Biotech Venture Between U.S. and Cuba to Develop New Cancer Treatments

New York Governor Andrew Cuomo recently announced the formation of the first-ever biotech venture between the U.S. and Cuba. Buffalo-based Roswell Park Comprehensive Cancer Center and Havana-based Centro de Inmunología Molecular (CIM) formed Innovative Immunotherapy Alliance S.A. to develop pioneering immunotherapies not widely studied or available outside of Cuba. The joint venture aims to advance the research and development of new cancer drugs that may prolong survival rates and quality of life for thousands of cancer patients.

The new joint venture will for the first time give American researchers access to CIMAvax-EGF and three other Cuban-developed cancer drugs that were not previously available in the U.S. The four Cuban developed immunotherapies are designed to augment the body’s defense system to fight cancer.

CIMAvax-EGF is an immunotherapy treatment for lung cancer. The drug works by blocking a type of protein, epidermal growth factor (EGF), that is needed by cancer cells to grow. In Cuba, lung cancer patients treated with CIMAvax-EGF live longer with an improved quality of life and minimal side effects. Researchers believe that CIMAvax-EGF may also prove effective in treating colon, head and neck, prostate, breast and pancreatic cancers, as well as for the prevention of certain cancers.

Governor Cuomo said, “This historic venture with Cuba will provide Roswell Park access to innovative cancer-fighting drugs that could revolutionize treatments and put us one step closer to eliminating the threat of cancer once and for all.”

Roswell Park President and CEO Candace S. Johnson, PhD, said, “This is a momentous step forward on one of our most significant undertakings. With the establishment of this company, we are entering a critical new phase of Roswell Park’s collaboration with these innovative Cuban scientists. Our goal is to develop these promising cancer therapies as quickly and effectively as possible so that they can benefit the greatest number of U.S. patients.”

Thomas Schwaab, MD, PhD, Chief of Strategy, Business Development and Outreach at Roswell Park, said, “It’s incredibly rewarding to see our collaboration reach this crucial juncture. Innovative Immunotherapy Alliance S.A. will provide the support, expertise and infrastructure that will make it possible for Roswell Park to study these drugs and get them to U.S. patients. We believe these unique immunotherapies have the potential to change the landscape of cancer treatment, and we are proud to partner with our CIM colleagues to advance development of these therapies as quickly and effectively as possible.”

Innovative Immunotherapy Alliance S.A., will be based in Cuba and will be operated jointly by CIM affiliate, CIMAB S.A., and by a Roswell Park subsidiary, GBCT II LLC. Roswell Park holds a license from the U.S. Office of Foreign Assets Control (OFAC) that permits preclinical and clinical research using these medical therapies.

Jose A. Aquino (@JoseAquinoEsq on Twitter) is a special counsel in the New York office of Duane Morris LLP, and a member of the Duane Morris Cuba Business Group. This blog is prepared and published for informational purposes only and should not be construed as legal advice. The views expressed in this blog are those of the author and do not necessarily reflect the views of the author’s law firm or its individual attorneys.

Effectiveness of Licensing Procedures for Agricultural Commodities to Cuba

The Bureau of Industry and Security (BIS) is requesting public comments on the effectiveness of its licensing procedures for the export of agricultural commodities to Cuba. The comments must be in writing and received by October 17, 2018. BIS requests that the comments be as specific as possible.

The comments will be considered by BIS in developing its biennial report to the Congress on the operation of the licensing system for the preceding two-year period, as required by the Trade Sanctions Reform and Export Enhancement Act of 2000. The report must include the number and types of licenses applied for, the number and types of licenses approved, the average amount of time elapsed from the date of filing of a license application until the date of its approval, the extent to which the licensing procedures were effectively implemented, and a description of comments received from interested parties. The biennial report is for the two-year period from October 1, 2016 through September 30, 2018.

BIS is an agency of the United States Department of Commerce that implements U.S. Government sanctions against Cuba and certain other nations. BIS administers and enforces the Export Administration Regulations (EAR), which regulate the export of commercial commodities, including the exports of agricultural commodities to Cuba.

All the comments will be made available for public inspection and copying. Material that the author does not want to be made public should not be submitted to BIS.

Additional information on BIS procedures and previous biennial reports are available at http://www.bis.doc.gov/​index.php/​policy-guidance/​country-guidance/​sanctioned-destinations/​13-policy-guidance/​country-guidance/​426-reports-to-congress.

Jose A. Aquino (@JoseAquinoEsq on Twitter) is a special counsel in the New York office of Duane Morris LLP, and a member of the Duane Morris Cuba Business Group. This blog is prepared and published for informational purposes only and should not be construed as legal advice. The views expressed in this blog are those of the author and do not necessarily reflect the views of the author’s law firm or its individual attorneys

U.S. Announces New Rules on Cuba Travel and Transactions

The U.S. Departments of Treasury, Commerce and State are publishing amended regulations in the Federal Register on November 9, 2017, which take effect immediately. The amendments implement President Trump’s June 2017 National Security Presidential Memorandum regarding Cuba. The regulations affect financial transactions and trade with Cuba, authorized travel to Cuba, and expand the scope of Cuban government officials with whom transactions are prohibited.

To read the full story, visit the Duane Morris LLP website.

FIRST LEGAL CARGO FROM CUBA IN MORE THAN HALF-CENTURY ARRIVES IN THE U.S.

Yesterday, the first legal cargo from Cuba in more than 50 years arrived in the United States. Two containers containing 40 tons of artisanal charcoal arrived by sea at Port Everglades in Fort Lauderdale. The charcoal, made from Cuban marabu, produces a highly efficient burning charcoal.

Once in the United States, the charcoal will be packaged in 33-pound bags under the brand name Fogo. The charcoal will be sold to restaurants and online directly to consumers. Cuban marabu charcoal has excellent heating qualities, it does not produce sparks, and burns long and clean, making it desirable for restaurant pizza and bread ovens.

Cuban marabu is made from an invasive woody plant from Africa that is considered a nuisance in Cuba. The marabu charcoal is produced by private, worker-owned cooperatives. The charcoal is sold by the cooperatives to a local packager, which sells it on to state-run export firm CubaExport. Products of cooperative farms in Cuba can be exported to the United States under the exemptions to the U.S. embargo permitted by President Obama.

The Obama Administration eased restrictions on imports of goods and services from private Cuban entrepreneurs in early 2015. The new regulations set forth a list of goods that are prohibited from being exported to the U.S., such as livestock, food products, ammunition, metals and minerals. Other products are eligible for export if they were produced by private Cuban entrepreneurs and are not on the list of prohibited items.

Jose A. Aquino (@JoseAquinoEsq on Twitter) is a special counsel in the New York office of Duane Morris LLP, and a member of the Duane Morris Cuba Business Group. This blog is prepared and published for informational purposes only and should not be construed as legal advice. The views expressed in this blog are those of the author and do not necessarily reflect the views of the author’s law firm or its individual attorneys.

Obama Administration Promotes Expanded Opportunities With Cuba.

On Friday, October 14, 2016, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) and the Department of Commerce’s Bureau of Industry and Security (BIS) issued new amendments to the Cuban Assets Control Regulations (CACR) and Export Administration Regulations (EAR). OFAC is the federal agency responsible for enforcement of U.S. international economic sanctions. BIS is the federal agency responsible for developing export control policies, issuing export licenses, and prosecuting violations.

The Obama Administration is making these amendments in further support normalizing bilateral relations with Cuba. The objective of the new rules is to facilitate greater engagement between the United States and Cuba across multiple sectors. The OFAC and BIS regulations were previously amended on January 16, June 15, and September 21, 2015, and January 27 and March 16, 2016 to implement President Obama’s policy to further engage and empower the Cuban people.

“President Obama’s historic announcement in December 2014 charted a new course for a stronger, more open U.S.-Cuba relationship,” said Treasury Secretary Jacob J. Lew. “The Treasury Department has worked to break down economic barriers in areas such as travel, trade and commerce, banking, and telecommunications. Today’s action builds on this progress by enabling more scientific collaboration, grants and scholarships, people-to-people contact, and private sector growth. These steps have the potential to accelerate constructive change and unlock greater economic opportunity for Cubans and Americans.”

“These amendments will create more opportunities for Cuban citizens to access American goods and services, further strengthening the ties between our two countries,” said U.S. Secretary of Commerce Penny Pritzker.

Among other things, the new amendments add and expand authorizations of transactions related to Cuban-origin pharmaceuticals and joint medical research, trade and commerce, civil aviation safety-related services, travel to Cuba, and humanitarian services designed to directly benefit the Cuban people. Some of the changes, which go into effect on October 17, 2016, are:

  • Cuban-developed pharmaceuticals will be able to gain approval by the US Food and Drug Administration (FDA). The FDA-approved Cuban-origin pharmaceuticals can be imported, marketed, sold and distributed in the United States.
  • Americans will be allowed to engage in joint medical research projects with Cuban nationals. Both non-commercial and commercial research projects will be permissible.
  • Americans engaged in approved health-related activities will be allowed to open and maintain bank accounts in Cuba for use in conducting the authorized busines
  • Americans will be permitted to enter into certain contingent contracts for trade with Cuba.
  • Americans who travel to Cuba will no longer be limited to bringing back goods worth up to $400, including $100 worth of tobacco and alcohol. OFAC is removing the monetary value limitations on what authorized travelers may import from Cuba into the United States. Normal limits on Americans’ importation of foreign products for personal use will apply to U. S. Citizens traveling from Cuba. OFAC is also removing the prohibition on Americans purchasing and bringing into the United States for personal use Cuban products obtained while traveling in third countries. Similarly, foreign travelers may bring Cuban-origin alcohol and tobacco products into the United States for personal use.
  • OFAC will waive the restriction prohibiting foreign vessels from entering a U.S. port for purposes of loading or unloading freight for 180 days after calling on a Cuban port for trade purposes.
  • BIS will generally authorize air cargo to transit Cuba.  The amended regulations allow cargo aboard aircraft bound for destinations other than Cuba to transit Cuba under a license exception.
  • BIS will authorize exports of certain consumer goods that are sold online or through other means directly to eligible individuals in Cuba for their personal use.
  • Americans will be allowed to provide civil aviation safety-related services to Cuba and Cuban nationals.

The Treasury regulations 31 Code of Federal Regulations (CFR), part 515, are available by clicking here. The Commerce regulations 15 CFR parts 730-774, are available by clicking here.

Jose A. Aquino (@JoseAquinoEsq on Twitter) is a special counsel in the New York office of Duane Morris LLP, and a member of the Duane Morris Cuba Business Group. This blog is prepared and published for informational purposes only and should not be construed as legal advice. The views expressed in this blog are those of the author and do not necessarily reflect the views of the author’s law firm or its individual attorneys.

Licensing Procedures for Agricultural Commodities to Cuba

The Bureau of Industry and Security (BIS) is requesting public comments on the effectiveness of its licensing procedures for the export of agricultural commodities to Cuba. BIS is an agency of the United States Department of Commerce that implements U.S. Government sanctions against Cuba and certain other nations. BIS administers and enforces the Export Administration Regulations (EAR), which regulate the export of commercial commodities, including the exports of agricultural commodities to Cuba.

Comments must be received by October 11, 2016. BIS will include a description of the comments in its biennial report to Congress, as required by the Trade Sanctions Reform and Export Enhancement Act of 2000. BIS’s report must also include the number and types of licenses applied for, the number and types of licenses approved, the average amount of time elapsed from the date of filing of a license application until the date of its approval, and the extent to which the licensing procedures were effectively implemented.

Jose A. Aquino (@JoseAquinoEsq on Twitter) is a special counsel in the New York office of Duane Morris LLP, and a member of the Duane Morris Cuba Business Group. This blog is prepared and published for informational purposes only and should not be construed as legal advice. The views expressed in this blog are those of the author and do not necessarily reflect the views of the author’s law firm or its individual attorneys.

Americans May Now Legally Smoke Cuban Cigars, But Only Outside the U.S.

The Obama administration has decriminalized smoking Cuban cigars while traveling abroad. Americans can now enjoy their favorite cigars while sunning on a beach in the Bahamas or relaxing in the Tuscan countryside without fear of criminal prosecution. Consumption of Cuban rum outside the U.S. has also been decriminalized.

While most Americans are aware that bringing Cuban cigars or rum into the country was a big no-no, not many of us knew that we were in violation of the U.S. embargo while buying them in other countries for local consumption. Under 2004 regulations, the U.S. embargo against Cuba was extended to purchases made in other countries. Thus, we faced criminal and civil penalties for smoking cigars or drinking rum made in Cuba while wandering overseas.

As of March 16, 2016, however, Americans can enjoy their favorite Cuban cigars and rum just about anywhere in the word, except within the United States. The Department of Treasury announced: “Effective March 16, 2016, persons subject to U.S. jurisdiction may purchase or acquire Cuban-origin merchandise, including alcohol and tobacco products, while in a third country provided such products are consumed while in a third country.”

Americans can also travel to Cuba and bring back their favorite rum and cigars. The recent loosening of regulations allow Americans visiting Cuba for permissible purposes to purchase alcohol and tobacco products for personal use while in Cuba, and may return to the United States with up to $100 worth of alcohol or tobacco products bought in Cuba.

Jose A. Aquino (@JoseAquinoEsq on Twitter) is a special counsel in the New York office of Duane Morris LLP, and a member of the Duane Morris Cuba Business Group. This blog is prepared and published for informational purposes only and should not be construed as legal advice. The views expressed in this blog are those of the author and do not necessarily reflect the views of the author’s law firm or its individual attorneys.

U.S. Relaxes Cuba Sanctions Ahead of President Obama’s Historic Trip to Havana

Days before President Obama makes a historic trip to Havana, the Department of the Treasury and the Department of Commerce announced a further loosening of restrictions on travel and trade with Cuba. The changes make it easier for Americans to travel to Cuba and facilitate the use of U.S. dollars in Cuban financial transactions.

Americans can now take “people-to-people” trips to Cuba on their own instead of through group tours. The new measures allow Americans to legally travel to Cuba by simply filling out a form asserting that the purpose of their travel is for educational purposes. The expanded allowable travel together with direct commercial fights that are to begin later this year will greatly increase the number of Americans visiting the island. The Obama administration hopes that the increased flow of visitors with U.S. dollars will be the catalyst that leads to the opening of the Cuban economy.

The Obama administration also loosened rules on the Cuban government’s use of the U.S. dollar. The new rules allow U.S. banks to process Cuban transactions that pass through the U.S. banking system. Cuban nationals in the United States will now be able to earn a salary or other recompense and be permitted to open accounts in American banks.

Treasury Secretary Jacob J. Lew, said in a statement: “Today’s steps build on the actions of the last 15 months as we continue to break down economic barriers, empower the Cuban people and advance their financial freedoms, and chart a new course in U.S.-Cuba relations.” Secretary Lew added: “Today we are building on this progress by facilitating travel for additional Americans looking to engage with Cubans; allowing Cuban citizens to earn a salary in the United States; and expanding access to the U.S. financial system, as well as trade and commercial opportunities.”

The move was also praised by Commerce Secretary Penny Pritzker: “Today’s amendments build upon President Obama’s historic actions to improve our country’s relationship with Cuba and its people. These steps not only expand opportunities for economic engagement between the Cuban people and the American business community, but will also improve the lives of millions of Cuba’s citizens.”

The Department of Commerce summarized the regulations as follows:

“Travel and Related Transactions–

  • People-to-people educational travel. Individuals will be authorized to travel to Cuba for individual people-to-people educational travel, provided that the traveler engages in a full-time schedule of educational exchange activities intended to enhance contact with the Cuban people, support civil society in Cuba, or promote the Cuban people’s independence from Cuban authorities and that will result in a meaningful interaction between the traveler and individuals in Cuba. Previously, the general license authorizing educational travel required such trips to take place under the auspices of an organization that was subject to U.S. jurisdiction and required all travelers to be accompanied by a representative of the sponsoring organization. This change is intended to make authorized educational travel to Cuba more accessible and less expensive for U.S. citizens, and will increase opportunities for direct engagement between Cubans and Americans. Persons relying upon this authorization must retain records related to the authorized travel transactions, including records demonstrating a full-time schedule of authorized activities. In the case of an individual traveling under the auspices of an organization that is a person subject to U.S. jurisdiction and that sponsors such exchanges to promote people-to-people contact, the individual may rely on the entity sponsoring the travel to satisfy those recordkeeping requirements.
  • Payment of salaries. Cuban nationals in the United States in a non-immigrant status or pursuant to other non-immigrant travel authorization will be authorized to earn a salary or compensation, consistent with the terms of the particular visa, provided that the recipient is not subject to any special tax assessments in Cuba. U.S. companies will be authorized to engage in transactions related to the sponsorship or hiring of Cuban nationals to work or perform in the United States similar to nationals from other countries, provided that no additional payments are made to the Cuban government in connection with such sponsorship or hiring. For example, Cuban athletes, artists, performers, and others who obtain the requisite visas will be able to travel to the United States and earn salaries and stipends in excess of basic living expenses. Transactions in connection with the filing of an application for non-immigrant travel authorizations will also be authorized.
  • Cuban-origin merchandise. OFAC will authorize certain dealings in Cuban-origin merchandise by individuals for personal consumption while in a third-country, and to receive or obtain services from Cuba or a Cuban national that are ordinarily incident to travel and maintenance within a third country. This authorization will allow, for example, Americans traveling in Europe to purchase and consume Cuban-origin alcohol and tobacco products while abroad similar to the travel exemptions in other sanctions programs.

Banking and financial services –

  • U-turn payments through the U.S. financial system. U.S. banking institutions will be authorized to process U-turn transactions in which Cuba or a Cuban national has an interest. This provision will authorize funds transfers from a bank outside the United States that pass through one or more U.S. financial institutions before being transferred to a bank outside the United States, where neither the originator nor the beneficiary is a person subject to U.S. jurisdiction.
  • Processing of U.S. dollar monetary instruments. U.S. banking institutions will be authorized to process U.S. dollar monetary instruments, including cash and travelers’ checks, presented indirectly by Cuban financial institutions. Correspondent accounts at third-country financial institutions used for such transactions may be denominated in U.S. dollars.
  • U.S. bank accounts for Cuban nationals. U.S. banking institutions will be authorized to open and maintain bank accounts in the United States for Cuban nationals in Cuba to receive payments in the United States for authorized or exempt transactions and to remit such payments back to Cuba.

Trade and commerce

  • Physical and business presence. OFAC will expand the existing authorization for “physical presence” (such as an office, retail outlet, or warehouse) to include entities that engage in authorized humanitarian projects, entities that engage in authorized non-commercial activities intended to provide support for the Cuban people, and private foundations or research or educational institutes engaging in certain authorized activities pursuant to sections 515.575, 515.574, and 515.576 of the CACR, respectively. OFAC will also expand the existing authorization for “business presence” (such as a joint venture) to include exporters of goods that are authorized for export or re-export to Cuba or that are exempt, entities providing mail or parcel transmission services or cargo transportation services, and providers of carrier and travel services to facilitate authorized transactions. The revised regulations will also clarify that the physical and business presence authorizations permit exporters and re-exporters of authorized or exempt goods to assemble such goods in Cuba. BIS will make conforming changes to the EAR to generally authorize exports and re-exports of eligible items to establish and maintain a physical or business presence that is authorized by OFAC.
  • Importation of software. The CACR currently authorizes the importation of Cuban-origin mobile applications. OFAC will expand this authorization to allow the importation of Cuban-origin software.
  • Shipping. BIS will generally authorize vessels to transport authorized cargo from the United States to Cuba and then sail to other countries with any remaining cargo that was onloaded in the United States.
  • Cuban private sector. BIS will adopt a licensing policy of case-by-case review for exports and re-exports of items that would enable or facilitate exports from Cuba of items produced by the Cuban private sector.

Grants and awards –

  • OFAC will authorize the provision of educational grants and awards, and clarify that an existing authorization applies to the provision of grants and awards for the humanitarian projects authorized in OFAC’s regulations. This step will further enable U.S. support for educational projects in Cuba and U.S. participation in philanthropic efforts.”

The Department of Treasury regulations, 31 CFR 515, are available here. The Department of Commerce regulations, 15 CFR 730-774, are available here.

For additional background, please refer to a recent Duane Morris alert “OFAC and BIS Publish Comprehensive Modifications Related to U.S. Policy Toward Cuba,” written by Duane Morris special counsel Brian Goldstein.

Jose A. Aquino (@JoseAquinoEsq on Twitter) is a special counsel in the New York office of Duane Morris LLP, and a member of the Duane Morris Cuba Business Group. This blog is prepared and published for informational purposes only and should not be construed as legal advice. The views expressed in this blog are those of the author and do not necessarily reflect the views of the author’s law firm or its individual attorneys.

Top Ten Reasons for U.S. Companies to Protect Brands in Cuba Now: Part I

Every company – regardless of size – has a name and/ or a trademark. Often, that name or trademark is a company’s most valuable asset, and should be protected as such.  Yet, historically, protection of trademarks in Cuba has not been high on U.S. companies’ agendas.  Protection of U.S. trademarks in Cuba is currently possible, is relatively simple, and is a smart and strategic business move: Below are  five of the top ten reasons to seek protection of trademarks in Cuba now:   Continue reading Top Ten Reasons for U.S. Companies to Protect Brands in Cuba Now: Part I