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BCIQ Glossary

A BioCentury Quick Guide

This partial Glossary considers some of the most common filters and definitions used by our customers. Please stay tuned for additional definitions over coming weeks or request your own using the "Provide Feedback" button to the right.

Asset Type (Deals Filters)

Main type of asset being acquired, partnered, or otherwise transacted. Multiple assets within the same type are grouped together. For example, a deal for two compounds will have a single asset type of Pharmaceutical Products and the corresponding Number of Products field will indicate multiple products within that asset type.

A deal involving more than one distinct asset type, such as a partnership for a technology platform with an option to acquire the company, will be a multiple asset type deal with each asset type containing its own corresponding categories and financial terms. BCIQ Deal search result tables and Deal Profiles will allow for the differentiation of single and multiple asset type deals.

COMPANY: An entire company that may be purchased in a full or majority acquisition that may potentially encompass the entire legal entity. This does not include business units, divisions, or facilities as those may be transacted in an asset purchase rather than a company merger or acquisition (see Business Units, Divisions, or Facilities).

PHARMACEUTICAL PRODUCTS: Pharmaceutical products include marketed human therapeutics and identified compounds in preclinical or later stages.

TECHNOLOGY PLATFORMS
Discovery and Target Technology: Technology used to discover or manipulate targets as well as discover compounds against targets and biomarkers for diseases. This includes therapeutic modality platforms (biologics, antibodies, RNA, proteins, macrocycles), genomics, screening, technologies, etc.

Delivery and Formulation Technology or Device: Technologies used to alter the delivery or formulation of drugs. This includes sustained release, extended release, abuse deterrents, vector technology, etc. This also includes devices used to deliver a drug. This includes inhalers, stents, (incl. drug eluting/coated stents), pumps, injection devices, pre-filled syringes, patches, etc.

Manufacturing Technology: Technologies used in the manufacturing of pharmaceutical products. This includes active pharmaceutical ingredients (API), cell lines, scale-up, fill and finish, etc.

MEDICAL DEVICES AND DIAGNOSTICS
Devices, Including Digital Therapeutics: Medical devices that provide therapeutic treatment. This includes cryotherapy, thermotherapy, electromagnetic, laser, photodynamic therapy, sonication, ultrasound, and other therapeutic devices (see Delivery and Formulation Technology or Device for drug/device combinations).

Diagnostic or Biomarker: Biomarkers are specific genes or genetic markers that may indicate disease, including digital biomarkers. This includes both the biomarker and IP relating to the biomarker that have already been discovered prior to deal signing. Companion diagnostics are developed in conjunction with a specific pharmaceutical product (see Discovery and Target Technology for biomarker and companion diagnostic discovery technology).

BUSINESS UNITS, DIVISIONS, OR FACILITIES: A separate operating business or division of a larger company or holding company. This also includes subsidiaries of larger companies. A facility may be a manufacturing plant, factory, lab, research center, or an office building.

CONTRACT SERVICES
Contract Research: Research performed by a contract research organization (CRO) without any rights to the resulting product or technology.

Contract Sales: Sales and marketing services performed by a contract sales organization (CSO) without any rights to the marketed product.

Other Services: Services that cannot be classified under any other contract services category above.

OTHER
Other Technology: Technologies that cannot be classified under any other technology platform category above. This includes data such as intellectual property (IP), patents, and clinical data. It also includes freedom to operate, which is freedom from being legally prosecuted for use of the particular asset.

Grants: Grants provided by non-profits and foundations. This does not include grants from the National Institutes of Health (NIH) or SBIR grants.

Priority Review Voucher: A PRV is issued to the sponsor of a rare pediatric disease product application and entitles the holder to priority review of a single New Drug Application or Biologics License Application. The sponsor receives the voucher upon approve of the rare pediatric disease product application. PRVs may be sold or transferred, and there is no limit on the number of times a PRV can be transferred.



Company Type (Company Filters)

Company types used in BCIQ are based on the company or organization's primary business objective.

GOVERNMENT: Government organizations include government-funded research departments and stockpiling organizations, and regional biopharma investment groups (e.g., NIH, U.S. Department of Defense).

BIOPHARMACEUTICAL COMPANIES: Biopharma companies are defined as those primarily engaged in researching, discovering, developing, and commercializing technologies and pharmaceutical drugs used in human medical therapies. This includes branded, generic, prescription, and over-the-counter (OTC) drug products. This also includes companies developing technology platforms that are used for drug discovery, chemical library screening, development/optimization, and formulation. Biopharma companies are then characterized by their market capitalization in three tiers, or as Private Biopharma. Reviews of market cap designations are conducted on a quarterly basis, and reviews of private/public status are conducted as needed for IPOs or other ownership events.

MEDICAL DEVICES AND DIAGNOSTICS: Medical Devices and Diagnostics companies are primarily engaged in developing, manufacturing, and commercializing devices such as those used for medical therapy, drug delivery, and monitoring. This category also includes companies primarily engaged in developing, manufacturing, and commercializing diagnostic tests and biomarkers for use in human therapies. This category does not include companies developing assays, reagents, and systems used primarily in laboratory research, or companies developing large-scale instrumentation systems (see Tools, Services, and Manufacturing).

TOOLS, SERVICES, AND MANUFACTURING: Tools, Services, and Manufacturing includes companies primarily engaged in lab reagents, tools and supplies used in pharmaceutical research (including software for bioinformatics, genomics and proteomics), contract research organizations (CRO), contract manufacturing organizations (CMO), and contract sales organizations (CSO). This category does not include industrial and biotechnology chemical manufacturers (see Other).

NON-PROFIT OR MAJOR DISEASE FOUNDATION: Non-Profit or Major Disease Foundations includes organizations that are engaged in funding and advising R&D and/or raising the awareness for certain diseases (e.g., Cystic Fibrosis Foundation).

ACADEMIC: Academic organizations include university and institutional technology transfer offices, and teaching and research hospitals.

FINANCIAL: Financial organizations include venture capital and private equity firms, corporate venture groups of biopharma companies, royalty buyout firms, and acquisition holding companies (e.g., DRI Capital, Royalty Pharma, Deerfield Management).

OTHER: This category includes consulting and software companies (other than bioinformatics software), special consortia, and companies primarily engaged in chemical manufacturing not specific to human pharmaceuticals. This category also includes companies primarily developing and commercializing veterinary medicines, nutraceuticals, agricultural products, packaging, and industrial / environmental biotechnology chemicals (e.g., Oracle, 3M Co., Kimberly-Clark Corp.).



Deal Type (Deals Filters)

Deal Type describes the general scope of the deal pertaining to the asset. Major categories include Mergers and Acquisitions, Partnerships and Asset Purchases. Subcategories allow further classifications as they may be applicable to the asset. For example, a pharmaceutical product asset may be dealt in a development and commercialization license.

MERGERS AND ACQUISITIONS
Full Acquisition: Acquisition in which 100% of the company is acquired.

Partial Acquisition: Acquisition in which 1-99% of the company is acquired.

Acquisition Option: An option to acquire the company in the future based on pre-negotiated terms.

Merger: Two companies merge to form a new company, with a new name.

Reverse Merger: A private company acquires a publicly listed company, resulting in a new company with a new name and symbol that is publicly listed.

PARTNERSHIPS
Development and Commercialization License: License granted by one company (licensor) to another company (licensee) to make, use, or sell a product or technology.

Research & Development Only or with Option: This includes when a period of research is conducted and funded by the partners where one company may or may not have the option to license the product or technology after a pre-negotiated milestone. This also includes when a company has the option to license the product or technology after a pre-negotiated milestone and there may be no collaboration between the companies before the option is exercised.

Joint Venture/Consortium: Two or more companies form a separate entity to develop a product or technology.

Sales, Marketing and Co-Promotion: License granted by one company (licensor) to another company (licensee) solely to sell, market, or co-promote a product. Deals involving clinical development are classified under Development and Commercialization License.

Cross-License or Settlement Results in a License: This includes when two or more companies exchange rights to develop, commercialize, or promote each other's products or technologies or a legal agreement that results in one company gaining a license to a disputed product or technology.

Academic/Foundational/Govt. Research: Research and license deals involving an academic institution, foundation, or governmental organization.

Other Unspecified Partnership: Partnerships that cannot be classified under any other partnership category above.

ASSET PURCHASES
Business Unit or Facility Purchase: Purchase of an entire business unit or division. The seller has no obligation to support the business unit or division unless pre-negotiated in the sale. This also includes purchase of a research, development, or manufacturing facility.

Product, Pipeline, or Platform Purchase: Purchase of all rights to a single pharmaceutical product, a pharmaceutical product pipeline, or a technology platform. The seller has no obligation to support the development or commercialization of the product unless pre-negotiated in the sale.

Royalty Stream Monetization: Purchase of the right to receive financial consideration generated by the sales of a product.

Other Unspecified Asset Purchase: Purchase of all rights to equipment, data, and IP or substantially all assets of a company. The seller has no obligation to support the development or commercialization of the asset unless pre-negotiated in the sale.

OTHER
Contract R&D and Manufacturing Service: Contract research, development, or manufacturing services provided by one company for another. This includes services provided by contract research organizations (CROs) and contract manufacturing organizations (CMOs). The company providing the service does not have any rights to the resulting product unless pre-negotiated in the contract.

Government or Payor Purchase Agreement: An agreement between a governmental organization and a company for the supply of pharmaceutical products. This includes vaccine stockpiles. This also includes an agreement between a drug development company and payor organization on the pricing and reimbursement of a drug.

Spin-Out and Company Formation: A company spinning out a technology, single product, product pipeline, or business unit into a newly formed, standalone company.



Drug Development Scope (Deals Filters)

Drug development scope describes the commercial and regulatory classification of an existing drug or its intended development. In M&A deals, this field is used to describe the primary drug development scope of the company being acquired. Drug development scope does not apply to technology platforms that are not being used to discover or develop a drug, medical devices, or diagnostics.

PATENTED PRESCRIPTION DRUG: Any proprietary compound that can be patented and prescribed as a drug.

REFORMULATION: A previously approved drug that is being altered to change the method or duration of delivery. This includes abuse deterrent formulations, liposomal delivery, inhalation delivery, oral delivery, PEGylation, topical formulation, transdermal delivery, sustained release formulation, and other formulations.

REPURPOSED DRUG: A previously approved drug that is being repurposed for a new disease category or indication.

GENERIC: A non-branded drug that contains the same active ingredient, formulation, dosage, and route of administration as its reference/branded drug.

BIOSIMILAR: A follow-on version of an approved biologic. Biosimilars are classified according to the company's description, and not necessarily based on their regulatory pathway.

OTC (OVER THE COUNTER) PRODUCT: Drugs sold directly to the consumer, without the need of a prescription.



Lead Product Status (Company Filters)

Lead Product Status: The latest stage of development for the company's lead product.



Milestones (Product Filters)

Milestones: Using the Product Filters, you can search for drugs with upcoming milestones. These events include PDUFA dates, clinical trial starts, data read-outs, regulatory submissions, and expected market launches.



Partnership Scope (Deals Filters)

Partnership Scope is a sub-classification applied to partnership deals that is used to add categorical information about the originally formed agreement. This includes differentiating characteristics or structural elements affecting the overall scope and/or financial consideration of the deal.

SIMPLE LICENSE HAND-OFF: The licensor does not have any continuing development or commercialization obligations after licensing the rights to the licensee.

SHARED OBLIGATIONS: The partners will share parts of the overall development and/or commercialization without specific cost sharing. For example, partners may collaborate in the research, development, and/or commercialization process, but only one company will develop the product at a single stage and bear those costs itself. Development and commercialization costs are not shared between companies.

CO-DEVELOPMENT/OPTION TO CO-DEVELOP: The partners will share clinical development obligations and costs. The partners may also have the option to enter into development cost sharing.

CO-PROMOTION/OPTION TO CO-PROMOTE: The partners will share sales obligations and costs with one partner booking sales of the product. The partners may also have the option to enter into co-promotion.

CO-MARKETING/OPTION TO CO-MARKET: The partners will share sales obligations and costs with each party booking sales under different product trade names. The partners may also have the option to enter into co-marketing.

SUPPLY/OPTION TO SUPPLY: The licensor may supply API or finished product in commercial quantities at a cost or cost-plus transfer price.

OPTIONS TO EXPAND TO ADDITIONAL COMPOUNDS, PRODUCTS, AND/OR TERRITORIES: The original partnership allows for the option to add compounds, products, disease areas, and/or territories to the ongoing development and/or commercialization.



Exclusivity (Deals Filters)

This is the limitations of who has rights to a certain product/technology in certain territories, indications, etc.

CO-EXCLUSIVE: Deal is limited to a certain company and third party under terms of agreement.

EXCLUSIVE: Deal is limited to a certain company under the terms of the agreement.

NON-EXCLUSIVE: Deal is not limited to any company.

NOT APPLICABLE: Deal would not contain any exclusivity. This is used for M&A and spin-out deals.

SEMI-EXCLUSIVE: Deal is partially limited. For instance, a company has exclusivity for a product in one territory, but non-exclusive rights in another territory.

UNDISCLOSED/UNKNOWN: Used when exclusivity is not indicated in the PR.

VARIES BY ASSET: Deal has assets that are a combination of any of the above exclusivity terms.



Partnered/Unpartnered (Products Filters)

PARTNERED/UNPARTNERED: Partners field refers to development and/or commercialization partners.



Phase of Development (Products Filters)

RESEARCH: Prior to any in vivo testing (i.e. in vitro testing). Stage also referred to as "discovery". If in vivo testing has begun, product will move to "preclinical".

PRECLINICAL: In vivo testing has begun.

IND: (Investigational New Drug) Product at IND submission stage.

Note: Companies submit an IND in order to begin clinical testing in humans (generally moves to Phase I or Phase I/II) - company must wait a minimum of 30 days to begin testing while FDA reviews IND - may start testing on day 31 if the FDA has not responded and has not put a clinical hold on testing within the 30 days.

CLINICAL
Pilot: Usually used for early-stage device or diagnostics that generally follow a different regulatory pathway than therapeutic drugs.

Phase 0, I, II, III: In-human clinical trials.

Pivotal: Usually used for later stage device or diagnostics that generally follow a slightly different regulatory pathway than therapeutic drugs. Pivotal/pilot also may be used when the company has not disclosed a specific phase of development for a drug; and pivotal may be used by a company to indicate that it expects to submit a non-Phase III trial of a drug for regulatory approval, e.g., "a pivotal Phase II trial".

REGISTRATION: Company has submitted regulatory application to regulatory body for approval or regulatory body has accepted for review (e.g., NDA, BLA, MAA, etc.).

APPROVED: Regulatory body has issued approval, but drug is not yet available for sale.

MARKETED: Product is available for sale in a given country.

POST-APPROVAL
Phase IV: Post-marketing surveillance trial.



Stage at Signing (Deal Filter)

Stage at Signing: This filter is the phase of development of a product/technology at the time a deal is announced. For a partnership, this will be the most advanced stage of the product/technology in the partnership. For a merger/acquisition, this will be the most advanced stage of the company being acquired/merging into the other company.



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