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For the predominant pathogens E. Currently Available Treatment Options. The manufacturing process must be capable of consistently producing quality batches of the drug candidate and, among other things, must develop methods for testing the identity, strength, quality, purity, and potency of the final drug. Specifically, the FDA may designate a product for Fast Track review if it is intended, whether alone or in combination with one or more other products, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition. There is no obligation for a drug manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act, but the manufacturer must develop an internal policy and respond to patient requests according to that policy. The transfer of the Shares shall have economic effect as from the Closing Date the " Effective Date " and, unless otherwise expressly stated in this Agreement, all rights including, without limitation, the right to receive dividends or distributions declared, made or paid and obligations, benefits and risk including, without limitation, economic risk, force majeure risk, etc. Exact name of registrant as specified in its charter.

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References to clauses contained herein shall be references to clauses of the SPA, unless expressly indicated otherwise herein. Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. Our competitors may also obtain marketing approvals for their products 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. Failure to comply with such requirements, including with respect to clinical trials conducted outside the European Union, can also lead regulatory authorities to refuse to take into account clinical trial data submitted as part of a marketing authorization application, or MAA. The Company has complied with all Tax obligations under applicable laws, in particular with intra-group transfer pricing rules. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information.

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If lefamulin or any of our other product candidates receive marketing approval, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. IRB must review and approve, among other things, the study protocol and informed consent information to be provided to study subjects. Key Attributes of Lefamulin. We plan to evaluate the merits of entering into collaboration agreements with other pharmaceutical or biotechnology companies that may contribute to our ability to efficiently advance our product candidates, build our product pipeline and concurrently advance a range of research and development programs for a variety of indications outside the United States.

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Commitments and contingencies Note We may advance these programs in the clinic based on available non-dilutive funding. Many compounds that initially showed promise in clinical or earlier stage testing have later been found to cause side effects or other safety issues that prevented further development of the compound.

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