commercialize medicines that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any medicines that we may develop. Our competitors
also may obtain FDA or other regulatory approval for their medicines more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.
Manufacturing
We do not own or operate,
and currently have no plans to establish, any manufacturing facilities. We currently rely, and expect to continue to rely, on third parties for the manufacture of our product candidates for preclinical or clinical manufacturing, testing, as well as
for commercial manufacture of any products that we may commercialize. We employ the services of Fujifilm Diosynth Biotechnologies UK LTD (Fujifilm UK) to supply the drug substance for exebacase. We do not yet have contracts to produce a
commercial supply of the drug substance for exebacase; however, we intend to pursue agreements with Fujifilm UK to do so. We employ the services of various vendors to produce exebacase in its final vialed drug product form. We do not have contracts
for the commercial supply of exebacase. We intend to pursue agreements with third party manufacturers regarding commercial supply of vialed drug product at an appropriate future time. We may choose to locate second fill finish third party
manufacturers to supply other world regions such as the European Union (the E.U.) or Asia.
Sales, Marketing and Distribution
We do not currently have an organization for the sales, marketing and distribution of pharmaceutical products. We may rely on licensing and co-promotion agreements with strategic partners for the commercialization of our products in the United States and other territories. If we choose to build a commercial infrastructure to support marketing in the
United States, such commercial infrastructure could be expected to include a targeted sales force supported by sales management, internal sales support, an internal marketing group and distribution support. To develop the appropriate commercial
infrastructure internally, we would have to invest financial and management resources, some of which would have to be deployed prior to any confirmation that any of our other products will be approved.
Government Regulation
The production,
distribution, and marketing of products employing our research and intellectual property or that we may license from third parties are subject to extensive governmental regulation in the United States and in other countries. In the United States,
our products will be regulated as biologics and subject to the Federal Food, Drug, and Cosmetic Act, as amended (the FDC Act), the Public Health Service Act, as amended (the PHSA) and the regulations of the FDA, as well as to
other federal, state, and local statutes and regulations. These laws, and similar laws outside the United States, govern the research, development, clinical and preclinical testing, manufacture, safety, effectiveness, approval, labeling,
distribution, sale, import, export, storage, record-keeping, reporting, advertising, and promotion and marketing of our products. Product development and approval within this regulatory framework, if successful, will require the expenditure of
substantial resources and take years to achieve. Violations of regulatory requirements at any stage may result in various adverse consequences, including the FDAs and other health authorities delay in approving or refusal to approve a
product and may result in enforcement actions and administrative or judicial sanctions.
The following provides further information on
certain legal and regulatory requirements that have the potential to affect our operations and the future marketing of our products.
FDA Approval
Process
In the United States, pharmaceutical products are subject to extensive regulation by the FDA. The FDC Act and other
federal and state statutes and regulations govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting,
sampling, and import and export of pharmaceutical products. In addition to
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