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Innovations in all of these areas have enabled our rapidly expanding suite of products, which allow our customers to interrogate biological systems at previously inaccessible resolution and scale.
−Removed: Our products have enabled researchers to make fundamental discoveries across multiple areas of biology, including oncology, immunology and neuroscience, and have helped empower the single cell revolution hailed by Science magazine as the 2018 “Breakthrough of the Year”.
−Removed: Our products have won many awards, including among others the technological advancements in single cell multimodal omics hailed by Nature Methods journal as the 2019 “Method of the Year” and the technological advancements in spatially resolved transcriptomics hailed by Nature Methods journal as the 2020 “Method of the Year”.
−Removed: Our Single Cell ATAC solution was named one of the top 10 life sciences innovations of 2019 by The Scientist magazine.
−Removed: Our Single Cell Multiome ATAC + Gene Expression solution and our Visium Spatial Gene Expression solution were named as two of the top 10 life sciences innovations of 2020 by The Scientist magazine.
−Removed: Since launching our first product in mid-2015 through December 31, 2020, we have sold 2,412 instruments to researchers around the world, including all of the top 100 global research institutions as ranked by Nature in 2019 based on publications and all of the top 20 global biopharmaceutical companies by 2019 research and development spend.
−Removed: We believe that this represents the very beginning of our penetration into multiple large markets.
+Added: Our products have enabled researchers to make fundamental discoveries across multiple areas of biology, including oncology, immunology and neuroscience, and have helped empower the single cell revolution hailed by Science magazine as the 2018 “Breakthrough of the Year.” Our products have won many awards, including among others the technological advancements in single cell multimodal omics hailed by Nature Methods journal as the 2019 “Method of the Year” and the technological advancements in spatially resolved transcriptomics hailed by Nature Methods journal as the 2020 “Method of the Year.” Between 2015 and 2021, a total of seven 10x products have been recognized by The Scientist magazine on their annual Top 10 Innovations list, an annual list of newly released products that have the potential to generate the biggest impact on scientific research.
+Added: Since launching our first product in mid-2015 through December 31, 2021, cumulatively we have sold 3,511 instruments to researchers around the world, including all of the top 100 global research institutions as ranked by Nature in 2020 based on publications and all of the top 20 global biopharmaceutical companies by 2020 research and development spend.
+Added: We believe that we remain in the very early stages of our penetration into multiple large markets.
We expect that 10x will power a “Century of Biology” in which many of humanity’s most pressing health challenges will be solved by precision diagnostics, targeted therapies and cures to currently intractable diseases.
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Resolution and scale are the imperatives underlying our technologies and products.
−Removed: Our Chromium and Visium product lines provide this resolution and scale along distinct but complementary dimensions of biology.
+Added: Our Chromium, Visium and forthcoming Xenium product lines provide this resolution and scale along distinct but complementary dimensions of biology.
Our Chromium products enable high throughput analysis of individual biological components, such as up to millions of single cells.
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Our products utilize our sensitive and robust molecular assays to convert biological analytes into detectable signals, enabling researchers to obtain vast amounts of information about diverse biological analytes together with their single cell and spatial context.
+Added: Our forthcoming Xenium platform for in situ analysis is being designed to give scientists the ability to not only locate and type cells in their tissue context, but also to address a variety of specific questions based on previous knowledge of their sample often discovered using our Chromium and Visium platforms.
Finally, we provide highly sophisticated and scalable software for analyzing the raw data researchers generate and presenting it in a form that is readily understood by biologists.
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• Our single cell solutions, all of which run on our Chromium instruments, include:
−Removed: ◦ Single Cell Gene Expression for measuring gene activity on a cell-by-cell basis;
−Removed: ◦ Single Cell Immune Profiling for measuring the activity of immune cells and their targets;
−Removed: ◦ Single Cell ATAC for measuring epigenetics, including the physical organization of DNA;
+Added: ◦ Low, Standard and High Throughput Single Cell Gene Expression Kits for measuring gene activity on a cell-by-cell basis from entry level to massively large-scale experiments;
+Added: ◦ Standard and High Throughput Single Cell Immune Profiling Kits for measuring the activity of immune cells and their targets;
+Added: ◦ Single Cell ATAC (Assay for Transposase Accessible Chromatin) for measuring epigenetics, including the physical organization of DNA;
◦ Single Cell Multiome ATAC+Gene Expression introduced in 2020 for measuring the genetic activity and epigenetic programming in the same cells across tens of thousands of cells in a single experiment.
−Removed: • Our Visium Spatial Gene Expression solution for measuring spatial gene expression patterns across a single tissue sample or gene expression and protein co-detection when combined with Immunofluorescence.
+Added: • Our Visium Spatial Gene Expression solution for measuring spatial gene expression patterns across a single fresh-frozen or formalin-fixed paraffin-embedded (FFPE) tissue sample or gene expression and protein co-detection when combined with Immunofluorescence.
Our Feature Barcode technology, which is currently compatible with our Single Cell Gene Expression and Immune Profiling solutions, allows researchers to simultaneously measure multiple analytes, such as protein and RNA, within the same set of cells or tissues.
−Removed: Our Targeted Gene Expression solution, which we introduced in 2020, is currently compatible with our Chromium Single Cell Gene Expression, our Chromium Single Cell Immune Profiling and our Visium Spatial Gene Expression Solutions and, allows researchers to target the genes most relevant for their research, validate their hypotheses faster and reduce sequencing costs.
+Added: Our Targeted Gene Expression solution, which we introduced in 2020, is currently compatible with our Chromium Single Cell Gene Expression, our Chromium Single Cell Immune Profiling and our Visium Spatial Gene Expression Solutions, allows researchers to target the genes most relevant for their research, validate their hypotheses faster and reduce sequencing costs.
+Added: Our CellPlex solution, which we introduced in 2021, is currently compatible with our Chromium Single Cell Gene Expression solution and allows researchers to increase sample and cell throughput by enabling multiple samples and higher cell loads to be loaded into each Chromium channel, lowering costs per sample and cost per cell for our customers.
Collectively, our solutions enable researchers to interrogate, understand and master biology at the appropriate resolution and scale.
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We also expect to pursue additional opportunities that will further expand our opportunity, including new potential applications of our single cell, spatial and in situ technologies in the future.
−Removed: As of December 31, 2020, we employed a commercial team of 290 employees, many of whom hold Ph.D.
−Removed: degrees, who help drive adoption of our products and support our vision.
+Added: As of December 31, 2021, we employed a commercial team of 417 employees, many of whom hold PhD degrees, who help drive adoption of our products and support our vision.
We prioritize creating a superior user experience from pre-sales to onboarding through the generation of novel publishable discoveries, which drive awareness and adoption of our products.
We have a scalable, multi-channel commercial infrastructure including a direct sales force in North America and certain regions of Europe and distribution partners in Asia, certain regions of Europe, Oceania, South America, the Middle East and Africa that drives our customer growth.
−Removed: This is supplemented with an extensive and highly specialized customer service infrastructure with Ph.D.-level specialists.
+Added: This is supplemented with an extensive and highly specialized customer service infrastructure with PhD-level specialists.
We currently have customers in more than 45 countries.
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Both of these efforts have provided substantial value and have been foundational in enabling multiple new research and clinical applications.
−Removed: However, much of the initial promise of the Human Genome Project and subsequent GWAS projects remains unfulfilled.
+Added: However, much of the initial promise of the Human Genome Project and subsequent GWAS projects remains
We believe this is ultimately due to the tremendous underlying complexity of biology.
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Our platforms, molecular assays and software
−Removed: Our Chromium platform, Visium platform, molecular assays and software constitute the building blocks of our integrated solutions.
+Added: Our Chromium platform, Visium platform, forthcoming Xenium platform, molecular assays and software constitute the building blocks of our integrated solutions.
These shared building blocks allow us to rapidly build and improve our solutions for studying biology at the appropriate resolution and scale:
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• Our Multiome ATAC+Gene Expression assays enables simultaneous multiomic interrogation of transcriptome and epigenome profiles from singe cells for deeper understanding of gene regulation.
−Removed: • Our Visium Spatial Gene Expression assay measures the spatial positions of biological analytes within tissues at high resolution.
+Added: • Our Visium Spatial Gene Expression assay, launched in 2019, measures the spatial positions of biological analytes within fresh-frozen tissues at high resolution.
+Added: In 2021, we launched Visium Spatial Gene Expression for FFPE which consists of a new chemistry applied to FFPE tissues with similarly high sensitivity and spatial resolution as Fresh Frozen samples.
• Our Targeted Gene Expression assay profiles a specific set of transcripts from 10x libraries, and enables researchers to maximize on-target sequencing reads.
The targeting solution, with comprehensive and customizable pre-designed gene panels, is compatible with both our GEM-RT and Visium platforms.
+Added: Our forthcoming Xenium platform for in situ analysis is being designed to give scientists the ability to not only locate and type cells in their tissue context, but also to address a variety of specific questions based on previous knowledge of their sample often discovered using our Chromium and Visium platforms.
Our software is essential to our mission of accelerating the mastery of biology.
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To that end, we have developed sophisticated and scalable software that completes our solutions which we provide to researchers generally free of charge.
−Removed: Our analysis software transforms large amounts of raw data into usable results, giving researchers user
−Removed: friendly tools to dynamically explore these results.
+Added: Our analysis software transforms large amounts of raw data into usable results, giving researchers user friendly tools to dynamically explore these results.
As larger and larger amounts of biological data are generated with greater ease, we believe that software tools will become increasingly critical for progress in biology.
−Removed: As of the first quarter of 2021, we have taken our software offerings a step further and introduced 10x Genomics Cloud Analysis, which will make it even easier for new 10x users to get started, and for our advanced users to scale to larger and more complex experiments.
−Removed: With Cloud Analysis, we are taking the technology that has underpinned and driven our own internal product development for years, and are bringing that to our customers.
+Added: In the first quarter of 2021, we introduced 10x Genomics Cloud Analysis, which makes it even easier for new 10x users to get started and for our advanced users to scale to larger and more complex experiments.
+Added: With Cloud Analysis, we are taking the technology that has underpinned and driven our own internal product development for years and bringing it to our customers.
Optimized for our software products, Cloud Analysis aims to be the easiest-to-use and fastest way to run 10x analysis available.
−Removed: And because we believe analysis is an integral part of our products, we are providing cloud analysis at no additional cost for every sample our customers run.
+Added: And because we believe analysis is an integral part of our products, we provide ample cloud analysis at no additional cost for every sample our customers run.
Since our founding, we have committed to making software engineering and computational biology world-class, core internal competencies.
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According to industry sources, the worldwide life sciences research tools market totaled more than $60 billion in 2020.
−Removed: Our diverse products and solutions allow biologists to interrogate and understand biological systems at exceptional resolution and
+Added: Our diverse products and solutions allow biologists to interrogate and understand biological systems at exceptional resolution and scale.
Our focus on enabling a comprehensive view of biology, and not narrowly focusing on a particular analyte such as DNA alone, has produced products which we believe have broad applications and target numerous opportunities across different areas of life sciences research.
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We also expect to pursue additional opportunities that will further expand our opportunity, including new potential applications of our single cell, spatial and In Situ technologies in the future.
−Removed: We believe a strong benchmark of the potential adoption of our solutions is the installed base of real-time polymerase chain reaction (“RT-PCR”) units, which is approximately 50,000 units globally.
+Added: We believe there is a large opportunity represented by the number of global academic labs.
+Added: Based on our internal estimates, we believe there are more than 100,000 global academic labs available to us consisting of United States and international academic research labs, including those funded by the National Institutes of Health ("NIH"), government funding institutions and other privately funded institutions.
+Added: In the United States alone, approximately 90,000 individual labs have applied for NIH funding over the past five years, and we estimate that more than 50,000 of these researchers work on projects that would benefit from adopting single cell and spatial genomics applications.
+Added: In addition to customer labs, we believe a strong benchmark of the potential adoption of our solutions is the installed base of real-time polymerase chain reaction (“RT-PCR”) units, which is approximately 50,000 units globally.
We also believe, based on industry sources, that there are over 15,000 next generation sequencers installed globally.
−Removed: While owners of next-generation sequencing instruments are one of several potential constituencies for buying our solutions, many of our customers do not own a sequencer and, as our installed base has grown, many of our customers have purchased multiple Chromium instruments.
−Removed: We believe that our opportunity for placements of our instruments is meaningfully larger than the installed base of next generation sequencers.
+Added: While owners of next-generation sequencing instruments are one of several potential constituencies for buying our solutions, many of our customers do not own a sequencer and, as the number of cumulative instruments we have sold has grown, many of our customers have purchased multiple Chromium instruments.
+Added: We believe that our opportunity for sales of our instruments is meaningfully larger than the installed base of next generation sequencers.
Growth of our opportunity is also driven by a broad and increasing range of applications for our solutions.
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Our position as a leader in a large and growing market.
−Removed: Since launching our first product in mid-2015 through December 31, 2020, we have sold 2,412 instruments and we serve thousands of researchers globally.
+Added: Since launching our first product in mid-2015 through December 31, 2021, cumulatively we have sold 3,511 instruments and we serve thousands of researchers globally.
We have fostered deep relationships with many key opinion leaders and as of December 31, 2021, our customers included all of the top 100 global research institutions as ranked by Nature in 2020 based on publications and all of the top 20 global biopharmaceutical companies by 2020 research and development spend.
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Our proprietary technologies.
−Removed: Through multiple years of development, acquisition and licensing, we have amassed a core set of technologies that form the foundation of our growing suite of products and solutions.
+Added: Through multiple years of development, acquisition and in-licensing, we have amassed a core set of technologies and intellectual property rights that form the foundation of our growing suite of products and solutions.
These technologies, including instruments, assays and software, combine a diverse set of disciplines, including chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering.
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Further, many of these technological elements can be utilized across multiple products, enabling us to leverage our existing infrastructure and investment when building future products, increasing the speed of product development and product performance.
−Removed: Worldwide we own or exclusively license over 330 issued or allowed patents and over 660 pending patent applications as of December 31, 2020.
+Added: Worldwide we own or exclusively in-license over 460 issued or allowed patents and over 830 pending patent applications as of December 31, 2021.
In addition to these owned and exclusively licensed patents and pending patent applications, we also license patents on a non-exclusive and/or territory restricted basis.
−Removed: Our intellectual property portfolio includes important patents in single cell analysis, epigenomics, spatial analysis, in situ analysis, and multi-omics.
+Added: Our intellectual property portfolio includes important patents and patent applications directed to single cell analysis, epigenomics, spatial analysis, in situ analysis and multi-omics.
Our rigorous product development processes and scalable infrastructure.
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We develop our products over a set of defined phases delineated by validating multifunctional reviews, which ensure our teams remain focused on quality, efficiency and profitability.
−Removed: This process allows many highly focused teams to execute on separate product development
−Removed: efforts in parallel while drawing effectively on the resources and capabilities of the company.
+Added: This process allows many highly focused teams to execute on separate product development efforts in parallel while drawing effectively on the resources and capabilities of the company.
We have also built extensive technological and operational infrastructure to support the efficient execution of these teams.
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As of December 31, 2021, we employed a commercial team of 417 full time employees.
−Removed: This includes an extensive and highly specialized customer service infrastructure with technical specialists covering multiple areas of expertise, including both experimental biology and software.
−Removed: Many members of our sales and customer service teams have a Ph.D.
−Removed: degree in the relevant scientific field.
−Removed: Both our sales and customer service teams help ensure our customers have a positive experience with our products.
+Added: This includes an extensive and highly specialized customer service infrastructure with technical specialists covering multiple areas of expertise, including experimental biology, tissue analysis and handling and software.
+Added: Many members of our sales and customer service teams have a PhD degree in the relevant scientific field.
+Added: Both our sales and customer service teams help ensure our customers are successful in designing and executing their experiments and have a positive experience with our products.
Our experienced multidisciplinary team .
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We aim to build new platforms, consumables and software that further our goals of interrogating, understanding and mastering biological systems at the needed resolution and scale.
−Removed: We prioritize innovations that meet large unmet market needs, such as measuring novel biological analytes with key functional impact at the single cell or spatial level.
+Added: We prioritize innovations that meet large unmet market needs, such as measuring novel biological analytes with key functional impact at the single cell level or with spatial context.
We expect that these investments in research and development will allow us to increase our penetration of our accessible markets.
−Removed: Expand the installed base of our Chromium instruments .
−Removed: Since our commercial launch in mid-2015 through December 31, 2020, we have placed 2,412 instruments and serve thousands of researchers globally.
−Removed: Utilizing our multi-channel sales and distribution infrastructure, we will continue to engage with researchers to increase our installed base of Chromium instruments.
+Added: Expand our sales of our Chromium instruments .
+Added: Since our commercial launch in mid-2015 through December 31, 2021, cumulatively we have sold 3,511 instruments and serve thousands of researchers globally.
+Added: Utilizing our multi-channel sales and distribution infrastructure, we will continue to engage with researchers to increase our sales of Chromium instruments.
We will target new customers in addition to expanding the number of instruments within institutions that have already recognized the significant value of our technology.
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We plan to drive wider adoption of our products within the workflows of our existing customers.
−Removed: For example, although most of the biopharmaceutical companies using our products use them at multiple sites, we believe that as our applications are increasingly incorporated into the validation steps in the drug development process, the amount of our consumables used will grow.
+Added: For example, although many biopharmaceutical companies use our products in early drug discovery phases from target identification to validation and across multiple sites, we believe that as our applications are increasingly incorporated into later stages in the drug development process, the amount of our consumables used will grow.
We have built a dedicated global strategic sales, marketing and business development team to support the adoption cycle by biopharmaceutical companies.
−Removed: The recent introduction of our Chromium Connect instrument is also aimed at driving higher consumable revenue growth, as the fully automated workflow will reduce bottlenecks caused by manual processes.
+Added: We have also added new instruments to our Chromium instrument lineup which are aimed addressing new customer use cases and driving higher consumable revenue growth.
+Added: For instance, our Chromium Connect instrument, launched in 2020, automates manual processes to reduce bottlenecks and encourage increased adoption.
+Added: Additionally, our Chromium X instrument, launched in 2021, enables expansion of single cell studies to routine million cell experiments.
We also plan to demonstrate new applications using our current solutions, including applications making synergistic use of multiple solutions.
Identify the most relevant technologies, create or acquire such technologies and develop them into new products .
−Removed: Over the years, we have developed, acquired and licensed a core set of technologies and associated intellectual property across a broad range of emerging areas within biology and life sciences.
+Added: Over the years, we have developed, acquired or in-licensed a core set of technologies and associated intellectual property rights across a broad range of emerging areas within biology and life sciences.
The ability to identify these core technologies and capabilities has complemented our internal product development process and enhanced our growing suite of products and solutions.
−Removed: continue to identify and acquire or license technologies and intellectual property that accelerate the development of new features and products or complement our existing features, products and technologies.
+Added: We will continue to identify and acquire or in-license technologies and intellectual property rights that accelerate the development of new features and products or complement our existing features, products and technologies.
For instance, we acquired Epinomics, Inc.
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We acquired ReadCoor, Inc.
−Removed: ("ReadCoor") and CartaNA AB ("CartaNA") in 2020, obtaining intellectual property, key technology advances, and deep talent and expertise in the emerging In Situ field.
+Added: ("ReadCoor") and CartaNA AB ("CartaNA") in 2020, obtaining intellectual property, key technology advances, and deep talent and expertise in the emerging In Situ field and forming the foundation for our forthcoming Xenium platform.
Additionally, in January 2021 we acquired Tetramer Shop ApS, a developer and provider of reagents for precise monitoring of antigen-specific T cells in research and development, enabling us to strengthen our efforts in immunology.
+Added: We expect to commercialize this technology with our BEAM-T product in 2022.
Promote our platforms as the standard for single cell, spatial and in situ analysis .
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One of our strategies is to broaden this recognition and promote the breadth of scientific achievements enabled by our products.
−Removed: To date, more than 2,200 peer-reviewed articles have been published using data generated by our portfolio of Chromium solutions.
−Removed: We also highlight successful instances where our Visium platform is used to analyze biological samples within their spatial context.
−Removed: Further research and discoveries will unfold as our solutions are utilized as the global standard and we believe our future third platform, based on In Situ technology, could be impactful on how biological research and clinical assays will be conducted in the future.
+Added: To date, more than 3,300 peer-reviewed articles have been published using data generated by our portfolio of Chromium and Visium solutions.
+Added: We believe further research and discoveries will unfold as our solutions are utilized as the global standard and that our forthcoming Xenium platform, based on in situ technology, could be impactful on how biological research and clinical assays will be conducted in the future.
Our products and technology
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They are built with our expertise in chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering.
−Removed: Our products begin with a researcher’s sample (such as a collection of thousands to millions of cells) and perform high-throughput barcoding to construct libraries that are compatible with standard sequencers.
+Added: Our products begin with a researcher’s sample (such as a collection of thousands to millions of cells or a slice of FFPE tissue) and perform high-
+Added: throughput barcoding to construct libraries that are compatible with standard sequencers.
Our proprietary software then provides turn-key analysis pipelines and intuitive visualization tools that allow researchers to easily interpret the biological data from the samples.
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Our Chromium Platform
−Removed: Our Chromium platform, which includes our Chromium Controllers, microfluidic chips and related consumables, enables high-throughput analysis of individual biological components.
−Removed: It is a precisely engineered reagent delivery system that divides a sample into individual components in up to a million or more partitions, enabling large numbers of parallel micro-reactions.
+Added: Our Chromium platform, which includes our Chromium Controller, Chromium X Series and Chromium Connect Instruments, microfluidic chips and related consumables, enables high-throughput analysis of individual biological components.
+Added: The Chromium instruments serve as precisely engineered reagent delivery systems that divide a sample into individual components in up to a million or more partitions, enabling large numbers of parallel micro-reactions.
The Chromium platform can be used to partition not only single cells, but also other biological materials such as cell nuclei and DNA molecules.
The large numbers of partitions generated using our Chromium products can be used for analyzing samples at high resolutions and at large scales.
−Removed: We pair a partitioned sample with our proprietary gel beads bearing barcodes that allow
−Removed: researchers to uniquely identify the contents of each partition and distinguish them from contents of other partitions.
+Added: We pair a partitioned sample with our proprietary gel beads bearing barcodes that allow researchers to uniquely identify the contents of each partition and distinguish them from contents of other partitions.
We refer to the partitions that are generated on our Chromium platform as “GEMs,” which stands for Gel beads in EMulsion.
We collectively refer to our partitioning and barcoding technologies as our GemCode technology.
−Removed: Our Chromium Controller, Chromium Connect and microfluidic chips .
−Removed: All of our Chromium consumables run on our Chromium Controller instrument.
−Removed: We have designed our instrument to be widely accessible to researchers with a list price of $75,000 and a form factor that easily fits on a standard laboratory bench.
−Removed: Our Chromium Controller operates exclusively with our microfluidic chips, which are highly engineered single-use devices that process sample and reagents.
−Removed: During our Chromium workflows, the researcher loads sample onto the microfluidic chip along with our proprietary gel beads and oils.
−Removed: The loaded chip is inserted into the Chromium Controller, which facilitates the generation of GEMs that contain sample and gel beads.
−Removed: Our Chromium Connect product is a high-throughput version of our Chromium instrument that incorporates liquid handling robotics to automate our workflow and can be utilized with our Single Cell Gene Expression solution.
+Added: Our Chromium Controller, Chromium X and iX, Chromium Connect and microfluidic chips .
+Added: Our Chromium consumables run on our Chromium instruments.
+Added: Our Chromium Controller and Chromium iX instruments are capable of running our Low Throughput and Standard Throughput consumables.
+Added: Our Chromium X instrument is capable of running Low, Standard and High Throughput consumables.
+Added: Customers are able to upgrade their Chromium iX to run Low, Standard and High Throughput consumables via firmware upgrade.
+Added: We have designed our instruments to be widely accessible to researchers with list prices of $35,000, $60,000 and $95,000 for the Chromium Controller, Chromium iX and Chromium X, respectively, and each of these instruments has a form factor that easily fits on a standard laboratory bench.
+Added: Our Chromium instruments operate exclusively with our microfluidic chips, which are highly engineered single-use devices that process samples and reagents.
+Added: During our Chromium workflows, the researcher loads a sample onto the microfluidic chip along with our proprietary gel beads and oils.
+Added: The loaded chip is inserted into the Chromium instrument, which facilitates the generation of GEMs that contain sample and gel beads.
+Added: Our Chromium Connect product is a high-throughput version of our Chromium Controller instrument that incorporates liquid handling robotics to automate our workflow and can be utilized with our Single Cell Gene Expression and Single Cell Immune Profiling solutions.
Our Gel Beads .
Within each GEM, the sample is co-encapsulated with one of our proprietary gel beads which are designed to contain a unique, identifying DNA barcode for subsequent sequencing and analysis.
−Removed: Our gel beads, which we manufacture in-house using proprietary methods, incorporate barcoded DNA molecules that are designed to react with the sample inside each
+Added: Our gel beads, which we manufacture in-house using proprietary methods, incorporate barcoded DNA molecules that are designed to react with the sample inside each GEM.
The GEMs act as individual reaction vessels to generate barcoded molecules.
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If a disease-causing cell occurs in only 1 in 10,000 cells in a sample, then measuring just 1,000 cells will be unlikely to find a single copy of the disease-causing cell.
−Removed: Our Single Cell Gene Expression and Immune Profiling solutions, on the other hand, have cell throughputs of up to 80,000 cells per run using one microfluidic chip which increases the likelihood of finding a copy of the disease-causing cell.
+Added: Our Standard Throughput Single Cell Gene Expression and Immune Profiling solutions, on the other hand, have cell throughputs of up to 80,000 cells per run using one microfluidic chip which increases the likelihood of finding a copy of the disease-causing cell.
+Added: With the launch of our High Throughput Single Cell Gene Expression and Immune Profiling solutions, we have increased cell throughput and enable analysis of up to 320,000 cells per microfluidic chip.
• High cell capture rate :
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This approach enables customers to identify and characterize rare cell types in a population of cells, characterize cell populations without prior knowledge of cell subtypes or cell markers, define novel cell types and cell states, discover new biomarkers for specific cell populations and analyze and understand cellular heterogeneity and its effects on biological systems.
−Removed: For this solution, customers run their samples of interest on the Chromium Controller or Chromium Connect to generate GEMs containing single cells and prepare single cell libraries using our reagents.
+Added: For this solution, customers run their samples of interest on the Chromium Controller, Chromium X Series or Chromium Connect to generate GEMs containing single cells and prepare single cell libraries using our reagents.
Researchers can sequence these single cell libraries on compatible third-party sequencers, analyze their data using our Cell Ranger analysis pipeline software and visualize their data using our Loupe Cell Browser software.
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This body of work is yielding significant insights into many different areas of biology and disease.
−Removed: For example, after the COVID-19 pandemic emerged in early 2020, a coalition of researchers from the Human Cell Atlas Biological Network re-analyzed single-cell gene expression datasets obtained from the respiratory system, retina, intestine, heart, muscle, liver, brain, skin, and many other tissues and organs.
−Removed: Through this work, the authors clarified the expression patterns of key genes responsible for SARS-CoV-2 infection
−Removed: of human cells throughout the body, providing the most detailed view for where SARS-CoV-2 could infect human cells, which suggested important implications for viral transmissibility.
+Added: For example, after the COVID-19 pandemic emerged in 2020, a coalition of researchers from the Human Cell Atlas Biological Network re-analyzed single-cell gene expression datasets obtained from the respiratory system, retina, intestine, heart, muscle, liver, brain, skin and many other tissues and organs.
+Added: Through this work, the authors clarified the expression patterns of key genes responsible for SARS-CoV-2 infection of human cells throughout the body, providing the most detailed view for where SARS-CoV-2 could infect human cells, which suggested important implications for viral transmissibility.
This analysis highlighted the forward-thinking importance of the Human Cell Atlas consortium efforts to use single-cell gene expression, supported by us to extensively catalogue all of the cells present throughout every tissue and organ in the human body as a foundation for future understanding of critical human diseases.
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By enabling paired immune receptor and transcriptome analysis in massive numbers of immune cells, our Single Cell Immune Profiling solution sheds insight on the clonality, diversity and cellular context of the immune repertoire.
−Removed: The workflow of this solution, which is similar to that of the Single Cell Gene Expression solution, utilizes our Chromium Controller to generate GEMs, followed by single cell library preparation and sequencing.
+Added: The workflow of this solution, which is similar to that of the Single Cell Gene Expression solution, utilizes our Chromium Controller, Chromium X Series or Chromium Connect to generate GEMs, followed by single cell library preparation and sequencing.
In contrast to Gene Expression, our Single Cell Immune Profiling solution uses a different biochemistry that obtains sequence information from the 5’ end of mRNA molecules, rather than their 3’ end.
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We believe that our Single Cell Immune Profiling Solution combined with Feature Barcode will enable extending this work at far higher scales.
−Removed: As a proof of concept for the immune map, we presented at the Advances of Genomes, Biology and Technology meeting in February 2019 results from a single experiment utilizing our Single Cell Immune Profiling Solution on approximately 200,000 T-cells from four individuals and 44 feature-barcoded antigens to identify T-cell receptor-antigen pairs.
−Removed: This experiment, which took place over approximately one week, generated a paired receptor-antigen dataset six times larger than the collection of all previously published receptor-antigen pairings.
−Removed: This leap was made possible by the tremendous resolution and scale with which the immune system can be analyzed using our solutions.
+Added: In 2022, we expect to make our Barcode Enabled Antigen Mapping (BEAM) Solution commercially available .
+Added: We anticipate that our BEAM-Ab and BEAM-T technologies will provide an end-to-end solution for the high-throughput discovery of antibodies and T-cell receptors respectively against multiple antigens in as quickly as one week.
+Added: We anticipate that this product will be especially suited for biotech and pharmaceutical companies and we expect the solution to include tailor made software designed to process and analyze these rich data sets.
Single Cell ATAC
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ATAC-seq is based on the fact that the transposase enzyme will preferentially tag and excise regions of the genome that have an “open” chromatin state that is unimpeded by proteins bound to genomic DNA.
−Removed: The tagged sequences can be sequenced to infer genomic regions of increased chromatin accessibility as well as map regions that are bound by transcription factor proteins responsible for regulating gene expression.
−Removed: ATAC–seq was pioneered by researchers at Stanford University and is exclusively licensed to us.
+Added: The tagged sequences can be sequenced to infer
+Added: genomic regions of increased chromatin accessibility as well as map regions that are bound by transcription factor proteins responsible for regulating gene expression.
+Added: ATAC–seq was pioneered by researchers at Stanford University and intellectual property rights directed to ATAC-seq are exclusively licensed to us.
ATAC-seq has now become an important tool in epigenetics and genome-regulation research.
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Our Visium Spatial Gene Expression product has significant improvements over the Spatial Transcriptomics product, including increased spatial resolution, increased gene sensitivity, a simpler workflow, compatibility with both hematoxylin and eosin (H&E) and immunofluorescence stains, and fully developed analysis and visualization software.
+Added: In 2021, we launched Visium Spatial Gene Expression for FFPE which featured an entirely new chemistry enabling Visium to be applied to FFPE tissues with similarly high sensitivity and the same spatial resolution as fresh frozen samples.
We intend to continuously innovate to provide enhanced resolution, performance, throughput and efficiency for our existing Visium Spatial Gene Expression product and we also intend to develop additional Visium spatial products using our other assays which, analogously to the Chromium platform, allow spatial interrogation of a broader range of biological analytes including DNA, immune molecules, epigenetics and protein.
+Added: Our Xenium platform
+Added: Our forthcoming Xenium platform for in situ analysis is being designed to give scientists the ability to not only locate and type cells in their tissue context, but also to address a variety of specific questions based on previous knowledge of their sample often discovered using our Chromium and Visium platforms.
+Added: In situ is a Latin expression that means “in the original place." In situ analysis is used to describe a method to detect and analyze RNA and protein molecules right where they are within the tissue, without the need to extract or capture them.
+Added: Based on our internal research and development and the acquisitions of ReadCoor and CartaNA, we expect our Xenium platform to be a complete end-to-end solution, including a robust instrument, consumables and software.
+Added: We anticipate it will be applicable to both fresh frozen and FFPE samples and have a menu of tissue-specific and research-specific gene panels along with the ability to design custom gene sets.
+Added: We expect the instrument to come with onboard analysis capabilities to process image data, localize RNA signals and perform secondary analysis.
+Added: We anticipate that customers will also be able to easily transfer data from the instrument and perform visualization and further analysis with 10x-provided software or other tools of their choice.
Our analysis and visualization software
Our software is a fundamental part of our integrated solutions and is comprised of two parts, analysis and visualization.
−Removed: Our analysis pipeline software tools, including Cell Ranger, Space Ranger, Long Ranger and Supernova, take raw sequencing data as input and transform them into biologically meaningful results.
+Added: Our analysis pipeline software tools, including Cell Ranger and Space Ranger, take raw sequencing data as input and transform them into biologically meaningful results.
Customers can further analyze these results in their own or third-party tools, or take them into our Loupe family of visualization software tools, which allow users to draw insights using an intuitive user interface without writing code.
Our analysis and visualization software is generally available to researchers free of charge, so as to accelerate the adoption of our products and software as a standard for genome, single cell and spatial analysis.
−Removed: We have also launched 10x Genomics Cloud Analysis, which makes it even easier for new 10x customers to get started, and for our advanced users to scale to larger and more complex experiments.
−Removed: Since our launch, we have shipped more than 50 major releases of our software.
+Added: In 2021, we launched 10x Genomics Cloud Analysis, which makes it even easier for new 10x customers to get started, and for our advanced users to scale to larger and more complex experiments.
We believe that the main factors that differentiate our software include:
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Peer-reviewed scientific publications using our products
−Removed: To date, more than 2,200 peer-reviewed articles have been published based on data generated using our products.
+Added: To date, we estimate that more than 3,300 peer-reviewed articles have been published based on data generated using our products.
More than 390 of these articles were published in three of the most highly regarded journals:
Cell , Nature and Science .
−Removed: Underscoring the reach of our products, these publications cover a wide range of research and applied areas from cell biology to genetic health to neuroscience with the top three areas of publication being immunology, developmental biology, and cancer research.
+Added: Underscoring the reach of our products, these publications cover a wide range of research and applied areas from cell biology to genetic health to neuroscience with the top three areas of publication, according to our estimates, being immunology, developmental biology and cancer research.
Research area
1 unchanged sentence
Immunology 573 17.3 %
−Removed: Developmental Biology 473 20.7
Cancer Research 518 15.6
−Removed: Neuroscience 278 12.2
+Added: Developmental Biology 494 14.9
Computational Method 306 9.2
+Added: Neuroscience 299 9.0
Cell Atlas 173 5.2
−Removed: Genome Assembly 158 6.9
−Removed: Genetic Health 118 5.2
Infectious Disease 137 4.1
Cell Biology 135 4.1
+Added: Genome Assembly 135 4.1
Assay Method 111 3.3
+Added: Genetic Health 87 2.6
Immuno-Oncology 75 2.3
−Removed: Genome Analysis 77 3.4
−Removed: Functional Genomics 61 2.7
Agrigenomics 61 1.8
+Added: Genome Analysis 53 1.6
Reproductive Biology 37 1.1
+Added: Functional Genomics 31 0.9
Method Comparison 29 0.9
Conservation Biology 18 0.5
+Added: Cardiovascular 16 0.5
Population Genetics 16 0.5
−Removed: Single Cell Multiomics Method 16 0.7
Microbiology 9 0.3
+Added: Single Cell Multiomics Method 5 0.2 %
We have seen robust quarter-over-quarter growth in the number of publications commensurate with our commercial growth and success:
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an approach that has been key to our success to date.
−Removed: Our research and development teams are currently located in our headquarters in Pleasanton, California, in Stockholm, Sweden and in Copenhagen, Denmark.
+Added: Our research and development teams are currently located in our headquarters in Pleasanton, California, in Stockholm, Sweden, in Copenhagen, Denmark and in Singapore.
The overarching goals of our research and development programs are to continue to bring new technologies to market that address the most pressing questions in biology and to provide exponential advances in human health.
8 unchanged sentences
In 2019, we introduced the first product on our Visium platform, which offers high spatial resolution, high sensitivity, efficient workflow and analysis and visualization software.
+Added: In 2021, we launched Visium Spatial Gene Expression for FFPE enabling Visium to be applied to FFPE tissues with similarly high sensitivity and the same spatial resolution as fresh frozen samples.
We are working to develop new technologies for our Visium platform that will further enhance the spatial resolution, usability and automation of our platform.
4 unchanged sentences
We plan to do this for key solution combinations where the information obtained from the two solutions is highly complementary.
−Removed: Investigate new technologies, including our emerging In Situ technology .
+Added: Investigate and develop new technologies, including our emerging Xenium platform .
We will seek to both develop and acquire new technologies that could be additive to or complementary with our current portfolio.
−Removed: For example, in 2020, we acquired ReadCoor and CartaNA, which we expect to utilize to build our In Situ platform with our internal research and development efforts.
+Added: For example, in 2020, we acquired ReadCoor and CartaNA, which when combined with internal innovations form the basis of our forthcoming Xenium In Situ Analysis Platform.
Our research and development costs were $211.8 million and $123.4 million for the years ended December 31, 2021 and 2020, respectively.
−Removed: In-process research and development costs, consisting of costs incurred to acquire intellectual property for research
−Removed: and development were $447.5 million for the year ended December 31, 2020.
−Removed: There were no similar purchases in the year ended December 31, 2019.
+Added: In-process research and development costs, consisting of costs incurred to acquire intellectual property for research and development were $447.5 million for the year ended December 31, 2020.
+Added: There were no similar acquisitions in the year ended December 31, 2021.
As of December 31, 2021, we employed 464 employees in research and development.
−Removed: Looking forward, we will continue to invest in efforts to support the ongoing development of our instruments, consumables and software across all three of our platforms, as well as enhance the overall performance of our solutions.
+Added: Looking forward, we
+Added: will continue to invest in efforts to support the ongoing development of our instruments, consumables and software across all three of our platforms, as well as enhance the overall performance of our solutions.
Commercial team
2 unchanged sentences
We sell our products primarily through our own direct sales force in North America and certain regions of Europe.
−Removed: As of December 31, 2020, our commercial organization consisted of 290 full time employees, including more than 100 commissioned sales representatives, many with Ph.D.
−Removed: degrees and many with significant industry experience.
+Added: As of December 31, 2021, our commercial organization consisted of 417 full time employees, including more than 160 commissioned sales representatives, many with PhD degrees and many with significant industry experience.
We sell our products through third-party distributors in Asia, certain regions of Europe, Oceania, South America, the Middle East and Africa.
5 unchanged sentences
Our products are integrated solutions comprised of instruments, consumables and software.
−Removed: We aim to drive customer adoption and the installed base of our Chromium instruments which then forms a base of users who drive revenue by purchasing our consumables.
+Added: We aim to drive customer adoption and sales of our Chromium instruments which then forms a base of users who drive revenue by purchasing our consumables.
Our products are designed to be easy to install and use without the need for extensive training.
1 unchanged sentence
Our strategy typically involves targeting key opinion leaders during the initial phase of our product launches, after which we aim to expand adoption of our products across a broader base of customers.
−Removed: As our customer base has grown, we have been able to leverage our larger installed base of instruments to accelerate the adoption of new solutions.
−Removed: Approximately half of our customers purchased our consumables relating to more than one of our solutions in both the years ended December 31, 2020 and 2019.
+Added: As our customer base has grown, we have been able to sell more instruments to accelerate the adoption of new solutions.
+Added: Over half of our customers purchased our consumables relating to more than one of our solutions in both the years ended December 31, 2021.
Our commercial strategy focuses on ensuring our customers are successful with our products.
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gel bead generation, surfactant synthesis and emulsion oil formulation, reagent formulation and tube filling, microfluidic chip manufacturing, kit assembly and packaging as well as analytical and functional quality control testing.
−Removed: Our Pleasanton, California manufacturing operations are ISO 9001:2015 certified, which covers design, development, manufacturing, distribution, service and sales.
+Added: Our Pleasanton, California and Singapore manufacturing operations are ISO 9001:2015 certified, which covers design, development, manufacturing, distribution, service and sales.
We obtain some components of our consumables from third-party suppliers.
−Removed: While some of these components are sourced from a single supplier, we have qualified second sources for several of our critical reagents, including microfluidic chips, arrays and oligonucleotides.
+Added: While some of these components are sourced from a single supplier, we have qualified second sources for some, but not all, of our critical reagents, enzymes and oligonucleotides.
We believe that having dual sources for our components helps reduce the risk of a production delay caused by a disruption in the supply of a critical component.
−Removed: For further discussion of the risks relating to our third-party suppliers, see the section titled “ Risk Factors—Risks related to our business and industry—We are dependent on single source and sole source suppliers for some of the equipment, components and materials used in our products and the loss of any of these suppliers could harm our business .
+Added: For further discussion of the risks relating to our third-party suppliers, see the section titled “ Risk Factors—Risks related to our business and industry—We and our customers are dependent on single source and sole source suppliers for some of the equipment, components and materials used in our products and the loss of any of these suppliers could harm our business .
The ability of our suppliers to meet our needs and the needs of our customers could be reduced or eliminated by the impacts of the COVID-19 pandemic.
−Removed: We outsource manufacturing for our Chromium Controller and Chromium Connect to a qualified contract manufacturer.
+Added: We outsource manufacturing for our Chromium Controller, Chromium X Series and Chromium Connect to a qualified contract manufacturer.
This manufacturer has represented to us that they maintain ISO 13485 certification.
3 unchanged sentences
We are led by a talented, global and diverse team of scientists, software developers and subject matter experts who help drive adoption of our products and support our vision.
−Removed: We have built a multidisciplinary team with talent and expertise across a diverse set of areas such as chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering, and have supplemented this diverse technical experience with our operational team with expertise in manufacturing, legal, sales, marketing, customer service and finance.
+Added: We have built a multidisciplinary team with talent and expertise across a diverse set of areas such as chemistry, molecular biology, microfluidics, hardware, computational biology and software engineering, and have supplemented this diverse technical experience with our operational team with expertise in manufacturing, legal, sales, marketing, customer service, human resources and finance.
As of December 31, 2021, we employed a total of 1,239 individuals, 956 of whom were employed in the United States and 283 of whom were employed outside the United States.
−Removed: As of December 31, 2020, our 852 employees included 336 in research and development, 290 in sales, marketing and support, 137 in general and administrative and 89 in manufacturing, of which many hold Ph.Ds in their respective disciplines.
+Added: As of December 31, 2021, our 1,239 employees included 464 in research and development, 417 in sales, marketing and support, 230 in general and administrative and 128 in manufacturing, of which many hold PhDs in their respective disciplines.
Additionally, most of our senior management team and the members of our board of directors hold either PhDs and/or other advanced degrees.
9 unchanged sentences
In addition, we regularly conduct an employee survey to gauge employee engagement and identify areas of focus.
−Removed: None of our employees are represented by a labor union or covered under a collective bargaining agreement, and we have never experienced a work stoppage.
+Added: We have never experienced a work stoppage.
+Added: In addition, none of our U.S.
+Added: employees are represented by a labor union or covered under a collective bargaining agreement.
+Added: In our international territories, apart from standard industry-wide labor unions and compulsory collective bargaining agreements, such as in Italy where we have fewer than ten employees, none of our employees are represented by a labor union or subject to a collective bargaining agreement.
We consider our relationship with our employees to be positive.
The life sciences market is highly competitive.
−Removed: There are other companies, both established and early stage, that have indicated that they are designing, manufacturing and marketing products for, among other things, genomics analysis, single cell analysis and spatial analysis.
+Added: There are other companies, both established and early stage, that have indicated that they are designing, manufacturing and marketing products for, among other things, genomics analysis, single cell analysis, spatial analysis and in situ analysis.
These companies include Becton, Dickinson and Company and Nanostring Technologies, Inc., each of which has products that compete with our products, as well as a number of other emerging and established companies.
−Removed: Some of these companies may have substantially greater financial and other resources than us, including larger research and development staff
−Removed: or more established marketing and sales forces.
+Added: Some of these companies may have substantially greater financial and other resources than us, including larger research and development staff or more established marketing and sales forces.
Other competitors are in the process of developing novel technologies for the life sciences market which may lead to products that rival or replace our products.
−Removed: However, we believe we are substantially differentiated from our competitors for many reasons, including our position as a leader in a large and growing market, proprietary technologies, rigorous product development processes and scalable infrastructure, customer experience and multidisciplinary teams.
+Added: We believe we are differentiated from our competitors for many reasons, including our position as a leader in a large and growing market, proprietary technologies, rigorous product development processes and scalable infrastructure, customer experience and multidisciplinary teams.
We believe our customers favor our products and company because of these differentiators.
−Removed: For further discussion of the risks we face relating to competition, see the section titled “ Risk Factors—Risks related to our business and industry—Our markets are highly competitive.
+Added: For further discussion of the risks we face relating to competition, see the section titled “ Risk Factors—Risks related to our business and industry—Our industry is highly competitive.
If we fail to compete effectively, our business and operating results will suffer .”
Government regulation
−Removed: The development, testing, manufacturing, marketing, post-market surveillance, distribution, advertising and labeling of certain of medical devices are subject to regulation in the United States by the Center for Devices and Radiological Health of the U.S.
−Removed: Food and Drug Administration (“FDA”) under the Federal Food, Drug, and Cosmetic Act (“FDC Act”) and comparable state and international agencies.
−Removed: A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component part or accessory, which is (1) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals, or (2) intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
−Removed: Medical devices to be commercially distributed in the United States must receive from the FDA either clearance of a premarket notification, known as 510(k), or premarket approval pursuant to the FDC Act prior to marketing, unless subject to an exemption.
−Removed: None of our products are currently medical devices and all of our products are currently designed “For Research Use Only.
−Removed: Not for use in diagnostic procedures” (“RUO”) products, as they are not meant for clinical applications.
−Removed: RUO products are not regulated as medical devices and are therefore not subject to the regulatory requirements enforced by the FDA.
−Removed: The products must bear the statement:
−Removed: “For Research Use Only.
−Removed: Not for Use in Diagnostic Procedures.” RUO products cannot make any claims related to safety, effectiveness or diagnostic utility and they cannot be intended for human clinical diagnostic use.
−Removed: In November 2013, the FDA issued a final guidance on products labeled RUO, which, among other things, reaffirmed that a company may not make any clinical or diagnostic claims about an RUO product.
−Removed: The FDA will also evaluate the totality of the circumstances to determine if the product is intended for diagnostic purposes.
−Removed: If FDA were to determine, based on the totality of circumstances, that our products labeled and marketed for RUO are intended for diagnostic purposes, they would be considered medical devices that will require clearance or approval prior to commercialization.
−Removed: Further, sales of devices for diagnostic purposes may subject us to additional healthcare regulation.
−Removed: We continue to monitor the changing legal and regulatory landscape to ensure our compliance with any applicable rules, laws and regulations.
+Added: The development, research, testing, manufacturing, marketing, post-market surveillance, distribution, packaging, import, export, sales, advertising, promotion and labeling of medical devices are subject to regulation in the United States by the U.S.
+Added: Food and Drug Administration (“FDA”) under the Federal Food, Drug, and Cosmetic Act (“FDC Act”) and outside the United States by comparable state and international agencies such as the national competent authorities of the European Union (“EU”) member states and the Medicines and Healthcare products Regulatory Agency in the United Kingdom.
+Added: The FDC Act defines a medical device to include, among other things, any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component part or accessory, which is (1) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals, or (2) intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
+Added: Pursuant to its authority under the FDC Act, the FDA has jurisdiction over medical devices, which are defined to include, among other things, in vitro diagnostic devices (“IVDs”).
+Added: In the EU, Directive 98/79/EC (“EU IVDD”) currently governs the rules applicable to IVDs.
+Added: The EU IVDD defines an IVD as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
+Added: (i) concerning a physiological or pathological state, or (ii) concerning a congenital abnormality, or (iii) to determine the safety and compatibility with potential recipients, or (iv) to monitor therapeutic measures.” National competent authorities of the EU member states enforce compliance with medical devices (including IVDs) requirements.
+Added: The EU rules are generally applicable in the European Economic Area (“EEA”) (which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland).
+Added: We believe that our current products are not medical devices within the meaning of the FDC Act and foreign regulations applicable in countries where we market our products, such as the EU IVDD in the EU, but we nevertheless market our products for research use only (“RUO”).
+Added: IVDs that are marketed for RUO are not intended for use in a clinical investigation or for clinical diagnostic use outside an investigation and must be labeled “For Research Use Only.
+Added: Not for use in diagnostic procedures.” Products that are intended for RUO and are properly labeled as RUO are exempt from compliance with the FDA’s requirements applicable to medical devices more generally, including the requirements for clearance or approval and compliance with manufacturing requirements known as the Quality System Regulation.
+Added: In the EU, the EU IVDD clearly indicates that:
+Added: “instruments, apparatus, appliances, materials or other articles, including software, which are intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation.” To be categorized as an RUO product, the product must have no intended medical purpose or objective.
+Added: Consequently, products labeled as RUO are essentially not subject to compliance with the EU IVDD requirements such as conformity with the essential requirements laid down in the EU IVDD.
+Added: A product labeled RUO but intended to be used diagnostically may be viewed by the FDA or foreign authorities as adulterated and misbranded under the FDC Act or foreign regulations and subject to FDA or foreign authorities enforcement action.
+Added: The FDA or foreign authorities may consider the totality of the circumstances surrounding distribution and use of an RUO product, including how the product is marketed, when determining its intended use.
+Added: Although we currently market our products as RUO, we may in the future develop products intended to be used for clinical or diagnostic purposes, which would result in the application of a more onerous set of FDA and foreign regulatory requirements.
+Added: Generally, unless an exemption applies, each new or significantly modified medical device we may seek to commercially distribute in the United States will require either a premarket notification to the FDA requesting permission for commercial distribution under Section 510(k) of the FDC Act, also referred to as a 510(k) clearance, or approval from the FDA of an application for premarket approval (“PMA”).
+Added: In the EU, there is currently no premarket government review of medical devices (including IVDs).
+Added: However, all IVDs placed on the EU market must meet the essential requirements of the EU IVDD including the requirement that an IVD must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users and others.
+Added: Compliance with the essential requirements of the IVDD is a prerequisite for European conformity marking (“CE mark”) without which IVDs cannot be marketed or sold in the EU.
+Added: The 510(k) clearance, PMA and CE mark processes can be resource intensive, expensive and lengthy, and require payment of significant (user) fees.
+Added: Medical devices are also subject to post-market requirements.
+Added: Failure to comply with applicable regulations can result in enforcement actions such as:
+Added: warning letters, fines, injunctions, civil or criminal penalties, termination of distribution, recalls or seizures of products, delays in the introduction of products into the market, total or partial suspension of production, refusal to grant future clearances, approvals or certifications, or withdrawals or suspensions of existing clearances, approvals or certifications.
+Added: Rules governing medical devices including IVDs may change.
+Added: For instance, the EU regulatory landscape concerning IVDs is evolving.
+Added: On April 5, 2017 Regulation (EU) 2017/746 (“EU IVDR”) was adopted to establish a modernized and more robust EU legislative framework, with the aim of ensuring better protection of public health and patient safety.
+Added: Unlike the EU IVDD, the EU IVDR is directly applicable in all EU member states without the need for member states to implement into national law.
+Added: This aims at reducing the risk of discrepancies in interpretation across the different European markets.
+Added: The EU IVDR will fully apply on May 26, 2022 but there will be a tiered system extending the grace period for many devices (depending on their risk classification) before they have to be fully compliant with the regulation.
+Added: The EU IVDR expressly provides that products intended for RUO are excluded from the scope of the regulation.
+Added: A material intended for RUO, without any medical purpose or objective, is therefore not considered as an IVD and is not subject to compliance with the IVD requirements.
+Added: Depending on the products in question, other regulations may be applicable to the RUO products.
Intellectual property
−Removed: Our success depends in part on our ability to obtain and maintain intellectual property protection for our products and technology.
−Removed: We utilize a variety of intellectual property protection strategies, including patents, trademarks, trade secrets and other methods of protecting proprietary information.
−Removed: Worldwide we own or exclusively license over 330 issued or allowed patents and 660 pending patent applications as of December 31, 2020.
+Added: Our success depends in part on our ability to obtain, maintain, enforce and defend intellectual property rights owned or licensed to us that are directed to our products and technology.
+Added: We utilize a variety of intellectual property protection strategies, including patents, trademarks, trade secrets, copyright and other methods of protecting proprietary information.
+Added: Worldwide we own or exclusively in-license over 460 issued or allowed patents and 830 pending patent applications as of December 31, 2021.
We also license additional patents on a non-exclusive and/or territory restricted basis.
−Removed: Patent rights generally have a term of twenty years from the date in which they were filed.
+Added: We seek trademark registration to protect key trademarks such as our 10X, 10X GENOMICS, CHROMIUM, VISIUM and XENIUM marks, however, we have not yet registered all of our trademarks in all of our current and potential markets.
We own registered trademarks on 10X GENOMICS and product related brand names in the United States and worldwide.
−Removed: We license certain U.S.
−Removed: and foreign patents and patent applications from various third parties for use in our products and technology.
−Removed: Some of these license agreements provide use the exclusive right to practice the licensed intellectual property subject to specific field or territory, general and administrative restrictions, and certain fee and royalty arrangements.
−Removed: Subject to common termination rights, these exclusive license agreements typically are in force until the last of the licensed patents expires or, in some cases, upon our failure to achieve specified sales volume thresholds.
−Removed: Certain of these agreements also require that any products related to the licensed patents be substantially manufactured in the United States.
−Removed: In connection with our acquisition of Spatial Transcriptomics, we are required to make contingent payments to the sellers based on revenue from sales of Spatial Transcriptomics products and Visium products, for the years ended December 31, 2019 through
−Removed: December 31, 2022.
+Added: Pursuant to certain license agreements, we in-license rights under certain U.S.
+Added: and foreign patents and patent applications from third parties directed to our products and technology.
+Added: Some of these agreements grant us an exclusive right to practice the licensed intellectual property rights in a specific field and/or territory, and are subject to customary restrictions.
+Added: We may also be obligated to pay our licensors certain milestones, royalties and/or other contingent payments.
+Added: Subject to customary termination rights, such exclusive license agreements typically will expire upon the last valid claim included in the licensed patents expires or, in some cases, upon our failure to achieve specified sales volume thresholds.
+Added: Certain of these agreements also require that any products that are covered by the licensed patents be substantially manufactured in the United States.
+Added: In September 2013, we entered into an exclusive license agreement with the President and Fellows of Harvard University (“Harvard”), pursuant to which we in-license exclusive, worldwide rights under certain of Harvard’s patents and patents applications in the field of sequencing sample preparation and single cell analysis (“Harvard Agreement”).
+Added: Subject to the terms of the Harvard Agreement, we are required to pay Harvard a low single-digit royalty percentage, based on the net revenue of certain products that are covered by the patents and patent applications licensed under the Harvard Agreement, payable until the last to expire of the valid claims included in such licensed patents and patent applications.
+Added: The Harvard Agreement is projected to expire in 2034.
+Added: In connection with our acquisition of Spatial Transcriptomics, we are required to make contingent payments to the sellers based on revenue from sales of Spatial Transcriptomics products and Visium products, for the years ended December 31, 2019 through December 31, 2022.
These contingent payments are equal to a percentage in the teens multiplied by such revenue.
−Removed: Pursuant to the license agreement we entered into with The Board of Trustees of the Leland Stanford Junior University (“Stanford”), we are required to pay Stanford a low single-digit royalty percentage based on the net revenue of certain ATAC-seq products during the applicable term of the licensed patents.
−Removed: Pursuant to the license agreement we entered into with the President and Fellows of Harvard University (“Harvard”), we are required to pay Harvard a low single-digit royalty percentage based on the net revenue of certain products covered by the licensed patents during the applicable term of those patents.
+Added: In September 2020, we entered into an exclusive license agreement with The Board of Trustees of the Leland Stanford Junior University (“Stanford”), pursuant to which we in-license exclusive, worldwide rights under certain of Stanford’s patents and patents applications directed to ATAC-seq technology in all field of use (“Stanford Agreement”).
+Added: Subject to the terms of the Stanford Agreement, we are required to pay Stanford a low single-digit royalty percentage based on the net revenue of certain ATAC-seq products that are covered by the patents and patent applications licensed under the Stanford Agreement, payable until the last to expire of the valid claims included in such licensed patents and patent applications.
+Added: The initial exclusivity period of the Stanford Agreement terminates in 2025, provided, we have the option to extend the exclusivity period for additional one-year terms if we meet certain minimum sales thresholds beginning in 2025.
+Added: If the exclusivity period ends or we fail to extend the exclusivity period, we retain a non-exclusive license under the licensed patents and patent applications.
+Added: The Stanford Agreement is projected to expire in 2038.
For the years ended December 31, 2021 and 2020, we made aggregate contingent and royalty payments under the Spatial Transcriptomics acquisition agreement, Stanford license agreement and Harvard license agreement, collectively, of less than $12.0 million and $7.0 million, respectively.
We expect the size of these payments to grow as our business grows.
−Removed: The patents we own expire beginning in 2033 and the patents we exclusively license expire beginning in 2028.
−Removed: The Harvard license is exclusive in the field of sequencing sample preparation and single cell analysis and is projected to terminate in 2034.
−Removed: The Stanford license is exclusive in all fields and the initial exclusivity period of the license terminates in 2025, however we have the option to extend the exclusivity period for additional one-year terms if we meet certain minimum sales thresholds beginning in 2025.
−Removed: If the exclusivity period ends or we fail to extend the exclusivity period, we retain a non-exclusive license to the applicable patents.
−Removed: The Stanford license is projected to terminate in 2038.
−Removed: Both the Harvard and Stanford licenses are worldwide licenses.
+Added: The patents we own expire beginning in 2033 and the patents we exclusively in-license expire beginning in 2028.
We intend to pursue additional intellectual property protection to the extent we believe it would be beneficial and cost-effective.
−Removed: We cannot provide any assurance that any of our current or future patent applications will result in the issuance of patents, or that any of our current or future issued patents will effectively protect any of our products or technology from infringement or prevent others from commercializing infringing products or technology.
+Added: We cannot provide any assurance that any of our current or future patent applications will result in the issuance of patents, or that any of our current or future issued patents will effectively protect any of our products or technology from infringement or prevent others from developing, manufacturing or commercializing products or technology that infringe, breach or violate our intellectual property rights.
For further discussion of the risks relating to intellectual property, see the section titled “ Risk Factors—Risks related to litigation and our intellectual property .”
+Added: Data Privacy and Security
+Added: Numerous state, federal and foreign laws, regulations and standards govern the collection, use, access to, confidentiality and security of health-related and other personal information, and could apply now or in the future to our operations or the operations of our partners.
+Added: In the United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal information.
+Added: In addition, certain foreign laws govern the privacy and security of personal data, including health-related data.
+Added: For example, the European Union General Data Protection Regulation (“GDPR”) imposes strict requirements for processing the personal data of individuals within the European Economic Area (“EEA”).
+Added: Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater.
+Added: Further, from January 1, 2021, companies have had to comply with the GDPR and also the United Kingdom GDPR (“UK GDPR”), which, together with the amended United Kingdom Data Protection Act 2018, retains the GDPR in United Kingdom national law.
+Added: The UK GDPR mirrors the fines under the GDPR, i.e., fines up to the greater of €20 million (£17.5 million) or 4% of global turnover.
+Added: Privacy and security laws, regulations and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.
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