3DT Holdings LLC v. Bard Access Systems Inc.

CourtDistrict Court, S.D. New York
DecidedFebruary 10, 2022
Docket1:17-cv-05463
StatusUnknown

This text of 3DT Holdings LLC v. Bard Access Systems Inc. (3DT Holdings LLC v. Bard Access Systems Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
3DT Holdings LLC v. Bard Access Systems Inc., (S.D.N.Y. 2022).

Opinion

USDC SDNY DOCUMENT UNITED STATES DISTRICT COURT ELECTRONICALLY FILED SOUTHERN DISTRICT OF NEW YORK DOC #:; conn □□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□□ X DATE FILED:_2/10/2022 3DT HOLDINGS LLC, : Plaintiff, : 17-cv-5463 (LIL) -y- OPINION AND ORDER BARD ACCESS SYSTEMS INC., : Defendant. LEWIS J. LIMAN, United States District Judge: Plaintiff 3DT Holdings LLC (“Plaintiff or “3DT”) and Defendant Bard Access Systems Inc. (““Defendant” or “Bard”’) each cross-move for summary judgment pursuant to Federal Rule of Civil Procedure 56. For the following reasons, 3DT’s motion for suminary judgment is denied, and Bard’s motion for summary judgment is granted in part and denied in part. BACKGROUND This case involves the sale and development of a technology for use in navigating, tracking, and confining the location of the tip of a catheter during heart surgery. On the parties’ cross-motions for summary judgment, the Court draws all reasonable inferences against the moving party. It grants summary judgment only if the facts that are not genuinely in dispute demonstrate the absence of a material issue and support entry of judgment as a matter of law. Plaintiff 3DT is a limited liability company organized under the laws of the state of Delaware, with its principal place of business in San Diego, California. Dkt. No. 73 91.1 3DT

1 The sole member of 3DT is Dr. Ghassan Kassab who is a full-time resident and citizen of the state of Califorma. Jd. § 1. The Court properly possesses diversity jurisdiction.

created an technology” intended to id. ¶ 3 (citing Dkt. No. 73-1 at 2); this technology is referred to as the “Precisive Navigation Technology,” id. Defendant Bard is a corporation organized under the laws of the state of Utah, with its

principal place of business in Salt Lake City, Utah. Id. ¶ 2. I. The Sale of the Precisive Navigation Technology from 3DT to Bard In 2013, 3DT entered into a sale transaction pursuant to which it sold its Precisive Navigation Technology to Bard for further development, regulatory approval, and sale. Dkt. No. 73 ¶¶ 4, 6–7. 3DT primarily vetted a total of four potential buyers, including Bard, that were interested in acquiring the Precisive Navigation Technology. Id. ¶ 5. The transaction was documented in three agreements executed by Bard and 3DT on August 29, 2013: An Asset Purchase Agreement (the “Purchase Agreement”), Dkt. No. 73-1, a Design, Development and Services Agreement (the “Development Agreement”), Dkt. No. 73-2, and a Statement of Work (“SOW”), Dkt. No. 73-3. Dkt. No. 73 ¶ 7. The Purchase Agreement, Development Agreement, and SOW are referred to collectively as the “Purchase Documents.” The language of the

Purchase Documents is critical to the disposition of this contract dispute. The Purchase Agreement The Purchase Agreement provided for 3DT to “sell, convey, assign, transfer and deliver” to Bard “all right, title and interest” of 3DT, free and clear of all encumbrances, to “the product incorporating the Precisive Navigation Technology . . . and all (x) prototypes thereof, (y) line extensions, modifications, improvements, additions, successors thereto, and (z) replacements therefor.” Dkt. No. 73-1 § 2.01. The purchase price was to be paid in two installments. Id. § 2.04. was to be tendered to 3DT at the time of closing. Id. § 2.04(a). The remaining was due to “be paid by Buyer [Bard] directly to Seller [3DT] (the “Full Milestone Payment”), either (1) upon receipt by [Bard] or its designee, assignee or transferee of its first 510(k) clearance from the FDA2 to market and sell a medical device that incorporates the Precisive Navigation Technology in the Buyer Field,” id. § 2.04(b); or (2) under some circumstances where it has ceased to provide

commercially reasonable support to the development of the product. Bard has not paid any of the Full Milestone Payment. It also has not received FDA clearance to market and sell a medical device incorporating the Precisive Navigation Technology. Whether Bard’s obligation to pay the Full Milestone Payment was triggered is at the heart of this lawsuit. Dkt. No. 1. 3DT claims that its right to the Full Milestone Payment was triggered, and it is entitled to the payment, while Bard claims that it has not breached the Purchase Agreement and that the condition precedent for the Full Milestone Payment has not occurred. Section 2.04(b) of the Purchase Agreement defines Bard’s obligations to support the development of the Precisive Navigation Technology and sets forth the circumstances under which, in the absence of FDA clearance, Bard is obligated to make the Full Milestone Payment.

It states: [Bard] shall be obligated to support the development of the Precisive Navigation Technology as and to the extent contemplated by the Development Agreement; provided that [Bard] may elect, at any time and for any reason, to not continue to support the development of the Precisive Navigation Technology as and to the extent contemplated under the Development Agreement, without violation of the 2 Under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, device manufacturers must provide a premarket notification to FDA when they intend to introduce a device into commercial distribution for the first time. FDA, 510(k) Clearances, https://www.fda.gov/medical- devices/device-approvals-denials-and-clearances/510k-clearances (last updated Aug. 31, 2021). This submission is called a 510(k) and is made “to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.” FDA, Premarket Notification 510(k), https://www.fda.gov/medical-devices/premarket-submissions- selecting-and-preparing-correct-submission/premarket-notification-510k (last updated Mar. 13, 2020). Once a submitter receives an order declaring a device to be substantially equivalent, the device can be marketed in the United States. Id.; see also Dkt. No. 73 ¶¶ 30–34. Development Agreement, if it provides at least thirty (30) days prior written notice thereof to [3DT] (“Notice of Discontinued Support”) and pays to [3DT], not later than forth-five [sic] (45) days following the date of such Notice of Discontinued Support, the Full Milestone Payment. Dkt. No. 73-1 § 2.04(b). In short, Bard has the right at any time and for any reason to stop or suspend work on the project but, if it does so, it ordinarily must pay 3DT the remaining . Section 4.05 of the Purchase Agreement states, in pertinent part, “Buyer will be the lawful owner of, and have good, valid and marketable title to, the Acquired Assets, free and clear of all Encumbrances.” Id. § 4.05. The Development Agreement The Development Agreement, to which the Purchase Agreement refers, defines Bard’s obligation to support the development of the Precisive Navigation Technology. It sets forth the agreement of the parties with respect to “the design, development validation and testing of one or more new Bard products in the Buyer Field that utilizes, incorporates, and/or employs the Precisive Navigation Technology.” Dkt. No. 73 ¶ 13 (citing Dkt. No. 73-2 at 1). The term of the Development Agreement runs from “the Effective Date and, unless earlier terminated as expressly provided herein, shall continue until the completion, expiration or termination (pursuant to Section 9.2 below) of the Statement of Work.” Id. ¶ 16 (citing Dkt. No. 73-2 § 9.1). The language of Section 2.1 of the Development Agreement is critical to the resolution of this dispute. It provides: Bard has interest in designing, developing, validating, testing and commercializing a possible Bard Product using the Precisive Navigation Technology, and, through this Agreement, wishes to engage 3DT to perform Services (as defined herein) in support of that endeavor.

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Bluebook (online)
3DT Holdings LLC v. Bard Access Systems Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/3dt-holdings-llc-v-bard-access-systems-inc-nysd-2022.