EXHIBIT B

Case 4:22-cv-00662-O Document 21-2 Filed 08/23/22 Page 1 of 4 PageID 131
Richard Boynton

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2022-8-3 Letter to Dechert and Kelly Hart Hallman.docx

3 August 2022

By E-mail

Eduardo Siva Romero/Erica Stein

Dechert LLP

32 rue de Monceau

Paris

France 

75008

Chad Arnette/Scott Wiehle 

Kelly Hart & Hallman LLP

201 Main Street

Suite 2500

Fort Worth

TX 76102

USA

Dear Sir/Madam,

Re: Ipsen’s letter to the FDA and Complaint for Injunctive Relief

1. We refer to: (i) the letter from François Garnier of Ipsen Biopharm Lrd (“Ipsen” or “your 

client”) to the US Food and Drug Administration (“FDA”) dated 2 August 2022; and (ii) 

the Complaint for Injunctive Relief filed in the United States District Court for the Northern 

District of Texas by your respective firms on 2 August 2022 on behalf of Ipsen. 

2. As a preliminary matter, it is striking that your client’s letter to the FDA and its Complaint 

for Injunctive Relief disclose the confidential arbitration Galderma S.A. has brought against 

Ipsen, but that neither refers to the Request for Interim Measures your client made in the 

course of that arbitration on 18 July 2022. There can be no doubt that both Mr. Garnier 

and Dechert (being the party and firm instructed to seek such measures) were fully aware 

of the fact that the Request for Interim Measures was made and we assume that Kelly Hart 

& Hallman had been properly instructed by its client and co-counsel, and was therefore 

also aware of its existence. However, we would welcome clarification if that assumption 

is wrong. 

3. The effect of the omission is that the FDA and the United States District Court for the 

Northern District of Texas have been presented with what is, at best, a partial and therefore 

seriously misleading picture. 

4. The Request for Interim Measures asks for an order that: 

“Galderma ... refrain from submitting any regulatory filing for QM-1114 in its own 

name in any of the Territories, including any related action 

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unauthorized by Ipsen in violation of its intellectual property rights, pending the 

resolution of this arbitration”

5. Galderma’s response essentially asks that the Tribunal refuse that request and order the 

opposite. More precisely, the response asks that the Tribunal: 

“Dismiss Ipsen’s request and allow Galderma to proceed with the regulatory filings for 

QM-1114 in Galderma’s own name, on a temporary basis, until the outcome of the 

arbitration is decided”

6. On 18 July 2022 our firm wrote to the Tribunal and to Dechert confirming that (inter alia), 

the proposed filing with the FDA is not expected to take place before mid-September 2022. 

As a result of this statement, the parties have liaised between themselves and with the 

Tribunal to put in place a timetable which would allow the Tribunal to render its decision 

on Ipsen’s request and Galderma’s counter request in “mid-September” 2022, before the 

FDA filings are ready to be made.

7. Whilst it was implicit in the correspondence and always understood by the parties, for the 

avoidance of any doubt we hereby confirm on behalf of Galderma SA and (to the extent 

necessary) Galderma Laboratories LP that it will not make any filing in respect of QM1114 with the FDA before the Tribunal has reached its decision on Ipsen’s Request for 

Interim Measures. As a result, there is not and cannot be any prospect of the FDA being 

asked to review any filing by Galderma unless or until the Tribunal has determined whether 

Galderma is entitled to submit the BLA. Likewise, there is not, nor has there ever been, 

any threat of irreparable harm relating to any of the allegations made in the pending United 

States District Court for the Northern District of Texas action.

8. In these circumstances, it was unnecessary for Ipsen to write to the FDA and improper to 

file an action seeking injunctive relief in the United States District Court for the Northern 

District of Texas. It was also misleading for it to request that the FDA refrain from 

reviewing the BLA until the conclusion of the arbitration in or around September 2023, 

without mentioning the fact that the Tribunal will be ruling as to whether Galderma is 

entitled to submit the BLA in the first place by mid-September 2022. 

9. Not only does Ipsen’s letter mislead the FDA, it also seeks to undermine the Tribunal’s 

consideration of both Ipsen’s own Request for Interim measures and the relief sought by 

Galderma in its response. By writing to the FDA before the Tribunal has rendered its 

decision on the Request for Interim Measures, Ipsen has sought to neuter the effect of any 

decision which goes in Galderma’s favour. It will be for Ipsen to explain to the Tribunal 

why it has sought to undermine its forthcoming decisions in the Request for Interim Relief 

and the arbitration more generally in this manner. 

10. In addition to the above, it is also worth making clear that the QM Agreement (as defined 

in the Complaint for Injunctive Relief) contains an arbitration clause which requires :

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“all disputes arising out of or or in connection with the [QM Agreement to] be finally 

settled under the Rules of Arbitration of the International Chamber of Commerce”.

11. The question of whether Galderma has the right to proceed with the FDA filing and 

commercialise QM-1114 obviously lies at the very heart of the arbitration. To the extent 

that Ipsen believes that Texas Trade Secret law has an effect on that analysis, it should have 

raised that issue in its Defence in the arbitration or in its Request for Interim Measures. The 

fact that Ipsen appears to have belatedly alighted upon a potential new line of argument 

does not mean that it can ignore the arbitration agreement and seek recourse in a forum it 

has contractually agreed to avoid.

12. Moreover, Article 28 of the ICC Rules makes it clear that the Tribunal should deal with 

any applications for conservatory or interim measures once the arbitration has commenced. 

Whilst we accept that “in appropriate circumstances” it remains possible to apply to a 

competent court for interim measures even after the arbitration has commenced, Ipsen has 

taken no steps to explain why it would be appropriate for it to ignore both the arbitration 

clause itself and the fact that it has already asked the Tribunal to grant the same relief it 

asks from the Texas court. It is difficult to reach any conclusion other than Ipsen is 

concerned that the Tribunal will not rule in its favour and is trying to manufacture another 

“bite of the cherry”. Such an approach is contrary to the purpose of an arbitration 

agreement and is not an “appropriate circumstance” to avoid the presumption in the ICC 

Rules that interim measures should be requested of a Tribunal once it has been formed.

13. In these circumstances, neither the Texas (nor any other) court has any jurisdiction to hear 

your client’s Complaint for Injunction Relief and it has no jurisdiction to grant any of the 

“restraining order, preliminary injunction and/or permanent injunction” requested in the 

Prayer for Relief, all of which are issues which are seised by, and will be determined by 

the Tribunal in the arbitration.

14. All of our clients rights are reserved in full including in respect of damages it suffers should 

you client’s ill advised letter to the FDA delay the commercialisation of QM-1114, injure 

our client’s reputation or standing before the FDA or by breaching the confidentiality of 

the arbitration process and of the QM Agreement itself by filing its Complaint for 

Injunctive Relief without taking steps to seal the file. 

Yours faithfully,

Kirkland and Ellis LLP

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