2013

[LICENSING AGREEMENT IN BANGLADESH ]

United International University

Submitted To: Mohammed Sohail Mustafa

Assistant Professor, School of Business United International University (UIU).

Submitted By: MD. Trique Aziz - 114092001 Rosma Akter khanom -114092005

Date of Submission- 30th April 2013

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Letter of Transmittal

30th April, 2013 To, Mohammed Sohail Mustafa Assistant Professor, School of Business United International University (UIU)

Dear Sir, Here is the recommendation report on analysis of licensing agreement in Bangladesh that you authorized. As you read the report, you will get some idea about the licensing agreement as well as their implications in Bangladesh. This report contains as much as possible necessary information about the licensing agreement, list of Pharmaceuticals Company that are implicated with licensing agreement, other sector such as RMG and telecommunication and lastly the effect of those companies in our country. We have collected all this necessary information from different sources on internet. We, therefore, pray and hope that you will encourage our work by accepting this report and if you have any further queries about the report you can contact us.

Sincerely, Md. Tarique Aziz

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Acknowledgement

This study is the outcome of the term paper writing program commenced by the International Business IBS3121 course trained by Mohammed Sohail Mustafa at United International University (UIU) for spring 2013 semester of students to enhancement the understanding and examines knowledge collect from a particular field. We are grateful to them who have honestly and ultimately support us in carrying out the study. Specially, we are gratified to our praiseworthy faculty Mohammed Sohail Mustafa because of his support gives us the prospect to begin the report punctually. We are thankful to the accountants of the company that they have directly helped us in finishing the term paper specially accumulating information. To conclude, we are obliged a thoughtful logical debt to the elder for part time help, support and priceless suggestion in thoughts and mounting of this report

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Table of Contents:

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Origin of the report

We made this report as a requirement of completing the International Business course curriculum. This report titled as licensing agreement in Bangladesh This course started from 10.2.2012 and will end in 11.5.2013. Our honorable course instructor is Mohammed Sohail Mustafa the lecturer of International Business, School of business who assigned this project. We learnt a lot from our Instructor. Significance: The outcome of the research will be helpful for developing knowledge under scrutiny for getting a clear picture about the effects of licensing agreement on Bangladesh. It will help to acknowledge the overall picture of foreign agreement under licensing and their good and bad effects in country.

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Methodology

The methodology of this report is mainly based on collection of data about the licensing companies practiced by internationally as well as effect of those estimates in our country perspectives and of many other different issues. The entire research has been approached at three different phases. At the first stage is the introductory part has been accomplished and later the second phase about lists of licensing companies and lastly the effect of licensing agreements in Bangladesh Data collection: Different types of data are used in this repot with a view to making the report preparation worthwhile. Data has been collected and analyzed by the 4 members of the assigned group. Our respectable Faculty has assisted us by providing generous approach. Regarding their expert advices we came to accomplish this exertion with extend knowledge with a practical view.

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Introduction:

A written contract under which the owner of a copyright, know how, patent, service mark, trademark, or other intellectual property, allows a licensee to use, make, or sell copies of the original. Such agreements usually limit the scope or field of the licensee, and specify whether the license is exclusive or non-exclusive and whether the licensee will pay royalties or some other consideration in exchange. While licensing agreements are mainly used in commercialization of a technology, they are also used by franchisers to promote sales of goods and services. Licensing is a contractual agreement to use a brand name, patent or property that is owned by another business entity. A licensing agreement represents a legal agreement that gives a person or entity the right to make or market a product or service to which someone else owns the rights. A licensing agreement may permit the use of intellectual properties, such as trademarks, patents or designs.
The terms related licensing: Licensor: The party, who grants individuals or companies the rights, is the "licensor," usually has final approval on the quality of the product, service or other creation. Licensor is generally the parent company. It may require that a model of the product or packaging meet its standards before final production and marketing can take place. The contract may also contain provisions that deal with the quantity of items that the party may produce sale territories, and requirements for disposing of excess or unsoldmerchandise. Licensee: The licensee has the right to use, manufacture or sell the property in exchange for an agreed payment to the licensor. The licensee agrees to follow certain restrictions as outlined in the agreement Fees: The licensee agrees to pay a fee or royalties to the licensor. Standard payments for rights run anywhere from 6 to 10 percent of sales. Generally, the consideration depends on the type of property involved and the licensee's understanding and sophistication in putting together licensing deals. Time Frame: The duration of the agreement is an important element of a licensing contract. Contracts usually have clauses that outline the length of the agreements as well adoptions for renewing contracts or stipulations for terminating licensing agreements

Licensing agreement in Bangladesh:

During the invention process you'll encounter an early fork in the road: should you go into business for yourself, or should you try to license your idea to an already established company or manufacturer? There are many factors to consider when making this decision, and this column will help you evaluate the pros and cons of each. First it's important to understand these two options. When you go into business yourself, you'll handle every step of the process--from creating a working prototype to overseeing the manufacturing to devising a marketing plan to sales to distribution. When you license your invention, most of these steps are taken on by the licensee and you're paid a royalty on net sales of the completed invention. Running your own

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business demands a greater commitment and tolerance for risk with the promise of greater rewards, while licensing your idea minimizes your risk, and also your financial return. Bangladesh launched a deep and wide-ranging trade reform strategy in the early 1990s. This included substantial reduction and rationalization of tariffs, removal of quantitative restrictions, move from multiple to a unified exchange rate system, convertible current account and an overall outward orientation of trade policy regime. As a result, the countrys trade integration, measured by the trade-GDP ratio, rose from 18% in 1990 to 43% in 2008. Despite apprehensions that Bangladesh might lose out to exporters from China and India following the phase-out of the MFA quotas, its share in global apparel and textile exports has remained stable and export volumes have continued their robust growth. The countrys main markets are the EU and the United States and its imports are dominated in general by machinery and textiles, with China and India being the most important sources of imports. Bangladesh also has substantial unrecorded trade with its neighbor India. Labor exports are also important, with remittance inflows at about 9% of GDP. The role of private sector driven export growth and diversification has been emphasized in Bangladeshs PRSP, making export-led growth a key thrust of its poverty reduction and growth strategies Implications of WTO Agreements and Unilateral Trade Policy Reforms for Poverty in Bangladesh: Short versus Long-Run Impacts: The authors examine the effects of WTO agreements and domestic trade policy reforms on production, welfare, and poverty in Bangladesh. They use a sequential dynamic computable general equilibrium (CGE) model, which takes into account accumulation effects, allowing for long-run analysis. The study is based on the 2000 Social Accounting Matrix (SAM) of Bangladesh including 15 production sectors, four factors of production (skilled and unskilled labor, agricultural and nonagricultural capital), and nine household groups (five in rural areas and four in urban areas). To examine the link between the macroeconomic effects and microeconomic effects in terms of poverty, the authors use the representative household approach with actual intra-group income distributions. The study presents five simulations for which the major findings are: (1) The Doha scenario has negative implications for the overall macro economy, household welfare, and poverty in Bangladesh. Terms of trade deteriorate and consumer prices, particularly food prices, increase more than nominal incomes, especially among poor households. (2) Free world trade has similar, but larger, impacts. (3) Domestic trade liberalization induces an expansion of agricultural and light manufacturing sectors, favorable changes in the domestic terms of trade. Although the short-run welfare and poverty impacts are negative, these turn positive in the long run when capital has adjusted through new investments. Rising unskilled wage rates make the poorest households the biggest winners in terms of welfare and poverty reduction. (4) Domestic liberalization effects far outweigh those of free world trade when these scenarios are combined. (5) Remittances constitute a powerful poverty-reducing tool given their greater importance in the income of the poor. Licensing agreement in Pharmaceutical industry in Bangladesh: The pharmaceutical industry in Bangladesh is one of the most developed hi-tech sectors within the country's economy. In 2000, there were 210 licensed allopathic drug-manufacturing units in the country, out of which only 173 were in active production; others were either closed down on their own or

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suspended by the licensing authority for drugs due to non compliance to good manufacturing practices or drug laws. The industry manufactured about 5,600 brands of medicines in different dosage forms. There were, however, 1,495 wholesale drug license holders and about 37,700 retail drug license holders in Bangladesh. After the promulgation of Drug Control Ordinance - 1982, the development of this sector was accelerated. The professional knowledge, thoughts and innovative ideas of the pharmaceutical professionals working in this sector are the key factors for these developments. Due to recent development of this sector, the industry is exporting medicines to global markets, including the European market. This sector is also providing 97% of the total medicine requirement of the local market. Some of the companies produce insulin, hormones, and anticancer drugs, which were not previously produced in Bangladesh. Leading pharmaceutical companies are expanding their business with the aim to expand into the export market. Recently, a few new industries have been established with high tech equipment and professionals to enhance the strength of this sector

Regulatory authorities with licensing agreement:

Two organizations, one governmental, The Directorate General of Drug Administration (DGDA). DGDA is the drug regulatory authority of Bangladesh, which is under the Ministry of Health and Family Welfare.DGDA regulates all activities related to import and export of raw materials, packaging materials, production, sale, pricing, license, registration etc. of all kind of medicine including those of Ayurvedic,Unani,Herbal and Homoeopathic system. And one semi-government, the Pharmacy Council of Bangladesh (PCB). PCB was established under the Pharmacy Ordinance in 1976.PCB regulates the practice of Pharmacy throughout Bangladesh. Control pharmacy practice in Bangladesh. The Bangladesh Pharmaceutical Society is affiliated with international organizations International Pharmaceutical Federation and Association. The National Drug Policy (2005) states that the WHOs current Good Manufacturing Practices (GMP) should be strictly followed and that manufacturing units will be regularly inspected by the DDA. Other key features of regulation are restrictions on imported drugs (where these are produced by four or more local firms); a ban on the production in Bangladesh of around 1,700 drugs which are considered non-essential or harmful; and strict price controls, affecting some 117 principal medicines. Roche Pharmaceutical We have started our journey in 2005 with a view to making contributions to promising pharmaceutical sector in Bangladesh and abroad. Accordingly, Radiant Pharmaceuticals entered into a licensee agreement in 2005 with the world famous innovative pharmaceutical company, F. Hoffmann-La Roche Limited, Switzerland, that rendered a further thrive for quality. We are manufacturing eight Roche brands in Bangladesh complying with the international standard. We also produce a number of generic medicines under our own brand names. Radiant is in a comfortable position to compete against other products in Bangladesh in terms of price and quality. Radiant's quality level is assured to be better than many of the products from developing countries as we have to meet stringent quality requirements of Roche.

BEXIMCO PHARMACEUTICALS LTD.

Rising cost of healthcare and medicines has become a global concern, and in order to reduce cost across the value chain, pharmaceutical companies from developed markets continue to look for suitable partners

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in developing countries for shifting or outsourcing their production. With decades of experience in generic drug manufacturing, world class capabilities as well as significant cost advantages, Beximco Pharma can be an ideal partner for you to meet your contract manufacturing needs. Since its inception, Beximco Pharma has established itself as a reliable partner for a number of world's leading pharmaceutical companies. The company has maintained a track record of sound professionalism and its management has always adhered to international standards providing a culture and working environment similar to that of a multinational company. Currently the company has contract manufacturing agreement with GlaxoSmithKline (GSK) for producing Metered Dose Inhaler product. These partnerships have provided BPL much valuable expertise and know-how to manufacture world-class products. The company offers significant cost advantage as a manufacturer, as the average wage in Bangladesh is probably the lowest in the world, and at least two to three times lower than that in China or India. Prospective partners can benefit themselves with competitive advantages like availability of highly skilled manpower at a very low cost, low energy cost, Govt. policy support, investor friendly environment etc. Generic Company Licensees and product lists: Originator pharmaceutical companies are increasingly using voluntary licenses (VLs) and other similar instruments (such as non-assert covenants and immunity from-suit agreements) to expand their operations through partnerships with generic manufacturers. A number of ARVs are now being produced under different forms of licensing arrangements between originator and generic producers. The following table provides a non-exhaustive list of voluntary licenses signed by different companies. The claim is that such voluntary licenses facilitate the production of affordable ARVs in developing countries. There is, however, very little publically available information about these deals in almost all cases (with the notable exception of licenses negotiated through the Medicines Patent Pool) companies do not disclose full terms and conditions of voluntary arrangements. Terms and conditions like the rate of royalty, clauses that govern active pharmaceutical ingredients (APIs) and formulations like fixed-dose combinations are shrouded in secrecy. As disclosure of terms and conditions is limited, the information provided below is piecemeal in many cases, generic manufacturers do not even provide the specific territories to which the drug can be supplied or not supplied, even to procurers like MSF citing confidentiality clauses in the VLs.

Nevertheless, a trend clearly emerges: that of originator companies limiting voluntary licenses to leastdeveloping countries and sub-Saharan Africa, and generally excluding lower middle- and middle-income countries (with the notable exception of India, which is sometimes included). There is no VL that covers all developing countries the geographical scope in different licenses ranges from 48 territories covered to 112. Licenses are often provided to a limited list of manufacturers. The table also reveals how voluntary licenses are also signed covering drugs which are not patented, or where patents have expired in most of licensed territories. In such cases, the actual impact of these agreements on public health, transfer of technology and/or local production for both the APIs and the finished formulations becomes even more questionable until full terms are properly disclosed. Claims as to the public health benefits of voluntary

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licensing arrangements can therefore not be verified until companies to open their contractual terms and conditions for public scrutiny. PatentGeneric holding Licensees company Company

Product

Eligible Countries

Comments

Abacavir (ABC)

GSK After Pfizer and GSK jointly announced the Since 2009, ViiV has creation signed a 69 countries: sub-Saharan Non-exclusive licences. of a new licence agreement with Africa Detailed terms and joint the + least-developed countries + conditions venture on following company: low-income countries. are confidential. HIV Aspen medicines, all licences were transferred to ViiV. Since 2006, BMS 48 countries: signed licence Africa agreements with the + India. following companies: Aspen; Emcure; Mylan (Matrix); plus three other companies, names of which are unknown. In 2011 BMS announced a technology transfer agreement with the Brazilian Ministry of Health to manufacture sub-Saharan Royalty-free nonexclusive licences and immunityfrom-suit agreements for manufacturing and distribution, including for paediatric formulations. Detailed terms and conditions are confidential.

Atazanavir Bristol(ATV) Myers Squibb (BMS)

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ATV by Farmanguinhos (Fiocruz). The details of this agreement are not public. Cobicistat Gilead (COBI) In 2011, Gilead signed 103 countries: Afghanistan; Non-exclusive licence an agreement with Angola, Anguilla, Antigua and granted to the Medicines Medicines Patent Pool Barbuda, Armenia, Aruba, Patent Pool, bearing a (MPP), authorising the Bahamas, Bangladesh, royalty of 5%, with no MPP to grant sub- Barbados, Belize, Benin, royalties on paediatric licences for Bhutan, Bolivia, British Virgin versions developed by manufacturing only for Islands, Burkina Faso, licencees. companies in India. Burundi,Cambodia, Cameroon, Cape Verde, Central African The Gilead licences with The following sub- Republic, Chad, Comoros, the MPP are only the licencees in India Congo, Congo (DRC), Cte agreements where full currently have signed dIvoire, Cuba, Djibouti, terms are public. The agreements with the Dominica, Dominican Rep., licences carry an IndiaMPP: Emcure; Equatorial Guinea, Eritrea, specific manufacturing Aurobindo; MedChem. Ethiopia, Fiji, Gabon, Gambia, restriction with further Georgia, Ghana, Grenada, limitation on territories to In 2011, in a separate Guatemala, Guinea, Guinea- which drugs can be arrangement, Gilead Bissau, Guyana, Haiti, supplied. Countries such also signed semi- Honduras, India, Jamaica, as China, Brazil, exclusive licences for Kenya, Kiribati, Kyrgyzstan, Ukraine, Sri Lanka, and the supply of COBI Laos, Lesotho, Liberia, Indonesia are excluded. with four Indian Madagascar, Malawi, Maldives, manufacturers: Mali, Mauritania, Mauritius, As a part of the 2011 Matrix: for Sri Lanka, Moldova, Mongolia, semi-exclusive licences Thailand Montserrat, Mozambique, with four preferred Hetero and Ranbaxy: Myanmar, Nauru, Nepal, Indian generic for Botswana, Namibia Nicaragua, Niger, Nigeria, manufacturers, Gilead Strides: for Ecuador, Pakistan, Palau, Papua New will charge 1015% El Salvador, Indonesia, Guinea, Rwanda, St Kitts and royalties. Kazakhstan, Nevis, Saint Lucia, St Vincent Turkmenistan. and the Grenadines, Samoa, So Tom and Prncipe, In addition to these Senegal, Seychelles, Sierra semi-exclusive Leone, Solomon Islands, territories, these Somalia, South Africa, South preferred licencees Sudan, Sudan, Suriname, can also cover Swaziland, Syria, Tajikistan,

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territories mentioned in Tanzania, Timor-Leste, Togo, Gilead-MPP licences. Tonga, Trinidad and Tobago, Detailed terms and Turks and Caicos, Tuvalu, conditions of these Uganda, Uzbekistan, Vanuatu, licences are Vietnam, Yemen, Zambia, confidential. Zimbabwe. Royalty-free exclusive nonlicences.

Since 2007, Janssen Aspen will register, (J&J) has signed Janssen 65 countries: sub-Saharan package and distribute Darunavir licence agreements with (Johnson & Africa + least-developed DRV at a differential (DRV) the following Johnson) countries + India. price. companies: Aspen; Emcure. Detailed terms and conditions are confidential. Since 2001, BMS signed licence agreements with the following companies: BristolDidanosine Myers (ddI) Squibb (BMS) Adcock-Ingram; 49 countries: Aspen; DanpongAfrica Adams; Enaleni; + India. Sonke; Varichem; Thembalani; AfrikaBiopharm; Aurobindo; Emcure; Ranbaxy, Mylan (Matrix).

11 immunity-from-suit agreements allowing generic companies to produce d4t and ddI. The sub-Saharan agreements are royaltyfree, include paediatric formulations. The agreements cover stavudine. also

Efavirenz (EFV)

Merck

Since 2007, Merck signed licence Royalty-free nonagreements with the exclusive licences. following companies: South Africa. There are no patents in rest of Sun-Saharan Detailed terms and Emcure; Arrow; Sonke; African countries. conditions are Aspen; Aurobindo; confidential. Cipla-Medpro; Adcock Ingram.

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Product

Patentholding company

Generic Company Eligible Countries Licensees

Comments

Elvitegravir Gilead

In 2011, Gilead signed 100 countries: Non-exclusive royaltyan agreement with bearing granted to the Medicines Patent Pool Afghanistan; Angola, Medicines Patent Pool. (MPP), authorising the Anguilla, Antigua and Royalty of 5%; no MPP to grant sub- Barbuda, Armenia, Aruba, royalties on paediatric licences for Bahamas, Bangladesh, versions developed by manufacturing only Barbados, Belize, Benin, licencees. for companies in Bhutan, Bolivia, British Virgin India. Islands, Burkina Faso, Gilead licences with MPP Burundi,Cambodia, are only the agreements The following sub- Cameroon, Cape Verde, where full terms are licencees in India Central African Republic, public. There is an India currently have signed Chad, Comoros, Congo, specific manufacturing agreements with the Congo (DRC), Cte dIvoire, restriction with further MPP: Emcure; Cuba, Djibouti, Dominica, limitation on territories Aurobindo; Equatorial Guinea, Eritrea, where drugs can be MedChem. Ethiopia, Fiji, Gabon, Gambia, supplied. Countries such Georgia, Ghana, Grenada, as China, Brazil, Sri In 2011, in a separate Guatemala, Guinea, Guinea- Lanka, and Indonesia are arrangement, Gilead Bissau, Guyana, Haiti, excluded. also signed semi- Honduras, India, Jamaica, exclusive licences for Kenya, Kiribati, Kyrgyzstan, As a part of the 2011 the supply of COBI Laos, Lesotho, Liberia, semiexclusive licences with four Indian Madagascar, Malawi, with four preferred manufacturers: Maldives, Mali, Mauritania, Indian generic Matrix: for Sri Mauritius, Moldova, manufacturers, Gilead will Lanka, Thailand Mongolia, Mozambique, charge 1015% royalties. Hetero and Ranbaxy: Myanmar, Nauru, Nepal, for Botswana, Nicaragua, Niger, Nigeria, Namibia Pakistan, Palau, Papua New Strides: for Ecuador, Guinea, Rwanda, St Kitts and El Salvador, Nevis, Saint Lucia, St Vincent Indonesia, and the Grenadines, Samoa, Kazakhstan, So Tom and Prncipe, Turkmenistan. Senegal, Seychelles, Sierra Leone, Solomon Islands, In addition to these Somalia, South Africa, South semi-exclusive Sudan, Sudan, Suriname, territories, these Swaziland, Syria, Tajikistan, preferred licencees Tanzania, Timor-Leste, Togo,

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can also cover territories mentioned Tonga, Trinidad and Tobago, in Gilead-MPP Turks and Caicos, Tuvalu, licences. Detailed Uganda,Uzbekistan, Vanuatu, terms and conditions Vietnam, Yemen, Zambia, of these licences are Zimbabwe. confidential. Royalty-free exclusive In 2009, Janssen (J&J) signed Janssen Sub-Saharan Africa a licence agreement (Johnson & leastdeveloped with the Johnson) countries. following company: Aspen and Emcure. nonlicence.

Etravirine (ETV)

Aspen will register and and distribute ETV formulations at a special price. Detailed terms conditions confidential. and are

Non-exclusive licences. GSK After Pfizer Some licences include a and GSK royalty of 5% on net sales jointly Since 2001, ViiV has conditions, others are announced signed 11 licence royalty-free. In 2009, GSK the creation agreements, including waived all royalty fees for of a new with the following 69 countries: sub-Saharan all sub-Saharan African Lamivudine joint companies: Africa + least-developed countries. (3TC) venture on countries + low-income HIV Aspen; Cipla Medpro; countries. According to ViiVs medicines, Feza; Thembalami; website, all voluntary all Biotech Laboratories; licences are now royaltylicences Sonke; Cosmos. free. were transferred Detailed terms and to ViiV. conditions are confidential. Nevirapine Boehringer Since 2004, BI signed 78 countries: least-developed Initially, BI signed (NVP) Ingelheim licence agreements countries + low-income royalty-bearing licence (BI) with the following countries + sub-Saharan agreements allowing for companies: Africa. manufacturing.

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Cosmos; Universal Pharmacy; Aspen; Gemini; Memphis; Cipla Medpro; Kimia Farma; Adcock Ingram/Ranbaxy (Thembalami). Since 2007, BI signed non-assert declarations with the following companies: Cosmos; Aspen; Biotech Laboratories; Memphis; Aurobindo; Cipla; Emcure; Strides. PatentGeneric holding Licensees company Company

In 2007, BI changed its policy to non-assert declarations allowing distribution at no additional costs. The only condition is that licencees must be produce WHOprequalified nevirapine products. Companies may request a royaltyfree licence for manufacturing in WHOprequalified plants.

Product

Eligible Countries

Comments

Since 2011, Merck signed licence agreements with the following companies: Emcure; Mylan (Matrix). In 2010 Brazilian Ministry of 60 countries: sub-Saharan Health has announced that it Africa and low-income is working on a technology Detailed terms countries. transfer agreement with conditions Merck for RAL. The confidential. agreement has yet not been signed formally and it proposed terms and conditions are not public. Non-exclusive licences.

Raltegravir Merck (RAL)

and are

Rilpivirine Janssen Since 2011, Janssen (J&J) has Originally 66 countries: sub- Royalty-bearing (Johnson signed licence agreements Saharan Africa + least- voluntary non& with the following companies: developed countries + India. exclusive licence. Johnson) Expanded in late 2011 to Aspen; Emcure; Hetero; include 112 countries Licensees will Mylan (Matrix); Strides. manufacture, register, The generic pharmaceutical market and distribute

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manufacturers in India will have rights to market the rilpivirine both as a product in sub-Saharan single agent and fixedAfrica, least-developed dose combination. countries and India. Aspen will have rights to market the Detailed terms and product in sub-Saharan conditions are Africa including South confidential. Africa. Since 2006, Roche signed licence agreements with the following companies: Saquinavir Roche (SQV) Adcock Ingram; Addis; Sub-Saharan Africa Aspen; Beximco; CAPS; leastdeveloped Cosmos; Muhimbili countries. University; Radiant; Regal; Shelys; Universal Corporation; Varichem; Zenufa. and Detailed terms conditions are confidential. and

BristolStavudine Myers (d4t) Squibb (BMS)

11 immunity-fromSince 2001, BMS signed suit agreements licence agreements with the allowing generic following companies: companies to produce d4t and ddI. The Adcock Ingram; Aspen; 49 countries: sub-Saharan agreements are Danpong- Adams; Enaleni; Africa + India. royalty-free, include Sonke; Varichem; paediatric Thembalani; AfrikaBiopharm; formulations. Aurobindo; Emcure; Ranbaxy. The agreements also cover didanosine. Company

Product

PatentGeneric holding Licensees company Gilead

Eligible Countries

Comments

Tenofovir (TDF)

Since 2006, Gilead Originally 95 countries, Gileads 2006 licences signed licence expanded in July 2011 to 112 were signed when agreements with the countries: opposition proceedings following companies: before Indian patent Afghanistan; Angola, office were pending. One

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Aspen; Alkem; Cadila; Anguilla, Antigua and generic manufacturer, Emcure; Hetero; Matrix Barbuda, Armenia, Aruba, Cipla, decided not to sign (Mylan); McNeil & Bahamas, Bangladesh, this deal and continued Argus; Medchem; Micro Barbados, Belize, Benin, manufacturing this drug. Labs; Ranbaxy; Sequent Bhutan, Bolivia, British The TDF patent in India Scientific; Shasun; Virgin Islands, Burkina Faso, was eventually rejected Strides. Burundi,Cambodia, but 2006 licencees Cameroon, Cape Verde, nevertheless continued In 2011, Gilead signed Central African Republic, working under the an agreement with Chad, Comoros, Congo, arrangements with Medicines Patent Pool Congo (DRC), Cte dIvoire, Gilead. (MPP), authorising the Cuba, Djibouti, Dominica, MPP to grant sub- Dominican Rep., Ecuador, El Non-exclusive royaltylicences for Salvador, Equatorial Guinea, bearing licences. manufacturing only for Eritrea, Ethiopia, Fiji, Gabon, companies in India. Gambia, Georgia, Ghana, Royalty rate of 5% Grenada, Guatemala, Guinea, lowered to 3% in July Aurobindo and Emcure, Guinea-Bissau, Guyana, Haiti, 2011; no royalties on who had originally Honduras, India, Indonesia, paediatric versions signed the 2006 licences, Jamaica, Kazakhstan, Kenya, developed by licencees. took advantage of a key Kiribati, Kyrgyzstan, Laos, provision in the Gilead- Lesotho, Liberia, Madagascar, Gilead licences with Medicines Patent Pool Malawi, Maldives, Mali, MPP are only the licence, which permits a Mauritania, Mauritius, agreements where full licencee to terminate the Moldova, Mongolia, terms are public. There is licence on a drug-by- Montserrat, Mozambique, an India specific drug basis, to terminate Myanmar, Namibia, Nauru, manufacturing restriction part of the 2006 licence Nepal, Nicaragua, Niger, with further limitation on in relation to TDF, so Nigeria, Pakistan, Palau, territories where drugs these companies are now Papua New Guinea, Rwanda, can be supplied. free to supply TDF St Kitts and Nevis, St Lucia, Countries such as China, without paying royalty to St Vincent and the Brazil, Sri Lanka, and Gilead under the 2006 Grenadines, Samoa, So Indonesia are excluded licence. Aurobindo and Tom and Prncipe, Senegal, Emcure are now sub- Seychelles, Sierra Leone, licencees to the Solomon Islands, Somalia, Medicines Patent Pool. South Africa, South Sudan, Sri Lanka, Sudan, Suriname, Swaziland, Syria, Tajikistan, Tanzania, Thailand, TimorLeste, Togo, Tonga, Trinidad and Tobago, Turkmenistan, Turks and Caicos, Tuvalu, Uganda, Uzbekistan, Vanuatu,

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Vietnam, Yemen, Zimbabwe.

Zambia,

The 2011 Gilead-Medicines Patent Pool licence for TDF product covers the same 112 territories. GSK Non-exclusive licences.

After Some licences include a Pfizer royalty of 5% on net and GSK Since 2001, ViiV has sales conditions, others jointly signed 11 licence are royalty-free. In 2009, announced agreements, including GSK waived all royalty the with the following 69 countries: sub-Saharan fees for all sub-Saharan creation Zidovudine companies: Africa + least-developed African countries. of a new (AZT) countries + low-income joint Aspen; Cipla Medpro; countries. According to ViiVs venture on Feza; Thembalami; website, all voluntary HIV Biotech Laboratories; licences are now royaltymedicines, Sonke; Cosmos. free. all licences Detailed terms and were conditions are transferred confidential. to ViiV. 3TC/AZT GSK Since 2001, ViiV has 69 countries: sub-Saharan Non-exclusive licences. signed 11 licence Africa + least-developed After agreements, including countries + low-income Some licences include a Pfizer with the following countries. royalty of 5% on net and GSK companies: sales conditions, others jointly are royalty-free. In 2009, announced Aspen; Cipla Medpro; GSK waived all royalty the Feza; Thembalami; fees for all sub-Saharan creation Biotech Laboratories; African countries. of a new Sonke; Cosmos. joint According to ViiVs venture on website, all voluntary HIV licences are now royaltymedicines, free. all licences Detailed terms and

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were transferred to ViiV. PatentGeneric holding Licensees company Company

conditions confidential.

are

Product

Eligible Countries

Comments

Originally 66 countries: sub-Saharan Africa + least-developed countries + India. Royalty-bearing Expanded in late 2011 voluntary non-exclusive to include 112 countries. licence. Since 2011, Janssen The generic (J&J) has signed Licensees will pharmaceutical Janssen licence agreements with manufacture, register, manufacturers in India (Johnson the following market and distribute Rilpivirine/TDF/3TC will have rights to & companies: rilpivirine both as a market the product in Johnson) Aspen; Emcure; single agent and fixedsub-Saharan Africa, Hetero; Mylan dose combination. leastdeveloped countries (Matrix); Strides. and India. Detailed terms and conditions are Aspen will have rights confidential. to market the product in sub-Saharan Africa including South 276 Africa. TDF/FTC Gilead Since 2006, Gilead Originally 95 countries, Gileads 2006 licence signed licence expanded in July 2011 was signed when agreements with the to 112 countries: opposition proceedings following companies: before Indian patent Afghanistan, Angola, office were pending. Aspen; Alkem; Cadila; Anguilla, Antigua and One generic Emcure; Hetero; Matrix Barbuda, Armenia, manufacturer, Cipla, (Mylan); McNeil & Aruba, Bahamas, decided not to sign this Argus; Medchem; Bangladesh, Barbados, deal and continued Micro Labs; Ranbaxy; Belize, Benin, Bhutan, manufacturing this Sequent Scientific; Bolivia, Botswana, drug. The TDF patent Shasun; Strides. British Virgin Islands, in India was eventually Burkina Faso, Burundi, rejected but 2006 In 2011, Gilead signed Cambodia, Cameroon, licencees nevertheless

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an agreement with Cape Verde, Central continued working Medicines Patent Pool African Republic, Chad, under previous (MPP), authorising the Comoros, Congo, arrangements with MPP to grant sub- Congo (DRC), Cte Gilead. licences for dIvoire, Cuba, Djibouti, manufacturing only for Dominica, Dominican Non-exclusive royaltycompanies in India. Rep., Ecuador, El bearing licences. Salvador, Equatorial Aurobindo and Emcure, Guinea, Eritrea, Royalty rate of 5% who had originally Ethiopia, Fiji, Gabon, lowered to 3% in July signed the 2006 Gambia, Georgia, 2011; no royalties on licences, took Ghana, Grenada, paediatric versions advantage of a key Guatemala, Guinea, developed by licencees. provision in the Gilead- Guinea-Bissau, Guyana, Medicines Patent Pool Haiti, Honduras, India, Gilead licences with licence, which permits Indonesia, Jamaica, MPP are only the a licencee to terminate Kazakhstan, Kenya, agreements where full the licence on a drug- Kiribati, Kyrgyzstan, terms are public. There by-drug basis, to Laos, Lesotho, Liberia, is an India specific terminate part of the Madagascar, Malawi, manufacturing 2006 licence in relation Maldives, Mali, restriction with further to TDF, so these Mauritania, Mauritius, limitation on territories companies are now free Moldova, Mongolia, where drugs can be to supply TDF without Montserrat, supplied. Countries paying royalty to Mozambique, Myanmar, such as China, Brazil, Gilead under the 2006 Namibia, Nauru, Nepal, Sri Lanka, and licence. Aurobindo and Nicaragua, Niger, Indonesia are excluded. Emcure are now sub- Nigeria, Pakistan, Palau, licencees to the Papua New Guinea, Medicines Patent Pool. Rwanda, St Kitts and Nevis, St Lucia, St Vincent and the Grenadines, Samoa, So Tom and Prncipe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Suriname, Swaziland, Syria, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tonga, Trinidad and

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Tobago, Turkmenistan, Turks and Caicos, Tuvalu, Uganda, Uzbekistan, Vanuatu, Vietnam, Yemen, Zambia, Zimbabwe. 2011 Gilead-Medicines Patent Pool licence also covers TDF product for the same 112 territories. PatentGeneric holding Licensees company Company

Product

Eligible Countries

Comments

Originally 66 countries: sub-Saharan Africa + least-developed countries + India. Royalty-bearing Expanded in late 2011 voluntary non-exclusive to include 112 countries. licence. Since 2011, Janssen (J&J) has signed The generic Licensees will Janssen licence agreements with pharmaceutical manufacture, register, (Johnson the following manufacturers in India market and distribute Rilpivirine/TDF/3TC & companies: will have rights to rilpivirine both as a Johnson) Aspen; Emcure; market the product in single agent and fixedHetero; Mylan sub-Saharan Africa, dose combination. (Matrix); Strides. leastdeveloped countries and India. Detailed terms and conditions are Aspen will have rights confidential. to market the product in sub-Saharan Africa including South Africa. TDF/FTC Gilead Since 2006, Gilead Originally 95 countries, Gileads 2006 licence signed licence expanded in July 2011 was signed when agreements with the to 112 countries: opposition proceedings following companies: before Indian patent Afghanistan, Angola, office were pending. Aspen; Alkem; Cadila; Anguilla, Antigua and One generic Emcure; Hetero; Matrix Barbuda, Armenia, manufacturer, Cipla,

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(Mylan); McNeil & Aruba, Bahamas, decided not to sign this Argus; Medchem; Bangladesh, Barbados, deal and continued Micro Labs; Ranbaxy; Belize, Benin, Bhutan, manufacturing this Sequent Scientific; Bolivia, Botswana, drug. The TDF patent Shasun; Strides. British Virgin Islands, in India was eventually Burkina Faso, Burundi, rejected but 2006 In 2011, Gilead signed Cambodia, Cameroon, licencees nevertheless an agreement with Cape Verde, Central continued working Medicines Patent Pool African Republic, Chad, under previous (MPP), authorising the Comoros, Congo, arrangements with MPP to grant sub- Congo (DRC), Cte Gilead. licences for dIvoire, Cuba, Djibouti, manufacturing only for Dominica, Dominican Non-exclusive royaltycompanies in India. Rep., Ecuador, El bearing licences. Salvador, Equatorial Aurobindo and Emcure, Guinea, Eritrea, Royalty rate of 5% who had originally Ethiopia, Fiji, Gabon, lowered to 3% in July signed the 2006 Gambia, Georgia, 2011; no royalties on licences, took Ghana, Grenada, paediatric versions advantage of a key Guatemala, Guinea, developed by licencees. provision in the Gilead- Guinea-Bissau, Guyana, Medicines Patent Pool Haiti, Honduras, India, Gilead licences with licence, which permits Indonesia, Jamaica, MPP are only the a licencee to terminate Kazakhstan, Kenya, agreements where full the licence on a drug- Kiribati, Kyrgyzstan, terms are public. There by-drug basis, to Laos, Lesotho, Liberia, is an India specific terminate part of the Madagascar, Malawi, manufacturing 2006 licence in relation Maldives, Mali, restriction with further to TDF, so these Mauritania, Mauritius, limitation on territories companies are now free Moldova, Mongolia, where drugs can be to supply TDF without Montserrat, supplied. Countries paying royalty to Mozambique, Myanmar, such as China, Brazil, Gilead under the 2006 Namibia, Nauru, Nepal, Sri Lanka, and licence. Aurobindo and Nicaragua, Niger, Indonesia are excluded. Emcure are now sub- Nigeria, Pakistan, Palau, licencees to the Papua New Guinea, Medicines Patent Pool. Rwanda, St Kitts and Nevis, St Lucia, St Vincent and the Grenadines, Samoa, So Tom and Prncipe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South

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Africa, South Sudan, Sri Lanka, Sudan, Suriname, Swaziland, Syria, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tonga, Trinidad and Tobago, Turkmenistan, Turks and Caicos, Tuvalu, Uganda, Uzbekistan, Vanuatu, Vietnam, Yemen, Zambia, Zimbabwe. 2011 Gilead-Medicines Patent Pool licence also covers TDF product for the same 112 territories. PatentGeneric Company holding Eligible Countries Licensees company

Product

Comments

The Quad Gilead (TDF/FTC/COBI/ elvitegravir)

In 2011, Gilead 100 countries: Non-exclusive signed an agreement royalty-bearing with Medicines Patent Afghanistan; Angola, granted to the Pool (MPP), Anguilla, Antigua and Medicines Patent authorising the MPP Barbuda, Armenia, Aruba, Pool. Royalty of 5%; to grant sub-licences Bahamas, Bangladesh, no royalties on for manufacturing Barbados, Belize, Benin, paediatric versions only for companies in Bhutan, Bolivia, British developed by India. Virgin Islands, Burkina Faso, licencees. Burundi,Cambodia, The following sub- Cameroon, Cape Verde, Gilead licences with licencees in India Central African Republic, MPP are only the currently have signed Chad, Comoros, Congo, agreements where full agreements with the Congo (DRC), Cte dIvoire, terms are public. MPP: Cuba, Djibouti, Dominica, There is an India Emcure; Aurobindo; Equatorial Guinea, Eritrea, specific manufacturing MedChem. Ethiopia, Fiji, Gabon, restriction with further Gambia, Georgia, Ghana, limitation on In 2011 as a separate Grenada, Guatemala, Guinea, territories where drugs arrangement Gilead Guinea-Bissau, Guyana, Haiti, can be supplied. also signed following Honduras, India, Jamaica, Countries such as

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semi-exclusive Kenya, Kiribati, Kyrgyzstan, licences with four Laos, Lesotho, Liberia, Indian manufacturers: Madagascar, Malawi, Matrix: for Sri Maldives, Mali, Mauritania, Lanka, Thailand Mauritius, Moldova, Hetero/Ranbaxy: for Mongolia, Mozambique, Botswana, Namibia Myanmar, Nauru, Nepal, Strides: for Ecuador, Nicaragua, Niger, Nigeria, China, Brazil, Sri El Salvador, Pakistan, Palau, Papua New Lanka, and Indonesia Indonesia, Guinea, Rwanda, St Kitts and are excluded. Kazakhstan, Nevis, Saint Lucia, St Vincent Turkmenistan. and the Grenadines, Samoa, For Gilead 2011 semiSo Tom and Prncipe, exclusive licences In addition to these Senegal, Seychelles, Sierra with four Indian semi-exclusive Leone, Solomon Islands, generic manufacturers territories these Somalia, South Africa, South Gilead will charge 10 licencees can also Sudan, Sudan, Suriname, 15% royalties. cover territories Swaziland, Syria, Tajikistan, mentioned in Gilead- Tanzania, Timor-Leste, Togo, MPP licences. Tonga, Trinidad and Tobago, Detailed terms and Turks and Caicos, Tuvalu, conditions of these Uganda,Uzbekistan, Vanuatu, licences are Vietnam, Yemen, Zambia, confidential. Zimbabwe.

Bangladeshi RMG Sector: The economy of Bangladesh is largely dependent on agriculture. However, in recent years, the Ready Made Garments (RMG) sector has emerged as the biggest earner of foreign currency. The RMG sector has experienced an exponential growth since the 1980s.The sector contributes significantly to the GDP. It also provides employment to around 4.2 million Bangladeshis. An overwhelming number of workers in this sector are women. This has affected the social status of many women coming from low income families. In the 1980s, there were only 50 factories employing only a few thousand people. Currently, there are 4490 manufacturing units. The RMG sector contributes around 76 percent to the total export earnings. In 2007 it earned $9.35 billion. This sector also contributes around 13 percent to the GDP, which was only around 3 percent in 1991. Of the estimated 4.2 million people employed in this sector, about 50 percent of them are women from rural areas. In 2000, the industry consisting of some 3000 factories employed directly more than 1.5 million workers of whom almost 80% were female. USA is the largest importer of Bangladeshi RMG products, followed by Germany, UK, France and other E.U countries.

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Telecommunication Industry in Bangladesh: The Telegraph branch under the Posts and Telegraph Department was created in 1853 in British India and was regulated afterward under the Telegraph act of 1885. Pakistan Telegraph and Telephone Department was constructed in 1962. After the independence of the Peoples Republic of Bangladesh in 1971, Bangladesh Telegraph and Telephone department was set up under the Ministry of Posts and Telecommunications. This was converted into a corporate body named Telegraph and Telephone Board by promulgation of Telegraph and Telephone Board Ordinance, 1975. On 24th February, 1979; Telegraph and Telephone Board was converted to Bangladesh Telegraph and Telephone Board (BTTB) as a Government Board. Many foreign investors are now interested to do business in telecom sector in Bangladesh which reveals that Bangladesh has become a significant hub for telecoms. It has been forecasted that the average revenue from telecoms sector will be Tk 1500crore2 a year. Bangladesh is a country which is densely populated and also is a flat and easily extends able coverage. The infrastructure and Tele-density is low which on the other hand made the market a perfect place for telecom business. The demand is very high and the consumer base is very large but the investment is low because of the topographic layout. The government has a receptive foreign investment policy with no restrictions on repatriation of profit. Even though the current infrastructure is not much developed but it is suitable for foreign investment. Bangladesh has a huge potential in Wi-Max and submarine cable which is a new technology in the country and has attracted the foreign telecom operators. Many foreign telecom operators are coming to Bangladesh to explore the potentiality of the technology. Some interested international telecom operators who want to start a business in Bangladesh are UK-based Orange Telecom, South Korean SK Telecom and UAEs Etisalat. It is almost mandatory to become a member of World GSM Association for a mobile operator. BTTB applied for that after receiving Operator License as well as operating frequency from BTRC. To become a member was imperative because in order to ensure security of SIMs, certain security algorithms are needed and World GSM Association is the lawful authority to issue those security algorithms. Without security it is not advisable to manufacture SIM. However Associate Membership was granted by World GSM Association in October, 2004 to BTTB and BTTB applied for the said security algorithms then after. In September, 2005 TeleTalk Bangladesh Ltd. obtained Membership of World GSM Association. Recently Bangladeshi government confirms Telenor license: Scandinavian operator Telenor has received assurance that it will retain its operating licence covering Bangladesh against the recommendation of a government commission. The firms Bangladeshi subsidiary, Grameenphone, is the countrys largest operator. Telenor has been embroiled in legal action claiming that the 1996 licensing agreement that led to Grameenphones inception should be annulled. The Bangladeshi finance minister Abul Maal Abdul Muhith has reportedly claimed that: In no way will we suspend or cease its [Telenors] operation, adding that he had yet to receive the final report from the

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commission. Grameenphones operating licence was in fact renewed last year by the Bangladeshi government after a lengthy delay. The government commission claims that if Telenor is allowed to continue operations, it must relinquish 16% of its business going back to 2002. It stipulates that the government should then use this money for aid and welfare purposes. Grameenphone is the Bangladeshi market leader with over 40 million subscribers. It is 56% owned by Telenor, and is the Scandinavian firms most profitable operation

Effect of licensing agreement in Bangladesh:

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