the case of an “Incentive Stock Option”, such a period cannot exceed three (3) months following the Optionee’s termination of Continuous Status as a Beneficiary. If, at the date of termination, the Optionee is not entitled to exercise all his or her Options, the Shares covered by the unexercisable portion of Options shall revert to the Plan. If, after termination, the Optionee does not exercise all of his or her Options within the time specified by the Administrator, the Options shall terminate, and the Shares covered by such Options shall revert to the Plan.
(c) | Disability of Optionee |
In the event that an Optionee’s Continuous Status as a Beneficiary terminates as a result of the Optionee’s Disability, unless otherwise resolved by the Board, the Optionee may exercise his or her Options at any time within six (6) months from the date of such termination, but only to the extent these Options are exercisable at the time of termination (but in no event later than the expiration of the term of such Options as set forth in the Notice of Grant). If, at the date of termination, the Optionee is not entitled to exercise all of his or her Options, the Shares covered by the unexercised portion of Options shall revert to the Plan. If, after termination, the Optionee does not exercise all of his or her Options within the time specified herein, the Options shall terminate, and the Shares covered by such Options shall revert to the Plan.
(d) | Death of Optionee |
In the event of the death of an Optionee during the term of the Options, unless otherwise resolved by the Board, the Options may be exercised at any time within six (6) months following the date of death, by the Optionee’s estate or by a person who acquired the right to exercise the Option by bequest or inheritance, but only to the extent these Options are exercisable at the time of death. If, at the time of death, the Optionee was not entitled to exercise all of his or her Options, the Shares covered by the unexercised portion of Options shall immediately revert to the Plan. If, after death, the Optionee’s estate or a person who acquired the right to exercise the Options by bequest or inheritance does not exercise the Options within the time specified herein, the Options shall terminate, and the Shares covered by such Options shall revert to the Plan.
10. | Non-Transferability of Options |
An Option may not be sold, pledged, assigned, hypothecated, transferred or disposed of in any manner other than by will or by laws of descent or distribution and may be exercised, during the lifetime of the Optionee, only by the Optionee.
11. | Adjustments Upon Changes in Capitalization, Dissolution |
(a) | Changes in capitalization |
In the event of the carrying out by the Company of any of the financial operations pursuant to article L.225-181 of the Commercial Code as follows:
- | amortization or reduction of the share capital, |
- | amendment of the allocation of profits, |
- | distribution of free shares, |
- | capitalization of reserves, profits, issuance premiums, |
- | the issuance of shares or securities giving right to shares to be subscribed for in cash or by set-off of existing indebtedness offered exclusively to the shareholders; |
the Company shall take the required measures to protect the interest of the Optionees in the conditions set forth in article L. 228-99 of the Commercial Code.
(b) | Dissolution or Liquidation |
In the event of the proposed dissolution or liquidation of the Company, to the extent that an Option has not been previously exercised, it will terminate immediately prior to the consummation of such proposed action. The Administrator may, in the exercise of its sole discretion in such instances, declare that any Option shall terminate as of a date determined by the Administrator and give each Optionee the right to exercise his or her Options as to Shares for which the Options would not otherwise be exercisable.
(c) | Change in Control |
No later than immediately prior to the completion of the relevant Liquidity Event (as defined below):
- in the event of a merger of the Company into another corporation or of the sale by one or several shareholders, acting alone or in concert, of the Company to one or several third parties of a number of Shares resulting in a transfer of more than fifty per cent (50%) of the Shares of the Company to said third parties (a “Liquidity Event”), the Optionee’s right to exercise the Options will be accelerated so that the Optionee may exercise all of them with effect immediately prior to the completion of the relevant Liquidity Event;
- the Options that may be exercised shall have to be exercised no later than immediately prior to the completion of the relevant Liquidity Event, it being specified that the Company shall inform the Optionee of any proposed Liquidity Event at least 15 days prior to the completion thereof; and
- any Options not exercised for any reason on or prior to the date of completion of a Liquidity Event will automatically lapse.
*********
For Incentive Stock Options, all assumptions, substitutions and adjustments shall be determined in accordance with Sections 422 and 424 of the US Code and the regulations promogated thereunder and for Non Statutory Options for US Beneficiaries in accordance with the Section 424 of the US Code.
12. | Grant |
12.1. The Date of Grant of an Option shall be, for all purposes, the date on which the Administrator decides to grant such Option. A notice of grant shall be provided to each Optionee within a reasonable time after the Date of Grant.
12.2. In the event of any tax liability arising on account of the grant of the Options, the liability to pay such taxes shall be that of the Beneficiary alone.
The Beneficiary shall enter into such agreements of indemnity and execute any and all documents as the Company may specify for this purpose, if so required at the Date of Grant and at any other time at the discretion of the Company, on such terms and conditions as the Company may think fit, for recovery of the tax due, from the Beneficiary.
13. | Amendment and Termination of the Plan |
(a) | Amendment and Termination |
The Administrator may at any time amend, alter, suspend or terminate the Plan.
(b) | Shareholders’ approval |
The Company shall obtain shareholders’ approval of any Plan amendment to the extent necessary and desirable to comply with US Applicable Laws (including the requirements of any exchange or quotation system on which Shares may then be listed or quoted). Such shareholders approval, if required, shall be obtained in such a manner and to such a degree as is required by the applicable law, rule or regulation.
(c) | Effect of amendment or termination |
No amendment, alteration, suspension or termination of the Plan shall impair the rights of any Optionee, unless mutually agreed otherwise between the Optionee and the Administrator, which agreement must be in writing and signed by the Optionee and the Company.
14. | Conditions Upon Issuance of Shares |
(a) | Legal Compliance |
Shares held by a US Beneficiary shall not be sold or issued pursuant to the exercise of an Option unless the exercise of such Option, and the issuance or sale and delivery of such Shares shall comply with all relevant provisions of law including, without limitation, the Commercial Code, the “Securities Act” of 1933, as amended, the “Exchange Act”, the rules and regulations promulgated thereunder, US Applicable Laws and the requirements of any stock exchange or quotation system upon which the Shares may then be listed or quoted.
(b) | Investment Representations |
As a condition to the exercise of an Option by a US Beneficiary, the Company may require the person exercising such Option to represent and warrant at the time of any such exercise that the Shares are being subscribed or purchased only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a representation is required.
15. | Liability of Company |
15.1. The inability of the Company to obtain authority from any regulatory body having jurisdiction, which authority is deemed by any counsel to the Company to be necessary to the lawful issuance or sale of any Shares hereunder, shall relieve the Company of any liability in respect of the failure to issue or sell such Shares as to which such requisite authority shall not have been obtained.
15.2. The Company and its Affiliated Companies may not be held responsible in any way if the Beneficiary for any reason not attributable to the Company or its Affiliated Companies was not able to exercise the Options or acquire the Shares.
16. | Shareholders’ Approval |
The Plan shall be subject to approval by the shareholders of the Company within twelve (12) months of the date the Plan is adopted by the Board. Such shareholder approval shall be obtained in the manner and to the degree required under the Commercial Code and US Applicable Laws.
17. | Law, Jurisdiction |
This Plan shall be governed by and construed in accordance with the laws of France.
The relevant court of the registered office of the Company shall be exclusively competent to determine any claim or dispute arising in connection herewith.
The grant of Options under this Plan shall entitle the Company to require the Beneficiary to comply with such requirements of law as may be necessary in the Options of the Company from time to time.
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* * *
Exhibit
NANOBIOTIX
STOCK OPTION GRANT AGREEMENT
Part I
NOTICE OF STOCK OPTION GRANT
[Optionee’s Name and Address]
You have been granted Options to subscribe ordinary Shares of the Company, subject to the terms and conditions of the 2018 Stock Option Plan (the “Plan”) and this Option Agreement. Options are governed by articles L. 225-177 and following of the French Commercial Code. They are not part of the employment agreement or of the office which has allowed the Optionee to be granted the Options. Neither do they constitute an element of the Optionee’s remuneration. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Option Agreement.
Date of Grant1: | ______ | |
Vesting Commencement Date2 | ______ | |
Exercise Price per Share: | EUR_______________ | |
Total Number of Shares Granted: | ___________________ | |
Total Exercise Price: | EUR____________ | |
Type of Options3 |
Incentive Stock Option subject to provisions of article 5 (b) of the Plan. |
|
Term/Expiration Date4 | ________________________ |
Where the exercise of an Option, as described under Article 9.(a) of the Plan, would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and the Optionee provides the Company with either the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
In the event that you infringe the above mentioned commitment, you shall be liable for any consequences resulting from such infringement for the Company and undertake to indemnify
1 date of the board meeting having allocated the Option.
2 date chosen by the Board as the Vesting Commencement Date; failing that, Date of Grant.
3 for U.S. Beneficiaries only.
4 date of termination of the Option (article 7 of the Plan), which shall not exceed 5 years for an ISO granted to a 10% owner and 10 years for a U.S. Optionee.
the Company in respect of all amounts payable by the Company in connection with such infringement.
Validity of the Options:
The Options will be valid as from the Date of Grant.
Vesting Schedule:
Unless otherwise determined or adapted by the Board, the Options may be exercised by the Optionee on the basis of the following initial vesting schedule subject to the condition precedent that the Optionee shall have previously returned to the Company the documents referred to under Section 2. of Part II of the Stock Option Grant Agreement duly initialed and signed:
[___°___]
- | at the latest within ten (10) years as from the Date of Grant or in case of death or Disability of the Optionee during such then (10) year period, six (6) months as from the death or Disability of the Optionee (it being hovewer specified, for the avoidance of doubt, that no Option granted to any U.S. Optionnee shall be exercised after the 10th anniversary of the Date of Grant). |
The number of Options that could be exercised pursuant to the above vesting schedule will always be rounded down to the nearest full number.
If the Optionee fails to exercise the Options in whole or in part within the said period of ten (10) years (as may be extended to six (6) months from the death or Disability of the Optionee, the Options will lapse automatically.
Termination Period:
Unless otherwise decided by the Board, in case of termination of the Optionee’s Continuous Status as a Beneficiary, the Options exercisable at the time of termination may be exercised for six (6) months, three (3) months for Incentive Stock Options after such termination, being specified that all other Options shall automatically expire at the time of termination.
Unless otherwise decided by the Board, upon the death or Disability of the Optionee, the Options may be exercised during a period of six (6) months as provided in the Plan.
Save as provided in the Plan, in no event shall the Options be exercised later than the Term/Expiration Date as provided above. Should the Options expire or become unexercisable for any reason without having been exercised in full, the unsubscribed Shares which were subject thereto shall, unless the Plan shall have been terminated, become available for future grant under the Plan.
By his signature and the signature of the Company’s representative below, the Optionee and the Company agree that the Options are granted under and governed by the terms and conditions of the Plan and this Option Agreement. The Optionee has reviewed the Plan and this Option
Agreement in their entirely, has had the opportunity to obtain the advice of counsel prior to executing this Option Agreement and fully understands all provisions of the Plan and Option Agreement. The Optionee hereby agrees to accept as binding, conclusive and final all decisions or interpretations of the Administrator upon any questions relating to the Plan and Option Agreement. The Optionee further agrees to notify the Company upon any change in the residence address indicated below.
NANOBIOTIX
STOCK OPTION GRANT AGREEMENT
Part II
TERMS AND CONDITIONS
1. Grant of Options.
1.1 The Administrator of the Company hereby grants to the Optionee named in the Notice of Grant attached as Part I of this Agreement (the “Optionee”), [___•___] options (the “Options”) to subscribe the number of ordinary Shares, as set forth in the Notice of Grant, at the exercise price per Share set forth in the Notice of Grant (the “Exercise Price”), subject to the terms and conditions of the Plan, which is incorporated herein by reference.
In the event of a conflict between the terms and conditions of the Plan and the terms and conditions of this Option Agreement, the terms and conditions of the Plan shall prevail.
If designated in the Notice of Grant as an Incentive Stock Option, this Option is intended to qualify as an Incentive Stock Option under Section 422 of the US Code although the Company makes no representation as to the tax status of the Option. However, if this Option is intended to be an Incentive Stock Option, to the extent that it exceeds the U.S.$ 100,000 rule of US Code Section 422(d) the excess shall be treated as a Non-Statutory Stock Option
1.2 An Option will be valid as from the Date of Grant.
1.3 In the event of any tax liability arising on account of the Grant of the Options, the liability to pay such taxes shall be that of the Beneficiary alone. The Beneficiary shall enter into such agreements of indemnity and execute any and all documents as the Company may specify for this purpose, if so required at the time of the Grant and at any other time at the discretion of the Company, on such terms and conditions as the Company may think fit, for recovery of the tax due, from the Beneficiary.
2. Exercise of Options
(a) Right to Exercise. An Option is exercisable during its term in accordance with the Vesting Schedule set out in the Notice of Grant and the applicable provisions of the Plan and this Option Agreement, subject to the condition precedent that the Optionee shall have previously returned to the Company, by electronic delivery under the conditions set forth in Article 10 below:
- Part I and Part II of the Stock Option Grant Agreement (Exhibit), duly initialed (all pages but for the signature page) and signed (signature page).
In the event of Optionee’s death, Disability or other termination of Optionee’s Continuous Status as a Beneficiary, the exercisability of an Option is governed by the applicable provisions of the Plan and this Option Agreement.
(b) Method of Exercise. An Option is exercisable by delivery of an exercise notice, in the form attached hereto (the “Exercise Notice”) stating the election to exercise the Option, the
number of Shares in respect of which the Option is being exercised (the “Exercised Shares”), and such other representations and agreements as may be required by the Company pursuant to the provisions of the Plan. The Exercise Notice shall be signed by the Optionee and shall be delivered in person or by certified mail to the Company or its designated representative or by facsimile message to be immediately confirmed by certified mail to the Company. The Exercise Notice shall be accompanied by payment of the aggregate Exercise Price as to all Exercised Shares. An Option shall be deemed to be exercised upon receipt by the Company of such fully executed Exercise Notice accompanied by the proof of payment of such aggregate Exercise Price.
No Share shall be issued pursuant to the exercise of an Option unless such issuance and exercise complies with all relevant provisions of law as set out under Section 14(a) of the Plan.
Upon exercise of an Option, the Shares issued to the Optionee shall be assimilated with all other Shares of the Company and shall be entitled to dividends for the fiscal year in course during which the Option is exercised.
3. Method of Payment. Payment of the aggregate Exercise Price shall be made by wire transfer with the execution of the corresponding exchange contract.
Where the exercise of an Option would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when (a) the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and (b) the Optionee provides the Company with either (i) the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, (ii) the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
The Company and its Affiliated Companies may not be held responsible in any way if the Beneficiary for any reason not attributable to the Company or its Affiliated Companies was not able to exercise the Option or purchase the Shares. The payment for the purchase of the shares shall be made by the Optionee under his/her own responsibility according to these Terms and Conditions.
4. Non-Transferability of Option. An Option may not be transferred in any manner otherwise than by will or by the laws of descent or distribution and may be exercised during the lifetime of the Optionee only by the Optionee. The terms of the Plan and this Option Agreement shall be binding upon the executors, administrators, heirs, successors and assigns of the Optionee.
5. Term of Options. Subject as provided in the Plan, an Option may be exercised only within the term set out in the Notice of Grant, and may be exercised during such term only in accordance with the Plan and the terms of this Option Agreement.
6. Entire Agreement - Governing Law. The Plan is incorporated herein by reference. The Plan and this Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and
agreements of the Company and Optionee with respect to the subject matter hereof, and may not be modified adversely to the Optionee’s interest except by means of a writing signed by the Company and Optionee. This agreement is governed by the laws of the Republic of France.
Any claim or dispute arising under the Plan or this Agreement shall be subject to the exclusive jurisdiction of the court competent for the place of the registered office of the Company.
7. Tax Obligations. Regardless of any action the Company or Optionee’s employer (the “Employer”) takes with respect to any or all income tax, social insurance, payroll tax, or other tax-related withholding (“Tax-Related Items”), Optionee acknowledges that the ultimate liability for all Tax-Related Items legally due by Optionee is and remains Optionee’s responsibility and that the Company and/or the Employer (1) make no representations or undertakings regarding the treatment of any Tax-Related Items in connection with any aspect of the Option grant, including the grant, vesting or exercise of the Option, the subsequent sale of shares of common stock acquired pursuant to such exercise and the receipt of any dividends; and (2) do not commit to structure the terms of the grant or any aspect of the Option to reduce or eliminate Optionee’s liability for Tax-Related Items.
Prior to exercise of the Option, Optionee will pay or make adequate arrangements satisfactory to the Company and/or the Employer to satisfy all withholding obligations of the Company and/or the Employer, if any. In this regard, Optionee authorizes the Company and/or the Employer to withhold all applicable Tax-Related Items legally payable by Optionee from Optionee’s compensation paid to Optionee by the Company and/or Employer or from proceeds of the sale of Shares. Alternatively, or in addition, if permissible under local law, the Company may sell or arrange for the sale of Shares that Optionee acquires to meet the withholding obligation for Tax-Related Items. Finally, Optionee will pay to the Company or the Employer any amount of Tax-Related Items that the Company or the Employer may be required to withhold as a result of Optionee’s participation in the Plan or Optionee’s purchase of Shares that cannot be satisfied by the means previously described. The Company may refuse to honor the exercise and refuse to deliver the Shares issuable upon exercise of the Options if Optionee fails to comply with Optionee’s obligations in connection with the Tax-Related Items as described in this section.
8. Nature of Grant. In accepting the grant, Optionee acknowledges that:
(a) the Plan is established voluntarily by the Company, it is discretionary in nature and it may be modified, amended, suspended or terminated by the Company at any time, unless otherwise provided in the Plan and this Agreement;
(b) the grant of the Option is voluntary and occasional and does not create any contractual or other right to receive future grants of options, or benefits in lieu of options, even if options have been granted repeatedly in the past;
(c) all decisions with respect to future option grants, if any, will be at the sole discretion of the Company;
(d) Optionee’s participation in the Plan shall not create a right to further employment with the employer and shall not interfere with the ability of the Employer to terminate Optionee’s employment relationship at any time with or without cause;
(e) Optionee is voluntarily participating in the Plan;
(f) the Option is an extraordinary item that does not constitute compensation of any kind for services of any kind rendered to the Company or the Employer, and which is outside the scope of Optionee’s employment contract, if any;
(g) the Option is not part of normal or expected compensation or salary for any purpose, including, but not limited to, calculating any severance, resignation, termination, redundancy, end of service payments, bonuses, long service awards, pension or retirement benefits or similar payments and in no event should be considered as compensation for, or relating in any way to, past services for the Company or the Employer;
(h) the Option grant will not be interpreted to form an employment contract with the Company, the Employer or any Subsidiary or affiliate of the Company;
(i) the future value of the underlying Shares is unknown and cannot be predicted with certainty;
(j) if the underlying Shares do not increase in value, the Option will have no value;
(k) if Optionee exercises Optionee’s Option and obtains Shares, the value of those Shares acquired upon exercise may increase or decrease in value, even below the exercise price;
(l) in consideration of the grant of the Option, no claim or entitlement to compensation or damages shall arise from termination of the Option or diminution in value of the Option or Shares purchased through exercise of the Option resulting from termination of Optionee’s employment the Company or the Employer (for any reason whatsoever) and Optionee irrevocably releases the Company and the Employer from any such claim that may arise; if, notwithstanding the foregoing, any such claim is found by a court of competent jurisdiction to have arisen, then, by signing this Agreement, Optionee shall be deemed irrevocably to have waived Optionee’s entitlement to pursue such claim; and
(m) in the event of termination of Optionee’s employment, Optionee’s right to receive the Option and vest in the Option under the Plan, if any, will terminate effective as of the date that Optionee receives notice of termination regardless of when such termination is effective; furthermore, in the event of termination of employment, Optionee’s right to exercise the Option after termination of employment, if any, will be measured by the date on which the Optionee receives notice of termination; the Company shall have the exclusive discretion to determine when Optionee is no longer actively employed for purposes of Optionee’s Option grant. In addition, any period of notice or compensation in lieu of such notice, that is given or ought to have been given under any contract, statute, common law or civil law shall be excluded.
9. Data Privacy. Optionee hereby explicitly and unambiguously consents to the collection, use and transfer, in electronic or other form, of Optionee’s personal data as described in this document by and among, as applicable, the Employer, the Company and its subsidiaries and affiliates for the exclusive purpose of implementing, administering and managing Optionee’s participation in the Plan.
Optionee understands that the Company and the Employer may hold certain personal information about Optionee, including, but not limited to, Optionee’s name, home address and telephone number, date of birth, social insurance number or other identification number, salary, nationality, job title, any shares of stock or directorships held in the Company, details of all options or any other entitlement to shares of stock awarded, canceled, exercised, vested, unvested or outstanding in Optionee’s favor, for the exclusive purpose of implementing, administering and managing the Plan (“Data”).
Optionee understands that the recipients of the Data may be located in the United States or elsewhere including outside the EEA, and that the recipients’ country (e.g., the United States) may have different data privacy laws and protections than Optionee’s country. Optionee understands that Optionee may request a list with the names and addresses of any potential recipients of the Data by contacting Optionee’s local human resources representative. Optionee authorizes the Company and any other possible recipients which may assist the Company (presently or in the future) with implementing, administering and managing the Plan to receive, possess, use, retain and transfer the Data, in electronic or other form, for the sole purpose of implementing, administering and managing Optionee’s participation in the Plan. Optionee understands that Data will be held only as long as is necessary to implement, administer and manage Optionee’s participation in the Plan. Optionee understands that Optionee may, at any time, view the Data, request additional information about the storage processing of the Data, require any necessary amendments to Data or refuse or withdraw the consents herein, in any case without cost, by contacting in writing Optionee’s local human resources representative. Optionee understands, however, that refusing or withdrawing Optionee’s consent may affect Optionee’s ability to participate in the Plan. For more information on the consequences of Optionee’s refusal to consent or withdrawal of consent, Optionee understands that Optionee may contact Optionee’s local human resources representative.
10. Electronic Delivery. The Company may, in its sole discretion, decide to deliver any documents related to the Option and participation in the Plan or future options that may be granted under the Plan by electronic means or to request Optionee’s consent to participate in the Plan by electronic means. Optionee hereby consents to receive such documents by electronic delivery and, if requested, to agree to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.
11. Severability. The provisions of this Agreement are severable and if any one or more provisions are determined to be illegal or otherwise unenforceable, in whole or in part, the remaining provisions shall nevertheless be binding and enforceable.
OPTIONEE: | NANOBIOTIX | |||
Signature | By: | |||
Print Name | Title: | |||
Residence Address | ||||
NANOBIOTIX
Societe Anonyme a directoire et conseil de surveillance having a share capital of
EUR.[_____] Registered office: [______]
[_o_]R.C.S. [____]
2018 STOCK OPTION PLAN
EXERCISE NOTICE
(Share subscription form)
NANOBIOTIX | |
[______] | |
[______] | |
France | |
[_______________], [__] | |
Attention: [____________] |
1. Exercise of Options. Effective as of today, __________________, ____, the undersigned (“Optionee”) hereby elects to subscribe _________________ (_________) ordinary shares (the “Shares”) of the Common Stock of NANOBIOTIX (the “Company”) under and pursuant to the Company’s 2018 Stock Option Plan (the “Plan”) adopted by the board on February 5, 2019 and the Stock Option Agreement dated ___________, ___ (the “Option Agreement”). The subscription price for the Shares shall be EUR. ______, as required by the Option Agreement.
2. Delivery of Payment. Optionee herewith delivers to the Company the full subscription price for the Shares.
3. Representations of Optionee. The Optionee acknowledges that Optionee has received, read and understood the Plan and the Option Agreement and agrees to abide by and be bound by their terms and conditions.
4. Rights as Shareholder. Until the issuance (as evidenced by the appropriate entry on the books of the Company) of the Shares, the Optionee shall have, as an Optionee, no right to vote or receive dividends or any other rights as a shareholder shall exist with respect to the Optioned Stock, except those the Optionee may have as a shareholder of the Company. No adjustment will be made for rights in respect of which the record date is prior to the issuance date for the Shares, except as provided in Section 11 of the Plan.
5. Tax consultation. The Optionee understands that Optionee may suffer adverse tax consequences as a result of Optionee’s subscription or disposition of the Shares. Optionee represents that Optionee has consulted with any tax consultants Optionee deems advisable in connection with the subscription or disposition of the Shares. The Optionee is not relying on the Company for any tax advice.
6. Entire Agreement - Governing Law. The Plan and Option Agreement are incorporated herein by reference. This Exercise Notice, the Plan and the Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and Optionee with respect to the subject matter hereof, and may not be modified adversely to the Optionee’s interest except by means of a writing signed by the Company and Optionee. This agreement is governed by the laws of the Republic of France.
*
* *
This Exercise notice is delivered in two originals one of which shall be returned to the Optionee.
Submitted by:
OPTIONEE(*) |
Accepted by:
NANOBIOTIX |
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Signature |
Signature
|
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Its: | ||||
Print Name | ||||
Address: | ||||
* The signature of the Optionee must be preceded by the following manuscript mention “accepted for formal and irrevocable subscription of [__________________]ordinary Shares”.
Exhibit 10.13
NANOBIOTIX
2019 STOCK OPTION PLAN
SUMMARY
Page | |||
1. | PURPOSES OF THE PLAN | 1 | |
2. | DEFINITIONS | 1 | |
3. | SHARES SUBJECT TO THE PLAN | 4 | |
4. | ADMINISTRATION OF THE PLAN | 4 | |
(a) | Procedure | 4 | |
(b) | Powers of the Administrator | 5 | |
(c) | Effect of Administrator’s Decision | 6 | |
5. | LIMITATIONS | 6 | |
6. | TERM OF PLAN | 6 | |
7. | TERM OF OPTIONS | 7 | |
8. | OPTIONS EXERCISE PRICE AND CONSIDERATION | 7 | |
|
(a) | Subscription or purchase Price | 7 |
(b) | Exercise Dates | 7 | |
(c) | Form of Consideration | 7 | |
9. | EXERCISE OF OPTIONS | 8 | |
(a) | Procedure for Exercise; Rights as a Shareholder | 8 | |
(b) | Termination of the Optionee’s Continuous Status as Beneficiary | 8 | |
(c) | Disability of Optionee | 9 | |
(d) | Death of Optionee | 9 | |
10. | NON-TRANSFERABILITY OF OPTIONS | 9 | |
11. | ADJUSTMENTS UPON CHANGES IN CAPITALIZATION, DISSOLUTION | 9 | |
(a) | Changes in capitalization | 9 | |
(b) | Dissolution or Liquidation | 10 | |
(c) | Change in Control | 10 | |
12. | GRANT | 11 | |
13. | AMENDMENT AND TERMINATION OF THE PLAN | 11 | |
(a) | Amendment and Termination | 11 | |
(b) | Shareholders’ approval | 11 | |
(c) | Effect of amendment or termination | 11 | |
14. | CONDITIONS UPON ISSUANCE OF SHARES | 11 |
Page | |||
(a) | Legal Compliance | 12 | |
15. | LIABILITY OF COMPANY | 12 | |
16. | SHAREHOLDERS’ APPROVAL | 12 | |
17. | LAW, JURISDICTION | 12 | |
Exhibit – Stock Option Grant Agreement | |||
Part I – Notice of Stock option grant | |||
Part II – Terms and conditions | |||
Exercise notice |
NANOBIOTIX
2019 STOCK OPTION PLAN
1. | Purposes of the Plan |
According to the authorization granted by by the extraordinary shareholders’ general meeting of April 11, 2019, the management board decided on March 11, 2020, in compliance with the provisions of articles L. 225-177 et. seq. of the French Commercial Code, to adopt the 2019 stock option plan of NANOBIOTIX, the terms and conditions of which are set out below.
The purposes of the Plan are:
- | to attract and retain the best available personnel for positions of substantial responsibility; |
- | to provide additional incentive to Beneficiaries; and |
- | to promote the success of the Company’s business. |
Options granted under the Plan to U.S. Beneficiaries are intended to be Incentive Stock Options or Non-Statutory Stock Options, as determined by the Administrator at the time of grant of an Option, and shall comply in all respects with US Applicable Laws in order that U.S. Beneficiaries may benefit from available tax advantages.
2. | Definitions. |
(a) | “Administrator” means the management board of the Company which shall administer the Plan in accordance with Section 4 of the Plan. |
(b) | “Affiliated Company” means a company which conforms with the criteria set forth in article L. 225-180 of the Commercial Code as follows: |
- | companies of which at least ten per cent (10%) of the share capital or voting rights is held directly or indirectly by the Company; |
- | companies which own directly or indirectly at least ten per cent (10%) of the share capital or voting rights of the Company; and |
- | companies of which at least fifty per cent (50%) of the share capital or voting rights is held directly or indirectly by a company which owns directly or indirectly at least fifty percent (50%) of the share capital or voting rights of the Company, |
(c) | “Beneficiary” means the president and the members of the management board (président et membres du directoire) or, as the case may be, the president of the board of directors (président du conseil d’administration), the general manager (directeur général) and the deputy general managers (directeurs généraux délégués) of the Company as well as any individual employed by the Company or by any Affiliated Company under the terms and |
conditions of an employment contract, it being specified that a term of office of member of the supersivory board of the Company or director of an Affiliated Company (remunerated or not) shall not be deemed to constitute an employment relationship. |
(d) | “Board” means the management board of the Company. |
(e) | “Commercial Code” means the French Commercial Code. |
(f) | “Company” means NANOBIOTIX, a corporation organized under the laws of the Republic of France. |
(g) | “Continuous Status as a Beneficiary” means as regards the president and the members of the management board or, as the case may be, the president of the board of directors, the general manager, the deputy general manager(s), that the term of their office has not been terminated and, as regards an employee that the employment relationship between the Beneficiary and the Company or any Affiliated Company is not terminated. Continuous Status as a Beneficiary shall not be considered terminated in the case of (i) any leave of absence having received a prior approval from the Company or requiring no prior approval under U.S. laws, or (ii) transfers between locations of the Company or between the Company or any Affiliated Company or the contrary or also from an Affiliated Company to another Affiliated Company. Leaves of absence which must receive a prior approval from the Company for the non-termination of the Continuous Status as a Beneficiary shall include leaves of more than three (3) months for illnesses or conditions about which the employee has advance knowledge, military leave, or any other personal leave. For purposes of U.S. Beneficiaries and Incentive Stock Options, no such leave may exceed ninety (90) days, unless reemployment upon expiration of such leave is guaranteed by statute contract or Company policies. If reemployment upon expiration of a leave of absence approved by the Company is not so guaranteed, on the 91st day of such leave any Incentive Stock Option held by a U.S. Beneficiary shall cease to be treated as an Incentive Stock Option and shall be treated for U.S. tax purposes as a Non-Statutory Stock Option. |
(h) | “Date of Grant” means the date of the decision of the Board to grant the Options. |
(i) | “Disability” means a disability declared further to a medical examination provided for in article L. 4624-1 of the French Labour Code or pursuant to any similar provision applicable to a foreign Affiliated Company. |
(j) | “Exchange Act” means the United States Securities Exchange Act of 1934, as amended. |
(k) | “Fair Market Value” means the value for one Share as determined in good faith by the Administrator, according to the following provisions, as provided in the Shareholder Authorization: |
(i) the Board may determine the subscription or purchase price of a share in compliance with the provisions of the law. However, the purchase or subscription price shall in no case be less than ninety five per cent (95%) of the average of the closing sales price for a share as quoted on stock exchange market during the
twenty market trading days prior to the day of the Board’s decision to grant the Options,
(ii) for US Beneficaries, the subscription or purchase price shall not be less than the fair market value of the Shares on the Date of Grant, determined as follows (a) if the Shares are listed or quoted for trading on an exchange, the value will be deemed to be the closing or last offer price, as applicable, of the Shares on the principal exchange upon which such securities are traded or quoted on such date, provided, if such date is not a trading day, on the last market trading day prior to such date; and (b) if the Shares are not listed or quoted for trading on an exchange, the fair market value of the Shares as determined by the Board, consistent with the requirements of Sections 422 with respect to Incentive Stock Options, and 409A of the US Code with respect to Options not intended to be Incentive Stock Options, it being specified that, when an Option entitles the holder to purchase shares previously repurchased by the Company, the exercise price, notwithstanding the above provisions and in accordance with applicable law, may not be less than 80% of the average purchase price paid by the Company for all shares so previously repurchased.
This price settled for the subscription or purchase of Shares shall not be modified during the period in which the Option may be exercised. However, if the Company makes one of the operations mentioned in article L. 225-181 of the French Commercial Code, it must take all necessary measures to protect Optionee’s interests in the conditions provided for by article L 228-99 of the French Commercial Code. In case of issuance of securities granting the common stock access, as well as in case of Company’s merger or scission, the Board may decide, for a limited period of time, to suspend the exercisability of the Options.
(l) | “Incentive Stock Option” means an Option intended to qualify as an incentive stock option within the meaning of Section 422 of the US Code and the regulations promulgated thereunder. |
(m) | “Non-Statutory Stock Option” means an Option which does not qualify as an Incentive Stock Option. |
(n) | “Notice of Grant” means a written notice evidencing the main terms and conditions of an individual Option grant. The Notice of Grant is part of the Option Agreement. |
(o) | “Option” means an option to purchase or subscribe Shares granted pursuant to the Plan. |
(p) | “Optionee” means a Beneficiary who holds at least one outstanding Option. |
(q) | “Option Agreement” means a written agreement entered into between the Company and an Optionee evidencing the terms and conditions of an individual Option grant. The Option Agreement is subject to the terms and conditions of the Plan. |
(r) | “Option Exchange Program” means a program whereby outstanding Options are surrendered in exchange for Options with different exercise conditions. |
(s) | “Parent” means a “parent corporation”, whether now or hereafter existing, as defined in Section 424(e) of the US Code. |
(t) | “Plan” means the 2019 Stock Option Plan as approved by the Board on March 11, 2020. |
(u) | “Share” means a share of common stock (action ordinaire) of the Company |
(v) | “Shareholders Authorization” means the authorization given by the shareholders of the Company in the extraordinary general meeting held on April 11, 2019 as increased or amended from time to time by a further general meeting of the shareholders permitting the Board to grant Stock Options. |
(w) | “Share Capital” means the issued and paid up capital of the Company. |
(x) | “Subsidiary” means a “subsidiary corporation”, whether now or hereafter existing, as defined in Section 424(f) of the US Code. |
(y) | “US Applicable Laws” means for the US the legal requirements relating to the administration of stock option plans under state corporate and securities laws and the US Code in force in the United States of America. |
(z) | “U.S. Beneficiary” means a Beneficiary of the Company or an Affiliated Company residing in the United States or otherwise subject to United States’ laws, regulations or taxation. |
(aa) | “US Code” means the United States Internal Revenue Code of 1986, as amended. |
(bb) | “U.S. Optionee” means an Optionee residing in the United States or otherwise subject to United States’ laws, regulations or taxation. |
3. | Shares Subject to the Plan |
Subject to the provisions of Section 11 of the Plan and pursuant to the Shareholder Authorization, the maximum aggregate number of Shares which may be optioned and issued under the Plan is equal to 500,000. For “Incentive Stock Options”, the maximum number of Shares which may be optioned and issued is equal to 500,000. The Shares optioned and issued under the Plan may be newly issued Shares, treasury Shares or Shares purchased on the open market.
Should the Option expire or become unexercisable for any reason without having been exercised in full, the unsubscribed Shares which were subject thereto shall, unless the Plan shall have been terminated, become available again for future grant under the Plan.
4. | Administration of the Plan |
(a) | Procedure |
The Plan shall be administered by the Administrator.
(b) | Powers of the Administrator. |
Subject to the provisions of the Commercial Code, the Shareholders Authorization, the Plan, and the US Applicable Laws, the Administrator shall have the authority, in its discretion:
(i) | to determine the Fair Market Value of the Shares, in accordance with Section 2(k) of the Plan; |
(ii) | to determine the Beneficiaries to whom Options may be granted hereunder; |
(iii) | to select the Beneficiaries and determine whether and to what extent Options are granted hereunder; |
(iv) | to approve or amend forms of agreement for use under the Plan; |
(v) | to determine the terms and conditions of any Options granted hereunder. Such terms and conditions include, but are not limited to, the exercise price, the time or times when Options may be exercised (which may be based on performance criteria), any vesting acceleration or waiver of forfeiture restrictions, and any restriction or limitation regarding any Option or the Shares relating thereto, based in each case on such factors as the Administrator, in its sole discretion, shall determine with the exception of the exercise price; it being specified that the Administrator’s discretion remains subject to the rules and limitations set forth in this Plan and in the Commercial Code; |
(vi) | to construe and interpret the terms of the Plan and Options granted pursuant to the Plan; |
(vii) | to prescribe, amend and rescind rules and regulations relating to the Plan, including rules and regulations relating to sub-plans established for the purpose of qualifying for preferred tax treatment under foreign tax laws; |
(viii) | to modify or amend each Option (subject to the provisions of Section 13(c) of the Plan), including the discretionary authority to extend the post-termination exercise period of Options after the termination of the employment agreement or the end of the term of office, longer than is otherwise provided for in the Plan; |
(ix) | to authorize any person to execute on behalf of the Company any instrument required to effect the grant of an Option previously granted by the Administrator; |
(x) | to implement an Option Exchange Program; |
(xi) | to determine the terms and restrictions applicable to Options; and |
(xii) | to make all other determinations deemed necessary or appropriate for administering the Plan. |
(c) | Effect of Administrator’s Decision. |
The Administrator’s decisions, determinations and interpretations shall be final and binding on all Optionees.
5. | Limitations |
(a) In the case of U.S. Beneficiaries, each Option shall be designated in the Notice of Grant either as an “Incentive Stock Option” or as a “Non-Statutory Stock Option”. Incentive Stock Options may only be granted to Beneficiaries of the Company or a Subsidiary who meet the definition of “employees” under Section 3401(c) of the US Code.
Nevertheless, the aggregate Fair Market Value of the Shares covered by Incentive Stock Options granted under the Plan or any other stock option program of the Company (or any Parent or subsidiary of the Company) that become exercisable for the first time in any calendar year shall not exceed U.S. $100,000: to the extent the aggregate Fair Market Value of such Shares exceeds U.S. $100,000, the Options covering those Shares the Fair Market Values of which causes the aggregate Fair Market Value of all such Shares to be in excess of U.S. $100,000 shall be treated as Non-Statutory Options. Incentive Stock Options shall be taken into account in the order in which they were granted, and the aggregate Fair Market Value of the Shares shall be determined as of the Date of the Grant.
(b) The Options are governed by articles L. 225-177 and following of the Commercial Code. They are not part of the employment agreement or of the office which has allowed the Optionee to be granted the Option. Neither do they constitute an element of the Optionee’s remuneration.
Neither the Plan nor any Option shall confer upon an Optionee any right with respect to continuing the Optionee’s employment or his term of office with the Company or any Affiliated Company, nor shall they interfere in any way with the Optionee’s right or the Company’s or Affiliated Company’s right, as the case may be, to terminate such employment or such term of office at any time, with or without cause.
(c) Other than as expressly provided hereunder, no member of the board of directors of the Company or of the supervisory board (in the event of change of management formula of the Company) or of an equivalent management body of an Affiliated Company shall be as such eligible to receive Options under the Plan.
6. | Term of Plan |
The Plan shall be effective and Options may be granted as of March 11, 2020; date of its adoption by the Board. Options may be granted hereunder until June 11, 2022. It shall continue in effect until the date of termination of the last Option in force, unless terminated earlier under Section 13 of the Plan.
7. | Term of Options |
The term of each Option shall be stated in the Notice of Grant as ten (10) years from the Date of Grant, in accordance with the Shareholders Authorization or, in case of death or Disability of the Optionee during such 10-year period, six (6) months from the death or Disability of the Optionee in accordance with French law, it being however specified, for the avoidance of doubt, that no Option granted to any U.S. Optionee shall be exercised after the 10th anniversary of the Date of Grant.
8. | Options Exercise Price and Consideration |
(a) | Subscription or purchase Price |
The per Share subscription or purchase price for the Shares to be issued or sold pursuant to exercise of an Option shall be determined by the Administrator on the basis of the Fair Market Value.
(i) In the case of an “Incentive Stock Option” granted to a U.S. Beneficiary who, at the time the Incentive Stock Option is granted, owns stock representing more than ten percent (10%) of the voting rights of all classes of stock of the Company or any Parent or Subsidiary of the Company and, to the extent such Beneficiary is permitted by the Commercial Code to receive Option grants, (x) the per Share subscription or purchase price shall be no less than 110% of the Fair Market Value per Share on the Date of Grant as defined in Section 2(k)(ii) and (y) the date of termination of the Option shall not exceed 5 years;
(ii) In the case of a “Non-Statutory Stock Option” or “Incentive Stock Option”, not covered by Section 8(a)(i) above, granted to any U.S. Beneficiary, the per Share subscription or purchase price shall be no less than 100% of the Fair Market Value per Share on the Date of Grant as defined in Section 2(k)(ii).
(b) | Exercise Dates |
At the time an Option is granted, the Administrator shall fix the period within which the Option may be exercised and shall determine any conditions which must be satisfied before the Option may be exercised. In so doing, the Administrator may specify that an Option may not be exercised until the completion of a service period in the Company or an Affiliated Company.
(c) | Form of Consideration |
The consideration to be paid for the Shares to be issued or purchased upon exercise of Options, including the method of payment, shall be determined by the Administrator. Such consideration shall consist entirely of an amount in Euro corresponding to the exercise price which shall be paid by wire transfer.
Where the exercise of an Option would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and the Optionee provides the Company with
either the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
9. | Exercise of Options |
(a) | Procedure for Exercise; Rights as a Shareholder |
Any Option granted hereunder shall be exercisable according to the terms of the Plan and at such times and under such conditions as determined by the Administrator and set forth in the Option Agreement.
An Option may not be exercised for a fraction of a Share.
An Option shall be deemed exercised when the Company receives: (i) written notice of exercise (in accordance with the provisions of the Option Agreement) together with a share subscription or purchase form (bulletin de souscription ou d’achat) duly executed by the person entitled to exercise the Option, and (ii) full payment for the Shares with respect to which the Option is exercised. Full payment may consist of any consideration and method of payment authorized by the Administrator and permitted by the Option Agreement and the Plan.
Where the exercise of an Option would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and the Optionee provides the Company with either the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
Upon exercise of an Option, the Shares issued or sold to the Optionee shall be assimilated with all other Shares of the Company of the same class and shall be entitled to dividends once the Shares are issued for the fiscal year during which the Option is exercised.
In the event that a Beneficiary infringes one of the above mentioned commitments, such Beneficiary shall be liable for any consequences resulting from such infringement for the Company and undertakes to indemnify the Company in respect of all amounts payable by the Company in connection with such infringement.
Granting of an Option in any manner shall result in a decrease in the number of Shares which thereafter may be available for purposes of the Plan, by the number of Shares as to which the Option may be exercised.
(b) | Termination of the Optionee’s Continuous Status as Beneficiary |
Upon termination of an Optionee’s Continuous Status as a Beneficiary, other than upon the Optionee’s death or Disability, the Optionee may exercise his or her Options, but only within
such period of time as is specified in the Notice of Grant, and only for the part of the Options that the Optionee was entitled to exercise at the date of termination (but in no event later than the expiration of the term of such Options as set forth in the Notice of Grant). Unless a longer period is specified in the Notice of Grant or otherwise resolved by the Board, an Option shall remain exercisable for six (6) months following the Optionee’s termination of Continuous Status as a Beneficiary. In the case of an “Incentive Stock Option”, such a period cannot exceed three (3) months following the Optionee’s termination of Continuous Status as a Beneficiary. If, at the date of termination, the Optionee is not entitled to exercise all his or her Options, the Shares covered by the unexercisable portion of Options shall revert to the Plan. If, after termination, the Optionee does not exercise all of his or her Options within the time specified by the Administrator, the Options shall terminate, and the Shares covered by such Options shall revert to the Plan.
(c) | Disability of Optionee |
In the event that an Optionee’s Continuous Status as a Beneficiary terminates as a result of the Optionee’s Disability, unless otherwise resolved by the Board, the Optionee may exercise his or her Options at any time within six (6) months from the date of such termination, but only to the extent these Options are exercisable at the time of termination (but in no event later than the expiration of the term of such Options as set forth in the Notice of Grant). If, at the date of termination, the Optionee is not entitled to exercise all of his or her Options, the Shares covered by the unexercised portion of Options shall revert to the Plan. If, after termination, the Optionee does not exercise all of his or her Options within the time specified herein, the Options shall terminate, and the Shares covered by such Options shall revert to the Plan.
(d) | Death of Optionee |
In the event of the death of an Optionee during the term of the Options, unless otherwise resolved by the Board, the Options may be exercised at any time within six (6) months following the date of death, by the Optionee’s estate or by a person who acquired the right to exercise the Option by bequest or inheritance, but only to the extent these Options are exercisable at the time of death. If, at the time of death, the Optionee was not entitled to exercise all of his or her Options, the Shares covered by the unexercised portion of Options shall immediately revert to the Plan. If, after death, the Optionee’s estate or a person who acquired the right to exercise the Options by bequest or inheritance does not exercise the Options within the time specified herein, the Options shall terminate, and the Shares covered by such Options shall revert to the Plan.
10. | Non-Transferability of Options |
An Option may not be sold, pledged, assigned, hypothecated, transferred or disposed of in any manner other than by will or by laws of descent or distribution and may be exercised, during the lifetime of the Optionee, only by the Optionee.
11. | Adjustments Upon Changes in Capitalization, Dissolution |
(a) | Changes in capitalization |
In the event of the carrying out by the Company of any of the financial operations pursuant to article L. 225-181 of the Commercial Code as follows:
- | amortization or reduction of the share capital, |
- | amendment of the allocation of profits, |
- | distribution of free shares, |
- | capitalization of reserves, profits, issuance premiums, |
- | the issuance of shares or securities giving right to shares to be subscribed for in cash or by set-off of existing indebtedness offered exclusively to the shareholders; |
the Company shall take the required measures to protect the interest of the Optionees in the conditions set forth in article L. 228-99 of the Commercial Code.
(b) | Dissolution or Liquidation |
In the event of the proposed dissolution or liquidation of the Company, to the extent that an Option has not been previously exercised, it will terminate immediately prior to the consummation of such proposed action. The Administrator may, in the exercise of its sole discretion in such instances, declare that any Option shall terminate as of a date determined by the Administrator and give each Optionee the right to exercise his or her Options as to Shares for which the Options would not otherwise be exercisable.
(c) | Change in Control |
No later than immediately prior to the completion of the relevant Liquidity Event (as defined below):
- in the event of a merger of the Company into another corporation or of the sale by one or several shareholders, acting alone or in concert, of the Company to one or several third parties of a number of Shares resulting in a transfer of more than fifty per cent (50%) of the Shares of the Company to said third parties (a “Liquidity Event”), the Optionee’s right to exercise the Options will be accelerated so that the Optionee may exercise all of them with effect immediately prior to the completion of the relevant Liquidity Event;
- the Options that may be exercised shall have to be exercised no later than immediately prior to the completion of the relevant Liquidity Event, it being specified that the Company shall inform the Optionee of any proposed Liquidity Event at least 15 days prior to the completion thereof; and
- any Options not exercised for any reason on or prior to the date of completion of a Liquidity Event will automatically lapse.
*********
For Incentive Stock Options, all assumptions, substitutions and adjustments shall be determined in accordance with Sections 422 and 424 of the US Code and the regulations promogated thereunder and for Non Statutory Options for US Beneficiaries in accordance with the Section 424 of the US Code.
12. | Grant |
12.1 The Date of Grant of an Option shall be, for all purposes, the date on which the Administrator decides to grant such Option. A notice of grant shall be provided to each Optionee within a reasonable time after the Date of Grant.
12.2 In the event of any tax liability arising on account of the grant of the Options, the liability to pay such taxes shall be that of the Beneficiary alone.
The Beneficiary shall enter into such agreements of indemnity and execute any and all documents as the Company may specify for this purpose, if so required at the Date of Grant and at any other time at the discretion of the Company, on such terms and conditions as the Company may think fit, for recovery of the tax due, from the Beneficiary.
13. | Amendment and Termination of the Plan |
(a) | Amendment and Termination |
The Administrator may at any time amend, alter, suspend or terminate the Plan.
(b) | Shareholders’ approval |
The Company shall obtain shareholders’ approval of any Plan amendment to the extent necessary and desirable to comply with US Applicable Laws (including the requirements of any exchange or quotation system on which Shares may then be listed or quoted). Such shareholders approval, if required, shall be obtained in such a manner and to such a degree as is required by the applicable law, rule or regulation.
(c) | Effect of amendment or termination |
No amendment, alteration, suspension or termination of the Plan shall impair the rights of any Optionee, unless mutually agreed otherwise between the Optionee and the Administrator, which agreement must be in writing and signed by the Optionee and the Company.
14. | Conditions Upon Issuance of Shares |
(a) | Legal Compliance |
Shares held by a US Beneficiary shall not be sold or issued pursuant to the exercise of an Option unless the exercise of such Option, and the issuance or sale and delivery of such Shares shall comply with all relevant provisions of law including, without limitation, the Commercial Code, the “Securities Act” of 1933, as amended, the “Exchange Act”, the rules and regulations promulgated thereunder, US Applicable Laws and the requirements of any stock exchange or quotation system upon which the Shares may then be listed or quoted.
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(b) | Investment Representations |
As a condition to the exercise of an Option by a US Beneficiary, the Company may require the person exercising such Option to represent and warrant at the time of any such exercise that the Shares are being subscribed or purchased only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a representation is required.
15. | Liability of Company |
15.1 The inability of the Company to obtain authority from any regulatory body having jurisdiction, which authority is deemed by any counsel to the Company to be necessary to the lawful issuance or sale of any Shares hereunder, shall relieve the Company of any liability in respect of the failure to issue or sell such Shares as to which such requisite authority shall not have been obtained.
15.2 The Company and its Affiliated Companies may not be held responsible in any way if the Beneficiary for any reason not attributable to the Company or its Affiliated Companies was not able to exercise the Options or acquire the Shares.
16. | Shareholder’s Approval |
The Plan shall be subject to approval by the shareholders of the Company within twelve (12) months of the date the Plan is adopted by the Board. Such shareholder approval shall be obtained in the manner and to the degree required under the Commercial Code and US Applicable Laws.
17. | Law, Jurisdiction |
This Plan shall be governed by and construed in accordance with the laws of France.
The relevant court of the registered office of the Company shall be exclusively competent to determine any claim or dispute arising in connection herewith.
The grant of Options under this Plan shall entitle the Company to require the Beneficiary to comply with such requirements of law as may be necessary in the Options of the Company from time to time.
*
* * *
Exhibit
NANOBIOTIX
STOCK OPTION GRANT AGREEMENT
Part I
NOTICE OF STOCK OPTION GRANT
[Optionnee’s Name and Address]
You have been granted Options to subscribe ordinary Shares of the Company, subject to the terms and conditions of the 2019 Stock Option Plan (the “Plan”) and this Option Agreement. Options are governed by articles L. 225-177 and following of the French Commercial Code. They are not part of the employment agreement or of the office which has allowed the Optionee to be granted the Options. Neither do they constitute an element of the Optionee’s remuneration. Unless otherwise defined herein, the terms defined in the Plan shall have the same defined meanings in this Option Agreement.
Date of Grant1: | [ o ] |
Vesting Commencement Date2 | [ o ] |
Exercise Price per Share: | EUR_______________ |
Total Number of Shares Granted: | [ o ] |
Total Exercise Price: | EUR____________ |
Type of Options3 | Non statutory Stock Options |
Term/Expiration Date4 | [ o ] |
Where the exercise of an Option, as described under Article 9.(a) of the Plan, would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and the Optionee provides the Company with either the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
1 date of the board meeting having allocated the Option.
2 date chosen by the Board as the Vesting Commencement Date; failing that, Date of Grant.
3 for U.S. Beneficiaries only.
4 date of termination of the Option (article 7 of the Plan), which shall not exceed 5 years for an ISO granted to a 10% owner and 10 years for a U.S. Optionee.
In the event that you infringe the above mentioned commitment, you shall be liable for any consequences resulting from such infringement for the Company and undertake to indemnify the Company in respect of all amounts payable by the Company in connection with such infringement.
Validity of the Options:
The Options will be valid as from the Date of Grant.
Vesting Schedule:
Unless otherwise determined or adapted by the Board, the Options may be exercised by the Optionee on the basis of the following initial vesting schedule subject to the condition precedent that the Optionee shall have previously returned to the Company the documents referred to under section 2. of Part II of the Stock Option Grant Agreement duly initialed and signed:
- | up to one third of the Options, as March 11, 2021, |
- | then up to an additional tranche equal to one third of the Options, as of each year elapsed as from March 11, 2021, i.e. as of March 11, 2022 for one third and as of March 11, 2023 for the last third, and |
subject, for each tranche to the continuous presence of the Optionee in the group during the corresponding reference period,
- | at the latest within ten (10) years as from the Date of Grant or in case of death or Disability of the Optionee during such then (10) year period, six (6) months as from the death or Disability of the Optionee (it being hovewer specified, for the avoidance of doubt, that no Option granted to any U.S. Optionnee shall be exercised after the 10th anniversary of the Date of Grant). |
The number of Options that could be exercised pursuant to the above vesting schedule will always be rounded up to the nearest full number.
If the Optionee fails to exercise the Options in whole or in part within the said period of ten (10) years (as may be extended to six (6) months from the death or Disability of the Optionee, the Options will lapse automatically.
Termination Period:
Unless otherwise decided by the Board, in case of termination of the Optionee’s Continuous Status as a Beneficiary, the Options exercisable at the time of termination may be exercised for six (6) months, three months for Incentive Stock Options after such termination, being specified that all other Options shall automatically expire at the time of termination.
Unless otherwise decided by the Board, upon the death of the Optionee, the Options may be exercised during a period of six (6) months as provided in the Plan.
Save as provided in the Plan, in no event shall the Options be exercised later than the Term/Expiration Date as provided above. Should the Options expire or become unexercisable for any reason without having been exercised in full, the unsubscribed Shares which were subject thereto shall, unless the Plan shall have been terminated, become available for future grant under the Plan.
By his signature and the signature of the Company’s representative below, the Optionee and the Company agree that the Options are granted under and governed by the terms and conditions of the Plan and this Option Agreement. The Optionee has reviewed the Plan and this Option Agreement in their entirely, has had the opportunity to obtain the advice of counsel prior to executing this Option Agreement and fully understands all provisions of the Plan and Option Agreement. The Optionee hereby agrees to accept as binding, conclusive and final all decisions or interpretations of the Administrator upon any questions relating to the Plan and Option Agreement. The Optionee further agrees to notify the Company upon any change in the residence address indicated below.
NANOBIOTIX
STOCK OPTION GRANT AGREEMENT
Part II
TERMS AND CONDITIONS
1. Grant of Options.
1.1 The Administrator of the Company hereby grants to the Optionee named in the Notice of Grant attached as Part I of this Agreement (the “Optionee”), [ o ] options (the “Options”) to subscribe the number of ordinary Shares, as set forth in the Notice of Grant, at the exercise price per Share set forth in the Notice of Grant (the “Exercise Price”), subject to the terms and conditions of the Plan, which is incorporated herein by reference.
In the event of a conflict between the terms and conditions of the Plan and the terms and conditions of this Option Agreement, the terms and conditions of the Plan shall prevail.
If designated in the Notice of Grant as an Incentive Stock Option, this Option is intended to qualify as an Incentive Stock Option under Section 422 of the US Code although the Company makes no representation as to the tax status of the Option. However, if this Option is intended to be an Incentive Stock Option, to the extent that it exceeds the U.S. $100,000 rule of US Code Section 422(d) the excess shall be treated as a Non-Statutory Stock Option
1.2 An Option will be valid as from the Date of Grant.
1.3 In the event of any tax liability arising on account of the Grant of the Options, the liability to pay such taxes shall be that of the Beneficiary alone. The Beneficiary shall enter into such agreements of indemnity and execute any and all documents as the Company may specify for this purpose, if so required at the time of the Grant and at any other time at the discretion of the Company, on such terms and conditions as the Company may think fit, for recovery of the tax due, from the Beneficiary.
2. Exercise of Options
(a) Right to Exercise. An Option is exercisable during its term in accordance with the Vesting Schedule set out in the Notice of Grant and the applicable provisions of the Plan and this Option Agreement, subject to the condition precedent that the Optionee shall have previously returned to the Company, by electronic delivery under the conditions set forth in Article 10 below:
- Part I and Part II of the Stock Option Grant Agreement (Exhibit), duly initialed (all pages but for the signature page) and signed (signature page).
In the event of Optionee’s death, Disability or other termination of Optionee’s Continuous Status as a Beneficiary, the exercisability of an Option is governed by the applicable provisions of the Plan and this Option Agreement.
(b) Method of Exercise. An Option is exercisable by delivery of an exercise notice, in the form attached hereto (the “Exercise Notice”) stating the election to exercise the Option, the
number of Shares in respect of which the Option is being exercised (the “Exercised Shares”), and such other representations and agreements as may be required by the Company pursuant to the provisions of the Plan. The Exercise Notice shall be signed by the Optionee and shall be delivered in person or by certified mail to the Company or its designated representative or by facsimile message to be immediately confirmed by certified mail to the Company. The Exercise Notice shall be accompanied by payment of the aggregate Exercise Price as to all Exercised Shares. An Option shall be deemed to be exercised upon receipt by the Company of such fully executed Exercise Notice accompanied by the proof of payment of such aggregate Exercise Price.
No Share shall be issued pursuant to the exercise of an Option unless such issuance and exercise complies with all relevant provisions of law as set out under Section 14(a) of the Plan.
Upon exercise of an Option, the Shares issued to the Optionee shall be assimilated with all other Shares of the Company and shall be entitled to dividends for the fiscal year in course during which the Option is exercised.
3. Method of Payment. Payment of the aggregate Exercise Price shall be made by wire transfer with the execution of the corresponding exchange contract.
Where the exercise of an Option would lead the Company to be liable for any payment, whether due to fees, taxes or to charges of any nature whatsoever, in place of the Optionee, such Option shall be deemed duly exercised when (a) the full payment for the Shares with respect to which the Option is exercised is executed by the Optionee and (b) the Optionee provides the Company with either (i) the receipt stating the payment by the Optionee of any such fee, tax or charge, as above described that would otherwise be paid by the Company upon exercise of the Option, in place of the Optionee or, (ii) the full payment, under the same conditions, of any amount due upon the exercise of the Option to be borne by the Company.
The Company and its Affiliated Companies may not be held responsible in any way if the Beneficiary for any reason not attributable to the Company or its Affiliated Companies was not able to exercise the Option or purchase the Shares. The payment for the purchase of the shares shall be made by the Optionee under his/her own responsibility according to these Terms and Conditions.
4. Non-Transferability of Option. An Option may not be transferred in any manner otherwise than by will or by the laws of descent or distribution and may be exercised during the lifetime of the Optionee only by the Optionee. The terms of the Plan and this Option Agreement shall be binding upon the executors, administrators, heirs, successors and assigns of the Optionee.
5. Term of Options. Subject as provided in the Plan, an Option may be exercised only within the term set out in the Notice of Grant, and may be exercised during such term only in accordance with the Plan and the terms of this Option Agreement.
6. Entire Agreement - Governing Law. The Plan is incorporated herein by reference. The Plan and this Option Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and
agreements of the Company and Optionee with respect to the subject matter hereof, and may not be modified adversely to the Optionee’s interest except by means of a writing signed by the Company and Optionee. This agreement is governed by the laws of the Republic of France.
Any claim or dispute arising under the Plan or this Agreement shall be subject to the exclusive jurisdiction of the court competent for the place of the registered office of the Company.
7. Tax Obligations. Regardless of any action the Company or Optionee’s employer (the “Employer”) takes with respect to any or all income tax, social insurance, payroll tax, or other tax-related withholding (“Tax-Related Items”), Optionee acknowledges that the ultimate liability for all Tax-Related Items legally due by Optionee is and remains Optionee’s responsibility and that the Company and/or the Employer (1) make no representations or undertakings regarding the treatment of any Tax-Related Items in connection with any aspect of the Option grant, including the grant, vesting or exercise of the Option, the subsequent sale of shares of common stock acquired pursuant to such exercise and the receipt of any dividends; and (2) do not commit to structure the terms of the grant or any aspect of the Option to reduce or eliminate Optionee’s liability for Tax-Related Items.
Prior to exercise of the Option, Optionee will pay or make adequate arrangements satisfactory to the Company and/or the Employer to satisfy all withholding obligations of the Company and/or the Employer, if any. In this regard, Optionee authorizes the Company and/or the Employer to withhold all applicable Tax-Related Items legally payable by Optionee from Optionee’s compensation paid to Optionee by the Company and/or Employer or from proceeds of the sale of Shares. Alternatively, or in addition, if permissible under local law, the Company may sell or arrange for the sale of Shares that Optionee acquires to meet the withholding obligation for Tax-Related Items. Finally, Optionee will pay to the Company or the Employer any amount of Tax-Related Items that the Company or the Employer may be required to withhold as a result of Optionee’s participation in the Plan or Optionee’s purchase of Shares that cannot be satisfied by the means previously described. The Company may refuse to honor the exercise and refuse to deliver the Shares issuable upon exercise of the Options if Optionee fails to comply with Optionee’s obligations in connection with the Tax-Related Items as described in this section.
8. Nature of Grant. In accepting the grant, Optionee acknowledges that:
(a) the Plan is established voluntarily by the Company, it is discretionary in nature and it may be modified, amended, suspended or terminated by the Company at any time, unless otherwise provided in the Plan and this Agreement;
(b) the grant of the Option is voluntary and occasional and does not create any contractual or other right to receive future grants of options, or benefits in lieu of options, even if options have been granted repeatedly in the past;
(c) all decisions with respect to future option grants, if any, will be at the sole discretion of the Company;
(d) Optionee’s participation in the Plan shall not create a right to further employment with the employer and shall not interfere with the ability of the Employer to terminate Optionee’s employment relationship at any time with or without cause;
(e) Optionee is voluntarily participating in the Plan;
(f) the Option is an extraordinary item that does not constitute compensation of any kind for services of any kind rendered to the Company or the Employer, and which is outside the scope of Optionee’s employment contract, if any;
(g) the Option is not part of normal or expected compensation or salary for any purpose, including, but not limited to, calculating any severance, resignation, termination, redundancy, end of service payments, bonuses, long service awards, pension or retirement benefits or similar payments and in no event should be considered as compensation for, or relating in any way to, past services for the Company or the Employer;
(h) the Option grant will not be interpreted to form an employment contract with the Company, the Employer or any Subsidiary or affiliate of the Company;
(i) the future value of the underlying Shares is unknown and cannot be predicted with certainty;
(j) if the underlying Shares do not increase in value, the Option will have no value;
(k) if Optionee exercises Optionee’s Option and obtains Shares, the value of those Shares acquired upon exercise may increase or decrease in value, even below the exercise price;
(l) in consideration of the grant of the Option, no claim or entitlement to compensation or damages shall arise from termination of the Option or diminution in value of the Option or Shares purchased through exercise of the Option resulting from termination of Optionee’s employment the Company or the Employer (for any reason whatsoever) and Optionee irrevocably releases the Company and the Employer from any such claim that may arise; if, notwithstanding the foregoing, any such claim is found by a court of competent jurisdiction to have arisen, then, by signing this Agreement, Optionee shall be deemed irrevocably to have waived Optionee’s entitlement to pursue such claim; and
(m) in the event of termination of Optionee’s employment, Optionee’s right to receive the Option and vest in the Option under the Plan, if any, will terminate effective as of the date that Optionee receives notice of termination regardless of when such termination is effective; furthermore, in the event of termination of employment, Optionee’s right to exercise the Option after termination of employment, if any, will be measured by the date on which the Optionee receives notice of termination; the Company shall have the exclusive discretion to determine when Optionee is no longer actively employed for purposes of Optionee’s Option grant. In addition, any period of notice or compensation in lieu of such notice, that is given or ought to have been given under any contract, statute, common law or civil law shall be excluded.
9. Data Privacy. Optionee hereby explicitly and unambiguously consents to the collection, use and transfer, in electronic or other form, of Optionee’s personal data as described in this document by and among, as applicable, the Employer, the Company and its subsidiaries and affiliates for the exclusive purpose of implementing, administering and managing Optionee’s participation in the Plan.
Optionee understands that the Company and the Employer may hold certain personal information about Optionee, including, but not limited to, Optionee’s name, home address and telephone number, date of birth, social insurance number or other identification number, salary, nationality, job title, any shares of stock or directorships held in the Company, details of all options or any other entitlement to shares of stock awarded, canceled, exercised, vested, unvested or outstanding in Optionee’s favor, for the exclusive purpose of implementing, administering and managing the Plan (“Data”).
Optionee understands that the recipients of the Data may be located in the United States or elsewhere including outside the EEA, and that the recipients’ country (e.g., the United States) may have different data privacy laws and protections than Optionee’s country. Optionee understands that Optionee may request a list with the names and addresses of any potential recipients of the Data by contacting Optionee’s local human resources representative. Optionee authorizes the Company and any other possible recipients which may assist the Company (presently or in the future) with implementing, administering and managing the Plan to receive, possess, use, retain and transfer the Data, in electronic or other form, for the sole purpose of implementing, administering and managing Optionee’s participation in the Plan. Optionee understands that Data will be held only as long as is necessary to implement, administer and manage Optionee’s participation in the Plan. Optionee understands that Optionee may, at any time, view the Data, request additional information about the storage processing of the Data, require any necessary amendments to Data or refuse or withdraw the consents herein, in any case without cost, by contacting in writing Optionee’s local human resources representative. Optionee understands, however, that refusing or withdrawing Optionee’s consent may affect Optionee’s ability to participate in the Plan. For more information on the consequences of Optionee’s refusal to consent or withdrawal of consent, Optionee understands that Optionee may contact Optionee’s local human resources representative.
10. Electronic Delivery. The Company may, in its sole discretion, decide to deliver any documents related to the Option and participation in the Plan or future options that may be granted under the Plan by electronic means or to request Optionee’s consent to participate in the Plan by electronic means. Optionee hereby consents to receive such documents by electronic delivery and, if requested, to agree to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.
11. Severability. The provisions of this Agreement are severable and if any one or more provisions are determined to be illegal or otherwise unenforceable, in whole or in part, the remaining provisions shall nevertheless be binding and enforceable.
OPTIONEE: | NANOBIOTIX | ||
Signature | By: | ||
Print Name | Title: | ||
[ o ]
|
NANOBIOTIX
Société Anonyme à directoire et conseil de surveillance having a share capital of EUR. [__o__]
Registered office: [___]
[ o ] R.C.S. [__]
2019 STOCK OPTION PLAN
EXERCISE NOTICE
(Share subscription form)
NANOBIOTIX | |
[______] | |
[______] | |
France | |
[_______________], [__] | |
Attention: [____________] |
1. Exercise of Options. Effective as of today, _______, , the undersigned (“Optionee”) hereby elects to subscribe _______________________ (______) ordinary shares (the “Shares”) of the Common Stock of NANOBIOTIX (the “Company”) under and pursuant to the Company’s 2019 Stock Option Plan (the “Plan”) adopted by the board on January [__o__], 2020 and the Stock Option Agreement dated ______________, __ (the “Option Agreement”). The subscription price for the Shares shall be EUR. ________, as required by the Option Agreement.
2. Delivery of Payment. Optionee herewith delivers to the Company the full subscription price for the Shares.
3. Representations of Optionee. The Optionee acknowledges that Optionee has received, read and understood the Plan and the Option Agreement and agrees to abide by and be bound by their terms and conditions.
4. Rights as Shareholder. Until the issuance (as evidenced by the appropriate entry on the books of the Company) of the Shares, the Optionee shall have, as an Optionee, no right to vote or receive dividends or any other rights as a shareholder shall exist with respect to the Optioned Stock, except those the Optionee may have as a shareholder of the Company. No adjustment will be made for rights in respect of which the record date is prior to the issuance date for the Shares, except as provided in Section 11 of the Plan.
5. Tax consultation. The Optionee understands that Optionee may suffer adverse tax consequences as a result of Optionee’s subscription or disposition of the Shares. Optionee represents that Optionee has consulted with any tax consultants Optionee deems advisable in connection with the subscription or disposition of the Shares. The Optionee is not relying on the Company for any tax advice.
6. Entire Agreement - Governing Law. The Plan and Option Agreement are incorporated herein by reference. This Exercise Notice, the Plan and the Option Agreement
constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior undertakings and agreements of the Company and Optionee with respect to the subject matter hereof, and may not be modified adversely to the Optionee’s interest except by means of a writing signed by the Company and Optionee. This agreement is governed by the laws of the Republic of France.
*
* *
This Exercise notice is delivered in two originals one of which shall be returned to the Optionee.
Submitted by:
OPTIONEE(*) |
Accepted by:
NANOBIOTIX |
||
Signature | Signature | ||
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Its: | ||
Print Name
[__o__] |
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Address: | |||
* The signature of the Optionee must be preceded by the following manuscript mention “accepted for formal and irrevocable subscription of [__________________] ordinary Shares”.
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1.
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PURPOSES OF THE PLAN
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1
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2.
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DEFINITIONS
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1
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3.
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SHARES SUBJECT TO THE PLAN
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4
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4.
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ADMINISTRATION OF THE PLAN
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4
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(a)
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Procedure
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4
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(b)
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Powers of the Administrator
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5
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(c)
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Effect of Administrator’s Decision
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6
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5.
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LIMITATIONS
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6
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6.
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TERM OF PLAN
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6
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7.
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TERM OF OPTIONS
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7
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8.
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OPTIONS EXERCISE PRICE AND CONSIDERATION
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7
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(a)
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Subscription or Purchase Price
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7
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(b)
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Exercise Dates
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7
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(c)
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Form of Consideration
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7
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9.
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EXERCISE OF OPTIONS
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8
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(a)
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Procedure for Exercise; Rights as a Shareholder
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8
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(b)
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Termination of the Optionee’s Continuous Status as Beneficiary
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9
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(c)
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Disability of Optionee
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9
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(d)
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Death of Optionee
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9
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10.
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NON-TRANSFERABILITY OF OPTIONS
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9
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11.
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ADJUSTMENTS UPON CHANGES IN CAPITALIZATION, DISSOLUTION
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10
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(a)
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Changes in Capitalization
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10
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(b)
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Dissolution or Liquidation
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10
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(c)
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Change in Control
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10
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12.
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GRANT
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11
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13.
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AMENDMENT AND TERMINATION OF THE PLAN
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11
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(a)
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Amendment and Termination
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11
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(b)
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Shareholders’ Approval
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11
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(c)
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Effect of Amendment or Termination
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11
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Page | |||
14.
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CONDITIONS UPON ISSUANCE OF SHARES
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11
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(a)
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Legal Compliance
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11
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(b)
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Investment Representations
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12
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15.
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LIABILITY OF COMPANY
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12
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16.
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SHAREHOLDERS’ APPROVAL
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12
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17.
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LAW, JURISDICTION
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12
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-
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to attract and retain the best available personnel for positions of substantial responsibility;
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-
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to provide additional incentive to Beneficiaries; and
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-
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to promote the success of the Company’s business.
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(a)
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“Administrator” means the management board of the Company which shall administer the Plan in accordance with Section 4 of the Plan.
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(b)
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“Affiliated Company” means a company which conforms with the criteria set forth in article L. 225-180 of the Commercial Code as follows:
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-
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companies of which at least ten per cent (10%) of the share capital or voting rights is held directly or indirectly by the Company;
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-
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companies which own directly or indirectly at least ten per cent (10%) of the share capital or voting rights of the Company; and
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-
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companies of which at least fifty per cent (50%) of the share capital or voting rights is held directly or indirectly by a company which owns directly or indirectly at least fifty percent (50%) of the share capital or voting rights of
the Company,
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(c)
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“Beneficiary” means the president and the members of the management board (président et membres du directoire) or, as the
case may be, the president of the board of directors (président du conseil d’administration), the general manager (directeur général) and the deputy general
managers (directeurs généraux délégués) of the Company as well as any individual employed by the Company or by any Affiliated Company under the terms and
conditions of an employment contract, it being specified that a term of office of member of the supervisory board of the Company or director of an Affiliated Company (remunerated or not) shall not be deemed to constitute an employment
relationship.
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(d)
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“Board” means the management board of the Company.
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(e)
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“Commercial Code” means the French Commercial Code.
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(f)
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“Company” means NANOBIOTIX, a corporation organized under the laws of the Republic of France.
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(g)
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“Continuous Status as a Beneficiary” means as regards the president and the members of the management board or, as the case may be, the president of the board of
directors, the general manager, the deputy general manager(s), that the term of their office has not been terminated and, as regards an employee that the employment relationship between the Beneficiary and the Company or any Affiliated
Company is not terminated. Continuous Status as a Beneficiary shall not be considered terminated in the case of (i) any leave of absence having received a prior approval from the Company or requiring no prior approval under U.S. laws, or
(ii) transfers between locations of the Company or between the Company or any Affiliated Company or the contrary or also from an Affiliated Company to another Affiliated Company. Leaves of absence which must receive a prior approval from
the Company for the non-termination of the Continuous Status as a Beneficiary shall include leaves of more than three (3) months for illnesses or conditions about which the employee has advance knowledge, military leave, or any other
personal leave. For purposes of U.S. Beneficiaries and Incentive Stock Options, no such leave may exceed ninety (90) days, unless reemployment upon expiration of such leave is guaranteed by statute contract or Company policies. If
reemployment upon expiration of a leave of absence approved by the Company is not so guaranteed, on the 91st day of such leave any Incentive Stock Option held by a U.S. Beneficiary shall cease to be treated as an Incentive Stock Option
and shall be treated for U.S. tax purposes as a Non-Statutory Stock Option.
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(h)
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“Date of Grant” means the date of the decision of the Board to grant the Options.
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(i)
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“Disability” means a disability declared further to a medical examination provided for in article L. 4624-1 of the French Labour Code or pursuant to any similar
provision applicable to a foreign Affiliated Company.
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(j)
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“Exchange Act” means the United States Securities Exchange Act of 1934, as amended.
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(k)
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“Fair Market Value” means the value for one Share as determined in good faith by the Administrator, according to the following provisions, as provided in the
Shareholder Authorization:
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(i)
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the Board may determine the subscription or purchase price of a share in compliance with the provisions of the law. However, the purchase or subscription price shall in no case be less than ninety five per
cent (95%) of the average of the closing sales price for a share as quoted on stock exchange market during the twenty market trading days prior to the day of the Board’s decision to grant the Options,
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(ii)
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for US Beneficiaries, the subscription or purchase price shall not be less than the fair market value of the Shares on the Date of Grant, determined as follows (a) if the Shares are listed or quoted for
trading on an exchange, the value will be deemed to be the closing or last offer price, as applicable, of the Shares on the principal exchange upon which such securities are traded or quoted on such date, provided, if such date is not a
trading day, on the last market trading day prior to such date; and (b) if the Shares are not listed or quoted for trading on an exchange, the fair market value of the Shares as determined by the Board, consistent with the requirements of
Sections 422 with respect to Incentive Stock Options, and 409A of the US Code with respect to Options not intended to be Incentive Stock Options, it being specified that, when an Option entitles the holder to purchase shares previously
repurchased by the Company, the exercise price, notwithstanding the above provisions and in accordance with applicable law, may not be less than 80% of the average purchase price paid by the Company for all shares so previously
repurchased.
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(l)
|
“Incentive Stock Option” means an Option intended to qualify as an incentive stock option within the meaning of Section 422 of the US Code and the regulations
promulgated thereunder.
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(m)
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“Non-Statutory Stock Option” means an Option which does not qualify as an Incentive Stock Option.
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(n)
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“Notice of Grant” means a written notice evidencing the main terms and conditions of an individual Option grant. The Notice of Grant is part of the Option Agreement.
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(o)
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“Option” means an option to purchase or subscribe Shares granted pursuant to the Plan.
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(p)
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“Optionee” means a Beneficiary who holds at least one outstanding Option.
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(q)
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“Option Agreement” means a written agreement entered into between the Company and an Optionee evidencing the terms and conditions of an individual Option grant. The
Option Agreement is subject to the terms and conditions of the Plan.
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(r)
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“Option Exchange Program” means a program whereby outstanding Options are surrendered in exchange for Options with different exercise conditions.
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(s)
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“Parent” means a “parent corporation”, whether now or hereafter existing, as defined in Section 424(e) of the US Code.
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(t)
|
“Plan” means the LLY 2019 Stock Option Plan as approved by the Board on October 24, 2019.
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(u)
|
“Share” means a share of common stock (action ordinaire) of the Company
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(v)
|
“Shareholders Authorization” means the authorization given by the shareholders of the Company in the extraordinary general meeting held on April 11, 2019 as increased
or amended from time to time by a further general meeting of the shareholders permitting the Board to grant Stock Options.
|
(w)
|
“Share Capital” means the issued and paid up capital of the Company.
|
(x)
|
“Subsidiary” means a “subsidiary corporation”, whether now or hereafter existing, as defined in Section 424(f) of the US Code.
|
(y)
|
“US Applicable Laws” means for the US the legal requirements relating to the administration of stock option plans under state corporate and securities laws and the US
Code in force in the United States of America.
|
(z)
|
“U.S. Beneficiary” means a Beneficiary of the Company or an Affiliated Company residing in the United States or otherwise subject to United States’ laws, regulations
or taxation.
|
(aa)
|
“US Code” means the United States Internal Revenue Code of 1986, as amended.
|
(bb)
|
“U.S. Optionee” means an Optionee residing in the United States or otherwise subject to United States’ laws, regulations or taxation.
|
(i)
|
to determine the Fair Market Value of the Shares, in accordance with Section 2(k) of the Plan;
|
(ii)
|
to determine the Beneficiaries to whom Options may be granted hereunder;
|
(iii)
|
to select the Beneficiaries and determine whether and to what extent Options are granted hereunder;
|
(iv)
|
to approve or amend forms of agreement for use under the Plan;
|
(v)
|
to determine the terms and conditions of any Options granted hereunder. Such terms and conditions include, but are not limited to, the exercise price, the time or times when Options may be exercised (which
may be based on performance criteria), any vesting acceleration or waiver of forfeiture restrictions, and any restriction or limitation regarding any Option or the Shares relating thereto, based in each case on such factors as the
Administrator, in its sole discretion, shall determine with the exception of the exercise price; it being specified that the Administrator’s discretion remains subject to the rules and limitations set forth in this Plan and in the
Commercial Code;
|
(vi)
|
to construe and interpret the terms of the Plan and Options granted pursuant to the Plan;
|
(vii)
|
to prescribe, amend and rescind rules and regulations relating to the Plan, including rules and regulations relating to sub-plans established for the purpose of qualifying for preferred tax treatment under
foreign tax laws;
|
(viii)
|
to modify or amend each Option (subject to the provisions of Section 13(c) of the Plan), including the discretionary authority to extend the post-termination exercise period of Options after the termination
of the employment agreement or the end of the term of office, longer than is otherwise provided for in the Plan;
|
(ix)
|
to authorize any person to execute on behalf of the Company any instrument required to effect the grant of an Option previously granted by the Administrator;
|
(x)
|
to implement an Option Exchange Program;
|
(xi)
|
to determine the terms and restrictions applicable to Options; and
|
(xii)
|
to make all other determinations deemed necessary or appropriate for administering the Plan.
|
-
|
amortization or reduction of the share capital,
|
-
|
amendment of the allocation of profits,
|
-
|
distribution of free shares,
|
-
|
capitalization of reserves, profits, issuance premiums,
|
-
|
the issuance of shares or securities giving right to shares to be subscribed for in cash or by set-off of existing indebtedness offered exclusively to the shareholders;
|
Date of Grant1:
|
24 Oct 22, 2019
|
Vesting Commencement Date2
|
Oct 24, 2019
|
Exercise Price per Share:
|
EUR 6.41
|
Total Number of Shares Granted:
|
500,000
|
Total Exercise Price:
|
EUR 3,205,000
|
Type of Options3
|
Non statutory Stock Options
|
Term/Expiration Date4
|
Oct 24, 2029
|
-
|
10% of the Options could be exercised when the price of one share of the Company on the Euronext market in Paris reaches EUR. 24,
|
-
|
an additional 10% of the Options could be exercised when the price of one share of the Company on the Euronext Paris market reaches EUR. 30,
|
-
|
an additional 40% of the Options could be exercised when the price of one share of the Company on the Euronext Paris market reaches EUR. 40, and
|
-
|
an additional 40% of the Options could be exercised when the price of one share of the Company on the Euronext Paris market reaches EUR. 60.
|
-
|
at the latest within ten (10) years as from the Date of Grant or in case of death or Disability of the Optionee during such then (10) year period, six (6) months as from the death or Disability of the
Optionee (it being hovewer specified, for the avoidance of doubt, that no Option granted to any U.S. Optionnee shall be exercised after the 10th anniversary of the Date of Grant).
|
OPTIONEE:
|
NANOBIOTIX
|
||
Signature
|
By:
|
|
|
Print Name
|
Title:
|
|
|
246 boulevard Raspail
75014 Paris
|
NANOBIOTIX
|
|
[______]
|
|
[______]
|
|
France
|
|
[_______________], [__]
|
|
Attention: [____________]
|
Submitted by:
OPTIONEE(*)
|
Accepted by:
NANOBIOTIX
|
||
Signature
|
Signature
|
||
|
Its:
|
|
|
Print Name
Laurent Lévy
|
|||
Address:
|
|||
◾ |
For French tax residents, (i) if the Liquidity Event occurs before or on the first anniversary date of the grant and (ii) if the change of control occurs after the first anniversary of grant, on the date of completion of the Liquidity
Event, it being specified that, in both cases, the relevant free shares will then be subject to a holding period until the second anniversary of the grant.
|
◾ |
For foreign tax residents, if the Liquidity Event occurs before the second anniversary of the grant, on the first anniversary of the grant, it being specified that, the relevant free shares will then be subject to a year-long holding
period as from their date of acquisition
|
Performance condition(s)
|
|
Assessment date(s) of
performance conditions,
if any
|
Assessment date(s) of
presence conditions
and end of vesting
period
|
|
Lock-
up period end
date
|
|||
AGA 2018-1
|
Internal performance(1) applicable to executive board members only
|
March 6, 2019
|
(2)
|
(2)
|
||||
AGA 2018-2
|
No performance condition
|
-
|
July 27, 2020 (3)
|
July 27, 2021
|
||||
AGA 2019-1
|
Internal performance(1) applicable to executive board members only
|
March 29, 2020
|
(4)
|
(4)
|
||||
AGA 2020-1
|
Internal performance(1)
|
March 11, 2021
|
March 11, 2022
|
March 11, 2023
|
(1)
|
Unless otherwise decided by the executive and supervisory board, based on the achievement of milestones in the development of our Company.
|
(2)
|
The AGA 2018-1 granted to French tax residents were definitely vested on March 6, 2020 and are now subject to a one-year lock-up period ending on March 6, 2021. The AGA 2018-1 granted to
foreign tax residents will be definitely vested on March 6, 2021 and will not be subject to any lock-up period.
|
(3)
|
As an exception to the 2018 free shares plan, the presence condition is not applicable.
|
(4)
|
The AGA 2019-1granted to French tax residents will be definitely vested on March 29, 2021 and will then be subject to a one-year lock-up period ending on March 29, 2022. The AGA 2018-1
granted to foreign tax residents will be definitely vested on March 29, 2022 and will not be subject to any lock-up period.
|