Kalik | Lewin - Agriculture and Biotechnology


International Trade \| Alcoholic Beverage \| Corporate and Commercial \| Legislative \| Agriculture and Biotechnology \| Intellectual Property
. Home Professionals Clients Contact	. --- --- --- - - - The career experience of KALIK \| LEWIN's principals as former Congressional staffers gives KALIK \| LEWIN unique perspective on the process of developing, drafting and lobbying on legislation in the U.S. Congress and pending regulatory matters before various government agencies. The firm takes a multi-disciplinary approach to legislative and regulatory advocacy, leveraging political capital, legal expertise and strong relationships across the Executive and Legislative branches to manage political risks and craft legislative solutions for clients. --- KALIK \| LEWIN advises clients on the regulatory requirements for testing imports to ensure compliance with sanitary and phytosanitary (SPS) standards for food and agricultural products. Working closely with the U.S. Department of Agriculture and the U.S. Customs Service, KALIK \| LEWIN provides clients with representation concerning imported food and agricultural products, including trade preference duty reductions, classification, drawback, quota management, quarantine regulations and labeling requirements. --- Food and agriculture clients benefit from KALIK \| LEWIN's expertise in regulatory matters under the Food and Drug Act. The firm represents clients before the Food and Drug Administration (FDA) on matters including labeling, standards of identity, traceability, developments in biotechnology and the regulation of genetically-modified organisms in food and feed (GMOs). --- Extensive experience working with the U.S. Department of Agriculture (USDA) gives KALIK \| LEWIN superior means with which to represent clients on regulatory and commercial compliance issues before the agencies of the USDA. The firm works extensively with the Animal and Plant Health Inspection Service (APHIS), the Foreign Agricultural Service (FAS), the Commodity Credit Corporation (CCC) and the Farm Services Administration (FSA) on issues including emergency disaster relief for crop loss, marketing orders, regulation of biotechnology products and services, importing and exporting agricultural products, and plant patents. - KALIK \| LEWIN regularly negotiates and assists biotechnology firms in the acquisition of strategic and operational research and development relationships, partnerships, alliances and joint ventures with universities, hospitals, government agencies and multinational industrial companies. The relationships and the associated agreements and transactions provide the intellectual capital, proprietary technologies and technology transfer terms and conditions which enable the development and commercialization of cutting-edge biotechnology and life science products. - For both proprietary technologies and licensed intellectual property, the terms and conditions of licensing agreements for patented processes and products and their underlying technologies require strategic advice and experienced guidance to allow a growing biotechnology company to bring its products to market. KALIK \| LEWIN has the experience crafting these arrangements on behalf of both inventors and their strategic partners to best serve emerging life sciences businesses in the acquisition of proprietary technology and the commercialization of biotechnology products. - Utilizing industry experts as partners and working together with institutional sponsors such as Johns Hopkins University and the National Cancer Institute, KALIK \| LEWIN has built a unique practice advising and assisting clients in the development and management of clinical trials for both diagnostic and therapeutic technologies. Using this experience, KALIK \| LEWIN is a strong partner to guide biotechnology companies through the scientific and regulatory requirements to allow new technologies and products to successfully meet clinical standards and proceed to regulatory approval.

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The career experience of KALIK | LEWIN's principals as former Congressional staffers gives KALIK | LEWIN unique perspective on the process of developing, drafting and lobbying on legislation in the U.S. Congress and pending regulatory matters before various government agencies. The firm takes a multi-disciplinary approach to legislative and regulatory advocacy, leveraging political capital, legal expertise and strong relationships across the Executive and Legislative branches to manage political risks and craft legislative solutions for clients.

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KALIK | LEWIN advises clients on the regulatory requirements for testing imports to ensure compliance with sanitary and phytosanitary (SPS) standards for food and agricultural products. Working closely with the U.S. Department of Agriculture and the U.S. Customs Service, KALIK | LEWIN provides clients with representation concerning imported food and agricultural products, including trade preference duty reductions, classification, drawback, quota management, quarantine regulations and labeling requirements.

---

Food and agriculture clients benefit from KALIK | LEWIN's expertise in regulatory matters under the Food and Drug Act. The firm represents clients before the Food and Drug Administration (FDA) on matters including labeling, standards of identity, traceability, developments in biotechnology and the regulation of genetically-modified organisms in food and feed (GMOs).

---

Extensive experience working with the U.S. Department of Agriculture (USDA) gives KALIK | LEWIN superior means with which to represent clients on regulatory and commercial compliance issues before the agencies of the USDA. The firm works extensively with the Animal and Plant Health Inspection Service (APHIS), the Foreign Agricultural Service (FAS), the Commodity Credit Corporation (CCC) and the Farm Services Administration (FSA) on issues including emergency disaster relief for crop loss, marketing orders, regulation of biotechnology products and services, importing and exporting agricultural products, and plant patents.

-

KALIK | LEWIN regularly negotiates and assists biotechnology firms in the acquisition of strategic and operational research and development relationships, partnerships, alliances and joint ventures with universities, hospitals, government agencies and multinational industrial companies. The relationships and the associated agreements and transactions provide the intellectual capital, proprietary technologies and technology transfer terms and conditions which enable the development and commercialization of cutting-edge biotechnology and life science products.

-

For both proprietary technologies and licensed intellectual property, the terms and conditions of licensing agreements for patented processes and products and their underlying technologies require strategic advice and experienced guidance to allow a growing biotechnology company to bring its products to market. KALIK | LEWIN has the experience crafting these arrangements on behalf of both inventors and their strategic partners to best serve emerging life sciences businesses in the acquisition of proprietary technology and the commercialization of biotechnology products.

-

Utilizing industry experts as partners and working together with institutional sponsors such as Johns Hopkins University and the National Cancer Institute, KALIK | LEWIN has built a unique practice advising and assisting clients in the development and management of clinical trials for both diagnostic and therapeutic technologies. Using this experience, KALIK | LEWIN is a strong partner to guide biotechnology companies through the scientific and regulatory requirements to allow new technologies and products to successfully meet clinical standards and proceed to regulatory approval.