N. Nicole Endejann

Product Exclusivity Strategies

• Advised companies on the creation and expansion of exclusivity strategies to protect therapeutic products through the interplay of patents, regulatory data and marketing exclusivity, trade secrets and other proprietary rights.
• Formulated strategies to maximize exclusivity for repurposed or repositioned drugs and biologics, including patent strategy and regulatory data exclusivity.
• Conducted eligibility assessments for patent listings in the Orange Book.
• Analyzed eligibility for and prepared patent term extension applications for drugs, biologics and medical devices.
• Advised on the interplay of FDA and patent law for drugs, biologics and medical device products.

Patent Prosecution and Strategic Counseling

• Advised a private company focused on licensing, developing and commercializing product candidates for the central nervous system (CNS), including epilepsy and psychiatry.
• Counseled a private pharmaceutical company developing breakthrough therapies for immunological and neurological conditions.
• Advised a public drug discovery company developing small molecule therapies in immune-inflammatory conditions.
• Counseling a private biopharmaceutical company developing topical, targeted therapies for rare genetic dermatological diseases.
• Advised a public specialty pharmaceutical company focused on medical and aesthetic dermatology, including developing a topical product for the treatment of seborrheic keratosis and warts, as well as topical and oral products to treat alopecia and vitiligo with Janus Kinsae inhibitors.
• Counseled a private biopharmaceutical company with multiple, ongoing late-stage clinical development programs in neurosciences and dementia, rare diseases, dermatology and endocrinology.
• Advised a public biotechnology company developing small molecule and enzyme-based therapeutics for restoring neurological function in patients with spinal cord injuries, multiple sclerosis and other neurological disorders.
• Counseled a clinical stage biopharmaceutical company developing highly selective and reversible endogenous human cell signaling technologies targeting orphan diseases in the areas of fibrosis and inflammation.
• Advised a public biotechnology company focused on the development of small molecule oncology products.
• Counseled a biopharmaceutical company focused on the development of peptide-based therapeutics for the treatment of diabetes.
• Advised a private company developing peptide-based therapeutics for pregnancy and immune-related disorders.
• Counseled a specialty pharmaceutical company focused on the development of therapeutics  for neonatal and pediatric patients.
• Counseled a public health care company focused on the development of oligoribonucleotide-based therapeutics, including siRNA and various ophthalmic therapeutics and diagnostics.

IP Due Diligence and Transactions

• Advised a large pharma company on numerous patent landscapes in the fields of mRNA vaccines and delivery technologies.
• Served as IP counsel to a clinical-stage biopharmaceutical company in a collaboration and license agreement to develop first-in-class treatments for epilepsy with a US$50 million upfront and up to US$1.7 billion in potential development, regulatory and commercial milestone payments.
• Served as intellectual property counsel to a global health care company in its equity investment valued at more than US$1 billion.
• Advised a private biopharmaceutical company, conducting IP due diligence in support of strategic alliances, collaborations and partnerships with academic institutions and pharmaceutical companies to augment its late-stage clinical development programs in neurosciences and dementia, rare diseases, dermatology, and endocrinology.
• Counseled a public specialty pharmaceutical company focused on medical and aesthetic dermatology.
• Conducted IP due diligence in support of licensing efforts.
• Advised a private specialty biopharmaceutical company in the dermatology industry and navigated through the IP due diligence process that led to an acquisition by a global multi­ specialty health care company worth up to US$275 million.
• Advised a drug discovery and development company in the neurologic space and navigated through the IP due diligence process that led to a US$345 million license agreement with a worldwide biotechnology company.
• Counseled a biopharmaceutical company in the molecular imaging field and navigated through the IP due diligence process that led to an acquisition of the company by a global pharmaceutical company worth up to US$800 million.
• Counseled a venture capital firm as part of a US$46 million financing that included conducting IP due diligence on a clinical stage pharmaceutical company developing antibiotics for drug­ resistant bacteria.
• Counseled a big pharma health care venture capital fund, conducting IP due diligence on a Swedish biotechnology company focused on immunotherapy for the treatment of chronic diseases.
• Advised a venture capital firm as part of a US$15 million financing that included conducting IP due diligence on a pharmaceutical company developing novel antibiotics for drug-resistant bacteria.
• Advised a venture capital firm as part of a US$30 million financing that included conducting IP due diligence on a specialty pharmaceutical company developing therapeutic products and medical devices for neurological and psychiatric diseases.
• Conducted internal IP due diligence reviews and audits on behalf of pharmaceutical, biopharmaceutical and medical device companies in preparation for partnering, financing and public offerings.
• Provided assistance to venture capital and investment funds in evaluating potential investment opportunities with biotechnology and pharmaceutical companies in relation to private placements/public financing transactions.
• Provided assistance to venture capital and investment funds in evaluating potential investment opportunities with biotechnology and pharmaceutical companies in relation to private placements/public financing transactions.
• Provided counsel on and prepared nondisclosure agreements, consulting agreements, license agreements and collaboration/joint venture agreements for bio-pharmaceutical companies.