June 30, 2020

To whom it may concern,

The BiotechInnova TechnoWeb Medical/Surgical N95 respirator complies with all regulatory and certification requirements in the United States for use in any institution and it meets and exceeds all necessary specifications for the most critical applications. Our innovative execution and manufacturing operations will also save the buyers considerable amount of capital while providing the highest performance medical & sterile N95 currently available. It is fully approved by the FDA and far exceeds Niosh standards (see attached FDA 510K approval of this respirator as a Class 2 medical device).

In addition, we want to provide some clarity regarding the current regulatory climate which are often a source of confusion for many buyers as they try to navigate a maze of rapidly changing regulatory complexity.

Because many hospitals have been requesting NIOSH certified N95 respirators, other institutions formed the opinion that this is the highest stand of quality and performance for respirators. However, hospitals are using NIOSH certified industrial respirators out of desperation due to shortages of what they really need - medical FDA approved N95s which require much higher performance standards to be granted FDA approval. Every N95 sold at HomeDepot and any other hardware store all have NIOSH certification. In other words, many hospitals are currently using industrial N95 respirators because of extreme shortages of medical N95 respirators.

The absolute highest standard for an N95 respirator for healthcare workers and the highest standard in general, are respirators that are FDA approved as a medical device under a 510K clearance. One of the

RE: Higher certification level than NIOSH & NIOSH status update

main differences is that industrial NIOSH certified N95s only filter contaminated air. But they do not provide splash resistance or effective protection from microorganisms. Whereas an FDA approved Class 2 medical device must provide splash resistance (in addition to all the performance parameters offered by industrial N95s); meaning that if a bodily fluid (for example, blood) sprays on a the wearers face, the bodily fluid will not penetrate through the mask. Ordinary NIOSH certified N95s do not offer this protection and in this example the wearer can get much more serious infection and illness than COVID-19.

The FDA specifically states after extensive testing and review of all scientific data related to the BiotechInnova TechnoWeb N95: ”This respirator is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material".

In addition, the 510K the FDA indicates that the BiotechInnova TechnoWeb N95 is medically equivalent to the 3M 1805 NIOSH certified N95. Medical equivalence means that the respirator must be at least as good or better than the predicate device (the 3M). In addition to these very high performance standards, the BiotechInnova TechnoWeb N95 respirator uses a nano technology material (NanoTec fiber, covered by 6 patents) which filters particles down to 0.1 microns while all other N95 respirators (medical and non-medical) filter down to only 0.3 microns. It is worth mentioning that the COVID-19 viral particle is approximately 0.12 microns in diameter. The other advantage is that the NanoTec fiber is extremely light and comfortable to wear. The wearer can use it for many hours without feeling the typical fatigue that starts to set in after about 15 - 30 minutes with an ordinary N95. Another important feature is that ordinary N95 performance degrades with time due to the breakdown of electrostatic forces due to build up of humidity (with every exhalation), which allows small particles to penetrate through after several hours of use. However, the NanoTec fiber is not affected by humidity and its filtration

performance remains constant over time. Its the same after many hours of use as it was when the wearer first puts it on.

The predicate device used by the FDA to establish medical equivalence was the 3M 1805 which is itself a higher performance and more costly respirator than the 3M 1860. Accordingly, the BiotechInnova TechnoWeb medical N95 respirator exceeds all specifications of the 3M 1860 while being much more comfortable to wear for long periods of time with no fatigue. The BiotechInnova TechnoWeb N95 also features a dual wearing mode allowing the user to use it with ear loops (which have an optimized geometry so as to not cause any pull or fatigue after long term use) or with bands behind the head as a more traditional N95.

In conclusion, the BiotechInnova TechnoWeb N95 is the highest performance medical N95 respirator that complies with all federal and international regulations, is fully approved by the highest medical authority in the United States (FDA), and is precisely the kind of respirator that is experiencing the most extreme shortages, extraordinarily difficult to obtain. It is the most ideal solution for all critical needs that can be supplied quickly, provide the highest possible protection, and will be extremely comfortable to wear for all frontlines workers.

Finally, please note that BiotechInnova is US brand and a US company with product manufactured to our very high standards and specifications and we carry liability insurance through Hartford. The manufacturing facility is our joint venture partner, Finetex, a multi-billion dollar publicly traded company listed on the KOSDAQ (South Korean stock exchange). Finetex employs hundreds of scientists and has been developing proprietary nano technology materials for close to a decade.

Based on our continued R&D efforts and testing, this is by far the most advanced medical N95 respirator that can be supplied at significant quantities quickly and has the highest level of approval.

In addition to the above, please note that although NIOSH certification is not needed (because FDA approval surpasses NIOSH approval standards), the BiotechInnova TechnoWeb N95 is in NIOSH pending status and has already passed and surpassed all NIOSH testing criteria. Our filing for NIOSH certification is an effort to avoid the extensive discussions and education required to clarify to many of our clients that NIOSH certification is irrelevant and not needed.

The documentation below clearly shows the current status of the NIOSH certification for the BiotechInnova Medical/Surgical N95. In particular, please see attached letter from Keller Asebey, one of the most prominent FDA & Life Sciences law firms in the United States that exclusively specializes in biotechnology and medical devices.

1

June 26, 2020 Daniel Khesin Biotech Innova, Inc. 9858 Clint Moore Road, Suite 111 Boca Raton, FL 33496

RE: NIOSH Certification for BiotechInnova’s TechnoWeb N95 Surgical Mask

Dear Mr. Khesin:

Through this communication we confirm that on June 13, 2020 Biotech Innova, Inc. (“BiotechInnova”) engaged our law firm, Keller Asebey Life Science Law PLLC (d/b/a for Edgar J. Asebey, P.A.) (“Firm”) to expedite CDC/NIOSH certification for its TechnoWeb N95 Surgical Mask (“the Mask”). It should be noted that the Mask received U.S. Food & Drug Administration (“FDA”) 510(k) Class II medical device clearance on May 18, 2018. As your company now seeks N95 Certification from NIOSH for the mask, BiotechInnova has recently provided our firm with over 200 pages of technical data supporting an application for certification of the Mask to NIOSH. Most importantly, you have provided our firm testing results for the two most important performance tests required for NIOSH Certification, the Inhalation / Exhalation Test and the Sodium Chloride Test. These tests were performed by Nelson Laboratories of Mission, Texas. The results of these tests were excellent, particularly the Inhalation/Exhalation Test which showed better performance than the 3M 1805 mask. Based on my experience, I believe the Masks easily qualify for NIOSH Certification and I estimate that it will take approximately 45 to 60 days to obtain NIOSH Certification. Please note that NIOSH application review times vary and this is something out of our control. Please do not hesitate to contact me if you have any additional questions. Best regards, Edgar J. Asebey, Esq. Managing Partner

Sponsor: Suk Joong Kwon

AJ Global, LLC / Lime nano, Inc 3711 Santa Inez St.

Mission, TX 78572

Robert Dieker electronically approved for 27 May 2020 19:21 (+00:00) Study Director Curtis Gerow Study Completion Date and Time

801-290-7500 | nelsonlabs.com | sales@nelsonlabs.com myf FRT0145-0001 Rev 3

Page 1 of 2

These results apply to the samples as received and relate only to the test article listed in this report. Reports may not be reproduced except in their entirety. Subject to NL terms and conditions at www.nelsonlabs.com.

Determination of Inhalation and Exhalation Resistance for Air-Purifying Respirators Final Report

Test Article: Nano Inhalation and Exjalation Purchase Order: Nano2015precert_Niosh

Study Number: 1298149-S01 Study Received Date: 11 May 2020

Testing Facility: Nelson Laboratories, LLC 6280 S. Redwood Rd. Salt Lake City, UT 84123 U.S.A.

Test Procedure(s): Standard Test Protocol (STP) Number: STP0145 Rev 05 Deviation(s): None

Summary: This procedure was performed to evaluate the differential pressure of non-powered air-purifying particulate respirators in accordance with 42 CFR Part 84.180. The air exchange differential or breathability of respirators was measured for inhalation resistance using NIOSH procedure TEB-APR-STP-0007 and exhalation resistance with NIOSH procedure TEB-APR-STP-0003. The differential pressure technique is a simple application of a basic physical principle employing a water manometer differential upstream and downstream of the test material, at a constant flow rate.

According to 42 CFR Part 84.64, pretesting must be performed by all applicants as part of the application process with NIOSH. Results seen below are part of that pretesting and must be submitted to and accepted by NIOSH for respirator approval.

The inhalation resistance criteria as stated in 42 CFR Part 84.180 is an initial inhalation not exceeding 35 mm water column height pressure. The test articles submitted by the sponsor conform to this NIOSH criterion for airflow resistance.

The exhalation resistance criteria as stated in 42 CFR Part 84.180 is an initial exhalation not exceeding 25 mm water column height pressure. The test articles submitted by the sponsor conform to this NIOSH criterion for airflow resistance.

All test method acceptance criteria were met. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.

Study Number 1298149-S01 Determination of Inhalation and Exhalation Resistance

for Air-Purifying Respirators Final Report

801-290-7500 | nelsonlabs.com | sales@nelsonlabs.com myf FRT0145-0001 Rev 3

Page 2 of 2

Results:

Test Article Number Inhalation Resistance (mm H2O) Exhalation Resistance (mm H2O)

1 8.5 7.8

2 8.3 7.8

3 8.1 7.6

Test Method Acceptance Criteria: The resistance measurement for the reference plate must be within ± 3 standard deviations of the mean established in the control chart.

Procedure: A complete respirator was mounted to a test fixture comprised of a metal plate with an approximate 3.5 inch diameter hole in the center to allow airflow to reach the mask. The sample holder was assembled by placing a Plexiglas collar around the test fixture and topping with another metal disc with a 3.5 inch opening in the center. The sample holder is held tightly together with clamps and connected to an air source. The manometer is attached to the sample holder by a connection port on the Plexiglas collar.

Before testing, the manometer was zeroed and the back pressure in the sample holder checked and verified to be acceptable. Resistance measurements were taken with a manometer capable of measuring at least 6 inches of water. For inhalation testing, a negative airflow (vacuum) was applied. For exhalation testing, a positive airflow (compressed air) was used. Airflow was passed through the sample holder at approximately 85 ± 2 liters per minute (L/min).

Sponsor: Suk Joong Kwon

AJ Global, LLC/Lime Nano, Inc 3711 Santa Inez St.

Mission, TX 78572

Robert Dieker electronically approved for 31 May 2020 21:33 (+00:00) Study Director Curtis Gerow Study Completion Date and Time

801-290-7500 | nelsonlabs.com | sales@nelsonlabs.com dh FRT0014-0002 Rev 6

Page 1 of 3

These results apply to the samples as received and relate only to the test article listed in this report. Reports may not be reproduced except in their entirety. Subject to NL terms and conditions at www.nelsonlabs.com.

Sodium Chloride (NaCl) Aerosol Test Final Report

Test Article: Nano NaCl Purchase Order: Nano2015precert_Niosh

Study Number: 1298150-S01 Study Received Date: 11 May 2020

Testing Facility: Nelson Laboratories, LLC 6280 S. Redwood Rd. Salt Lake City, UT 84123 U.S.A.

Test Procedure(s): Standard Test Protocol (STP) Number: STP0014 Rev 09 Deviation(s): None

Summary: This procedure was performed to evaluate particulate filter penetration as specified in 42 CFR Part 84 and TEB-APR-STP-0059 for requirements on a N95 respirator. Respirators were conditioned then tested for particle penetration against a polydispersed, sodium chloride (NaCl) particulate aerosol. The challenge aerosol was dried, neutralized, and passed through the test article at a concentration not exceeding 200 mg/m3. The initial airflow resistance and particle penetration for eachrespirator was determined.

According to 42 CFR Part 84.64, pretesting must be performed by all applicants as part of the application process with NIOSH. Results seen below are part of that pretesting and must be submitted to and accepted by NIOSH for respirator approval.

All test method acceptance criteria were met. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.

Study Number 1298150-S01 Sodium Chloride (NaCl) Aerosol Test Final Report

801-290-7500 | nelsonlabs.com | sales@nelsonlabs.com dh FRT0014-0002 Rev 6

Page 2 of 3

Results: The NIOSH N95 filter efficiency as stated in 42 CFR Part 84.181 is a minimum efficiency for each filter of ≥95% (≤5% penetration). The test articles submitted by the sponsor conform to the NIOSH N95 criteria for filter efficiency.

Test Article Number Correcteda Initial Airflow

Resistance (mm H2O)

Maximum Particle Penetration

(%)

Filtration Efficiency (%)

1 12.2 2.16 97.84

2 13.4 2.07 97.93

3 11.9 2.13 97.87

4 11.6 1.96 98.04

5 11.9 2.26 97.74

6 11.5 2.00 98.00

7 11.8 2.49 97.51

8 12.0 1.86 98.14

9 11.7 1.96 98.04

10 12.8 1.76 98.24

11 12.6 1.87 98.13

12 11.9 1.84 98.16

13 13.0 1.71 98.29

14 12.1 1.74 98.26

15 11.8 1.75 98.25

16 11.9 1.86 98.14

17 12.4 1.81 98.19

18 13.9 1.71 98.29

19 13.9 1.70 98.30

20 16.4 1.77 98.23 a The final airflow resistance value for each test article was determined by subtracting out the background resistance from the system.

Test Method Acceptance Criteria: The filter tester must pass the “Tester Set Up” procedure. The airflow resistance and particle penetration of the reference material must be within the limits set by the manufacturer.