UNITED STATES DISTRICT COURT 

SOUTHERN DISTRICT OF FLORIDA 

AVINI HEALTH CORPORATION, 

 Plaintiff, 

v. 

BIOGENUS LLC, 

 Defendant. 

_________________________________/

CASE NO. 22-CV-61992-RAR 

DEFENDANT BIOGENUS LLC’S FEDERAL RULE 12(B)(1) MOTION TO DISMISS 

PLAINTIFF’S FIRST AMENDED COMPLAINT 

 Defendant, BIOGENUS LLC (“BioGenus” or “Defendant”), by and through its 

undersigned counsel and pursuant to Federal Rule of Civil Procedure 12(b)(1), hereby moves to 

dismiss Plaintiff AVINI HEALTH CORPORATION’s (“Avini” or “Plaintiff”) January 17, 2023 

filed First Amended Complaint (D.E. 18) (hereinafter “FAC”) for lack of subject matter 

jurisdiction. 

I. Introduction and Factual Background 

Avini’s FAC asserts a single cause of action for breach of the March 1, 2022 Production 

and Supply Agreement (“Agreement”) between Avini and BioGenus. D.E. 18, FAC, ¶¶ 47-56. 

As pled, Avini’s single cause of action, as in the original Complaint, is based on two theories: (1) 

Avini alleges BioGenus supplied a non-conforming product to Avini; and (2) BioGenus was 

purportedly required, but failed to offer, a new, so called, “REDOX” product to Avini for sale. As 

shown herein, despite Avini’s additional, albeit very minor, allegations from the original 

Complaint, Avini still has not suffered an injury in fact. Therefore, Avini’s single cause of action 

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for breach of contract should be dismissed. 

First, the signatories to the Agreement (FAC, D.E. 18, pg 11, Exhibit ‘A’) are limited only 

to Avini and BioGenus. Under the Agreement, Avini agreed to submit purchase orders to 

BioGenus for manufacture of spherical silver nanoparticles in deionized water (the “Product”). 

D.E. 18, pg 11 at § 2. After the Agreement was entered, Avini never sent a single purchase order 

to BioGenus for the Product. Subsequent to formation of the Agreement, BioGenus has only 

received one purchase order for the Product from a different company called “Nutra Pharma 

Corporation.” A true and correct copy of that single purchase order from Nutra Pharma 

Corporation to BioGenus is attached as Exhibit A hereto. Accordingly, Avini lacks standing to 

sue, and thus lacks subject matter jurisdiction for the instant suit, because it has not yet ordered a 

single Product under the Agreement. Under this set of established facts, Avini has not suffered an 

injury in fact. While Avini’s FAC was amended to allege that Avini and BioGenus extraneously 

and orally agreed that “purchase orders would be made by Nutra Pharma on Plaintiff’s behalf,” 

this parol evidence, not contained within the four corners of an integrated contract, cannot cure the 

defects of Avini’s first complaint. Avini and Nutra Pharma Corporation are sperate and distinct 

legal entities, such that one entity does not have standing to enforce the rights of another. (D.E. 

18, FAC, ¶ 29). 

Second, Avini claims that under Section 7 of the Agreement, BioGenus is required to offer 

Avini a first right of refusal for all new BioGenus products to sell in the Territory (as defined by 

the Agreement) through the channel of trade (as defined in the Agreement).1

 The FAC avers that 

1

 BioGenus disputes Avini’s interpretation of this section of the Agreement, but for purposes of 

this motion will, for the sake of argument, use Avini’s flawed interpretation. 

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BioGenus has a new REDOX product for sale that it has not yet offered to Avini, thereby breaching 

the Agreement. (D.E. 18, FAC, ¶¶ 10–25). However, like Avini’s first attempt to alleged breach 

of contract, Avini has not suffered an injury in fact. Importantly, BioGenus is not presently, nor 

has it yet been capable of commercially manufacturing or selling a new, but still under 

development, REDOX product. BioGenus is not, and has never been, in possession of equipment 

and technology capable of producing the anticipated REDOX product on a scale sufficient to meet 

the demands as alleged in Avini’s FAC. In short, BioGenus does not have, nor has it ever had, a 

new product to offer to Avini. BioGenus has made small samples of a REDOX product it has under 

development and has provided samples to a few people for testing purposes only. But there can be 

no injury in fact, because there is no product that can be offered to Avini. Avini’s new allegations 

still do not sufficiently raise a plausible claim for relief sufficient to withstand a motion to dismiss. 

Instead, Avini makes conclusory allegations that “[s]everal of these distributors have confirmed 

such sales to Plaintiff,” without offering even rudimentary factual support, e.g., names or identities 

of these distributors, quantities of the new REDOX they allegedly purchased, the cost of the 

alleged new REDOX, and/or any specific dates on which the new REDOX was allegedly sold. 

(D.E. 18, FAC, ¶ 23). Avini’s conclusory allegations are not sufficient in the face of Defendant’s 

sworn declaration (attached hereto) to rehabilitate its first pleading. 

Based on the foregoing, Avini does not have standing to bring the instant action for breach 

of contract and has failed to allege a ripe, justiciable case or controversy. Avini’s FAC should thus 

be dismissed pursuant to Federal Rule 12(b)(1). 

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II. Avini Lacks Subject Matter Jurisdiction to Bring the Instant Action 

A. Subject Matter Jurisdiction Does Not Exist Where a Party Has Not Suffered 

Injury in Fact; Lack of Subject Matter Jurisdiction Requires Dismissal and 

Cannot be Remedied

Article III of the Constitution limits the jurisdiction of federal courts to consideration of 

actual “cases” and “controversies.” U.S. Const Art. III § 2. The “triad of injury in fact, causation, 

and redressability constitutes the core of Article III’s case-or-controversy requirement, and the 

party invoking federal jurisdiction bears the burden of establishing its existence.” Stalley ex rel. 

U.S. v. Orlando Reg’l Healthcare Sys., Inc., 524 F.3d 1229, 1232 (11th Cir. 2008). “[F]irst and 

foremost, there must be alleged ... an injury in fact – a harm suffered by the plaintiff that is concrete 

and actual or imminent, not conjectural or hypothetical.” Id. (citations and quotations omitted). 

Thus, “a plaintiff without an injury in fact lacks Article III standing, and the federal courts do not 

have subject matter jurisdiction over his or her complaint.” Id. 

Instead, federal courts possess only that power authorized by Constitution and statute. See 

Bender v. Williamsport Area Sch. Dist., 475 U.S. 534, 541 (1986). A cause of action is 

presumptively outside this limited jurisdiction until it is demonstrated otherwise. See Kokkonen v. 

Guardian Life Ins. Co. of Am., 511 U.S. 375, 377 (1994). Therefore, the burden of establishing

jurisdiction rests upon the party asserting it. See id.; see also McNutt v. Gen. Motors Acceptance 

Corp., 298 U.S. 178, 182–83 (1936). Because federal courts are “powerless to act beyond [their] 

statutory grant of subject matter jurisdiction, a court must zealously insure that jurisdiction exists 

over a case.” Smith v. GTE Corp., 236 F.3d 1292, 1299 (11th Cir. 2001). When a federal court 

concludes that it lacks subject matter jurisdiction, “the court must dismiss the complaint in its 

entirety.” Arbaugh v. Y&H Corp., 546 U.S. 500, 514 (2006). Requisite for subject matter 

jurisdiction is standing to bring suit, and standing must be present at the inception of the lawsuit; 

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where sufficient standing does not exist at the outset, this cannot be remedied, and a case must 

promptly be dismissed, because a plaintiff would have no standing to make a motion to substitute 

the real party in interest or otherwise change its pleadings. Gonzalez ex rel. Gonzalez v. Reno, 86 

F. Supp. 2d 1167, 1279-80 (S.D. Fla. 2000); Lujan v. Defs. of Wildlife, 504 U.S. 555, 560 (1992).

In an action for breach of contract, standing to sue does not exist where a party suing on a 

contract is not the actual party that was harmed by the alleged breach of contract. In re Univ. of 

Miami COVID-19 Tuition & Fee Refund Litig., 524 F. Supp. 3d 1346, 1354–55 (S.D. Fla. 2021); 

see also Thole v. U. S. Bank N.A, 140 S. Ct. 1615, 1620 (2020). Applying this standard, even a 

corporate entity cannot exercise the rights of its subsidiary. Wright v. JPMorgan Chase Bank, N.A.,

169 So. 3d 251, 255 (Fla. Dist. Ct. App. 2015). Two business entities are not interchangeable for 

purposes of bringing or defending a lawsuit; rather, they are separate and distinct legal entities. 

Crowley Mar. Corp. v. Robertson Forwarding Co., No. 20-20151-CIV, 2020 WL 4366079, at *1 

(S.D. Fla. July 30, 2020). Thus, where one business entity itself has not suffered injury in fact, it 

does not have standing to sue for injuries allegedly suffered by another entity, even if it is a related 

entity or subsidiary. Id. 

B. Extrinsic Evidence, such as Testimony, Documents, and Affidavits, are to be 

Considered on a Motion to Dismiss for Lack of Subject Matter Jurisdiction 

A Rule 12(b)(1) motion may challenge subject matter jurisdiction based on the face of the 

pleadings or based on the actual substantive facts of the case. See Morrison v. Amway Corp., 323 

F.3d 920, 925 n.5 (11th Cir. 2003). When a defendant has made a factual challenge to subject 

matter jurisdiction, the burden is on the plaintiff to prove that jurisdiction exists. See Principal Life 

Ins. Co. v. Alvarez, No. 11 Civ. 21956, 2011 WL 4102327, at *2 (S.D. Fla. Sept. 14, 2011) (citing 

OSI, Inc. v. United States, 285 F.3d 947, 951 (11th Cir. 2002)). 

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When a defendant properly challenges subject matter jurisdiction under Rule 12(b)(1), the 

district court “is free to independently weigh facts, and ‘may proceed as it never could under Rule 

12(b)(6) or [Rule] 56.’” Morrison, 323 F.3d at 925 (quoting Lawrence v. Dunbar, 919 F.2d 1525, 

1529 (11th Cir. 1990)). In determining subject matter jurisdiction, “matters outside the pleadings, 

such as testimony and affidavits are [to be] considered.” McElmurray v. Consol. Gov’t of Augusta-

-Richmond Cnty., 501 F.3d 1244, 1251 (11th Cir. 2007) (emphasis added, citation and quotation 

marks omitted). Furthermore, “no presumptive truthfulness attaches to plaintiff’s allegations, and 

the existence of disputed material facts will not preclude the trial court from evaluating for itself 

the merits of the jurisdictional claims.” Lawrence, 919 F.2d at 1529 (emphasis added, citation and 

quotation marks omitted); see also Hames v. City of Miami, 479 F. Supp. 2d 1276, 1284 (S.D. Fla. 

2007) (“in the context of a factual challenge to jurisdiction, there is no presumption of truthfulness 

in favor of the plaintiff’s allegations and the governing standard is more akin to that of a Rule 56 

motion”). In other words, federal courts permit subject matter jurisdiction to be challenged by facts 

outside of the complaint, e.g., by receiving affidavits, evidentiary documents, etc. See Case v. 

Miami Beach Healthcare Grp., Ltd., 166 F. Supp. 3d 1315, 1317 (S.D. Fla. 2016); see also Salerno 

v. Fla. S. Coll., 488 F. Supp. 3d 1211, 1213 (M.D. Fla. 2020); see also Bloomgarden v. Allstate 

Fire & Cas. Ins. Co., 499 F. Supp. 3d 1160, 1162 (S.D. Fla. 2020). 

C. Avini’s FAC Lacks Subject Matter Jurisdiction Because It Fails to Establish 

Standing and/or any Ripe, Justiciable Case or Controversy 

As previously stated, the FAC alleges a singular cause of action based on two breaches of 

the Agreement by BioGenus: (1) that BioGenus supplied non-conforming silver nanoparticles to 

Avini, (D.E. 18, FAC, ¶ 26); and (2) that BioGenus was required, but failed to offer a new and 

improved “REDOX” product to Avini for sale (id. at ¶ 24). Avini’s cause of action, under both 

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theories of breach fails because there is no injury in fact. 

i. Avini Has Not Suffered Injury in Fact Because Avini Never Submitted a 

Purchase Order Pursuant to the Agreement 

Under the Agreement, Avini agreed to purchase (through the submission of purchase 

orders) and BioGenus agreed to manufacture and supply the Product. (D.E. 18, FAC, pg 11 at § 

2). The Agreement does not provide that any other entities could submit purchase orders for the 

Product, but Schedule A of the Agreement states that the Product would be “sold in 5 gallon tubs 

and shipped to Nutra Pharma Corporation . . . .” Id. at pg 15, Schedule A (emphasis added). 

Although product was to be shipped to Nutra Pharma Corporation, Section 2 of the Agreement 

specifically states that purchase orders would be submitted by Avini. (Id. at pg. 11 at § 2.) 

Avini attempts to rehabilitate its original Complaint by alleging in the FAC new paragraph 

29, that “Prior to entry into the Agreement, Plaintiff and Defendant discussed the role of Nutra 

Pharma with respect to the purchase/manufacture of the nano silver product and agreed that 

purchase orders thereunder would be made by Nutra Pharma on Plaintiff’s behalf.” (D.E. 18, FAC 

¶ 29). However, this allegation is based on improper parol evidence and is undermined by the 

integration clause contained within the Agreement at section 31 (D.E. 18, FAC, pg 17, § 31): 

Entire Agreement: This document represents the entire agreement between the 

parties hereto and supersedes and replaces all other agreements and negotiations 

regarding the subject matter herein, whether written or oral. This Agreement may 

only be modified in writing executed by both parties hereto. 

“Florida law, of course, recognizes the parol evidence rule.” Ungerleider v. Gordon, 214 

F.3d 1279, 1282 (11th Cir. 2000). The parol evidence rule makes “evidence of a prior or 

contemporaneous oral agreement [...] inadmissible to vary or contradict the unambiguous 

language of a valid contract.” Johnson Enters. of Jacksonville v. FPL Group, 162 F.3d 1290, 1309 

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(11th Cir.1998). This rule particularly applies when the parties intend that a written contract 

incorporate their final and complete agreement. Id. See also J.M. Montgomery Roofing Co. v. Fred 

Howland, Inc., 98 So.2d 484, 485–86 (Fla.1957). The rule is one of substantive law, not evidence, 

so it is applied by federal courts sitting in diversity. See Johnson Enters., 162 F.3d at 1309 n. 47. 

Additionally, when the terms of a contract expressly contradict plaintiff’s allegations regarding the 

contract, this renders the plaintiff’s claim implausible, thus subject to dismissal. Leader Glob. 

Sols., LLC v. Tradeco Infraestructura, S.A. DE C.V., 155 F. Supp. 3d 1310, 1317 (S.D. Fla. 2016) 

(granting a motion to dismiss complaint, holding that “[t]he terms of the [document] however, 

expressly contradict Plaintiff's allegations regarding the [agreement], rendering the claim 

implausible”). The Agreement expressly states that “During the term of this Agreement, Client 

agrees to submit Purchase Orders to Manufacturer,” (D.E. 18, FAC, pg 11, § 2), and expressly and 

plainly defines “Client” as “Avini Health Corporation” only (D.E. 18, FAC, pg 11, ¶1). Avini and 

BioGenus intended that the Agreement be the complete and final contract between them and any 

factual allegations regarding the Agreement that are not reflected in the Agreement itself may not 

be considered. 

Nutra Pharma Corporation is not a party to the Agreement. The Agreement was entered 

into and signed by only Avini and BioGenus. (See, id.) Yet, after entering the Agreement, 

BioGenus never received a purchase order from Avini, as contemplated by section 2. See 

Samuelson Dec., ¶ 6.2 The only purchase order BioGenus received was from Nutra Pharma 

Corporation dated May 25, 2022. See Exhibit A; see also Exhibit B, Samuelson Dec., ¶¶ 4–5. 

2

 A true and correct copy of the Declaration of Gary Samuelson (“Samuelson Dec.”) is attached 

as Exhibit B hereto. 

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The purchase order from Nutra Pharma Corporation was authorized by Rik Deitsch, Nutra Pharma 

Corporation’s CEO (who is not an Avini employee). See Exhibit B, Samuelson Dec., ¶¶ 4–5. 

According to the FAC, Avini alleges that it has been harmed because BioGenus supplied Product 

under the Agreement that did not meet certain specifications. See D.E. 18, FAC, ¶ 52.) However, 

Avini never submitted a purchase order and never received Product pursuant to a purchase order; 

therefore, Avini cannot have been harmed and there can be no injury in fact. In re Univ. of Miami 

COVID-19 Tuition & Fee Refund Litig., 524 F. Supp. 3d 1346, 1354–55 (S.D. Fla. 2021) (standing 

to sue does not exist where a party suing on a contract is not the actual party that was allegedly 

harmed by the asserted breach of contract). Further, Nutra Pharma Corporation is not a party to 

the Agreement and thus has no cognizable claim under the Agreement. Crowley Mar. Corp. v. 

Robertson Forwarding Co., No. 20-20151-CIV, 2020 WL 4366079, at *1 (S.D. Fla. July 30, 2020) 

(two business entities are not interchangeable for purposes of bringing or defending a lawsuit; 

rather, they are separate and distinct legal entities). Thus, Avini’s new allegations cannot save its 

claim, e.g., D.E. 18, FAC, paragraph 30, that Nutra Pharma Corporation essentially functioned as 

a drop-shipper for Plaintiff’s orders, and, e.g., D.E. 18, FAC, paragraph 36, that Nutra Pharma 

Corporation is Avini’s “affiliate,” because the entities are legally separate and distinct. Id. 

In light of the foregoing, Avini has suffered no injury in fact and possesses no standing to 

sue. Avini’s breach of contract thus claim should be dismissed for lack of subject matter 

jurisdiction. 

ii. Avini Has Not Suffered Injury in Fact Because the Alleged New REDOX 

Product Has Never Been Commercially Available for Sale 

Avini’s other allegation to support its breach of contract claim is that BioGenus refused, or 

refuses, to sell a “newer/improved” REDOX product to Avini. See D.E. 18, FAC, ¶ 24. However, 

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this too does not suffice to establish that Avini suffered an injury in fact, nor does it demonstrate 

that BioGenus breached the Agreement. BioGenus is not presently, nor has it ever been capable of 

manufacturing or selling its new, but still under development, REDOX product commercially. 

Exhibit B, Samuelson Dec., ¶ 7. BioGenus is not, and has never been, in possession of the 

equipment and technology capable of producing the still under development REDOX product on 

a scale sufficient to meet the demands as alleged in Avini’s FAC. Id. As such, BioGenus has never 

had a new product to offer to Avini, and therefore could not have breached the provision to offer 

new products to Avini, nor could Avini have suffered an injury therefrom. Id. 

BioGenus is trying to develop a new and improved REDOX product, and during this 

research and development stage, BioGenus has handed out samples to colleagues and friends to 

test the new product and provide feedback. But BioGenus has not finished its research and 

development of the new product, does not yet know if it can be sold commercially, and does not 

have the equipment or facilities to manufacture the new product for commercial distribution. Id. 

at ¶ 8. As such, there can be no breach of the Agreement and no injury in fact to Avini. 

Avini’s new allegations that “Defendant did, in fact, sell multiple bottles of the 

new/improved REDOX product to multiple of Plaintiff’s distributors – both at the July 9, 2022 

dinner and subsequent thereto. Several of these distributors have confirmed such sales to Plaintiff” 

(D.E. 18, FAC, ¶ 23) and “Plaintiff specifically asked why Mr. Samuelson was not supplying the 

new product to Plaintiff, and Mr. Samuelson responded that he wanted Defendant to be the 

exclusive seller/supplier of the product” (D.E. 18, FAC, ¶ 25) still cannot demonstrate that Avini 

did suffer an actual injury in fact when BioGenus, to date, has not finished its research and 

development of the new product, cannot presently sell it commercially, and does not have the 

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equipment or facilities to manufacture the new product for commercial distribution. Exhibit B, 

Samuelson Dec., ¶ 7. 

Additionally, even Avini’s new allegations do not suffice to save its second pleading, as 

these conclusory allegations fail to state the names of any distributors BioGenus allegedly sold the 

new REDOX to, nor provide what quantities of the new REDOX BioGenus allegedly sold, nor 

state on which dates these transactions occurred. See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 

555-57 (2007) (“[F]actual allegations must be enough to raise a right to relief above the speculative 

level...;” a pleading must contain enough fact to raise a reasonable expectation that discovery will 

reveal evidence of illegal conduct; the pleading must contain something more than a statement of 

facts that merely creates a suspicion of a legally cognizable right of action); see also Ashcroft v. 

Iqbal, 556 U.S. 662, 678 (2009) (pleading must meet the plausibility standard, which asks for more 

than a sheer possibility that a defendant has acted unlawfully; only a complaint that states a 

plausible claim for relief survives a motion to dismiss; where even well-pleaded facts do not permit 

the court to infer more than a mere possibility of misconduct, the complaint has not shown that the 

pleader is entitled to relief, and thus must be dismissed). 

Although Avini has alleged speculative future lost sales and profits for the sale of a new 

REDOX product, D.E. 18, FAC, ¶ 54), the allegations fail to invoke this Court’s jurisdiction. Risk 

of future harm, e.g., loss of future income, alone, does not suffice to establish injury in fact 

standing. See In re Mednax Servs., Inc., Customer Data Sec. Breach Litig., No. 21-MD-02994-

RAR, 2022 WL 1468057, at *7 (S.D. Fla. May 10, 2022); see also Whitmore v. Arkansas, 495 

U.S. 149, 158 (1990) (“Allegations of possible future injury do not satisfy the requirements of Art. 

III; rather, a threatened injury must be certainly impending to constitute injury in fact”) (citations 

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and quotation marks omitted). Here there is no injury in fact and no standing to bring the lawsuit. 

III. Conclusion 

For the foregoing reasons, BioGenus respectfully requests that this Court dismiss the FAC 

for lack of subject matter jurisdiction under Federal Rule 12(b)(1) as Avini has not (and cannot) 

aver or establish any basis to suggest it has suffered an injury in fact under the Agreement. 

Respectfully submitted January 31, 2023. 

 /s/ Robert H. Thornburg 

Robert H. Thornburg 

Fla. Bar No. 630829 

E-Mail: rthornburg@allendyer.com

David I. Roncayolo 

Fla Bar No. 121663 

Email: droncayolo@allendyer.com 

ALLEN, DYER, DOPPELT 

& GILCHRIST, P.A. 

1221 Brickell Ave., Suite 2400 

Miami, Florida 33131 

Telephone: (305) 374-8303 

Facsimile: (305) 374-8306 

Counsel for Defendant BioGenus LLC

CERTIFICATE OF SERVICE 

I HEREBY CERTIFY that on January 31, 2023, I electronically filed the foregoing document 

with the Clerk of the Court using CM/ECF. I also certify that the foregoing document is being served this 

day on all counsel of record, either via transmission of Notices of Electronic Filing generated by CM/ECF 

or in some other authorized manner for those counsel or parties who are not authorized to receive 

electronically Notices of Electronic Filing. 

By: /s/ Robert H. Thornburg 

 Robert H. Thornburg 

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