Contract
Exhibit 4.6
2 September 2016
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Chairman and CEO
Advance Accelerator Applications USA, Inc.
The Empire State Building
350 Fifth Avenue, Suite ▇▇▇▇
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▇▇▇▇▇▇ ▇▇▇▇▇▇ of America
Chief Executive Officer
Advance Accelerator Applications
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Dear ▇▇. ▇▇▇▇▇:
This Letter of Agreement is intended to document an agreement between Advanced Accelerator Applications (hereafter to be referred to as “Sponsor”) and Accelovance Europe S.r.l. (hereinafter to be referred to as “Accelovance”) with respect to the clinical trial known as, “A multicenter, stratified, open, randomized, comparator-controlled, parallel groups phase III study comparing treatment with 177Lu-DOTAO-Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive midgut carcinoid tumours” (the “Study”).
Accelovance has assumed responsibility for management of the Study from a predecessor company and is committed to manage the Study to its successful completion. In consideration of Accelovance’s efforts and the expanded scope of the Study, the Sponsor hereby agrees to the Study Budget adjustments described as Amendment 2 and Amendment 3 included below.
The Letter Agreement may be executed in counterparts, each of which, when executed and delivered, shall be deemed to be an original, and all of which, when joined, shall together constitute one and the same agreement.
IN WITNESS WHEREOF, the Parties have executed this Letter Agreement by their duly authorized officers as of the date indicated above.
| ACCELOVANCE EUROPE S.r.l. Socio Unico – Società soggetta a controllo e coordinamento da parte di ACCELOVANCE, Inc. | ||
Sede Operativa ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇ (▇▇) – Italia Tel: ▇▇▇ ▇▇ ▇▇▇▇▇▇▇ Fax: ▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ |
Sede Legale ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ |
Cap. Soc. €1.000.000,00 i.v. P. IVA 12396690153 C.F. e N. iscrizione Reg. Imp. Milano 03777940374 ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ |
ADVANCED ACCELERATOR APPLICATIONS
| By: | /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇ | |
| Name: | ▇▇▇▇▇▇▇ ▇▇▇▇▇ | |
| Title: | Chief Executive Officer | |
| Date: | 9/2/2016 |
ACCELOVANCE EUROPE S.R.L.
| By: | /s/ Nigel trim | |
| Name: | Nigel Trim | |
| Title: | Managing Director | |
| Date: | 7 Sep 2016 |