0001193125-19-129335.txt : 20190430 0001193125-19-129335.hdr.sgml : 20190430 20190430161204 ACCESSION NUMBER: 0001193125-19-129335 CONFORMED SUBMISSION TYPE: 1-K PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20181231 FILED AS OF DATE: 20190430 DATE AS OF CHANGE: 20190430 FILER: COMPANY DATA: COMPANY CONFORMED NAME: LunaDNA, LLC CENTRAL INDEX KEY: 0001741687 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMPUTER PROCESSING & DATA PREPARATION [7374] IRS NUMBER: 830631362 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 1-K SEC ACT: 1933 Act SEC FILE NUMBER: 24R-00186 FILM NUMBER: 19781834 BUSINESS ADDRESS: STREET 1: 415 SOUTH CEDROS AVENUE STREET 2: SUITE 260 CITY: SOLANA BEACH STATE: CA ZIP: 92075 BUSINESS PHONE: 858 299-4669 MAIL ADDRESS: STREET 1: 415 SOUTH CEDROS AVENUE STREET 2: SUITE 260 CITY: SOLANA BEACH STATE: CA ZIP: 92075 FORMER COMPANY: FORMER CONFORMED NAME: LunaTrust LLC DATE OF NAME CHANGE: 20180523 1-K 1 primary_doc.xml 1-K LIVE 0001741687 XXXXXXXX N N 12-31-2018 Annual Report 12-31-2018 4110 Campus Point Court San Diego CA 92130 888-299-4669 Limited Liability Company Interests LunaDNA, LLC 0001741687 DE 82-0631362 true PART II 2 d709594dpartii.htm PART II PART II
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 1-K

ANNUAL REPORT

ANNUAL REPORT PURSUANT TO REGULATION A OF THE SECURITIES ACT OF 1933

For the fiscal year ended December 31, 2018

LunaDNA, LLC

(Exact name of registrant as specified in its charter)

Commission File Number: 024-10903

Delaware   82-0631362

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

4110 Campus Point Court

San Diego, CA

(Address of principal executive offices)

 

92121

(Zip Code)

(858) 299-4669

Registrant’s telephone number, including area code

Limited Liability Company Interests

(Title of each class of securities issued pursuant to Regulation A)


Table of Contents

TABLE OF CONTENTS

Statement Regarding Forward-Looking Information

     3  

Business

     4  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     17  

Directors and Officers

     18  

Security Ownership of Management and Certain Securityholders

     21  

Interest of Management and Others in Certain Transactions

     22  

Other Information

     22  

Index to Financial Statements

     22  

Exhibits

     35  

 

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Part II.

STATEMENT REGARDING FORWARD-LOOKING INFORMATION

We make statements in this Annual Report on Form 1-K (“Annual Report”) that are forward-looking statements within the meaning of the federal securities laws. These forward-looking statements contain information about our expectations, beliefs or intentions regarding our business, financial condition, results of operations, strategies or prospects, and other similar matters. These forward-looking statements are based on management’s current expectations and assumptions about future events, which are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict. These statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning.

Many factors could cause actual results to differ materially from those in forward-looking statements. Unknown or unpredictable factors that could also adversely affect our business, financial condition and results of operations may arise from time to time. The forward-looking statements discussed in this report may not prove to be accurate. Accordingly, you should not place undue reliance on these forward-looking statements, which only reflect the views of management as of the date of this Annual Report. We undertake no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results or expectations, except as required by law.

 

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  Item 1.

Business

Our Company

LunaDNA, LLC, which we refer to as LunaDNA, our Company, we, us or our, is building the world’s first and largest human health database that is owned by a community comprised of its members, which we refer to as the Database. Our Database is comprised of self-contributed genomic, phenotypic, medical, health and related data satisfying our requirements, which we refer to as Member Data. Through community participation, we aim to create a dynamic, secure, and longitudinal Database along with a supporting ecosystem geared towards the improvement of human health. By making the Database available, with our members’ consent, to researchers, we aim to facilitate discoveries which lead to new treatments, increased actionability, and greater predictive power of genomic information for disease and wellness applications. The personal health impact, societal health benefits, and economic value that can be created through clearer associations between genomics and health outcomes can be realized in a myriad of ways, including accelerating toward an era of precision medicine and preventative healthcare.

We are a limited liability company managed by LunaPBC, Inc., a Delaware public benefit corporation, which we refer to as our Manager. We issue unit-denominated common limited liability company interests to our members, which we refer to as shares. Unlike the holders of common stock in a corporation, our shareholders have very limited rights, as described in further detail under “Securities Being Offered” on page 36 of our offering circular dated December 3, 2018, which we refer to as the Offering Circular, and have no right to control our operations. We believe that keeping our platform attractive will include, but will not be limited to, managing our Company in a manner that maximizes funds for distributions to our members no less frequent than annually. However, we do not guarantee the frequency or amount distributions to our members, and as discussed at “Our Limited Liability Company Operating Agreement—Distributions and Dividends” on page 42 of our Offering Circular, our Manager has control over the frequency and amount of distributions.

On December 5, 2018, we commenced principal operations and admitted a person other than our Manager as a member. As of April 26, 2019, we have issued 19,068 shares, with an additional 6,580 shares earned but not yet issued.

Recent Developments – Genetic Alliance Partnership

In January 2019, our Manager entered into a Master Agreement, or the Agreement, with Genetic Alliance, or GA, a non-profit organization, in order to merge GA’s Platform for Engaging Everyone Responsibly engagement platform, or PEER, with our Database, once the Database IP contains PEER equivalent functionality. The initial term of the Agreement ends on the fifth anniversary of the date on which both parties agree in writing that the Database IP substantially contains PEER equivalent functionality. We currently estimate that the term will start by the end of 2019.

PEER is an award-winning technology solution for collecting health data directly from individuals. In 2015, PEER was honored by the White House as one of nine leading platforms in the advancement of precision medicine. PEER gives individuals complete control over how their PEER data is shared for research. Organizations and communities interested in using PEER to collect individual health data for a specific purpose do so by creating customized registries. Currently, PEER is used by 45 disease communities representing approximately 50,000 individual participants. The GA network includes more than 1,200 disease-specific advocacy organizations, as well as reaches over 10,000 universities, private companies, government agencies, and public policy organizations.

Pursuant to the Agreement, our Manager granted a non-exclusive, non-transferable license to GA to use the Database IP that contains PEER equivalent functionality for so long as the Agreement is in effect. Additionally, GA granted our Manager a non-exclusive license to use the PEER application and PEER data during the term of the Agreement, subject to various restrictions.

Pursuant to the Agreement, GA is transitioning stewardship of PEER data to our Manager. GA and our Manager hope to facilitate the ultimate use of a more functional integrated database, which includes both our Database and PEER data, by researchers or other third-party users. The Agreement also calls for GA and our Manager to negotiate a value sharing arrangement with GA in connection with success generated through the efforts of GA. Such efforts of GA may include ongoing enrollment, support, and sustaining of GA partners and GA’s efforts with PEER participants to increase engagement in research studies. We currently contemplate that certain expenses of hosting the PEER data will be the responsibility of our company after March 31, 2020 under our Management Agreement.

PEER participants will also be able to join the LunaDNA community and be eligible to receive shares when contributing their Member Data to the Database, subject to local regulations or laws, such as those governing securities, data rights, or data privacy.

The Agreement may be terminated by either party for convenience upon 18 months’ advance written notice or sooner upon material, uncured default.

Implementation of the Agreement is subject to technical and operational uncertainty, and the goal of merging of our Database with the PEER database may not happen within the contemplated time frame, or at all.

Genomics Opportunity

The application of genomics is relevant at many points during an individual’s life (see Figure 1). We envision a future where everyone’s genomic information is individually owned and referenced at many stages of life—from planning a baby, to

 

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determining the medication that is best suited to the individual’s unique biology, through managing disease and maximizing wellness. Scientific and medical research has made clear that the information encoded in our genome will be able to help individuals—as patients and personal health advocates—understand inherent health strengths and provide insights into possible health risk factors, equipping individuals and their health practitioners to approach preventative healthcare strategies and lifestyle decisions more informatively. Genomic data can also provide an assessment on the impact of lifestyle on an individual’s biology.

 

LOGO

Figure 1. Timeline of Sequencing Applications in Medicine from Pre-Womb to Tomb

Despite advances in genomics technology that make genome sequencing more accessible than ever from a cost perspective (see Figure 2), modern science, research and medicine are still far from broad and lifelong adoption of genomic information for many reasons, including information complexity, reimbursement of genomics by payers, and lack of common frameworks around data interpretation, usage, and management. One of the most powerful challenges to the genomics trajectory and impact opportunity, especially in the healthcare system, is that genomic information is largely regarded as not actionable or predictive enough due to limited scientific research. To unlock the power of the genome and its potential for discovery, science, research, and medicine, we must create a new platform for research.

Genomics data is now plentiful, as described in “Leveraging Intersecting Trends” below. The true issue is data aggregation and organization to enable discovery, which is why we are building the Database.

 

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LOGO

Figure 2. Cost per ‘draft’ whole human genome sequence, National Human Genome Research Institute

Unlocking the Potential for Discovery

The Database aims to address four primary issues that have hindered genomics research:

 

  1.

The scale and scope of discovery datasets have been insufficient for discovery and broad applicability of discoveries to the widest population. Researchers require more samples, more data types (DNA, phenotype, health history, lifestyle, environment, nutrition), and greater diversity (gender, ethnicity, age, socioeconomic).

 

  2.

The data in databases have lacked a harmonized structure; they cannot be aggregated for calibrated and reproducible discoveries.

 

  3.

Data is siloed and will likely remain isolated, despite calls to share data. Most institutional incentives and business models are to retain data because that’s what their business or laboratory was established to do and what their members and stakeholders expect them to do; moreover, in many instances, consent was not granted from the individual to release their data for research.

 

  4.

People have been treated as specimen sources and not holders of tremendous value for medical research. Genomic research has been disease-centric as opposed to being people-centric. People care about their holistic health, which includes both prevention (to maximize wellness) and treatment (during sickness). The current health industry rewards only disease treatments. We believe that people hold valuable health information and should be treated as research partners and recognized and rewarded for their contributions to our mission.

People-Centric Model

When enabled, we feel that individuals will seek involvement as research partners with the opportunity to fight disease, especially if they are managing a chronic condition. In addition to the need to accelerate our understanding and treatments of common complex disease, approximately 7,000 different types of rare disease and disorders afflict 30 million people in the United States that remain a mystery. Similar to the United States, Europe has approximately 30 million people living with rare diseases, and an estimated 350 million people worldwide suffer from rare diseases. Healthy people also bring tremendous research value, not only as controls in disease study, but also as study subjects to understand how they have avoided disease.

 

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We are aiming to unlock the power of the genome by unlocking the potential for discovery with the largest aggregation of genomic and health data ever assembled. By engaging individuals proactively and responsibly, our goal is to facilitate purpose-driven deep engagement that will lead to an information-rich, active, and longitudinal data community. Through a silo-free, people-centered effort, we aim to achieve the scale and scope to enable research for a wide range of diseases, both common and rare, as well as increase our understanding of healthy states. We believe a flexible platform of magnitude architected with smart contract capability and technical extensibility to ingest data associated with new monitors of health states (e.g., wearables) will have the statistical power to reveal the genomic underpinnings of many diseases and also to detect associations between nutritional, environmental, or other exposures to health outcomes.

Market Background

The Genomics Era

On June 26, 2000, in the East Wing of the White House, United States President William J. Clinton and British Prime Minister Tony Blair announced the successful completion of the first whole human genome sequence. This groundbreaking scientific achievement, called the Human Genome Project, encompassed over 10 years and cost $2.7 billion to complete. Sequencing a human genome heralded a new era for understanding and treating human disease based on the fundamental building blocks of life – DNA. With the sequence of the human genome in hand, the next step was to identify the genetic variants that increase the risk for common diseases like cancer and diabetes. The vision was that if the underpinnings of disease could be decoded, then precision or personalized medicine would be possible.

The State of Genomic Discovery

Genomics is the study of the function and the evolution of genomes. In humans, this typically refers to the 23 pairs of chromosomes and mitochondrial DNA that make up the full complement of DNA present in every cell. Many hereditary diseases, such as Huntington’s Disease, as well as other conditions, can be traced back to specific gene mutations observable in the DNA code. To date, genomic research studies have identified genetic causes of hundreds of traits and diseases, including breast cancer, high cholesterol, rheumatoid arthritis, schizophrenia, height, atrial fibrillation, and responses to various medications. These studies not only provide diagnostic value for families and individuals but, moreover, provide meaningful insights into gene function and disease mechanisms that enable better drug design and targeted treatments.

During the last decade, genome-wide association studies (GWAS) that utilize common variants in our genome, instead of analyzing the whole genome, have emerged as the primary method of discovering genetic variants associated with complex traits and disease. The GWAS approach was utilized primarily due to economics. The measurement of hundreds of thousands of common variants in our genome was more than one-thousand times less costly than acquiring 3.3 billion bases in whole genome sequencing studies. Unlike traditional linkage mapping approaches, which are based on analyzing patterns of disease inheritance in families, GWAS is based on the observation that common polymorphic genetic markers that are close to a causative disease allele are often statistically associated with disease status in large cohorts of unrelated individuals.

A major strength of GWAS is its ability to locate causative genetic variants with fine-scale resolution. However, GWAS requires obtaining and analyzing data from large numbers of samples. In many cases, data from tens of thousands of individuals are required to achieve adequate statistical power.

Although GWAS studies have successfully identified thousands of common genomic variants that contribute to diseases, each variant rarely accounts for more than a small fraction of disease causation. The full genome, including rare genomic variants detected through direct DNA sequencing, the microbiome, the epigenome, and other environmental factors are together thought to explain the vast majority of disease impacting human health. Detailed genome sequencing of millions of individuals will be required to fully understand genetic contributions to disease and health. While large amounts of genomic and other data are freely available from public databases such as the National Center for Biotechnology Information (NCBI), in general, such data have been of little interest to the pharmaceutical industry due to the high variation in data quality and standards of data encoding. To meet these criteria, pharmaceutical companies typically rely on data collected in-house.

In summary, the causes of many genetic diseases remain stubbornly hidden despite advances in technology to read whole genomes of individuals cost-effectively. We envision that the scope, scale, and harmonized data architecture of the Database will help reveal genotype-phenotype associations that otherwise could not be found due to lack of statistical power and/or data interoperability.

 

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Precision Medicine

Precision medicine proposes to invert the healthcare framework by recognizing that each patient is biologically unique. Rather than clinical trials to determine whether a therapy is safe and effective for most of the population before it is available to all of the population, personalized medicine applies technology to big data to investigate whether therapies will be effective for that specific patient and, equally important, if it will not be effective and potentially harmful for that patient.

This distinction is important because diseases are unique to the individual. Diseases manifest and progress differently in different people, and treatments that are effective for one person may fail altogether for another. The promise of precision medicine is that patients will respond to targeted therapies and avoid the all too common, ineffective, costly, and often damaging treatment regimen. The cost of “imprecise” medicine has been well documented (see Figure 3).

 

LOGO

Figure 3. Personalized medicine: Time for one-person trials

 

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Our DNA represents a “barcode” that is individually unique and can be leveraged in precision medicine and health. Futurists project that everyone will have genome information as a resource, on file and actionable, before they get sick so that it can be leveraged to maximize the health strengths that individuals naturally possess, while avoiding an individual’s inherent health weakness through lifestyle decisions. Precision medicine will increasingly leverage advances in big data to analyze large amounts of genomic data and apply the understanding gained to individual diseases and treatment. As stated, for centuries, the engine of medicine has been the clinical trial that poses the central question, “what is effective for most people?”. Genomic data and the technology developed to compute, analyze, and understand these data is increasingly regarded as the engine of medicine going forward.

We believe that the research enabled by our Database will drive the development and application of more genome-guided therapeutics, ensuring that the right medicine is given to the right patient at the right time.

The DNA-Aware and Data-Engaged Consumer

The popularity of the direct-to-consumer (DTC) genetic testing market segment signals an ever-expanding paradigm shift among consumers who are seeking more individualized health insights and greater control over their own healthcare.

Since the 1980s, consumers have pushed for access to their laboratory results, but access became slow to evolve due to concerns by doctors and regulators that consumers may try to self-diagnose without understanding the complexity of the data. With advances in genetic testing technology at accessible cost points and the mainstream nature of personalized medicine, DTC laboratory testing is becoming increasingly popular—attributed in part to actress Angelina Jolie’s op-ed in The New York Times in May 2013 called ‘My Medical Choice,’ which documents her medical decisions based on BRCA1 gene mutations and family history of cancer. Likewise and following suit, consumers are becoming health hobbyists and self-quantifiers, taking individualized healthcare into their own hands. Consumers have become medical consumers as well as patients. This has created a shift in the doctor/patient relationship as individuals have become more knowledgeable about their own health, view themselves as unique biologically in a one-sizefits all healthcare system, and want more control over their personal information and treatment decisions.

Almost 20 years since the Human Genome Project, consumer-directed genomic testing has become practically routine with over 12 million individuals purchasing genetic tests ranging from entertaining applications in genealogy and wellness to genetic profiling of tumors to provide targeted treatment guidance. A January 2018 report from market research firm Kalorama Information estimates that the consumer market for genetic health testing alone could nearly triple from about $99 million in 2017 to $310 million in 2022.

As technological advances continue to drive down the costs of genome sequencing, from approximately $1,000 per genome today to $100 or less within the next few years, there will be an increasing availability of this highly valuable health data. Several trends are continuing to shape the DTC market including the growing demand for maximizing wellness, early disease detection and diagnosis, personalized medicine, importance of disease monitoring, and expanded digital monitoring and sensing technologies. In addition, consumer-directed but physician mediated genomic tests are emerging with companies like Veritas Genetics partnering with healthcare systems like the Mayo Clinic.

Privacy, Security, and Trust

Arguably, no data is as personal as an individual’s own genome—the essential blueprint of each individual’s life, and, to an extent, each individual’s family. Privacy concerns are paramount in the design of any biomedical study involving human participants and especially genomics. These concerns arise from the many potential abuses of personal genetic and medical data, including denial of healthcare services due to genetic predispositions, racial discrimination, and disclosure of intimate familial relationships such as non-paternity.

In current practice, privacy is typically protected by concealing the identities of study participants, while certain types of de-identified data are shared freely. Standard data security controls are often sufficient for protecting identity data itself, but in many cases the freely-shared component remains vulnerable to misuse. For example, advances in re-identification techniques have made it possible to infer surnames from certain types of genetic data. For this reason, genomic data and pre-defined aspects of one’s personal information are not shared publicly by data aggregation efforts, even when de-identified.

There are a variety of reasons people participate in biomedical studies. Some reasons may be personal, such as the desire to know one’s ancestry and disease predispositions. Other motivations may be broader or more altruistic, such as the desire to

 

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improve human health and society. In all cases, there must exist a level of trust between the research participant and the investigators that they are pursuing a shared goal. Unfortunately, failure of researchers to maintain the trust of study participants can have lasting negative effects on science as a whole.

A notable example is the 2010 legal battle between the Havasupai tribe and Arizona State University that ensued after researchers used genetic data collected from tribe members to study sensitive topics outside the perceived scope of the project (type 2 diabetes), such as inbreeding, demographic history, and schizophrenia. Further eroding public trust in research activities is the fact that many pharmaceutical and biotech companies forgo an open, collaborative approach to research and development for strategic reasons because they estimate its benefits are outweighed by legal, regulatory, and intellectual-property risks. The perceived lack of transparency and sense of common purpose often discourages study participants from providing broad consent to use their data in these cases. Trust remains a significant factor in individuals both consenting to studies and providing important health and medical data.

Privacy, security, and trust are core pillars of the Database and are reflected in our team, mission, transparency, and the technology we are using to ensure the best possible management and maintenance of information. It is important to note that we, unlike others who are brokering sale of individuals’ data, will be marketing discovery based on de-identified metadata.

Research Participant Consent

Nearly all medical research requires some form of informed consent by, or on behalf of, the research participant. In this process, the individual enrolling in the study provides their voluntary agreement to participate in the research, and understands the risks associated with their participation. Sometimes the field of the informed consent is very narrow, such as in clinical trials for pharmaceutical companies interested in deep, focused studies of a particular biological function or disease. In other cases, the consent can be broad, enabling future exploratory studies into research questions that are yet to be defined. Occasionally, data collected as part of a research study can be shared and/or re-examined by other investigators for a secondary study. In practical terms, this variability means the usefulness of a collection of data sets is circumscribed by the subset with the narrowest terms of consent. This presents a clear scalability problem and limits the utility of historical datasets, if the individuals comprising the data are unavailable to provide a more broad informed consent.

Our Manager has endeavored to ensure our informed consent process is clear and effective.

Drug Development & Data Monetization

One of the primary use cases for mining genomic databases is the opportunity to identify new drug targets. Rational drug design leverages biological understanding to develop therapies targeted at disease pathways and mechanisms of action, and can be applied to both common and rare diseases. By understanding the genetics of disease and the role mutated genes play in the cell, drug developers can pursue a more “rational” design approach. This promise of genomic insights to drive better drug development motivated the purchase of deCODE Genetics by drug developer Amgen in 2012 and at least a dozen pharmaceutical company partnership deals with consumer genetics company 23andMe, which reportedly holds genomic data on approximately four million customers.

A recent example of how rare genetic mutations can lead to understanding of the biology underlying common diseases and lead to cures for the broader population came from the study of a small sample of patients with familial hypercholesterolemia (FH). FH is suspected when LDL-cholesterol is above 190 mg/dL in adults and above 160 mg/dL in children without cholesterol-lowering treatment and poses a life-long risk of severe cardiovascular disease. Based on these family studies, researchers discovered a monogenic form of FH that is due to severe mutations in one of three genes: LDLR, APOB, or PCSK9. This observation led to the development of monoclonal antibodies to lower LDL by blocking the PCSK9 gene, and has now been commercialized by five different drug companies offering the therapy to lower cholesterol in the general population, not just those with FH.

Currently, an estimated 90 percent of potential medicines entering clinical trials fail to demonstrate the necessary efficacy and safety, and never reach patients. Many of these failures are due to an incomplete understanding of the link between the biological target of a drug and human disease. By contrast, medicines developed with human genetic evidence have had substantially higher success rates and patient care has benefited. In the spirit of more rational drug design guided by genomic information, Regeneron Pharmaceuticals reportedly brought together AbbVie, Alnylam Pharmaceuticals, AstraZeneca, Biogen, and Pfizer to each commit $10 million to enable genomic sequencing of the UK Biobank of 500,000 samples. These deals demonstrate a growing interest in access to genomic information for discovering drug targets, repositioning drugs, and

 

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better understanding the genetic underpinnings of disease. Our model enables smaller participants to make discoveries and provide an alternative source of data for “big pharma.”

Data Challenges

Unfortunately, much of the genomic data and phenotype data collected by commercial genomics companies, laboratories, and pharmaceutical companies remains siloed and inaccessible to the research and medical communities. In some cases, the reason is inefficient database design or poor data management practices. The pharmaceutical industry lags behind other sectors in several indicators of digital maturity. More often, however, is the strategic decision to attempt to extract value from data themselves, hampering meaningful data sharing across organizational boundaries. Additionally and importantly, the revenues of their data monetization strategies have never been shared with those who contributed the data. Often discovery companies go to great lengths and expense to ensure data provenance, completeness, and integrity, and hence these institutions attribute a much lower value to data from other entities.

Many pharmaceutical companies have begun integrating patient data from apps, wearable devices, and electronic medical records (EMRs) to improve healthcare and make discoveries about disease. Technology companies are also entering this market, such as IBM with its Watson Health program, and Apple with its HealthKit platform. Given these trends, it seems unlikely to us that the pace of future research will be limited by information technology problems, but rather hindered by corporate self-interest to keep the data private.

Another major challenge is the current state of EMRs. While adoption of EMRs is almost at 100 percent in the United States, in this new health economy, effective implementation of EMRs is still in the early stages. The standards deployed in terms of how they are used and the medical terminology adopted varies greatly from institution to institution. Standards for medical nomenclature and inter-relationship, or ontology, can vary greatly and, in some cases, health care providers still rely on the comments section of the patient record to record important information. Historic clinical records are often simply PDF files or pictures of hand written medical histories. Ingesting, curating, and harmonizing this information to the quality required for identifying links between our genome and our lifestyle to disease remains a major task and challenge.

By aligning with a broad base of members who individually have access to their data generated from these previously siloed sourced, we plan to collect, aggregate and make available to researchers a much broader range of data then available from the current siloed sources.

Our Solution

Leveraging Intersecting Trends

The two intersecting trends of inexpensive and accessible personal DNA testing and nearly frictionless transaction capacity create our opportunity. As discussed above in the section “—Market Background—The DNA-Aware and Data-Engaged Consumer” above, individual DNA testing is going mainstream, led by consumer-friendly companies like 23andMe, Ancestry.com, MyHeritage, and National Geographic in partnership with Helix, a partially owned subsidiary of Illumina. For example, Ancestry.com announced they sold 1.5 million DNA test kits between Black Friday and Cyber Monday in 2017. Approximately 12 million people reportedly have genotyping or sequencing data purchased through DTC genetic testing companies.

In addition to DTC products, there are new and emerging opportunities for individuals to receive their DNA information that can be contributed to us. Consumer-directed and physician-mediated wellness offerings are growing in popularity as individuals look to work with a healthcare provider to maximize their wellness. For example, the Mayo Clinic offers preventative whole genome sequencing through Veritas Genetics. Large-scale population health projects like the United States National Institute of Health’s All of Us Research Program will accelerate individual’s access to their genomic information. We also plan to engage with disease foundations who have very engaged patient communities and funding for genomics research, but who typically lack the interest and skills to stand up and manage a genomics database.

Together, these forces create the ideal time and place to develop a shared, secure, and member-controlled medical research data platform.

Broad Data Collection & Engagement

To date, obtaining large volumes of high-quality biological, health, and lifestyle data has been a major challenge in the medical research field. By being independent and agnostic to DNA analysis technology platform and brand, we can gather

 

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data from multiple sources without conflict of interest. A member’s genomic information can be acquired by companies that help him or her learn about himself or herself, while also being shared in the Database in support of disease discovery. There is no need to choose between these two options.

As part of our solution, new members can join our community and receive shares by contributing validated genomic information and providing consent for such data to be used anonymously in population-wide disease research. A wide range of genomic data types will be accepted, including genotyping, exome, and whole genome data files. In addition to the genomic data, we will collect high-quality health, medical, and environmental data from new and existing members. These data can come from EMRs, surveys on diet and exercise, health history, and data from biometric/wearable devices.

Given the high variation in data quality throughout the industry, we will take certain measures to validate the data submitted by our members and potential members to assure a high quality of data in our Database. Such measures will include requiring members to provide supporting information along with submissions, employing spam-blocking techniques, cross-checking data, assessing overlap and generally confirming that data is submitted in accordance with our terms for such data type.

Recognition of the importance of these combined datasets is demonstrated in the launch of large-scale projects including:

 

   

Geisinger Health System’s MyCode Community Health Initiative including genome sequence data from 250,000 individuals, coupled to health records;

 

   

Apple’s Health app including heart rate, activity, sleep, and nutrition data;

 

   

Biometric data such as that collected by implanted and radio frequency-enabled pacemakers or glucose monitors;

 

   

Regeneron-UK BioBank partnership including genome sequence data from 500,000 individuals, coupled to health records and a wide range of phenotypes collected by UK BioBank; and

 

   

The National Institute of Health’s All of Us Research Program including environmental, wearable (e.g., FitBit), and genomic data on one million United States residents.

The data collected in these projects are often accessible to the data owners (i.e., the patient/participant), but are often primarily captured in siloed databases and infrequently shared with the broader research and medical communities. Our solution is compatible with these efforts in that we are requesting that our members share their data with us on a non-exclusive basis.

One of our main goals is to encourage participants to remain active and engaged in the research process over time, providing regular data contributions and coming back to learn about how their data is being used. Crowdsourced funding platforms such as Patreon have been successful at building long-term relationships between artists and art patrons by providing a means to share art on a regular weekly or daily schedule, and see art in early creative stages. Such a relationship between scientists and study participants could greatly benefit the scientific creative process as well.

Platform Description

We are building our “community-owned” Database by providing our members share ownership in our Database as consideration for contributing personal genomic and phenotypic data, such as medical, health and health-related data for medical research, as described in “Securities Being Offered—Consideration” beginning on page 37 of the Offering Circular.

Our Database will earn income through the sale of access to its de-identified metadata and research findings to our customers in the research and medical industries.

Information inputs into our Database include self-contributed information, medical data, and DTC testing product data files. Our Database is extensible such that future data inputs (e.g., wearables) can be added. The collective de-identified data creates a metadata resource for nonprofit and for-profit research to be conducted with the help of enabling informatics and artificial intelligence resources. As value is derived from the access to and discoveries from our Database, a portion of that value flows back to the community via their share ownership.

Research Queries

We make de-identified Member Data in an aggregated, indexed, or otherwise analyzed fashion available to third-parties for their research use in ways that are designed to avoid the potential for learning the identity of the person or persons who contributed a particular item or set of Member Data. This population-level research may have various purposes, including the

 

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advancement of genomic science, identifying links between human genomes and disease, and other commercial applications, such as determining opportunities for targeted research that would seek your voluntary participation (e.g. how many members share a particular genotype and phenotype).

Targeted Research

We may use individual Member Data to determine whether you may be eligible to participate in targeted research and to then seek your voluntary participation in the targeted research. For example, if a third-party pharmaceutical company is interested in doing research on individuals who may have a particular genotypic, genomic, or phenotypic profile, we may query our Database to determine the subset of members (based on their de-identified Database record number) that have the relevant profile for participation in the study, and then initiate an anonymous invitation to matching members to request their participation in the study.

We may receive compensation from researchers for identifying potential members for targeted research. Initially, our Manager will negotiate with these researchers to provide them introductory access to members and our Manager may be compensated by such researchers for such services without sharing such compensation with our Company or any members. The research sponsors may thereafter negotiate directly with our members, and any such members who elect to participate in any such targeted research may be compensated directly by such researchers. Any such compensation to members will be determined entirely through private agreements between such members and the applicable researchers.

Community Ownership

By making our Database community-owned, our members become participants in and beneficiaries of the project, encouraging new members to join and members to actively participate and continue contributing their data to us for additional shares. As a member deposits more genomic, phenotypic, biometric (e.g., wearables) and other valuable Member Data in the Database, that member’s ownership stake in our Database increases. When medical or research organizations pay us to run queries against the Database, our profits from these transactions will enable dividends to our Database members, proportionately to the number of shares held and therefore the value of data each member contributed.

We believe that as our Database grows, it will become increasingly valuable to the medical and research industries. Unlike other companies currently marketing DTC test kits, proceeds generated by selling query access to our Database, such as to pharmaceutical companies, will inure in part to the benefit of the member community. Members will always retain the ability to withdraw their Member Data from our Database by terminating their consent with respect to their Member Data or purging selected Member Data.

Community ownership addresses many of the challenges that exist due to: prevalence of data silos; lack of trust in commercial entities monetizing an individual’s data; lack of trust in research activities that go dark once information is provided; and lack of single data standards hindering large-scale biomedical research studies.

We will update members on studies being performed and results that accrue. It is anticipated that a primary motivation for many members will be to support the greater good through scientific discovery. We aim to encourage this type of participation through regular communications in order to build trust in the management of our Database and its contributions to science.

Extensibility of the Database

The first focus of our Database is driving associations between genomic information and health outcomes, as well as determining social determinants of health. However, as science advances and other “omic technologies” (which are primarily aimed at the universal detection of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics)) in a specific biological sample (see Figure 4), such as gut microbiome or proteomics become less expensive and more accessible to patients and consumers, our Database will be scalable and capable of incorporating these other data types to further researchers’ ability to understand and digitize the medical and health essence of a human being.

 

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LOGO

Figure 4. Geographic information system (GIS) of a human being.

The ability to digitize the medical essence of a human being is predicated on the integration of multi-scale data, akin to a digital map, which consists of superimposed layers of data such as street, traffic and satellite views. For a human being, these layers include demographics and the social graph, biosensors to capture the individual’s physiome, imaging to depict the anatomy (often along with physiologic data), and the biology from the various omics (genome-DNA sequence, transcriptome, proteome, metabolome, microbiome, and epigenome). In addition to all these layers, there is one’s important environmental exposure data, known as the “exposome.”

Blockchain Technology

To provide our community of members with transparency into our operations, including providing a tamper-evident record of the transactions described below, we are evaluating the feasibility of using the blockchain to store select information about several types of transaction related to our company. Implementation of a blockchain for these functions entails various risks, and we may for that or various other reasons abandon these efforts. At the present time and if feasible, we plan to store the following record types in our blockchain, which we currently store using only conventional database technology.

 

   

Members Joining or Withdrawing: When a new member first joints our community by contributing Member Data to our Database, or if an existing member withdraws from our Company, we would record that fact together with an anonymized identifier for that member in the blockchain. Member identities will be anonymized by using a hashed or numerical identifier or similar de-identifying measure to represent each member.

 

   

Member Data Contribution or Withdrawal: When a new or existing member contributes new Member Data to our Database, or an existing Member has us purge some or all of his or her Member Data from our Database, we would record the type of data submitted or purged, the number of shares issued to the member (in case of a contribution) or redeemed by us or the member (in case of a purge), and the member’s de-identified identifier discussed in the preceding bullet point.

 

   

Database Queries: When a third party conducts a query against our Database, we would add the occurrence of the query and the anonymized identity of the third party to the blockchain. In some cases we may add a description of the query as well. The blockchain will not include any results of queries.

We may in the future add additional data types to our blockchain to create greater transparency to our community, subject to our privacy and security policies.

 

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The largest advantage of blockchain technology over exclusive reliance on our current conventional database technology is that we intend to implement our blockchain solution using an independent, decentralized network of servers, such as the Ethereum (or similar) network, to improve public verifiability. The decentralized network operates by having multiple nodes validate any changes to the blockchain, such as the addition of a new transaction, and a change is accepted to the blockchain only if a majority of nodes agree that the transaction is valid. Independence means that independent third parties will control the nodes validating transaction and updating the blockchain. In our intended implementation, the network would not delete old transactions; instead, each new transaction would be added to the existing blockchain, enabling members to have a full transaction history.

While blockchain technology is relatively new, we anticipate that the advantages of this approach would be twofold. First, every member or potential investor would have assurances that every block of data retrieved from the blockchain – i.e., every transaction –is uncorrupted and unaltered since its initial recording. Second, each member or potential investor can trace how the blockchain has been appended over time and validate that our current reports to members, including the member’s share holdings and the total outstanding shares, are accurate.

In the event we implement our blockchain, we also intend to develop a tool which will enable anybody to review the data stored in the blockchain. Moreover, since we intend to make our blockchain publicly accessible on the Ethereum (or similar) network, any third party, including any member or potential investor, would be able to develop their own tools, or employ existing compatible tools provided by third parties, to retrieve the blockchain data.

Our Unique Advantages

Public Service Vision

Our Company was founded with a vision of public service at least as important as potential financial remuneration. Trust in us by our members is paramount. We recognize our members are voluntarily placing some of their most private health data in our Database, and we understand we will need to work hard to earn and maintain the trust that informs that contribution. Our operating agreement authorizes our Manager, a public benefit corporation, to make decisions that prioritizes public welfare. However, as demonstrated by other public benefit corporations, such as Patagonia and Warby Parker, what is in the interest of the public can also show significant financial returns in the long run.

Public benefit corporations are a relatively new class of corporations that are intended to produce a public benefit and to operate in a responsible and sustainable manner. Under Delaware law, public benefit corporations are required to identify in their certificate of incorporation the public benefit or benefits they will promote and their directors have a duty to manage the affairs of the corporation in a manner that balances the pecuniary interests of the stockholders, the best interests of those materially affected by the corporation’s conduct, and the specific public benefit or public benefits identified in the public benefit corporation’s certificate of incorporation. Public benefit corporations organized in Delaware are also required to assess their benefit performance internally and to disclose publicly at least biennially a report detailing their success in meeting their benefit objectives.

Our Manager’s public benefit, as provided in its certificate of incorporation, is to create and maintain a community-owned genomic and phenotypic database that is designed to solve humankind’s most important medical challenges.

Given the large number of rare, chronic, and overlooked diseases, and the huge volume of genomics data being generated, it is critical that genomics data be made available to researchers to support the public good. Traditionally, this has been the domain of government institutions such as the National Institutes of Health and various non-profit foundations. However, foundations, while supportive of data sharing, are often not in the position to build the required technology to create the searchable container, or database, nor are they in a position to be responsible for sustaining the data and safeguarding the privacy and security of the data.

First Class Team in the Epicenter of Genomics

Our Manager’s executive team is comprised of experienced leaders in science and genomics, engineering, economics, and large-scale consumer engagement platforms. See “Directors and Officers” beginning on page 18.

 

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San Diego, the Capital of Genomics

We are proud to be headquartered in San Diego, where biotech and high tech, especially as it relates to genomics, are part of our economic and community fabric. As the number one most patent intensive genomics market in the United States, San Diego is leading the charge in a new era of healthcare. Personalized medicine and technology are taking precedence, with local genomics companies, research institutions, and universities at the forefront. Other highlights from the San Diego Regional Economic Development Corporation 2017 report include:

 

   

Leadership: San Diego is poised to continue its leadership in the field of precision medicine. With more than 115 genomics-related firms, San Diego has companies that handle every aspect of the genomics value-chain, from sampling and sequencing (e.g., Illumina, Thermo Fisher Scientific) to analysis and interpretation (e.g., AltheaDX, Human Longevity, Inc.) to clinical applications (e.g., Celgene, Arcturus Therapeutics), creating a complete ecosystem. Additionally, San Diego conducts the fundamental scientific research, due in part to the concentration of research institutes, that form the basis for many global genomics therapies and interventions.

 

   

Capital: While San Diego is home to just one percent of the United States population, it received 22 percent – $292 million – of the venture capital funding in genomics in 2016. Continually, San Diego’s numerous nonprofit research institutes command a large share of federal funding (e.g., NIH). In fact, San Diego received $3.2 million federal contract dollars in 2016 – more than any other United States region.

 

   

Talent: San Diego produces more genomics-ready graduates, relative to the size of its workforce, than any other United States region. With nearly 2,000 average genomics-related degrees (biochemistry, cognitive science, and bioinformatics) conferred per year, San Diego’s genomics companies benefit from the preparatory work of the region’s top academic institutions. In that vein, it is projected that the local talent pool for key genomics occupations will grow by an additional 10 percent by 2021.

Government Regulation

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

We are not subject to the Health Insurance Portability and Accountability Act of 1996, as amended, commonly known as HIPPA, because we are not a “covered entity” for purposes of that law. Accordingly, the privacy and other protections afforded to patients by HIPAA do not apply to us.

European General Data Protection Regulation (GDPR)

The European General Data Protection Regulation, commonly referred to as the GDPR, went into effect in May 2018. The GDPR increases privacy rights for individuals in Europe, extends the scope of responsibilities for data controllers and data processors and imposes increased requirements and potential penalties on companies offering goods or services to individuals who are located in Europe or monitoring the behavior of such individuals (including by companies based outside of Europe). Noncompliance can result in penalties of up to the greater of €20 million, or 4% of global company revenues. While we are currently accepting only members who reside in the United States, and hence are currently not subject to the requirements of the GDPR, we have structured our policies and procedures to comply with the GDPR.

Employees

We have no full time employees. We are managed by our Manager. Currently, our Manager has 12 full-time and one part-time employee.

Legal Proceedings

We know of no existing or pending legal proceedings against us or our Manager, nor are we or our Manager involved as a plaintiff in any proceeding or pending litigation.

 

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  Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Overview

We were organized as a limited liability company under the laws of the State of Delaware on April 23, 2018. We are managed by LunaPBC, Inc., a Delaware public benefit corporation, which we refer to as our Manager. We have entered into a management services agreement, which we refer to as the Management Agreement, with our Manager to provide business, operational and financial management services to us. The rights, duties and powers of our Manager are governed by the terms of the Management Agreement and the Company operating agreement, which we refer to as our Operating Agreement. We seek to build the world’s first and largest human health database of Member Data, which we refer to as our Database, that is owned by a community comprised of its members. Our Database is comprised of various types of genomic and phenotypic data, such as medical, health and health-related data.

Operating Results

During the period from April 23, 2018 (inception) to December 4, 2018, our Manager was our sole member. As such, we have accounted for the expenses paid on our behalf by our Manager as our expenses with a corresponding credit to members’ share capital, in accordance with the guidance in Staff Accounting Bulletin Topic 5T – Accounting for expenses or liabilities paid by principal stockholder(s) (“SAB Topic 5T”).

At December 4, 2018, the expenses paid on our behalf by our Manager total $532,173. These expenses primarily consisted of all fees, costs and expenses incurred in connection with our organization and in connection with the initial offer and sale of our shares, including legal and accounting fees.

Our Manager automatically resigned as, and ceased to be, a member on December 5, 2018 when the first contributor of data to LunaDNA was admitted as a member. From December 5, 2018, we do not believe that SAB Topic 5T continues to apply and have ceased recording as our expenses those expenses that our Manager incurred on our behalf after our Manager resigned as a member and for which our Manager does not have a contractual right of reimbursement. Our Manager is obligated to cover our expenses without reimbursement until March 30, 2020 pursuant to our Management Agreement.

Liquidity and Capital Resources

To date, all of our expenses have been covered by our Manager. Our Manager is obligated to cover our expenses without reimbursement until March 30, 2020 pursuant to our Management Agreement. As discussed in Operating Results above, we have accounted for the expenses paid on our behalf by our Manager as our expenses with a corresponding credit to member’s share capital, in accordance with the guidance in SAB Topic 5T. From December 5, 2018, we have ceased recording as our expenses those expenses that our Manager incurred on our behalf after our Manager resigned as a member and for which our Manager does not have a contractual right of reimbursement.

In the future, we will be obligated to promptly reimburse our Manager for all our expenses advanced by our Manager, in accordance with our Management Agreement (which the Manager may modify unilaterally). Our dependence on our Manager for funding of these expenses raises substantial doubt about our ability to continue as a going concern.

Our Manager’s capacity to fund all of our organizational expenses and to fund our operational expenses and the development expenses through the time when we generate significant revenues from operations is dependent on our Manager’s existing cash resources and its ability to obtain additional capital financing from investors sufficient to meet our needs and the needs of our Manager’s other operations. Our Manager has funded its operations and our operations primarily by sales of equity securities. Our Manager believes that it will be able to raise capital that, combined with its existing cash resources, will be sufficient to fund all of our organizational expenses and to fund our operational expenses and the development expenses through the time when we generate significant revenues, at which time our revenues may be used to pay both our operational expenses and the management fee to our Manager (which management fee may then fund further development expenses). However, there can be no assurance that our Manager will be successful in its fundraising efforts. If our Manager is not successful in its intended fundraising efforts, our Manager may be required to delay various planned expenditures for development and marketing of our Database, which delays could materially adversely delay generation of revenues and potentially jeopardize our ability to continue as a going concern.

We may not generate operating revenue for an indeterminate period of time, until third parties begin to pay us for services related to our Database. Upon generation of revenue, we will be obligated to pay a management fee to our Manager.

Plan of Operations

We commenced principal operations on December 5, 2018 when the first member data contribution was accepted and the first shares were issued to a member contributing data. We have not generated any revenues to date. Our only activities from April 23, 2018 (inception) through December 4, 2018 were organizational activities and those necessary to prepare for the offering of our shares. We may not generate operating revenue for an indeterminate period of time until third parties begin

 

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to pay us for services related to the Database. We expect to incur increased expenses as a result of being a public company (for legal, financial reporting, accounting and auditing compliance). We will rely on our Manager to fund our plan of operations for the next twelve months.

 

  Item 3.

Directors and Officers

We do not have any directors, officers, or significant employees. We are managed by our Manager, and we sometimes refer to our Manager’s officers and directors as our officers and directors and as our management. Neither our Manager, nor our Manager’s directors, is elected by our members, and neither will be subject to re-election by our members in the future. Our Manager may not be removed by our members for any reason.

Our Manager has a board of directors consisting of three directors. The following are the directors, key officers and significant employees of our Manager, who by virtue of their collective ownership of our Manager, control our Manager. No other person or entity controls our Manager.

 

Name

  

Position with Manager

   Age     

Term of Office

   Approximate Hours per
Week for Part-Time
Employees
 
Robert Kain    Chief Executive Officer and Director      57      Since October 2017   
Dawn Barry    President and Director      44      Since January 2018   
Scott Kahn, Ph.D.    Chief Information Officer      59      Since January 2018      30 Hours  
David Lewis    Chief Financial Officer, Treasurer, Secretary and Director      47      Since October 2017   
Debora Thompson    Vice President, Strategic and Business Ops      45      Since March 2018   

Kenneth Bloom

James White

  

VP & Chief Architect

VP, Commercial

    

41

42

 

 

  

Since April 2018

Since April 2019

  

Robert Kain has been LunaPBC’s Chief Executive Officer (Principal Executive Officer) since October 2017. Bob is a renowned pioneer in genomics and a co-founder of LunaPBC. Bob joined Illumina pre-IPO in 1999 and retired in 2014 as the Chief Engineering Officer. At Illumina, Bob led the invention of the modern, high-throughput genome sequencer that brought the cost from millions of dollars per genome down to less than $1,000 U.S. dollars. Bob is lead inventor on 28 United States patents that led to the breakthroughs that have revolutionized genome sequencing. Prior to joining Illumina, Bob was the Director of the Microarray Business Unit at Molecular Dynamics. He is also on the Scientific Advisory Boards of Dovetail Genomics, Singular Genomics, and Edenroc Biosecurity, and is the co-founder and acting chief executive officer of Revere Biosensor, a private company. Additionally, he is the co-founder and chairman of the board of a successful health & fitness business, Mesa Rim Climbing and Fitness Center, with multiple locations in San Diego and Reno, Nevada. Bob received a BS in Physics from San Diego State University and an MBA from Saint Mary’s College of California.

Dawn Barry has been LunaPBC’s President since January 2018. Dawn is an esteemed thought leader and veteran of the genomics industry and a co-founder of LunaPBC. She has given TED talks and is a frequent guest speaker on personalized medicine and genomics. Dawn served as the Vice President of Applied Genomics at Illumina, Inc through January 2018. Dawn integrated market development strategies with product and business model innovation to accelerate the application of genomics in medicine and personal healthcare. Dawn joined Illumina in 2005. Prior to Illumina, Dawn spent seven years at Genaissance Pharmaceuticals, one of the first genomics startups focused on individualized medicine and DNA-based diagnostic testing. Dawn was named San Diego Business Journal’s 2017 Business Woman of the Year and was a speaker at TEDxSanDiego 2016. She holds a BS in biology from the University of Vermont and a MBA from the University of Connecticut School of Business.

Scott Kahn, Ph.D., has been LunaPBC’s Chief Information Officer since January 2018. Scott leads LunaPBC’s information and data strategy and information security. Scott joined Illumina in 2005 as its first Chief Information Officer and also served as its VP of Commercial and Enterprise Informatics, where he led all corporate information services, software development, and bioinformatics. Prior to Illumina, Scott was the Chief Science Officer and General Manager of Life Sciences at Accelrys (currently Biovia/Dassault Systems) responsible for 65 percent of the company’s business. Scott received his PhD in Theoretical Organic Chemistry and was an Assistant Professor of Chemistry at the University of Illinois Urbana-Champaign.

 

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David Lewis has been LunaPBC’s Chief Financial Officer, Treasurer and Secretary since October 2017. David is a co-founder of LunaPBC and leads the company’s strategic funding and investment initiatives. A successful life science, equity and credit investor, David’s background is in investing in public and private companies on behalf of institutional investors, family offices, and high-net worth individuals. David started his career in investment banking at Lehman Brothers in 1994, then left banking to pursue several analyst and portfolio manager roles at CitiGroup, First Manhattan, and J Goldman & Co. In 2006 David Co-founded Ganley Investments with the financial backing of a large multinational family office, and served as its Chief Investment Officer. He holds a Bachelor of Business Science with honors in Accounting and Finance from the University of Cape Town, South Africa.

Debora Thompson has been LunaPBC’s Vice President, Strategic and Business Operations, since March 2018. Debora joined LunaPBC in March 2018 to spearhead strategic planning and execution of the LunaPBC infrastructure development. Prior to that, she spent over 10 years at Illumina leading projects and teams to accelerate genotyping and next-generation sequencing into applied and clinical markets. She served as chief of staff to both the new and emerging markets and applied genomics business units. Her passion and commitment to improving healthcare through discovery is anchored by a background in clinical molecular biology research and almost 20 years in biotech. She holds an MS from the University of Central Florida.

Kenneth (Kirby) Bloom has been LunaPBC’s Chief Architect since April 2018. In that role, Kirby is primarily responsible for architecting and developing the engagement and discovery platform that invites, aggregates, and organizes Member Data; establishes members as shareholders; and enables medical research across the de-identified aggregated Member Data. Prior to this role, Kirby was Head of Software & Informatics at Illumina, Inc. where he led the ideation and development of several sample-to-answer software solutions for Illumina’s sequencing and microarray platforms serving forensics, transplant diagnostics, food and agriculture, microbiology, and clinical segments. He began working at Illumina in 2007. With almost 20 years of experience in software design, engineering and databases, Kirby specializes in user centric interfaces and experiences and highly scalable, distributed cloud architectures and data engineering. He holds a BS in Management Information Systems from Texas Tech University and is currently working towards his Masters in Information & Data Science at University of California, Berkeley.

James White has been LunaPBC’s Vice President, Member Engagement & Experience since April 2019. James joined LunaPBC to reinforce and exemplify the member-first mission through people-centered design. He is an advocate of technology democratization to advance health discovery and human well-being. As an agency leader with over twenty years of brand strategy, consumer advertising and experience design, James has built effective infrastructure for shareholders, consumers and brands. James has worked with companies such as Adidas, GlaxoSmithKline and Qualcomm to create a formula to measure return on meaningful experience. He now will apply his methodologies to shape the Luna member experience. James holds a Joint Honours Degree, BSc. Psychology & Human Physiology from the University of Birmingham, UK.

Family Relationships

There are no family relationships among any of our officers or directors.

Potential Conflicts of Interest

Since we do not have an audit or compensation committee comprised of independent persons, the functions that would have been performed by such committees are performed by our Manager. Thus, there is a potential conflict of interest in that our Manager has the authority to determine issues concerning its own and its management’s compensation and other audit issues that may affect management decisions.

Involvement in Certain Legal Proceedings

In the last five years,

 

   

no petition under the federal bankruptcy laws or any state insolvency law has been filed by or against, nor has a receiver, fiscal agent or similar officer been appointed by a court for the business or property of, any director of executive officer of our Manager, or any partnership in which he or she was general partner at or within two years before the time of such filing, or any corporation or business association of which he or she was an executive officer at or within two years before the time of such filing, and

 

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no director of executive officer of our Manager has been convicted in a criminal proceeding (excluding traffic violations and other minor offenses).

Compensation of our Manager

For information regarding the compensation of our Manager, please see “Compensation of our Manager” on page 32

of our Offering Circular.

 

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  Item 4.

Security Ownership of Management and Certain Securityholders

The following table sets forth the approximate beneficial ownership of our shares as of April 26, 2019 for each director, key officer and significant employee of our Manager and for the directors, key officers and significant employees of our Manager as a group. As of such date, 25,648 shares were issued or earned. No person or group holds more than 10% of our shares.

 

Name of Beneficial Owner (1) (2)    Number of
Shares
 Beneficially 
Owned
       Percent of  
  All Shares  
 

Robert Kain

     54        *    
  

 

 

    

 

 

 

Dawn Barry

     4        *    
  

 

 

    

 

 

 

Scott Kahn, Ph.D.

     64        *    
  

 

 

    

 

 

 

David Lewis

     54        *    
  

 

 

    

 

 

 

Debora Thompson

     54        *    
  

 

 

    

 

 

 

Kenneth Bloom

     52        *    
  

 

 

    

 

 

 

James White

     2        *    
  

 

 

    

 

 

 

All directors and executive officers of our Manager as a group (7 persons)

     284        1.1
  

 

 

    

 

 

 
*    Represents less than 1% of our outstanding common shares.

 

(1)

  

 

Under SEC rules, a person is deemed to be a “beneficial owner” of a security if that person has or shares “voting power,” which includes the power to dispose of or to direct the disposition of such security. A person also is deemed to be a beneficial owner of any securities which that person has a right to acquire within 60 days. Under these rules, more than one person may be deemed to be a beneficial owner of the same securities and a person may be deemed to be a beneficial owner of securities as to which he or she has no economic or pecuniary interest.

 

(2)

  

 

Each listed beneficial owner has an address in care of our principal executive offices at 4110 Campus Point Court, San Diego, CA 92130.

 

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  Item 5.

Interest of Management and Others in Certain Transactions

Please see “Interest of Management and Others in Certain Transactions and Conflicts of Interest” on page 34 of our Offering Circular.

During the period from April 23, 2018 (inception) to December 4, 2018, our Manager was our sole member. As such, we have accounted for the expenses paid on our behalf by our Manager as our expenses with a corresponding credit to paid in capital, in accordance with the guidance in SAB Topic 5T.

At December 4, 2018, the expenses paid on our behalf by our Manager totaled $532,173. These expenses primarily consisted of all fees, costs and expenses incurred in connection with our organization and in connection with the initial offer and sale of our shares, including legal and accounting fees.

Our Manager automatically resigned as, and ceased to be, a member on December 5, 2018 when the first contributor of data to LunaDNA was admitted as a member. From December 5, 2018, we do not believe that SAB Topic 5T continues to apply and have ceased recording as our expenses those expenses that our Manager incurred on our behalf after our Manager resigned as a member and for which our Manager does not have a contractual right of reimbursement. Our Manager is obligated to cover our expenses without reimbursement until March 30, 2020 pursuant to our Management Agreement.

 

  Item 6.

Other Information

None.

 

  Item 7.

Financial Statements

 

     Page  

Independent Auditor’s Report

     23  

Balance Sheet

     24  

Statement of Operations

     25  

Statement of Changes in Members’ Capital

     26  

Statement of Cash Flows

     27  

Notes to the Financial Statements

     28  

 

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Independent Auditors’ Report

To the Members

LunaDNA LLC

Solana Beach, CA

Report on the Financial Statement

We have audited the accompanying financial statements of LunaDNA, LLC, a Delaware limited liability company, which comprise the balance sheet as of December 31, 2018, and the related statement of operations, statement of changes in members’ capital, and statement of cash flows for the period since inception (April 23, 2018) through December 31, 2018, and the related notes to the financial statements.

Management’s Responsibility for the Financial Statement

Management is responsible for the preparation and fair presentation of these financial statements in accordance with accounting principles generally accepted in the United States of America; this includes the design, implementation and maintenance of internal control relevant to the preparation and fair presentation of the financial statement that is free from material misstatement, whether due to fraud or error.

Auditors’ Responsibility

Our responsibility is to express an opinion on these financial statements based on our audit. We conducted our audit in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free from material misstatement.

An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend on the auditors’ judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to LunaDNA, LLC’s preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of LunaDNA, LLC’s internal control. Accordingly, we express no such opinion. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.

Opinion

In our opinion, the financial statements referred to above presents fairly, in all material respects, the financial position of LunaDNA, LLC as of December 31, 2018 and the results of its operations and its cash flows for the period since inception (April 23, 2018) through December 31, 2018 in accordance with accounting principles generally accepted in the United States of America.

Matter of Emphasis

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has incurred losses and is dependent on additional financing to fund operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans regarding those matters are also described in Note 2 to the financial statements. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.

/s/ Mayer Hoffman McCann P.C.

San Diego, California

April 30, 2019

 

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LunaDNA, LLC

Balance Sheet

December 31, 2018

 

Assets

  

Intangible Assets — Member Data

    $ 540    
  

 

 

 

Total Assets

    $         540    
  

 

 

 

Liabilities and Members’ Capital

  

Liabilities

  

Due to Members

    $ 150    
  

 

 

 

Total Liabilities

    $ 150    
  

 

 

 

Members’ Capital

  

Members’ Share Capital

     390    
  

 

 

 

Total Members’ Capital

    $ 390    
  

 

 

 
  
  

 

 

 

Total Liabilities and Members’ Capital

    $ 540    
  

 

 

 

The accompanying notes are an integral part of these financial statements.

 

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LunaDNA, LLC

Statement of Operations

For the period from April 23, 2018 (inception) through December 31, 2018

 

Expenses

  

General and Administrative

     $ 532,173   
  

 

 

 

Total Expenses

     $       532,173   
  

 

 

 

Net Loss

     $ (532,173)  
  

 

 

 

The accompanying notes are an integral part of these financial statements.

 

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LunaDNA, LLC

Statement of Changes in Members’ Capital

For the period from April 23, 2018 (inception) through December 31, 2018

 

     Members’  
     Share Capital  

Balance as of April 23, 2018

    $ -      

Contributions

     532,563   

Net Loss

     (532,173)  
  

 

 

 

Balance as of December 31, 2018

     $ 390   
  

 

 

 

The accompanying notes are an integral part of these financial statements.

 

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LunaDNA, LLC

Statement of Cash Flows

For the period from April 23, 2018 (inception) through December 31, 2018

 

Cash Flows From Operating Activities

  

Net Loss

    $ (532,173)  
  

 

 

 

Net Cash used in Operating Activities

     (532,173)  
  

 

 

 

Cash Flows from Financing Activities

  

Contributions by Manager paid directly to vendors

     532,173   
  

 

 

 

Net cash provided by Financing Activities

     532,713   
  

 

 

 

Net Increase (Decrease) in Cash and Cash Equivalents

     -      

Cash and Cash Equivalents, Beginning of Period

     -      
  

 

 

 

Cash and Cash Equivalents, End of Period

    $ -      
  

 

 

 

Supplemental disclosure of non-cash items:

  

Shares issued for member data

    $ 390  

Shares to be issued for member data

    $ 150  

The accompanying notes are an integral part of these financial statements.

 

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LunaDNA, LLC

NOTES TO THE FINANCIAL STATEMENTS

As of December 31, 2018

1. Organization and Purpose

LunaDNA, LLC (the “Company”), a Delaware limited liability company, was formed on April 23, 2018. The Company was formed to build, operate, maintain, query and otherwise deal with databases comprised of member data that is licensed to the Company (collectively, the “Database”). The Company is building a human health database that is owned by a community comprised of its members which is referred to as the Database. The Database is comprised of self-contributed genomic, phenotypic, medical, health and related data satisfying our requirements, which is referred to as Member Data. The Company commenced principal operations on December 5, 2018 but has not generated revenue as of December 31, 2018.

The Company has entered into a management services agreement (the “Management Agreement”) with LunaPBC, Inc. (the “Manager”), a Delaware public benefit corporation, to provide business, operational and financial management services to the Company. The rights, duties and powers of the Manager are governed by the Management Agreement and Company operating agreement (“Operating Agreement”). The Manager, acting alone, has the power and authority to act for and bind the Company. The Management Agreement may not be terminated by the Company and can be terminated by the Manager with thirty days’ written notice.

2. Going Concern

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company is a business that has not generated any revenues as of April 30, 2019.

The Company has no plans to raise capital to fund its operations, and it is therefore dependent on the Manager for all Organizational Expenses (defined in Note 10 – Expenses) and presently dependent on the Manager for all Operational Expenses (defined in Note 10 – Expenses). The Company is also dependent on the Manager for all costs associated with development, improvement and maintenance of the Database (“Development Expenses”). The Manager is not entitled to reimbursement for Organizational Expenses. The Manager is not entitled to reimbursement for Operational Expenses paid by the Manager that are or would have been, but for the provisions of the Management Agreement denying such reimbursement, accrued by the Company on or before March 31, 2020 (see Note 10 – Expenses). The Manager will be entitled to reimbursement for Operational Expenses accrued by the Company after March 31, 2020. The Manager is not entitled to reimbursement for Development Expenses. While the Manager intends to continue to fund the Company’s expenses for the next 12 months and beyond, the Manager has not committed to the Company to fund any particular amounts for any of these purposes and may not have the financial resources to do so. The Company’s dependence on the Manager for funding of these expense, losses incurred and lack of funds raise substantial doubt about the Company’s ability to continue as a going concern.

The Manager’s ability to fund all of the Organizational Expenses and to fund Operational Expenses and Development Expenses through the time when the Company generates significant revenues from operations is dependent on the Manager’s existing cash resources and the ability of the Manager to obtain additional capital financing from investors sufficient to meet the needs of the Company and the Manager’s other operations. The Manager has funded its operations and the Company’s operations primarily by sales of equity securities. The Manager believes that it will be able to raise capital that, combined with its existing cash resources, will be sufficient to fund all of the Organizational Expenses and to fund Operational Expenses and Development Expenses through the time when the Company generates significant revenues, at which time revenues earned by the Company may be used to pay both Operational Expenses and the management fee to the Manager (which management fee may then fund further Development Expenses). However, there can be no assurance that the Manager will be successful in its fundraising efforts. If the Manager is not successful in its intended fundraising efforts, the Company will be required to delay various planned expenditures for development of the Database, which delays could adversely delay generation of revenues and potentially jeopardize the Company’s ability to continue as a going concern.

3. Summary of Significant Accounting Policies

The following is a summary of significant accounting policies applied by the Company in preparation of its financial statements. The policies are in accordance with the accounting principles generally accepted in the United States of America (“GAAP”) and are presented in U.S. dollars.

Use of Estimates - The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets

 

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and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Income Taxes – The Company has elected to be taxed as a corporation and uses the liability method of accounting for income taxes as set forth in ASC 740, Income Taxes. Under the liability method, deferred taxes are determined based on the temporary differences between the financial statement and tax basis of assets and liabilities using tax rates expected to be in effect during the years in which the basis differences reverse. A valuation allowance is recorded when it is unlikely that the deferred tax assets will be realized. The Company assesses its income tax positions and records tax benefits for all years subject to examination based upon our evaluation of the facts, circumstances and information available at the reporting date. In accordance with ASC 740-10, for those tax positions where there is a greater than 50% likelihood that a tax benefit will be sustained, the Company’s policy is to record the largest amount of tax benefit that is more likely than not to be realized upon ultimate settlement with a taxing authority that has full knowledge of all relevant information. For those income tax positions where there is less than 50% likelihood that a tax benefit will be sustained, no tax benefit will be recognized in the financial statements. The Company has evaluated its income tax positions and has determined that it does not have any uncertain tax positions. The Company will recognize interest and penalties related to any uncertain tax positions through its income tax expense. The Company may in the future become subject to federal, state, and local income taxation though it has not been since its inception. The Company is not presently subject to any income tax audit in any taxing jurisdiction.

Recent Accounting Pronouncements – Management does not believe that any recently issued, but not yet effective, accounting standards could have a material effect on the accompanying balance sheet. As new accounting pronouncements are issued, the Company will adopt those that are applicable under the circumstances.

4. Member Data

The Company established the value for the different types of Member Data, which was used to determine the number of shares issued in exchange for the contribution of such Member Data, based on the fair value as determined by an accepted standard. In using an accepted standard, the Company noted the absence of bona fide sales of similarly limited and revocable Member Data rights made within a reasonable time. The Company used three independent, market-based valuation methods to determine the fair value of Member Data received in exchange for the Company’s shares. The valuation of Member Data involved first estimating the fair value of Genotyping by DNA Genome-Wide Microarray or by Sequencing data, which is referred to as a GT file. Other genomic contributions were then valued in relation to the fair value of a GT file.

Each valuation method applied was based on observable, third-party market transaction data using either the market approach valuation technique or the income approach valuation technique. The market approach is a valuation technique that uses prices and other relevant information generated by market transactions involving identical or comparable (that is, similar) assets, liabilities, or a group of assets and liabilities, such as a business. The market approach bases the value measurement on what other similar unrelated enterprises or comparable transactions indicate the value to be. Specifically, investments by unrelated parties in comparable equity securities (or assets) of the subject enterprise or transactions in comparable equity securities (or assets) of comparable enterprises are evaluated. Financial and nonfinancial metrics may be used in conjunction with the market approach to estimate the fair value of the privately issued securities of the subject enterprise. The income approach uses valuation techniques that convert future amounts (for example, cash flows or income and expenses) to a single current amount (that is, discounted). The fair value measurement is estimated on the basis of the value indicated by current market expectations about those future amounts. The income approach obtains its conceptual support from its basic assumption that value emanates from expectations of future income and cash flows.

Two of the Company’s valuation methods were based off of the market approach and yielded values of $3.75 and $3.33 per GT file. The Company’s third valuation method was based off of the income approach and yielded a value of $3.35 per GT file. The Company took the arithmetic mean of the three methods to arrive at an estimated fair value of $3.48 for a GT file. The Company determined to issue 50 shares for each GT file, resulting in an estimate of the fair value of each share at $0.069, which was rounded to $0.07 per share. The Company established 50 shares per GT file to yield a baseline value per share (that is, $0.07) that enables it to value more precisely other Member Data types as a fraction or multiple of the value of the GT File.

 

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5. Fair Value Measurements

The Company uses a three-tier fair value hierarchy to prioritize the inputs used in the Company’s fair value measurements. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets for identical assets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.

While the Company has valued the member data based on certain observable, third-party market transaction data (see Note 4), the Company has classified member data within Level 3 of the fair value hierarchy because each valuation method also utilizes significant unobservable inputs. For the two market approach methods, significant unobservable inputs include the average number of times a consumer would license his or her GT file, the percentage of information that a mid-price electronic health record (EHR) would contain when compared to the total information that the Company would be able to obtain from a highly engaged member, and the percentage of information a GT file of a member would represent compared to the total value of all contributions by that member. For the income approach method, significant unobservable inputs include the projected number of members, the number of studies/queries per member, the associated revenues for the first seven years after qualification, the estimated growth rate in earnings per member, the discount rate, and the long-term sustainable annual growth rate.

The following table provides a reconciliation of assets measured at fair value using significant unobservable inputs (Level 3) for the period ended December 31, 2018:

 

     Level 3 
Assets 
 

Balance at April 23, 2018

    $ -      

Additions to Member Data

     540   
  

 

 

 

Balance at December 31, 2018

    $         540   

6. Members’ Capital

Pursuant to the Operating Agreement, the Company is authorized to issue an unlimited amount of unit-denominated common limited liability company interests, which it refers to as shares. Pursuant to its offering circular, filed with the Securities and Exchange Commission (the “SEC”) pursuant to Rule 252(g)(2) on December 3, 2018, the Company may issue up to 714,285,714 shares for an aggregate, maximum gross dollar offering of $50,000,000 in an offering (the “Offering”) qualified under Regulation A under the Securities Act of 1933, as amended (the “Securities Act”). The shares will not be offered for cash but in exchange for genomic, phenotypic, medical, health and related data satisfying our requirements, which the Company refers to as Member Data. The aggregate offering price or aggregate sales for our shares is based on the fair value of Member Data as established by an accepted standard. At December 31, 2018 the Company has issued 5,566 shares at a par value of $0.07 per share and 2,146 shares that have been earned but not yet issued.

The shares are non-transferable, except as may be required by law, and are not listed for trading on any exchange or automated quotation system. The members do not have any voting, consent or management rights relating to the management and operation of the Company, except to appoint a liquidator upon the dissolution of our Company if the Company does not have a Manager at that time.

A member may resign as a member for all purposes at any time by redeeming all of its shares. A member may, at any time and from time to time, elect to terminate the Company’s license to use the Member Data he or she contributed to the Company by written notice to the Company made in accordance with the then current Member Data policies, in which case the Shares issued in exchange for the Company’s original rights to such Member Data will be redeemed. A member will automatically cease to be a member for all purposes immediately upon such member ceasing to own of record any shares.

From April 23, 2018 to December 4, 2018 the Manager was the sole member of the Company. In accordance with our operating agreement, the Manager automatically resigned as, and ceased to be, a member upon another person being admitted as a member of the Company. Accordingly, the Company accounts for the expenses paid on its behalf by

 

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the Manager while the Manager is the sole member as expenses of the Company with a corresponding credit to Members’ Share Capital, in accordance with the guidance in SAB Topic 5T. On December 5, 2018, the Company commenced principal operations and admitted a person other than the Manager as a member. As a result, the Manager automatically resigned as a member. Once an investor became a member, the sole relationship between the Company and the Manager is the contractual services relationship that exists pursuant to the Operating Agreement and the Management Agreement and the manager provisions of the Delaware Limited Liability Company Act (Chapter 18 of Title 6 of the Delaware Code), and the Company does not believe that the guidance in SAB Topic 5T continues to apply on or after December 5, 2018. Accordingly, the Company has not recorded as expenses of the Company those expenses that the Manager incurred after the Manager was no longer a member and for which the Manager does not have a contractual right of reimbursement. As of December 4, 2018, the expenses paid on behalf of the Company by the Manager total $532,173.

Contributions

An individual may be admitted as a member and issued shares by contributing Member Data, as defined in the Operating Agreement, to the Company in accordance with the Company’s Member Data policies, subject to the Manager accepting such contribution. Members have no obligation to contribute funds to the capital of the Company or to make additional contributions. A member may, in such member’s discretion, make additional contributions of Member Data in return for additional shares from time to time in accordance with the Company’s Member Data policies, subject to the Manager accepting such contribution.

Distributions

The Manager intends for the Company to distribute (i) distributable cash from operations (but excluding proceeds from the sale of all or substantially all of the Company’s assets) for each annual period no less frequently than once per annum; provided that if the estimated distribution per share is not expected to exceed $0.02, as adjusted appropriately for any share dividend, share split, combination or other similar recapitalization with respect to the Company’s equity, the Manager may elect to not make a distribution in such annual period, and (ii) proceeds, if any, realized by or available to the Company (after deducting therefrom an amount for addition to a reserve for contingencies, working capital, and the payment of unreserved or unfunded Company obligations, such amounts to be established by the Manager in its discretion) from the sale of all or substantially all of the Company’s assets within thirty days following the receipt by the Company of such proceeds. Upon a member’s resignation or termination as a member or partial redemption of shares, the member will no longer be entitled to any further distributions with respect to the Shares redeemed, irrespective of whether distributable cash was available for distribution at or prior to such time.

7. Company Operating Agreement

The Manager was the sole initial member. The Manager automatically resigned as, and ceased to be, a member upon the admittance of another person as a member of the Company. In the event the Company would otherwise have no member, the Manager will automatically be admitted as a member, but will again automatically resign upon the subsequent admission of another person as member of the Company as provided in the immediately preceding sentence. In its capacity as initial member, the Manager had no obligation to make any contribution to, or pay any liabilities of, the Company, and had no right or entitlement to any distributions from the Company.

8. Related Party Transactions

The Company anticipates conducting various transactions with the Manager, a related party, including but not limited to those specified in the Management Agreement (see Note 10). The Company and the Manager are under common control. The Company will follow the accounting and disclosure requirements under ASC 850-10-50 with regards to any related party transactions and relationships.

9. Due to Members

At December 31, 2018, 2,146 shares have been earned but not yet issued. These shares have been recorded as a liability of $150 on the balance sheet.

 

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10. Management Agreement

Management Fee

The Company is obligated to pay to the Manager a management fee (the “Management Fee”) calculated as the sum of (i) 50% of the Net Revenues (defined below) of the Company; plus (ii) the amount of all Non-Profit Revenue (defined below) of the Company.

“Net Revenues” means (i) all revenue (excluding Non-Profit Revenue) recognized by the Company from (a) discovery activities that derive value from the content contained in the Database and (b) license fees, royalties and other revenue derived from intellectual property acquired through collaborations with third parties with respect to Member Data, less (ii) Operational Expenses. For this purpose, Operational Expenses do not include Organizational Expenses, Operational Expenses borne by the Manager (See Note 10 – Expenses) or the Management Fee. See also Note 10 –Manager Operations Separate from the Company, concerning activities that the Manager may conduct that do not generate revenue for the Company and are therefore excluded from Net Revenues.

“Non-Profit Revenue” means all revenues recognized by the Company from transactions with corporations, trusts, unincorporated association, or other types of organizations (“Non-Profit Organizations”) that (i) are exempt from federal income tax under section 501(c)(3) of the Internal Revenue Code of 1986, as amended, (ii) have applied in good faith for a determination of such exemption from the Internal Revenue Service, or (iii) would be eligible to be so exempt, in the reasonable opinion of the Manager, if operated in the United States. Examples of Non-Profit Organizations include disease foundations, research organizations, and organizations for the benefit of minority or economically disadvantaged groups. License fees, royalties and other revenues earned from Collaboration IP (as defined below) generated through collaboration with a Non-Profit Organization are not Non-Profit Revenue and will be included in Net Revenues, even if such license fees, royalties and other revenues are paid by Non-Profit Organizations.

The Manager will determine the Management Fee with respect to Net Revenues and Non-Profit Revenue for each fiscal quarter. The Management Fee is payable within ten (10) days following the closing of the Company’s books for each quarter, to the extent of available cash in the Company. To the extent sufficient cash is not available at a payment date, the unpaid portion of the Management Fee will accrue and be paid promptly following the Company’s receipt of cash sufficient to pay the amount in arrears.

Manager Operations Separate from the Company

The Company will earn revenues from data discovery activities that derive value from the content contained in the Database, such as (i) providing to third parties including but not limited to pharmaceutical and biotechnology discovery companies (collectively, “Customers”), access to the Database for population-level research, and (ii) making available to Customers, directly or through the Manager, contact information for Members who have elected to allow the sharing of such contact information. The Management Agreement indicates that certain activities are not data discovery activities and permits the Manager in its sole discretion to choose to conduct such activities for its own or for its affiliate’s account or for Customers without accounting to the Company for the revenues derived from such activities. Excluded activities are:

• Communication and member engagement services provided to Customers following a data discovery activity that identifies or provides contact information of members;

• assisting Customers in collecting longitudinal data of identified members that is at the time of initial collection outside the Database;

• the offer or sale of value added goods and services to members, whether by the Manager, an affiliate of the Manager or a third party offering goods or services that may be of interest to members;

• professional services such as scientific consultation or project management; and

• any and all other activities of the Manager that do not derive direct value from the content of the Database.

Database Development and Intellectual Property License

Pursuant to the Management Agreement, the Manager develops and improves the Database at the Manager’s sole expense. The Manager will own all intellectual property, including U.S. and foreign patents and trade secrets, conceived or discovered by the Manager, solely or jointly, related to the Database (collectively, “Database IP”). Database IP does not include intellectual property rights the Company acquires from collaborations with third parties that obtain access to the Database (“Collaboration IP”), which Collaboration IP will be owned by the Company.

 

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The Company enjoys a non-exclusive license for the Database IP, which license will continue in perpetuity in the event of termination of the Management Agreement, the Manager ceasing to serve as manager of the Company or the dissolution of the Manager.

Other Intellectual Property

The Manager owns certain trademarks, trade dress, logos, internet domain names, websites and associated software and social media accounts created for the Company. The Company has an exclusive license to all such properties but the Manager has reserved a non-exclusive right to use such properties in connection with its operations that are separate from those of the Company.

Expenses

The Manager is responsible for, and not entitled to reimbursement for, all fees, costs or expenses incurred by it on behalf of the Company in connection with organizing and managing the Company and in connection with the initial offer and sale of the Shares, including printing, travel, filing fees, marketing expenses, legal and accounting fees, and similar fees incurred in connection with the investigation, evaluation, registration, qualification, issuance and sale thereof, such as costs incurred in qualifying for the exemption from registration pursuant to Regulation A under the Securities Act with the SEC, including any post-qualification amendments or supplements to the initial Regulation A offering statement (collectively, the “Organizational Expenses”).

The Company is obligated to reimburse the Manager promptly for all Operational Expenses (defined below) advanced by the Manager. Notwithstanding the foregoing, the Manager is not entitled to reimbursement for Operational Expenses paid by the Manager if such Operational Expenses are or would have been, but for the provisions of the Management Agreement denying reimbursement, accrued by the Company under generally accepted accounting principles on or before March 31, 2020. “Operational Expenses” are all costs and expenses related to the Company’s operations, but excluding the Organizational Expenses, costs to develop Database IP and the Manager’s overhead and compensation related expenses, including compensation and expenses of the officers, directors, employees, auditors, attorneys and other agents of the Manager and fees and expenses for administrative, bookkeeping, clerical and related support services, office space and facilities, utilities, telephone and email of the Manager, all of which are the responsibility of the Manager.

11. Income Taxes

The Company accounts for income taxes under the asset and liability method. Deferred income taxes reflect the temporary differences between assets and liabilities recognized for financial reporting purposes and amounts recognized for income tax reporting purposes, net operating loss carryforwards, and other tax credits measured by applying currently enacted tax laws. Valuation allowances are provided when necessary to reduce deferred tax assets to an amount that is more likely than not to be realized.

The Company has evaluated the available evidence supporting the realization of its gross deferred tax assets including the amount and timing of future taxable income and has determined that it is more likely than not that the $32,000 deferred tax assets will not be fully realized and has established a valuation allowance against those assets as of December 31, 2018.

At December 31, 2018, the Company has federal and state (California) net operating loss carryforwards of approximately $1,000 each which are available to offset future taxable income. The federal carryforwards are carried forward indefinitely and the state carryforwards will expire by December 31, 2038. In addition, net operating loss carryforwards may be limited in the event of changes in ownership as defined by Internal Revenue Code Section 382.

The Financial Accounting Standards Board provides guidance regarding how uncertain tax positions that have been taken or are expected to be taken on a company’s tax return should be recognized, measured, presented, and disclosed in the consolidated financial statements. The Company believes that it has not taken any significant uncertain tax positions. Generally, the tax returns and amount of taxable income of the Company are subject to examination by federal and state taxing authorities during the three and four-year period, respectively, prior to the period covered by the consolidated financial statements.

 

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12. Subsequent Events

The Company has evaluated subsequent events through April 30, 2019, the date these financial statements were available to be issued.

As of April 30, 2019, the Company has issued an additional 13,502 shares, with a further 4,434 shares earned but not yet issued.

On April 29, 2019, the Company and the Manager entered into an amendment to the Management Agreement, which amendment was effective as of April 23, 2018. The amendment clarified and conformed the definition of “Database IP” (see Note 10—Database Development and Intellectual Property License). The amendment had no adverse effect on the rights or obligations of the Company under the Management Agreement.

In January 2019, the Manager entered into a Master Agreement (the “GA Agreement”), with Genetic Alliance (“GA”), a non-profit organization, in order to merge GA’s Platform for Engaging Everyone Responsibly (“PEER”) engagement platform with the Database, once the Database IP contains PEER equivalent functionality. The initial term of the GA Agreement ends on the fifth anniversary of the date on which both parties agree in writing that the Database IP substantially contains PEER equivalent functionality. The Company currently estimates that the term will start by the end of 2019.

Pursuant to the GA Agreement, the Manager granted a non-exclusive, non-transferable license to GA to use the Database IP that contains PEER equivalent functionality for so long as the GA Agreement is in effect. Additionally, GA granted the Manager a non-exclusive license to use the PEER application and PEER data during the term of the GA Agreement, subject to various restrictions.

The Agreement also calls for GA and our Manager to negotiate a value sharing arrangement with GA in connection with success generated through the efforts of GA. The Company currently contemplates that certain expenses of hosting the PEER data will be the responsibility of the Company after March 31, 2020 under the Management Agreement.

The GA Agreement may be terminated by either party for convenience upon 18 months’ advance written notice or sooner upon material, uncured default.

 

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  Item 8.

Exhibits

The following exhibits are filed as part of this Annual Report:

 

Number

  

Exhibit

2a    Certificate of Formation of the Company, filed April 23, 2018 (incorporated by reference to Exhibit 2(a) to the Company’s Form 1-A filed on October 5, 2018)
2b    Certificate of Amendment to the Certificate of Formation of the Company, filed September 25, 2018  (incorporated by reference to Exhibit 2(b) to the Company’s Form 1-A filed on November 5, 2018)
2c    Amended and Restated Limited Liability Company Operating Agreement of LunaDNA, LLC, effective as of April 23, 2018  (incorporated by reference to Exhibit 2(c) to the Company’s Form 1-A filed on November 19, 2018)
4a    Form of Subscription Agreement, including form of LunaDNA Consent and form of Privacy Policy  (incorporated by reference to Exhibit 4(a) to the Company’s Form 1-A filed on November 19, 2018)
6a*    Amended and Restated Management Agreement, effective as of April 23, 2018, by and between LunaPBC, Inc. and the Company

* Filed herewith.

 

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SIGNATURES

Pursuant to the requirements of Regulation A, this issuer has duly caused this Annual report to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of San Diego, State of California, on April 30, 2019.

 

LunaDNA, LLC
By:   LunaPBC, Inc.
  Its Manager
By:  

/s/ Robert Kain

 

Robert Kain

Chief Executive Officer

Pursuant to the requirements of Regulation A, this Annual Report has been signed below by the following persons on behalf of the issuer in the capacities and on the dates indicated.

 

Signature

  

Title

  

Date

/s/ Robert Kain

   Chief Executive Officer and Director of LunaPBC, Inc. (Principal Executive Officer)    April 30, 2019
Robert Kain      

/s/ David Lewis

   Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) and Director of LunaPBC, Inc.    April 30, 2019
David Lewis      

/s/ Dawn Barry

   President and Director of LunaPBC, Inc.    April 30, 2019
Dawn Barry      

 

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EX1K-6 MAT CTRCT 3 d709594dex1k6matctrct.htm EX1K-6 MAT CTRCT EX1K-6 MAT CTRCT

Exhibit 6a

AMENDED AND RESTATED

MANAGEMENT SERVICES AGREEMENT

THIS AMENDED AND RESTATED MANAGEMENT SERVICES AGREEMENT (this “Agreement”) is made as of April 29, 2019, by and between LunaPBC, Inc., a Delaware corporation f/k/a Luna DNA, Inc. (the “Manager”), and LunaDNA LLC, a Delaware limited liability company f/k/a LunaTrust LLC (the “Company” and, together with the Manager, the “Parties”). All capitalized terms that have not been defined herein shall have the meanings ascribed to such terms as provided in the Limited Liability Company Agreement of LunaTrust LLC (the “Operating Agreement”).

WHEREAS, the Company desires to receive business, operational and financial management services from the Manager and to obtain the benefit of the Manager’s experience in such matters generally;

WHEREAS, the Manager is willing to provide business, operational and financial management services to the Company, and the compensation arrangement set forth in this Agreement is designed to compensate the Manager appropriately for such services;

WHEREAS, the Parties intend that the amendments to the Amended and Restated Management Services Agreement, dated as of April 23, 2018 (the “Effective Date”), by and between the Parties, effected hereby (the “Amendments”), be effective as of the Effective Date; and

WHEREAS, the Parties have determined that the Amendments will not have any adverse effect on the rights or obligations of the Company as they reflect the original intent of the Parties.

NOW, THEREFORE, in consideration of the foregoing premises and the respective agreements hereinafter set forth and the mutual benefits to be derived therefrom, the parties hereto hereby agree as follows:

1.        Engagement. The Company hereby engages the Manager to provide business, operational and financial management services to the Company, and the Manager hereby agrees to provide business, operational and financial management services to the Company on the terms and subject to the conditions set forth herein.

2.        Services of the Manager. The Manager hereby agrees during the term of this engagement to manage all aspects of the business of the Company in order to build, maintain, operate and improve the world’s first and largest human health database that is owned by its community (the “Database”). The Database will be comprised of Member Data. The Manager will manage the Company with the goals to (i) create and maintain a community-owned genomic and phenotypic Database that is designed to solve humankind’s most important medical challenges, consistent the Manager’s public benefit, (ii) make the Database dynamic, secure, and longitudinal, (iii) promote a supporting ecosystem for the Database, and (iv) generate revenue from which to make distributions to Members. The Manager shall have the sole discretion as to the emphasis to be placed upon each of these goals. The services of the Manager (the “Services”) will include, to the extent necessary or appropriate for the above purposes, the exercise of all powers of the Manager set forth in Section 4.1 of the Operating Agreement.

3.        Personnel. The Manager shall provide and devote to the performance of this Agreement such employees, representatives and agents of the Manager as Manager shall deem appropriate for the furnishing of the services required thereby, at the Manager’s sole expense and without a right of reimbursement from the Company.

 

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4.        Intellectual Property. Subject to the License Terms set forth in Exhibit A (the “License Terms”), which are incorporated herein by reference and made a part hereof:

4.1        The Manager shall develop, improve and maintain the Database at the Manager’s sole expense.

4.2        The Manager shall create and own for the benefit of the Company various trademarks, domain names, website content and software, and social media accounts and content.

4.3        The Company shall own all intellectual property acquired through collaborations with third parties with respect to Member Data (“Collaboration IP”).

4.4        To the extent that the Manager determines to use any of the Manager’s registered and unregistered U.S. and foreign trade names, trademarks, trade dress and service marks, Internet domain names, Internet addresses and other computer identifiers, websites or web pages, brand names, logos or corporate names owned by the Manager and not subject to Section 4.2 and the corresponding provisions of the License Terms (“Manager IP”) for the benefit of the Company in the course of providing the Services, the Company shall have a non-exclusive, royalty-paid, worldwide license for such use. The Manager shall have no obligation to use Manager IP for the benefit of the Company, and the Manager may cease any such use for the benefit of the Company at any time in its sole discretion, which cessation will automatically terminate the Company’s rights set forth in this Section 4.4 with respect to such use.

5.        Management Fee. Commencing as of the Effective Date, the Company shall pay, to the Manager a management fee (the “Management Fee”) calculated as the sum of (a) an amount equal to the product of (x) fifty percent (50%) and (y) the Net Revenues of the Company; plus (b) an amount equal to all Non-Profit Revenue. Terms used in this Section 5 have the following meanings and are subject to the following provisions:

5.1        “Company Expenses” shall mean Operational Expenses accrued by the Company in accordance with GAAP, which for the avoidance of doubt do not include Organizational Expenses, Operational Expenses borne by the Manager pursuant to Section 6 or the Management Fee.

5.2        “Data Discovery Activities” means discovery activities that derive value from the content contained in the Database, such as (i) providing to third parties including but not limited to pharmaceutical and biotechnology discovery companies (collectively, “Customers”), Access to the Database for population-level research, and (ii) making available to Customers, directly or through the Manager, contact information for Members who have elected via their Community Agreements to allow the sharing of such contact information. Examples of Data Discovery Activities involving making available Member contact information include, but are not limited to, identification of Members based on criteria defined by Customers to identify candidates for a study and requests by Customers for updated contact information stored in the Database in order to follow up on a Member’s prior participation in a study. Data Discovery Activities exclude the following activities of the Manager, which the Manager may in its sole discretion choose to conduct for its own or for its Affiliate’s account or for Customers, which activities do not constitute operations of the Company or sources of Net Revenues:

(a)        Communication and Member engagement services provided to Customers following a Data Discovery Activity that identifies or provides contact information of Members;

 

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(b)        assisting Customers in collecting longitudinal data of identified Members that is at the time of initial collection outside the Database (it being understood that such data may in connection with such services by the Manager be Contributed to the Database);

(c)        the offer or sale of value added goods and services to Members (other than Shares) for consideration other than Contributions, whether by the Manager, an Affiliate of the Manager or a third party offering goods or services that may be of interest to Members;

(d)        professional services such as scientific consultation or project management; and

(e)        any and all other activities of the Manager, whether or not involving Database IP (as defined below) or Manager IP, that do not derive direct value from the content of the Database.

5.3        “Net Revenues” means all revenue recognized by the Company from (a) Data Discovery Activities and (b) license fees, royalties and other revenue derived from Collaboration IP, in each case accordance with generally accepted accounting principles (“GAAP”), other than Non-Profit Revenue, less Company Expenses.

5.4        “Non-Profit Revenue” means all revenues recognized by the Company from transactions with corporations, trusts, unincorporated association, or other types of organizations (“Non-Profit Organizations”) that (i) are exempt from federal income tax under section 501(c)(3) of the Internal Revenue Code of 1986, as amended, (ii) have applied in good faith for a determination of such exemption from the Internal Revenue Service, or (iii) would be eligible to be so exempt, in the reasonable opinion of the Manager, if operated in the United States. Examples of Non-Profit Organizations include disease foundations, research organizations, and organizations for the benefit of minority or economically disadvantaged groups. Notwithstanding the foregoing, license fees, royalties and other revenues earned from Collaboration IP generated through collaboration with a Non-Profit Organization are not Non-Profit Revenue and will be included in Net Revenues, even if such license fees, royalties and other revenues are paid by Non-Profit Organizations.

5.5        The Manager will determine the Management Fee with respect to Net Revenues and Non-Profit Revenue for each fiscal quarter. The Management Fee shall be payable within ten (10) days following the closing of the Company’s books for each quarter, to the extent of available cash in the Company. To the extent sufficient cash is not available at a payment date, the unpaid portion of the Management Fee shall accrue and be paid promptly following the Company’s receipt of cash sufficient to pay the amount in arrears. The Management Fee shall be payable regardless of whether any services are requested or provided in such quarter (or in any other quarter) and regardless of whether the Company finds the Manager’s services to be complete and/or useful.

6.        Expenses. The Company shall promptly reimburse the Manager for all Company expenses advanced by the Manager, in accordance with the Operating Agreement. Notwithstanding the foregoing, the Manager will not be entitled to reimbursement for Operational Expenses paid by the Manager if such Operational Expenses are, or would be but for the provisions of this Section 6, accrued by the Company under generally accepted accounting principles on or before March 31, 2020. To the extent that any payment of expenses of the Company by the Manager is not reimbursed by the Company and is properly allocable as an expense of the Company for federal, state and local tax purposes, a portion of the Management Fees for a like amount shall be treated as a reimbursement to the Manager for such expenses and not as a payment of Management Fees.

 

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7.        Other Revenue Sources. With the exception of revenue derived from the Company’s provision to third parties of Access to the Database for population-level research, the Company will not participate in revenues deriving from the Database IP or the Manager IP, such as third-party targeted research participation or advertising directed to Members on websites or other communication platforms used by the Manager for the benefit of the Company. For purposes of this Agreement, “Database IP” means (a) all worldwide intellectual property rights that are necessary or appropriate for the organization, structure or operation of the Database, or any substitute, expansion or upgrade of the Database, including worldwide patents, trade secrets, know-how, and copyrights, and (b) any improvements, developments, innovations or new inventions conceived or discovered by the Manager, solely or jointly, related to any of the foregoing.

8.        Term. This Agreement will continue from the date hereof until terminated by the Manager with thirty (30) days prior notice. This Agreement may not be terminated by the Company.

9.        Waiver of Liability. The provisions of Section 4.4(a) of the Operating Agreement apply to the Services and the Manager’s performance under this Agreement and are incorporated herein by reference.

10.      Confidentiality.

10.1      Non-Disclosure. Each Party agrees to regard and preserve as confidential all non-public information related to the business and activities of the other Party and its Affiliates, which may be obtained by such Party from any source or may be developed as a result of this Agreement or the Operating Agreement, including financial and business information, strategy, trade secrets, know-how, technical information, specifications, past, present and future operations, partner, client, staff, end user, athlete, trainer, consultant, medical professional and supplier identities, Member Data, and other non-public information, whether tangible, intangible, visual, electronic or otherwise, together with notes, analysis, compilations, studies and/or other documents prepared by a Party, its directors, officers, employees, agents and representatives based upon, containing or otherwise reflecting such information (collectively, “Confidential Information”). Each Party agrees to hold the Confidential Information of the other in confidence and shall not disclose such information to any Person, or use (directly or indirectly) any such information for its own benefit or the benefit of any other party. Even when disclosure is permitted, each Party agrees to limit access to and disclosure of the other Party’s Confidential Information to its employees on a “need to know” basis only. Notwithstanding the foregoing, either Party may disclose the other Party’s Confidential Information (a) pursuant to applicable law or regulation or compulsion of proper judicial or other legal process; provided, however, that the disclosing Party shall provide prompt notice of the same prior to such required disclosure such that the other Party may seek a protective order or other appropriate remedy to safeguard, restrict or limit the disclosure of such Confidential Information, (b) to establish a Party’s rights under this Agreement, including to make such court filings as it may be required to do, or (c) with respect to Member Data, in accordance with the Company’s agreements with the respective contributors of such Member Data.

10.2      Exclusions. Information shall not be considered “Confidential Information” hereunder to the extent, but only to the extent that, such information (a) is or becomes publicly available through no fault, default or breach of or by the receiving Party; (b) is or was rightfully acquired by the receiving Party from an independent third party without restriction or obligation of confidentiality and without breach of any agreement or obligation; (c) is or was independently developed by the receiving Party without use of or reference to Confidential Information of the other Party, or (d) is approved for release without restriction by the disclosing Party.

 

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10.3      Recipients; Equitable Relief. Each Party shall, in advance, ensure that each individual who obtains or is in a position to obtain Confidential Information of the other Party, understands and has agreed to comply with the obligations in this Section 10. Further, in the event of a breach or threatened breach of either Party’s obligations in this Section 10, the other Party shall suffer immediate and irreparable harm for which money damages may be difficult to calculate or provide inadequate compensation. Accordingly, either Party shall be entitled to an injunction, restraining order or other equitable relief to enforce compliance with the provisions of this Section 10; provided, however, that no specification herein of any particular legal or equitable remedy shall be deemed or construed to prohibit either Party from seeking or obtaining any other remedy under this Agreement, at law or in equity.

11.      Indemnification. The provisions of Section 4.5 of the Operating Agreement apply to the Services and the Manager’s performance under this Agreement and are incorporated herein by reference; provided that the indemnity provisions of the License Terms shall apply to the subject matter thereof.

12.      Future Subsidiaries. At the request of the Manager, the Company shall cause and take all action needed such that any direct or indirect subsidiary of the Company becomes a guarantor and agrees to the terms hereof (including those set forth and contemplated by Sections 9 and 11).

13.      Independent Contractor. The Manager shall perform services hereunder as an independent contractor, retaining control over and responsibility for its own operations and personnel. Neither the Manager nor its officers, employees or agents shall be considered employees or agents of the Company as a result of this Agreement, nor shall any of them have authority by execution of this Agreement to contract in the name of or bind the Company, except as expressly agreed to in writing by the Company.

14.      Representations and Warranties.

14.1      Mutual Representations. Each Party hereby represents and warrants to the other Party as follows: (a) it is duly organized, validly existing and in good standing as a corporation or other entity as represented herein under the laws and regulations of its jurisdiction of incorporation, organization or chartering; (b) it has the full right, power and authority to enter into this Agreement, to grant the rights and licenses (as applicable) granted hereunder and to perform its obligations hereunder; (c) the execution of this Agreement by its representative whose signature is set forth at the end hereof has been duly authorized by all necessary corporate action of the Party; and (d) when executed and delivered by such Party, this Agreement will constitute the legal, valid and binding obligation of such Party, enforceable against such Party in accordance with its terms.

14.2      Disclaimers EXCEPT AS SET FORTH HEREIN, NO EXPRESS OR IMPLIED WARRANTIES ARE GIVEN BY MANAGER OR ITS AFFILIATES WITH RESPECT TO THE INTELLECTUAL PROPERTY RIGHTS LICENSED HEREUNDER OR ANY OTHER MATTER OR SUBJECT ARISING OUT OF THIS AGREEMENT, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ANY IMPLIED WARRANTY ARISING OUT OF COURSE OF DEALING OR USAGE OF TRADE, AND ANY IMPLIED WARRANTY OF FREEDOM FROM INFRINGEMENT, OR REGARDING THE VALIDITY, SCOPE, OWNERSHIP OR ENFORCEABILITY OF ANY SUCH INTELLECTUAL PROPERTY.

15.      Limitation of Liability. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, NEITHER PARTY SHALL BE LIABLE FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY, SPECIAL, PUNITIVE, OR ENHANCED DAMAGES, OR FOR ANY LOSS OF ACTUAL OR ANTICIPATED PROFITS (REGARDLESS OF HOW THESE ARE

 

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CLASSIFIED AS DAMAGES), WHETHER ARISING OUT OF BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE (INCLUDING THE ENTRY INTO, PERFORMANCE, OR BREACH OF THESE TERMS), REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE AND WHETHER SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

16.      Miscellaneous.

16.1      Notices. The provisions of Section 10.1 of the Operating Agreement apply to all notices, requests, demands, claims and other communications hereunder.

16.2    Mandatory Arbitration. To the maximum extent permitted by law, all Claims arising under this Agreement will be resolved by final and binding arbitration in San Diego, California, in accordance with Section 10.2 of the Operating Agreement.

16.3      Entire Agreement. This Agreement contains the complete and entire understanding and agreement of the Manager and the Company with respect to the subject matter hereof and supersedes all prior and contemporaneous understandings, conditions and agreements, oral or written, express or implied, respecting the engagement of the Manager in connection with the subject matter hereof.

16.4      Partial Invalidity. If any one or more of the provisions contained in this Agreement, or the application thereof in any circumstance, is held invalid, illegal or unenforceable in any respect for any reason, then the validity, legality and enforceability of any such provision in every other respect and of the remaining provisions hereof shall not be in any way impaired, unless the provisions held invalid, illegal or unenforceable shall substantially impair the benefits of the remaining provisions of this Agreement. The Company agrees that, pursuant to Section 16.9, the Manager may replace such invalid, illegal or unenforceable provision of this Agreement with a valid, legal and enforceable provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid, illegal or unenforceable provision, without providing the notice to Members that may otherwise be required.

16.5      Waiver. No failure by any party to insist upon the strict performance of any covenant, duty, agreement or condition of this Agreement or to exercise any right or remedy consequent upon a breach thereof shall constitute a waiver of any such breach or any other covenant, duty, agreement or condition.

16.6      Governing Law. This Agreement will be governed by and construed according to the laws of the State of Delaware, without regard to any conflicts of law principles (whether of the State of Delaware or any other jurisdiction) that would cause the application of the substantive laws of any jurisdiction other than the State of Delaware.

16.7      Jurisdiction; Venue; Service of Process. Subject to Section 16.2, any action, suit or other proceeding arising out of or in connection with or related to this Agreement shall be conducted only in San Diego, California. Each of the parties hereto hereby (a) irrevocably consents and submits to the exclusive personal jurisdiction of and venue in the state and federal courts located in San Diego, California in any legal action, equitable suit or other proceeding arising out of or related to this Agreement; (b) waives any right it may have to assert the doctrine of forum non conveniens or similar doctrine or to object to venue with respect to any proceeding brought in accordance with this Section 16.7; (c) stipulates that the state and federal courts located in San Diego, California shall have in personam jurisdiction and venue over each of them for the purposes of litigating any dispute, controversy or proceeding arising out of or related to this Agreement, and (d) agrees that, to the fullest extent

 

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permitted by law, service of process may also be made on such party by prepaid certified mail with a proof of mailing receipt validated by the U.S. Postal Service constituting evidence of valid service, and that, to the fullest extent permitted by applicable law, service so made shall have the same legal force and effect as if served upon such party personally within the State of California.

16.8      Prevailing Party; Attorney’s Fees. If any party hereto commences any action against any other party hereto with respect to the enforcement or interpretation of this Agreement, then the prevailing party (as defined in Section 10.2(h) of the Operating Agreement) in such action shall be entitled to an award of its costs of litigation, including attorney’s fees.

16.9      Amendment. This Agreement may be amended, modified, or waived, at any time or from time to time, without the written consent of the Company, except that the consent of the Company shall be required for any amendment, modification or waiver of Section 3 of the License Terms or the definition in the License Terms of “Trigger Events”. If any such amendment, modification or waiver may reasonably have an adverse effect on the rights or obligations of the Company, such amendment, modification or waiver shall not be effective until the date thirty (30) days after notice thereof to the Members (and any Member who does not wish to agree to such amendment, modification or waiver may redeem all of its Shares and resign as a Member per Section 6.11 of the Operating Agreement).

16.10    Execution in Counterparts. This Agreement may be executed in counterparts (including by means of facsimile or other form of electronic or digital image transmission), each of which shall be deemed an original but all of which taken together shall constitute one and the same agreement.

16.11    Assignment. The Manager may assign this Agreement without the consent of the Company. The Company may not assign this Agreement without the consent of the Manager.

16.12    Successors and Assigns. Except as otherwise provided herein, all covenants and agreements contained in this Agreement shall bind and inure to the benefit of the parties hereto and their respective heirs, executors, administrators, successors, legal representatives and permitted assigns, whether so expressed or not.

16.13    Computation of Time. The provisions of Section 10.15 of the Operating Agreement apply to this Agreement.

16.14    Interpretation. Unless otherwise stated or the context clearly requires otherwise: (a) all section and exhibit references are to the corresponding article or section of or exhibit to this Agreement, (b) any pronoun used in this Agreement shall include the corresponding masculine, feminine or neuter forms, (c) the singular form of nouns, pronouns and verbs shall include the plural and vice versa, (d) the use of the words “includes,” “including” and words of similar import in this Agreement shall be by way of example rather than by limitation (thus shall be deemed to be followed by the phrase “without limitation”), (e) reference to any agreement, document or instrument means such agreement, document or instrument as amended or otherwise modified from time to time in accordance with the terms thereof, and if applicable, the terms hereof, and (f) the use of the words “or,” “either” and “any” shall not be exclusive. In the event that an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties hereto, and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any of the provisions of this Agreement. Without limiting the Manager’s authority under Section 10.11 of the Operating Agreement or Section 16.9, the Manager may interpret this Agreement in any reasonable manner that resolves any conflicts between the provisions of this Agreement and the Management Agreement, and such interpretations shall be binding on the Company and the Manager.

 

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16.15    Entire Agreement. This Agreement and the Management Agreement contain the entire understanding and agreements among the parties hereto, are intended to be a complete and exclusive statement of the agreement and understanding of the parties hereto in respect of the subject matter contained herein and therein, and supersede any prior understandings and agreements among them respecting the subject matter hereof and thereof. There are no restrictions, promises, warranties or undertakings, other than those set forth or referred to herein or therein. The parties hereto have voluntarily agreed to define their rights, liabilities and obligations respecting the subject matter hereof exclusively in contract pursuant to the express terms and provisions of this Agreement and the Management Agreement; and the parties hereto expressly disclaim that they are owed any duties or are entitled to any remedies not expressly set forth in this Agreement or any other Transaction Document.

16.16    Electronic or Digital Delivery of Signatures. The provisions of Section 10.21 of the Operating Agreement apply to this Agreement.

16.17    Survival. Sections 9, 11 and 14 shall survive and continue in full force in accordance with their respective terms notwithstanding any termination of this Agreement.

16.18    Severability. This Agreement is severable. If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction or other authority to be invalid, void, unenforceable or against its regulatory policy, the remainder of the terms, provisions, covenants and restrictions of this Agreement shall nevertheless remain in full force and effect and shall in no way be affected, impaired or invalidated. Upon such determination that any term, provision, covenant or restriction is invalid, illegal, void, unenforceable or against regulatory policy, the parties hereto shall negotiate in good faith to modify this Agreement so as to effect and conform with the original subjective intent of the parties hereto as closely as possible in an acceptable manner.

*        *        *         *

 

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IN WITNESS WHEREOF, the undersigned have caused this Management Services Agreement to be duly executed and delivered on the date and year first above written.

 

LunaPBC, Inc.

By:

 

/s/ Bob Kain

 

Name: Bob Kain

 

Title: Chief Executive Officer

LunaTrust LLC

By: LunaPBC, Inc., its Manager

By:

 

/s/ Bob Kain

 

Name: Bob Kain

 

Title: Chief Executive Officer

Signature Page to Management Services Agreement


EXHIBIT A

LICENSE TERMS

These LICENSE TERMS (these “Terms”) are incorporated by reference into that certain Management Services Agreement, made and entered into as of April 23, 2018 (the “Management Services Agreement”), by and between Luna DNA, Inc., a Delaware corporation (“Licensor”), and LunaTrust LLC, a Delaware limited liability company (“Licensee” and, together with Licensor, the “Parties”). For avoidance of doubt, these Terms do not include other parts of the Management Services Agreement.

R E C I T A L S

WHEREAS, on April 23, 2018, Licensor formed Licensee, and Licensor has entered into that certain Limited Liability Company Agreement of Licensee dated as of April 23, 2018 (the “Operating Agreement”) for the principal purpose of building, operating, maintaining, querying and otherwise dealing with databases comprised of Member Data (as defined in the Operating Agreement) that is owned by its members and licensed to the Licensee (collectively, the “Database”), and to engage in any other lawful business activities in connection therewith, or related to the business of the Licensee (the “Business”);

WHEREAS, capitalized terms used but not defined herein shall have the respective meanings ascribed thereto in the Operating Agreement;

WHEREAS, the Licensor is the Manager of the Licensee and the Parties have entered into that certain Management Services Agreement, dated as of the date hereof (the “Management Services Agreement”), in which Licensor has agreed to manage all aspects of the business of Licensee;

WHEREAS, Licensor owns by assignment all (a) United States patent applications for inventions conceived by Licensor’s personnel related to the operation and management of databases for omic data or phenotype data, (b) foreign patent applications for the inventions described in clause (a) next above, and (c) any and all patents issuing on or registered from the foregoing, and any and all reexaminations, reissues, additions or extensions of any such patents (the items described in clauses (a) – (c) next above, collectively, together with any other such patents assigned to Licensor as Manager of Licensee or in connection with the Database or the Business, the “Licensed Patents”);

WHEREAS, in addition to the Licensed Patents, Licensor owns other intellectual property rights that are necessary or appropriate for the organization, structure or operation of the Database, or any substitute, expansion or upgrade of the Database, including trade secrets, know-how, Software (as defined below) and copyrights, and any improvements, developments, innovations or new inventions conceived or discovered by Licensor, solely or jointly, related to any of the foregoing, but excluding any Off-the-Shelf Software (as defined below) (collectively, together with any other such intellectual property rights created by Licensor as Manager of Licensee in connection with the Business, “Licensed Database IP”);

WHEREAS, Licensor owns the trademarks, trade dress and logos listed and referenced in Schedule A attached hereto (collectively, together with any other trademarks, trade dress and logos created by Licensor as Manager of Licensee in connection with and for the benefit of the

 

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Business, “Licensed Marks”) and the domains listed and referenced in Schedule A attached hereto (“Domains”);

WHEREAS, Licensor has developed and will continue to develop certain Software (a) to operate the Database on servers in the cloud, including querying the database (including database schema, stored procedures and the like, the “Database Software”), and (b) to operate the Company’s website, including functionality for (i) creating user accounts and managing user settings; (ii) issuing Shares to Members; (iii) providing interactive user features, and (iv) providing news and information about the Company, the Business and the Database to Members and potential Members; but in each case of clauses (a) and (b) of this paragraph, excluding any Off-the-Shelf Software (the “Website Software” and, together with the Database Software, the “Licensed Software”);

WHEREAS, Licensor has created, and may in the future create, social media accounts related to and for the benefit of the Business (collectively, together with any other social media accounts created by Licensor as Manager of Licensee, the “Social Media Accounts”); and

WHEREAS, Licensor is willing to grant to Licensee licenses for the Licensed Patents, the Licensed Database IP, the Domains, the Licensed Software, and the Licensed Marks, and in the event of a Trigger Event to assign to Licensee the Assigned IP (as defined below), all on the terms and subject to the conditions set forth herein.

A G R E E M E N T

NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:

1.        Definitions. As used in these Terms, the following terms shall have the following meanings:

Off-the-Shelf Software” means any Software or rights thereto which (A) Licensor has acquired subject to a “shrink wrap” or similar commercial end-user licenses or commodity type licenses widely available to the public generally (and there is no reason to believe it will not be available to Licensee) on non-discriminatory terms, or (B) consists of non-customized third-party Software licensed to Licensor which is generally available to other Persons (and there is no reason to believe it will not be available to Licensee) on substantially similar terms and conditions; including in each case Software or rights thereto supplied or installed by a hosting or other service provider

Law” means any statute, law, ordinance, regulation, rule, code, order, constitution, treaty, common law, judgment, award, decree, other requirement, or rule of law of any federal, state, local or foreign government, or political subdivision thereof, or any arbitrator, court, or tribunal of competent jurisdiction.

Licensed IP” means the Licensed Patents, Licensed Database IP, Licensed Marks and Licensed Software.


Licensed Manager Usage” means any use by Licensor of (a) the Licensed Marks as permitted by Section 2.2(b), (b) the Domains as permitted by Section 2.3, or (c) the Social Media Accounts as permitted by Section 2.4.

Licensed Methods” means any methods, procedures, processes, or other subject matter whose use or practice would constitute an infringement of Licensor’s patent rights but for the license granted to Licensee hereunder.

Licensed Products” means products (including Software) that incorporate or are produced by the practice of subject matter claimed in Licensed Patents, and whose manufacture, use, sale, import, or offer for sale would constitute an infringement of Licensor’s patent rights but for the license granted to Licensee hereunder.

Losses” means losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including reasonable attorneys’ fees (outside counsel fees, in-house counsel time and expenses and administrative costs).

Social Media Content” means all intellectual property rights (including all rights under copyright, trademark, trade name and trade dress law and all rights to sue for past infringements thereof) in the content hosted at or used by, or services provided using, any Social Media Accounts (including, for avoidance of doubt, any Developed Works (as defined below)), that Licensor may have, including all graphics, photographs, images, audio, video, logos, and other multimedia and text.

Social Media Contracts” means any contracts (express or implied) relating to the hosting, design or maintenance of any Social Media Accounts.

Software” means any software or computer program, including firmware and other software embedded in hardware devices, whether in the form of source code, assembly code, script, interpreted language, instruction sets or binary or object code (including compiled and executable programs), including any library, component or module of any of the foregoing, together with (i) any related default configuration files, (ii) runtime data, files and objects, such as icons, buttons, configuration files and the like, needed for the proper operation of the Software, (iii) screens, user interfaces, report formats, templates and menus, and (iv) user documentation and help files, including with regard to any command-line options and switches. With respect to source code, “Software” also includes (A) all code written in any programming language, scripting language, XML or other format, (B) developer comments, (C) associated header or interface definition files, (D) IDE configuration or project files and the like, (E) compilation or build files, scripts or tools, (F) API and class documentation, Gantt charts and other diagrams, materials or other documentation explaining the structure, flow controls, class hierarchy, algorithms, data structures, API or composition of such source code, (G) compilation or build instructions (whether meant for use by developers or compilation or build programs, scripts or tools), (H) interpreted data (including JavaScript and other runtime or client scripts), stylesheets, icons, buttons, and other images, video, audio and other multimedia files, materials and data used in the generation of the executable or needed for the proper execution, use or display of the Software, and (I) any design notes and material proprietary information or algorithms contained in or relating to such source code.

Trigger Events” means the occurrence of any of the following events: (a) the termination of the Management Services Agreement, (b) Luna DNA, Inc. ceasing to be the


Manager of Licensee or the Manager under the Management Services Agreement, or (c) the dissolution of the Licensor.

Website Content” means all intellectual property rights (including all rights under copyright, trademark, trade name and trade dress law and all rights to sue for past infringements thereof) in the content hosted at or used by (including, for avoidance of doubt, any Developed Works), or services provided using, the Domains, that Licensor may have, including all graphics, photographs, images, audio, video, logos, and other multimedia and text.

Website Contracts” means any contracts (express or implied) relating to the hosting, design or maintenance of the websites hosted on the Domains.

2.        License.

2.1        License Grant. Subject to the terms and conditions of these Terms, Licensor grants to Licensee a non-exclusive, royalty-free, fully paid up, non-sublicensable, non-transferable, perpetual, worldwide right and license to (a) use the Licensed Database IP, the Licensed Software (including, with respect to the Website Software, the source code thereto), the Website Content and the Social Media Content, solely in connection with the Business, and (b) practice the Licensed Patents and to make, use, sell, offer for sale, and import Licensed Products, and to practice the Licensed Methods, solely in connection with the Business.

2.2        Trademark License. Subject to the terms and conditions of these Terms:

(a)        Licensor grants to Licensee an exclusive, royalty-free, fully-paid up, sublicensable, transferrable, perpetual, worldwide right and license to use the Licensed Marks and any related trade dress in connection with the operation, promotion and advertising of the Business, and the worldwide promotion, advertising, distribution and sale of the Company and related services and products.

(b)        Licensee hereby grants to Licensor a non-exclusive royalty-free, fully-paid up, non-sublicensable, non-transferrable, worldwide right and license to use the Licensed Marks and any related trade dress in connection with the operation, promotion and advertising of Licensor’s business, and the worldwide promotion, advertising, distribution and sale of the Licensor and related services and products.

2.3        Domains. Licensor shall use the Domains (including any websites hosted on the Domains) in connection with and for the benefit of the Business (it being understood that Licensor may use the Domains in connection with Licensor’s business prior to a Trigger Event, without prejudice to Section 3.3).

2.4        Social Media Accounts. Licensor shall use the Social Media Accounts in connection with and for the benefit of the Business (it being understood that Licensor may use the Domains in connection with Licensor’s business prior to a Trigger Event, without prejudice to Section 3.5).


3.        Trigger Events. In the event of (and subject to the occurrence of) a Trigger Event, the following provisions shall apply automatically, without the need for any action by Licensor, Licensee or any other Person:

3.1        Software. Licensor grants to Licensee a non-exclusive, royalty-free, fully paid up, non-sublicensable, non-transferable, perpetual, worldwide right and license to use, modify, distribute, reproduce, perform, display, create derivative works of, or translate the Licensed Database IP and any Software theretofore licensed to Licensee under these Terms (for avoidance of doubt, excluding Off-the-Shelf Software, but including any Developed Works which constitute Software) (collectively, the “Licensed Software”), both in object code and source code.

3.2        Trademarks. Licensor assigns, conveys and transfers to Licensor all right, title and interest in and to the Licensed Marks, together with the goodwill of the business symbolized by the Licensed Marks, all applications and registrations therefor, and all claims for damages arising out of or relating to past or continuing infringements thereof, if any, with the right to sue for and collect such damages. Upon the occurrence of a Trigger Event, the license granted in Section 2.2(b) shall automatically terminate. After a Trigger Event, Licensor agrees that it shall not (a) adopt, seek to register, file or prosecute any application or other filing anywhere in the world for any trademark, service mark, certification mark, composite mark or other type of mark, trade dress, corporate name or other type of legal entity name, trade name, domain name, email address, social media account, identifying logo or other identifier of source in any language that is confusingly similar to or dilutive of the Licensed Marks or any other source identifier owned or used as an identifier of source by Licensee, unless expressly requested to do so in writing by Licensee; (b) adopt, adapt, use or display any marks, logos, names, brands, distinctive identification or other material of any kind that is or may be likely to cause confusion to any consumers or otherwise dilute or adversely affect Licensee’s rights in the Licensed Marks; or (c) create a combination or composite mark that includes the Licensed Marks, commingle the Licensed Marks with the trademarks of Licensor or any third party, or use the Licensed Marks in any manner that, directly or indirectly, would dilute, demean, ridicule or otherwise tarnish the image of the Licensed Marks, Licensee or its Affiliates.

3.3        Domains. Licensor assigns, conveys and transfers to Licensor all right, title and interest in and to the Domains, the registration therefor, and any and all intellectual property rights and goodwill arising from Licensor’s use thereof, and all claims for damages arising out of or relating to past or continuing infringements thereof, if any, with the right to sue for and collect such damages.

3.4        Websites. Licensor assigns, conveys and transfers to Licensee all right, title and interest in and to (a) all Website Content, any registration therefor, the content associated therewith, and any and all intellectual property rights and goodwill arising from Licensor’s use thereof that Licensor may have, (b) all Website Contracts, and (c) all claims for damages arising out of or relating to past or continuing infringements or breaches, as the case may be, thereof, if any, with the right to sue for and collect such damages.

3.5        Social Media. Licensor assigns, conveys and transfers to Licensee all right, title and interest in and to (a) the Social Media Accounts, the registration therefor, the content associated therewith, and any and all intellectual property rights and goodwill arising from Licensor’s use thereof that Licensor may have, (b) all claims for damages arising out of or relating to past or continuing infringements thereof, if any, with the right to sue for and collect such damages, (c) all Social Media Content, and (d) any Social Media Contracts (together with


the Social Media Accounts and Social Media Content, the “Social Media Assets”). As of the date of such Trigger Event, Licensee shall assume maintenance of the Social Media Accounts and Licensor shall do all things necessary or desirable to facilitate the transition to Licensee.

3.6        Liabilities. Licensor shall remain solely responsible for any liabilities arising prior to such Trigger Event of the operation of the Assigned Assets (as defined below). Licensee shall be solely responsible for any liabilities arising out of the operation of the Social Media Assets and Internet Assets from and after such Trigger Event.

3.7        Further Assurances. From time to time after such Trigger Event and without further consideration, upon the request of Licensee, Licensor shall execute and deliver such documents and instruments of conveyance and transfer as Licensee may reasonably request in order to consummate more effectively the assignment, conveyance and transfer as contemplated by this Section 3 and to vest in Licensee title to the Licensed Marks, Domains, Website Content, Website Contracts and Social Media Assets assigned, conveyed and transferred by this Section 3 (collectively, the “Assigned Assets”), or to otherwise more fully consummate the transactions contemplated by this Section 3, and Licensee, upon the request of Licensor, shall execute and deliver such documents and instruments of contract assumption as Licensor may reasonably request in order to confirm Licensee’s liability for the obligations assumed as provided in Section 3.6 or otherwise to more fully consummate the transactions contemplated by this Section 3. Without limiting the generality of the foregoing, Licensor further covenants that, upon reasonable request on or after such Trigger Event, it will, without charge to Licensee, execute all documents and take all such further actions as may be reasonably necessary, desirable or convenient to enable Licensee to obtain and maintain full ownership of, and enforce its rights, title and interest in and to, the Domains, the Website Content, the Website Contracts and the Social Media Assets (collectively, the “Assigned Assets”), including (i) assisting Licensee with the investigation, preparation, discovery and prosecution of any actual or threatened litigation against any counterparty to any Social Media Contract or Website Contract, (ii) effectuating the transfer of the Domains to Licensee in a timely manner, at its sole expense, including (A) completing, or using its reasonable efforts to complete, and cause any other Person who may have a registered interest in any Domain (the “Domain Parties”) to complete, any and all forms required by the registrars of the Domains (the “Registrars”) to effect transfer of the Domains registrations to Licensee, and (B) filing, or causing to be filed, such forms with the Registrars within five (5) business days of such Trigger Event, (iii) providing to Licensee all credentials needed to manage and use any Social Media Accounts, (iv) filing a duly executed and proper trademark assignment with the PTO, (v) promptly providing to Licensee the full and complete source code to the Licensed Software, and (vi) immediately forwarding to Licensee any messages, email or other communications related to any Assigned Assets to Licensee.

4.        Reservation of Rights. All rights not expressly granted herein are reserved to the Licensor, and except for the rights and licenses granted to Licensee pursuant to these Terms, nothing shall be construed to restrict, impair, encumber, license, alter, deprive or adversely affect any of Licensor’s rights or interests therein or any other of Licensor’s intellectual property, brands, information, content, processes, methodologies, products, goods, services, materials or rights, tangible or intangible. Without limiting the foregoing, (a) no use of the Licensed IP shall be permitted except as expressly provided in these Terms, and (b) no rights in and to any other trademarks, brands, logos or other intellectual property are granted. For the avoidance of doubt, Licensor shall have the right to use and exploit, and to grant third parties the right to use and exploit, the Licensed Database IP for any purpose, including for purposes competitive with the Business, in any and all territories.


5.        Ownership and Protection of Licensed IP.

5.1        Ownership.

(a)        Pre Trigger Event. Licensee acknowledges that Licensor is the owner of the Licensed IP, including Developed Works (as defined below). For the avoidance of doubt, Licensor shall have the sole and exclusive right to obtain, hold and renew, in its own name and for its own benefit, all applicable intellectual property right protections in connection with the Licensed IP and Developed Works, and all applications and registrations therefor.

(b)        Post Trigger Event. Notwithstanding Section 5.1(a), from and after a Trigger Event, (i) Licensor acknowledges that Licensee is the owner of the Licensed Marks, Domains, Website Content and Social Media Content, including any Developed Works which constitute Website Content or Social Media Content (all of the intellectual property rights referenced in this clause (i), collectively, the “Assigned IP”), and (ii) for the avoidance of doubt, Licensee shall have the sole and exclusive right to obtain, hold and renew, in its own name and for its own benefit, all applicable intellectual property right protections in connection with the Assigned IP and all applications and registrations therefor.

(c)        Developed Works. Subject to Section 3, Licensee acknowledges and agrees that Licensor shall have exclusive, unlimited ownership rights to intellectual property, works, work product, and all other materials and items, tangible or intangible, created or developed by Licensor as a result of or in connection with the Business, whether as individual items or as combinations of components, whether or not jointly developed with others and whether or not completed, including all inventions, discoveries, improvements, concepts, ideas, research, drafts, notes, and data, together with all intellectual property rights appurtenant thereto (collectively, “Developed Works”). In the event and to the extent that exclusive title or ownership rights may not or do not originally vest in Licensor as contemplated hereunder, Licensee hereby agrees to irrevocably (subject to Section 3) assign, transfer and convey to Licensor all right, title and interest therein and shall give Licensor, and any Licensor designee, all reasonable assistance and execute all documents necessary to assist or enable Licensor to perfect, preserve (subject to Section 3), register and record its rights in and to such Developed Works. Licensee hereby irrevocably appoints Licensor as its attorney-in-fact, coupled with an interest, to execute and file any such documents in Licensee’s name. For the avoidance of doubt, subject to Section 3, Licensee may not use the Developed Works for any purpose other than to develop, operate, maintain and support the Database and otherwise in connection with the Business. Notwithstanding anything to the contrary set forth in these Terms, Licensor shall not own any intellectual property rights Licensee acquires from collaborations with third parties with respect to Member Data.

5.2        Enforcement. Each Party shall promptly notify the other Party in writing of (a) any actual or potential infringement, counterfeiting, or other unauthorized use of any of the Database IP by any other Person (an “Infringement”) of which it becomes aware; and (b) any claim or cause of action involving the Database IP that is threatened or instituted against such Party or any other Person of which such Party becomes aware. Licensor shall have the sole right, in its discretion, to enforce its rights in any of the Database IP, including to bring action with respect to any Infringement.


5.3        No Encumbrances. Except with Licensor’s written approval, Licensee shall not grant or attempt to grant a security interest in any of the Database IP or record any such security interest against any application or registration regarding the Database IP with any Governmental Authority.

6.        Use of Licensed Marks.

6.1        Acknowledgement. The Parties acknowledge the high standards, goodwill and reputation for quality symbolized by the Licensed Marks. Accordingly, Licensor shall, at all times prior to a Trigger Event, use the Licensed Marks in a manner which meets or exceeds such standards. All use of the Licensed Marks and any goodwill accruing as a result of that use shall inure solely and exclusively to the benefit of Licensee.

6.2        Trademark Notices. The Parties shall comply with all marking, legend and notice requirements under applicable Law and shall display such markings, legends and notices in accordance with any standards, parameters and usage guides that may be furnished by Licensee from time to time.

6.3        Prohibited Actions. Each Party agrees that, prior to a Trigger Event, and Licensor further agrees that, after a Trigger Event, it shall not: (a) contest, dispute, attack or question the validity of, or assist any individual or entity in contesting, attacking or questioning, the title or any rights of or claims by Licensor (or, after a Trigger Event, Licensee) in and to the Licensed Marks anywhere in the world; (b) directly or indirectly seek for itself or assist any third party to use, register, record, obtain, acquire or attempt to pursue any rights, proprietary or otherwise, in the Licensed Marks anywhere in the world; (c) engage in any illegal, deceptive, unfair or unethical trade practices in connection with any use of the Licensed Marks; or (d) take any action, directly or indirectly, or fail to take any action required hereunder, which is or could be construed as detrimental, damaging or inconsistent with the rights of Licensor (prior to a Trigger Event) or Licensee (after a Trigger Event) in the Licensed Marks, including any action that may adversely affect the high reputation, distinctiveness and goodwill associated with the Licensed Marks.

6.4        Quality Assurance. Licensee shall have the right to exercise reasonable quality control over Licensor’s use of the Licensed Trademarks, including to maintain the validity of the Licensed Trademarks, to maintain consistency of the use of the Licensed Trademarks, and to promote and protect the goodwill associated therewith. Licensor shall comply with all reasonable marking requirements of Licensee, and, to the extent reasonably practicable, shall display such legends and notices with its use of the Licensed Trademarks as may be required by Licensee.

7.        Licensed Software.

7.1        Prohibited Uses. Licensee will not use the Licensed Software for any purposes beyond the scope of the licenses granted in these Terms. Without limiting the generality of the foregoing, prior to a Trigger Event, Licensee will not (a) distribute any copies of the Licensed Software except as expressly authorized in these Terms; (b) assign, sub-license, sell, lease or otherwise transfer or convey Licensee’s rights under any licenses granted in these Terms; or (c) with respect to Licensed Software for which source code has not been provided to Licensee, (i) modify or create any derivative works of the Licensed Software (or any component thereof), except with the prior written consent of Licensor; or (ii) decompile, disassemble, reverse


engineer or otherwise attempt to obtain or perceive the source code from which any component of the Licensed Software is compiled or interpreted.

7.2        Notification and Correction of Defects. Licensor agrees that it shall promptly notify Licensee of any defect, including any security vulnerability or potential exploit, it knows affects any Licensed Software, and shall (a) promptly notify the Licensee of (i) any actual exploits as they become known, and (ii) the best methods for eliminating or managing the risk posed by any vulnerability or to ward off any exploit, as such methods become known, and (b) use its commercially reasonable efforts expeditiously to distribute a patch, at no cost to Licensee, to correct any such material defect.

8.        Indemnification by Licensor.

8.1        Licensor shall defend, indemnify, and hold Licensee and its Affiliates (other than Licensor), and their respective employees, officers, directors, agents and representatives (collectively, the “Licensee Indemnified Parties”), harmless from and against any and all losses, costs and reasonable expenses (including reasonable attorneys’ fees), damages, and liabilities arising out of any claim by any third party against any Licensee Indemnified Party that any use of, or access to, the Licensed Database IP, Licensed Software or Licensed Manager Usage by such Licensee Indemnified Party as expressly authorized under or contemplated by these Terms infringes or misappropriates, as applicable, any trademarks, patent, copyrights, trade secrets or other intellectual property rights of any third party; provided that Licensee gives Licensor (i) prompt written notice of such claim; (ii) reasonable authority to control and direct the defense and settlement of such claim; and (iii) such information and assistance as Licensor may reasonably request, at Licensor’s expense, in connection with such defense or settlement. Notwithstanding the foregoing, Licensor shall not settle any third-party claim against any Licensee Indemnified Party (A) if such settlement requires such Licensee Indemnified Party to admit to any wrongdoing (other than in respect of any actual wrongdoing by such Licensee Indemnified Party), or (B) unless (i) such settlement completely and forever releases such Licensee Indemnified Party with respect thereto, or (ii) such Licensee Indemnified Party provides its prior written consent to such settlement. In any action for which Licensor provides defense on behalf of any Licensee Indemnified Party, such Licensee Indemnified Party may participate in such defense at its own expense by counsel of its choice.

8.2        Notwithstanding Section 8.1, Licensor shall have no obligation or liability to the extent that the alleged infringement is caused by (i) the combination, operation, or use of the Licensed Database IP, Licensed Software or Licensed Manager Usage with products, services, information, materials, technologies, business methods or processes not furnished by Licensor; (ii) modifications to the Licensed Database IP, Licensed Software or Licensed Manager Usage, which modifications are not made by Licensor or its agents; (iii) failure to use updates to the Licensed Database IP, Licensed Software or Website Content provided by Licensor, provided that updates to the Licensed Database IP and Licensed Software are in all material respects equivalent to, and may be readily substituted for, the Software being updated; and provided further that Licensee shall be afforded a reasonable amount of time to implement any update; or (iv) use of the Licensed Database IP or Licensed Software except in accordance with any applicable user documentation or specifications which have been specifically notified to Licensee (circumstances under the foregoing clauses (i) - (iv), collectively, “Licensee Indemnity Responsibilities”).

8.3        Upon the occurrence of any claim for which indemnity is or may be due under this Section 8, or in the event that Licensor reasonably believes that such a claim is likely,


Licensor may, at its option (i) appropriately modify the Licensed Database IP, Licensed Software or Licensed Manager Usage so that they become non-infringing (provided such modifications do not alter the functionality or operations of the Licensed Database IP or Licensed Software in any material adverse respect), or substitute functionally equivalent software or services (at no cost to the Licensee, including for any required customizations); (ii) obtain a proper license to the applicable third-party intellectual property rights; or (iii) if the foregoing options in clause (i) and (ii) are not reasonably available, terminate the license to the affected Licensed Database IP or Licensed Software or cease use of the affected Licensed Manager Usage. The obligations set forth in this Section 8 shall constitute Licensor’s entire liability and Licensee’s sole remedy for any actual or alleged infringement or misappropriation referred to in Section 8.1.

9.        Indemnification by Licensee.

9.1        Licensee shall indemnify, defend (at Licensor’s option) and hold Licensor and its Affiliates (other than Licensee and its subsidiaries) and their respective employees, officers, directors, agents and representatives (collectively, the “Licensor Indemnified Parties”), harmless, from and against any and all losses, costs and reasonable expenses (including reasonable attorneys’ fees), damages, and liabilities arising out of (a) any claim by any third party against any Licensor Indemnified Party that any use of, or access to, the Licensed Trademarks, Social Media Content or any Website Content by such Licensor Indemnified Party as expressly authorized under or contemplated by these Terms infringes or misappropriates, as applicable, any trademarks, copyrights, trade secrets or other intellectual property rights of any third party, (b) any Licensee Indemnity Responsibilities, or (c) Licensee’s material breach of these Terms. Licensor agrees to give Licensee (i) prompt written notice of such claim; (ii) authority to control and direct the defense or settlement of such claim; and (iii) such information and assistance as Licensee may reasonably request, at Licensee’s expense, in connection with such defense or settlement. Notwithstanding the foregoing, Licensee shall not settle any third-party claim against any Licensor Indemnified Party (A) if such settlement requires such Licensor Indemnified Party to admit to any wrongdoing (other than in respect of any actual wrongdoing by such Licensor Indemnified Party), or (B) unless (i) such settlement completely and forever releases such Licensor Indemnified Party with respect thereto, or (ii) such Licensor Indemnified Party provides its prior written consent to such settlement. In any action for which Licensee provides defense on behalf of any Licensor Indemnified Party, such Licensor Indemnified Party may participate in such defense at its own expense by counsel of its choice.

9.2        The obligations set forth in this Section 9 shall constitute Licensee’s entire liability and Licensor’s sole remedy for any actual or alleged infringement or misappropriation caused by Licensee or for any breach of these Terms.

10.        Term. The term of these Terms shall be perpetual.

[Schedule follows]


SCHEDULE A

LICENSED MARKS

Trademarks: LunaTrust

DOMAINS

lunatrust.com

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