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The plaintiff (Merck Sharp & Dohme LLC) sought an interlocutory injunction to restrain the defendants (collectively Mylan) from offering, putting on the market or using products containing sitagliptin and metformin prior to the expiry on 7 April 2023 of supplementary protection certificate (SPC) number 2008/024.

Unfortunately we are not automatically informed about your pregnancy. For employees the doctor will certify the expected date of birth for the employer. Its important to make sure, that the Merck BKK will receive a copy of this to send you all information about benefits while pregnancy, just in time. We need the certificate to calculate your maternity leave and maternity allowance.

As soon as you receive the certificate of the expected date of birth please send a copy to your Merck BKK and your employer. We will automatically send you the application for maternity allowance 7 weeks before the expecting date of birth. We will also contact your employer to calculate the maternity allowance. As soon as we have received all documents you will receive the payment for the first 6 weeks.

In or about late 1995 or early 1996, Merck and Hubbard allegedly discovered that certain of the latter's pure line and grandparent breeding stock was susceptible to, and certain lines were in fact afflicted by, a virulent cancer virus.[3] (Id. 48.) Nasik alleges that over approximately the next 18 months, defendants concealed the problem because of fears of eroding market share and the possible effect such news could have on Merck's upcoming merger with Rhone Merieux, and conspired to distribute and sell diseased breeding stock worldwide in order to continue reaping profits from such sales. Pursuant to the alleged conspiracy, diseased chicks were diverted to India and other third world countries "where defendants believed that early detection of the disease would be unlikely." (Id. 48, 49, 70-77.) Nasik further alleges that Hubbard representatives were told not to reveal the disease unless a customer first produced evidence of its existence. (Id. 77, 84, 92.) The alleged deception also included the procurement of false export certificates from the United States Department of Agriculture ("USDA"), which, Nasik claims, are intended in part "to ensure that animals, poultry, semen, embryos, and hatching eggs intended for export are free from evidence of communicable disease and exposure thereto ...." (Id. 49, 51-62, 99, 102.) The "issuing veterinarians" for such certificates were Shaw and Rector. (Id. 100.)

Even accepting the allegations in the Amended Complaint as true, and reading them in the light most favorable to Nasik, the Court finds that Nasik has failed to adequately plead that it was fraudulently induced into signing the Release. In support of its assertions of fraud, Nasik relies on a single statement by Hacker, Merck's Vice President and Assistant General Counsel, unspecified statements by other individual defendants, the USDA certificates, and the failure of defendants to disclose three statements that appeared in written correspondence among certain of the individual defendants. The Court considers each of the alleged misrepresentations in turn.

*531 Third, Nasik asserts that it relied, to its detriment, on misleading USDA certificates which (i) were "issued" by defendants and (ii) which "ensure to the importing country (in this case, India) and the importer (in this case, Nasik) that the product is good and free and clear of diseases." (Pl. Opp. Hubbard and Merial at 7.) However, the USDA certificates are not representations by defendants, but of USDA, even if, as Nasik asserts, the USDA endorsing veterinarian relies on Shaw's and Rector's certifications in providing the endorsement. (Amend. Compl. 55.) Further, as the moving defendants point out, while such certificates reflect the visible condition of a particular flock at the hatchery at the time of inspection, they clearly do not warrant that the stock in question, or future chickens, will not develop disease or growth problems.[14] Thus, even if the Court determined that the USDA certificates could be construed as statements to Nasik by private veterinarians Shaw and Rector or by defendants as a whole, it would not be reasonable for Nasik to rely on the certificates as a general testament to the health of Hubbard ISA's breeding stock for the purpose of entering into the Release.

Second, Nasik alleges that USDA is an enterprise. While USDA is distinct from the alleged RICO defendants, neither the Amended Complaint nor the RICO Statement specifically alleges, and no facts are alleged that would lead the Court to infer, that any of the defendants conducted the affairs of USDA, or in any way controlled such federal government agency. The Supreme Court has held that "to conduct or participate, directly or indirectly, in the conduct of such enterprise's affairs [under Section 1962(c)], one must participate in the operation or management of the enterprise itself." Reves v. Ernst & Young, 507 U.S. 170, 185, 113 S. Ct. 1163, 122 L. Ed. 2d 525 (1993). Such is plainly not the case with USDA. While certain of the defendants, specifically Shaw and Rector, are alleged to have participated in the USDA's export certification process and made misleading representations to USDA concerning the health of the grandparent breeding stock sent to Nasik, there is no allegation, nor could one plausibly be made in good faith, that these doctors were involved in the operation or management of the agency. Nasik's claim that Shaw and Rector "participat[ed] in and controll[ed] the preparation and issuance of fraudulent USDA certificates," (Pl. Opp. Merck. at 14), is not reflected in the Amended Complaint, because it is contrary to the process of certification described therein. (Amend.Compl. 51-55.) Even if the doctors' influence over the issuance of such certificates was substantial, USDA's purportedly "ministerial" role nevertheless reflects its control over its own operations and management. (Pl. Opp. Merck. at 14; Amend. Compl. 55 (stating that USDA "review[s] the certification of the [outside] issuing veterinarian prior to endorsing it and makes it clear that the endorsing Veterinary Services veterinarian is relying upon the issuing veterinarian's certification")); see also Eli Lilly & Co. v. Roussel Corp., 23 F. Supp. 2d 460, 489-90 & n. 44 (D.N.J.1998) (finding that plaintiff's allegations that defendants obtained regulatory approval by submitting false documents to the Food and Drug Administration ("FDA") were not sufficient allegations of "operation and management" of the FDA within the meaning of Reves). Accordingly, Nasik's claim under Section 1962(c) must be dismissed.

That leaves Shaw and Rector, each of whom has moved, pursuant to Rule 12(b) (2), to dismiss the Amended Complaint against him for lack of personal jurisdiction. The Court grants their respective motions. First, contrary to Nasik's contention, these defendants did not either "expressly or impliedly agree[] to this venue for this action." (Amend. Compl. 3.) Neither Shaw nor Rector are parties to the Release, and therefore are not subject to the New York forum selection clause contained therein. Second, the record does not reflect that either of these defendants "maintains offices, transacts business or [is] licensed to do business in this district." (Id.) In fact, Nasik does not allege, and the Court sees no reason to infer, that either Shaw or Rector has any contacts with New York whatsoever. Shaw is a veterinarian with a private practice in New Hampshire, and Rector is a veterinarian employed by the State of North Carolina; the Amended Complaint alleges only that they "issued" USDA certificates in their respective locales which Hubbard subsequently sent to India. (Id. 100-102.) Thus, neither Shaw nor Rector is subject to jurisdiction under the "doing business" prong of New York's jurisdictional analysis, or the "transaction of business" prong of New York's long-arm statute.[23] New York Civil Practice Law & Rules ("CPLR") 301, 302(a).

[7] Merck has submitted several documents, which are referenced in the Amended Complaint, incorporated therein, or which were clearly in Nasik's possession and relied on by Nasik in filing suit. These documents include the 1994 Agreement, the Draft Complaint, the Release, the 1998 Agreement, a letter from Nasik's former counsel to Nasik containing drafts of the 1998 Agreement, and a USDA export certificate for chicks sent from Hubbard to Nasik in February 1996. (Exs. A-E to Gluck Aff.; Supplemental Affidavit of Matthew Gluck dated Oct. 25, 2000, Ex. F; Merial and Hubbard's Reply Brief in Support of Their Motion to Dismiss ("Merial and Hubbard Rep."), Ex. A.) The Court considers such documents on the instant motions to dismiss.

[18] Specifically, Nasik alleges that (i) on May 25, 1998, its former counsel in New York received a fax from Merck in New Jersey containing a draft of the "Settlement Agreement"; (ii) on August 26, 1998, Hacker sent a fax from New Jersey to Nasik in India containing a draft of the 1998 Agreement; and (iii) on November 20, 1998, Merck sent a fax from New Jersey to Nasik in India informing them that copies of the 1998 Agreement had been sent by courier to Merial. (Amend. Compl. 131; RICO Stmt. 5.) Nasik only states, in conclusory fashion, that these faxes were "clearly connected to the plan of the Defendants to induce Nasik into settlement and shield all Defendants from liability." (RICO Stmt. 5.) Moreover, neither the three alleged letters and/or faxes in which alleged omissions by defendants were made, nor the USDA certificates, support Nasik's allegations of fraud. See Part III .C, supra. 2351a5e196