Belmac Hygiene, Inc. v. Belmac Corp.

121 F.3d 835, 1997 U.S. App. LEXIS 22347, 1997 WL 476337
CourtCourt of Appeals for the Second Circuit
DecidedAugust 22, 1997
DocketNos. 911, 1332, Dockets 96-7330, 96-7374
StatusPublished
Cited by7 cases

This text of 121 F.3d 835 (Belmac Hygiene, Inc. v. Belmac Corp.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Second Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Belmac Hygiene, Inc. v. Belmac Corp., 121 F.3d 835, 1997 U.S. App. LEXIS 22347, 1997 WL 476337 (2d Cir. 1997).

Opinion

VAN GRAAFEILAND, Circuit Judge:

Belmac Hygiene, Inc. appeals from a judgment of the United States District Court for the Southern District of New York which followed a non-jury trial before Judge Sweet. The judgment dismissed Belmac Hygiene’s suit for breach of contract, fraudulent inducement and negligent misrepresentation against its partner in a joint venture, Medstar, Inc., Medstar’s parent, Maximed, Inc., and Maximed’s principal shareholder, Robert Cohen. Defendants cross-appeal the dismissal of their counterclaim alleging fraud and breach of contract by Belmac Hygiene. Medstar also appeals the dismissal of its jointly tried claim of breach of an agreement of guaranty against Belmac Hygiene’s parent, Belmac Corporation. The district court’s opinion is reported at 910 F.Supp. 966 (1996).

THE FACTS

Robert Cohen, founder and CEO of Maximed, eo-owned certain patents relating to an intra-vaginal drug delivery system known as “Lotus RDC.” The system was believed to have many practical applications, including its use as a vaginal contraceptive eventually named “Lotus 24.”

To obtain financial backing for the development and production of its Lotus products, Maximed produced a 42-page business plan dated September 1, 1998 (the “Business Plan”) to attract potential investors. Among other things, the Business Plan detailed Maximed’s history and business, its patented technology, its marketing strategy, its financial projections and its management (including a scientific advisory board). The Business Plan stated that Maximed had filed a notice of intention to market Lotus 24 with the Food and Drug Administration (“FDA”) in April 1992 and made certain representations about the FDA approval process for Lotus 24, specifically the absence of a need for FDA review:

LOTUS 24, the Company’s vaginal contraceptive product, the first intended for marketing, is in a unique regulatory position. The active ingredient in LOTUS 24, nonoxynol-9, has been determined as safe and effective under the guidelines set forth in the FDA Monograph on Vaginal Contraceptives. The monograph describes the parameters that all spermicidal preparations must meet and the Company’s product meets or exceeds those requirements. The other components of the formulation are Generally Regarded As Safe (GRAS). As a result, there is no review requirement by the FDA. In April, 1992, a notice of intention to market LOTUS 24 was filed with the FDA. The FDA has thirty days to respond with any objections before marketing may commence. No objections have been received by the company.

The Business Plan also stated that: (1) Maximed had identified a manufacturer for all of its products, including Lotus 24 and its applicator; (2) pursuant to the relevant FDA monograph, Lotus 24 would “be immediately marketed upon completion of funding”; (3) there were “no significant initial capital expenditures”; and (4) sales were expected to commence six months after funding.

In 1993, Belmac Corporation (“Belmac”) was seeking a pharmaceutical product to market. James Murphy, then-president of MacroChem Corporation and later Belmac’s president and CEO, learned of the Lotus RDC products being developed by Maximed. Murphy contacted Belmac’s chief science officer and senior vice-president, Dr. Robert M. Stote, who in turn arranged to meet with Cohen to discuss Maximed’s products. In January 1994, before meeting with Cohen, [837]*837Stote requested certain information, including:

All pertinent information on the Lotus
RDC method of drug delivery
Patents
FDA submissions/correspondenee Regulatory opinions Manufacturing methods Formulation work/Stability data Scientific data re: in vitro/in vivo-anti viral, anti bacterial, anti fungal activity All clinical data

In response, Maximed provided Belmac with the Business Plan, copies of its patents and a copy of a letter to the FDA’s over-the-counter labeling group, dated April 15,1992. The FDA letter reads in part:

This letter will serve to notify you that Maximed Corporation intends to market LOTUS ESPERNIL (trade name), a nonoxynol-9 vaginal suppository, which conforms to the criteria of the Food and Drug Administration’s (FDA) proposed monograph on Over-The-Counter (O-T-C) contraceptives ....
In vitro testing of LOTUS ESPERNIL in accordance with the International Planned Parenthood Federation (IPPF) Agreed Test For Total Spermicidal Power revealed that the product was spermicidal at forty (40) seconds and for up to twelve (12) hours. A copy of the summary report provided by the University of Miami School of Medicine is appended (Attachment I).
The results of stability tests undertaken at the University of Kansas Medical Center, reveal that the product has a shelf life of at least nine (9) months and is likely to have a shelf life of twenty-four (24) months. A copy of the summary stability report is appended (Attachment II).
The labeling for LOTUS ESPERNIL is being provided to the O-T-C Labeling Group, for your review. A copy of the labeling is appended (Attachment III).

The only item attached to the copy of the letter provided to Belmac was the labeling attachment, but it was not marked as “Attachment III.” Moreover, although Stote asked Cohen for the stability test results (referred to in the letter as “Attachment II”), Cohen did not provide them.1

Between January and March 1994 Belmac representatives, including Stote, met with Cohen to explore the possibility of a business arrangement to manufacture and sell Lotus RDC products. Belmac made clear that it was not interested in a development project but wished only to enter into a business relationship involving at least one product that was ready to be manufactured, marketed and sold. During these meetings Cohen made certain oral representations consistent with the Business Plan, including (1) that Lotus 24 was ready for marketing; (2) that it would be marketed in 4 to 6 months; (3) that Maximed had identified a manufacturer that was qualified to produce the product; (4) that a contract with the manufacturer could be signed as soon as Maximed obtained financing; and (5) that no further capitalization would be required. He also verified certain manufacturing cost figures contained in the draft partnership agreement.

On March 11, 1994, Belmac and Maximed, through their wholly-owned subsidiaries, Belmac Hygiene and Medstar, entered into a Partnership Agreement pursuant to which they agreed to develop and sell the Lotus RDC products, beginning with the Lotus 24 contraceptive device. The partnership was to be overseen by a management committee composed of three representatives of each of the two partners. Cohen, one of Maximed’s representatives, became the Partnership’s CEO. Under the terms of the Partnership Agreement Belmac Hygiene pledged to contribute $1,000 initially to the venture’s capital and up to $10,000,000 in additional funding as deemed necessary by the management committee, and Medstar agreed to contribute its Lotus technology, including the relevant patents. The Agreement also contained a guar[838]*838anty by Belmac of Belmac Hygiene’s funding obligations.

During the next few months Belmac funded all partnership activities. A target date of June 15 was set for a finished product to be ready for clinical trials and other testing.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Munoz v. Boyard (In re Boyard)
538 B.R. 645 (E.D. New York, 2015)
Johnson v. Schmitz
237 F. Supp. 2d 183 (D. Connecticut, 2002)
Israel v. State Farm Mutual Automobile Insurance
239 F.3d 127 (Second Circuit, 2000)
Robotic Vision Systems, Inc. v. Cybo Systems, Inc.
17 F. Supp. 2d 151 (E.D. New York, 1998)

Cite This Page — Counsel Stack

Bluebook (online)
121 F.3d 835, 1997 U.S. App. LEXIS 22347, 1997 WL 476337, Counsel Stack Legal Research, https://law.counselstack.com/opinion/belmac-hygiene-inc-v-belmac-corp-ca2-1997.