Cooperation Agreement for Research Focused on Technology Development between FAPESP and GlaxoSmithKline Brasil Ltda (GSK) Versão em português
The Sao Paulo Research Foundation, FAPESP, a juridical person of public law, established under the authorization of State Law number 5.918 of 18 October, 1960, with Statutes approved by State Decree number 40.132 of 23 May, 1962, registered at the National Tax Payer Roll under number 43.828.151/0001-45, with head office at Rua Pio XI, 1500, Alto da Lapa, São Paulo, SP, hereinafter named FAPESP and hereby represented by its President, Professor Celso Lafer, with special address as stated above for FAPESP, and Glaxo SmithKline Brasil Ltda., registered at CNPJ under the number of 33.241.743/0001-10, with registered office at Estrada dos Bandeirantes, 8.464, Jacarepaguá, Rio de Janeiro, RJ, , hereinafter named GSK and hereby represented by (representatives), hereby designated as Parties or Party, decide to celebrate the present agreement, under the following terms and conditions:
“Affiliate”: means, when associated with a party to this Cooperation Agreement, any entity which controls, is controlled by, or is under common control with, that party. In this context, “control” shall mean (1) ownership by one entity, directly or indirectly, of at least forty percent (40%) of the voting stock of another entity; (2) power of one entity to direct the management or policies of another entity, by contract or otherwise; or (3) any other relationship between a party and an entity which both GSK and FAPESP have agreed in writing may be considered an “Affiliate” of a party;
“Applicable Laws”: shall mean all applicable provisions of all statutes, laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, injunctions, awards judgments, permits and licenses of or from governmental authorities, including, without limitation, those relating to or governing the use or regulation of the subject item;
“Confidential Information”: means all information (including, without limitation, study protocols, case report forms, clinical data, other data, reports, specifications, computer programs or models and related documentation, know-how, trade secrets, or business or research plans) of one part or its Affiliates that are: (1) provided to the other part in connection with this Agreement, or in connection with a request for proposals, proposals, or otherwise related to a project which potentially could be the subject of a new agreement , whether or not the agreement is ever executed; or (2) created or developed by one part or a third party associated with (including, without limitation, employees, agents, or subcontractors of each part depending on the case), or by study investigators and staff, in connection with this Cooperation Agreement.
“Parties”: means GSK, FAPESP or both depending on the context;
“Third Party”: means any Person other that the Parties, or their respective affiliates.
1.1 The purpose of this Agreement is to establish the conditions for selection and funding of scientific and technological research involving collaboration between scientists working in public or private research or teaching institutions in the State of São Paulo, Brazil and/or scientists from the GSK.
The research should help build scientific and technological competencies, strategic alliances to promote the scientific and technological development, promote the dissemination of knowledge and provide results that have potential for applications with a corporate or commercial benefit, whether direct or indirect, in areas of interest to GSK and FAPESP, as described in Annex I, which is an integral and inseparable Cooperation of this Agreement for all legal intents and purposes;
1.2 The research will be selected through publicly announced Call for Research Proposals, prepared according to the guideline in Annex II, which is an integral and inseparable of this Cooperation Agreement for all legal intents and purposes.
2. Execution of Agreement
2.1 This Agreement will be supervised by a Joint Steering Committee (JSC) formed by two representatives from FAPESP and two representatives from GSK.
2.1 The Joint Steering Committee will have the following responsibilities:
a) Specify themes, after consultation to the Parties, for the Calls for Research Proposals (CFRP), which should be written observing the guidelines of Annex II.
b) Pre-select the received proposals according to their compliance with the terms and themes of the corresponding Calls for Research Proposals.
c) Issue a recommendation to the Scientific Director of FAPESP about each one of the proposals received, after they have been analyzed by the external reviewers and by the Area Coordinators at FAPESP and according to the rules of FAPESP, stated in Annex III.
d) Supervise the selected research proposal, fostering the collaboration among the scientists and students participating with other initiatives.
e) Find solutions to all technical, administrative and financial questions that may arise during the term of the present Agreement, as well as supervising the execution of the activities arising from the present Agreement, referring to their respective superior officers as required.
2.3 The Calls for Research Proposals will be issued by FAPESP, after the express and written agreement of the JSC.
2.4 Both FAPESP and GSK may relieve or appoint their representatives to the Joint Steering Committee at any time, without consultation of the other party, but informing the other party with 24 business hours antecedence.
2.5 In the event that a Proposal will not be supported under this Agreement, either Party may at its sole discretion elect to provide support, individually, by its own mechanisms, without prejudice to this Agreement and no breach of the terms of it.
3 Financial Clauses
3.1 Financial support for the research selected under this agreement will encompass a total of £400,000.00 per year from FAPESP and £400,000.00 maximum per year from GSK, to a total of £8,000,000 over the ten years duration of this agreement.
3.2 GSK or FAPESP may provide additional funding for selected research under this Agreement at their sole discretion.
3.3 The funding will be disbursed according to the working plan and the schedule of disbursements approved in each proposal.
3.4 The release of funds and the procedures for the execution of expenditure can only start after the signing of the Agreement between FAPESP, GSK and the Institutions where the proposals approved under this Agreement are to be developed.
4.1 FAPESP and GSK agree to keep confidential the content of the proposals submitted for analysis in the scope of this agreement.
4.2 FAPESP can publish a summary containing the Title, Host Institution, Principal Investigators and composition of the research team, relevant dates and an abstract of each selected proposal.
4.3 Each Party for itself and its agents undertake not to disclose, reproduce, use or give notice to third parties, and to keep confidential any operations, data, materials, details, technical and commercial innovations and information clearly identified as confidential of the disclosing Party as may be disclosed to such a receiving Party.
4.4 It assured the Parties, together or separately, the right of disclosure, in various media, this Agreement. The communication will be limited to affirming the existence of this Agreement, being forbidden the dissemination of data, documents and any information generated as a function of the partnership now established.
5 Intellectual Property
5.1 All rights and obligations relating to Intellectual Property over the results of the research activities financed under this agreement will be defined and determined by Terms of Agreement between GSK, FAPESP and the Institutions to which the Principal Investigators of the selected projects are affiliated, according to Annex II, Section 3, e. FAPESP may participate in intellectual property rights according to the dispositions of Portaria PR 04/2011.
5.2 This Agreement does not affect the ownership of any Intellectual Property in any Background or in any other technology, design, work, invention, software, data, technique, Know-how, or materials (including but not limited to Materials that are not Results. The Intellectual Property in the aforementioned will remain the property of the party that contributes them to the Project (or its licensors). No license to use any Intellectual Property is granted or implied by this Agreement except the rights expressly granted in this.
6 Good Practices Commitment
6.1 GSK declares hereby that is aware, knows and understands the terms of Brazilian anticorruption laws or any other applicable laws on the subject of this Cooperation Agreement, in particular Law No. 12.486, of August 1th, 2013, and the Foreign Corrupt Practices Act (FCPA) of the United States of America, with the commitment to refrain of any activity that is a violation of the provisions established in the Anticorruption Laws.
6.2 GSK, for itself and their officers, directors, employees, agents, owners and shareholders, acting on their behalf, hereby declares that is aware and fully agrees with the terms of the Code of Scientific Good Practices of FAPESP, which becomes integral part of this Agreement and will not engage in any act or omission in the fulfillment of the responsibilities established in the referred document.
6.3 For the purposes of this Clause, GSK declares in this Cooperation Agreement that:
a) It has not violated, is violating or will violate the national and international anti-corruption laws;
b) It is aware that any activity that violates the anti-corruption laws is forbidden and knows the possible consequences of such violation.
6.4 Any noncompliance of anticorruption laws by Parties, in any of its aspects, will motivate the cancellation of this Cooperation Agreement, regardless of any notice.
7.1 This Agreement will be valid from the date of signature and will remain in force for 10 years after that date, with exception to the confidentiality clause that will remain in effect for five (5) years after the termination of this agreement.
8.1 Either party can terminate this Agreement at any time by communicating the other party of their intention of cancellation with a minimal pre-warning of 3 months. This cancellation will not affect projects which are ongoing at the time it occurs, including the celebration, execution and disbursements of the Agreements according to Annex II, Section 3, d.
9.1 Any notices or requests in connection with this Agreement will be in writing and addressed to the Parties as follows:
Dr Helen Sneddon
Green Chemistry Performance Unit
GlaxoSmithKline R&D Ltd
Medicines Research Centre
Gunnels Wood Road
Fundação de Amparo à Pesquisa do Estado de São Paulo
Rua Pio XI, 1500, Alto da Lapa
CEP 05468-901, São Paulo, SP, Brasil
A/C: Diretor Científico
10 Labor untying
10.1 The personnel assigned to perform the services, by a party does not maintain connection with the other party of any kind, taking responsibility for each party for all costs related to labor, social welfare and / or tax relating to its employees, contractors or agents, assuming therefore their status as single employer.
10.2 Each party so unilaterally takes on responsibility for any possible grievance that can be attempted against the other parties for their employees, contractors or agents, in terms of services provided.
11.1 The Parties shall also the following conditions:
a) All communications regarding this Agreement shall be deemed made regularly if made in writing whether by fax, email or letter and delivered against receipt, duly attested by account representatives accredited to the addresses of the Parties.
b) Meetings between representatives accredited by the parties, and any events that may have implications in this Agreement shall be recorded in minutes or detailed reports, and
c) Neither Party shall make warranties or representations, or assume or create any obligations on behalf of the other party, unless explicitly permitted hereunder or authorized in writing by the other Party. Each Party shall be solely responsible for the acts of all of their respective employees, agents and representatives.
d) The Parties to this Agreement are independent, neither party is an agent, representative or partner of the other Party.
e) Parties declare that this instrument corresponds to the final manifestation, complete and exclusive agreement between the two, replacing the proposals or prior Agreements, oral or written, and all other communications between them, with respect to the subject matter of this Agreement.
f) Any amendment of this Agreement shall be held by an amendment, signed by the Parties that, will join the Covenant.
g) All the attachments shall be read in accordance to the agreement and in any chance those attachments cannot be interpreted or modify the main agreement.
h) The total or partial invalidity of any provision of this Agreement will not affect the fulfillment of the remaining provisions contained in this Agreement. If any part of the Agreement will be deemed invalid by any Court, such decision shall not affect the validity of the remainder, and must therefore continue the outstanding force and effect as if the invalid provisions had never featured this instrument since its celebration.
i) The abstinence of the exercise by either party, secured the rights or powers herein or tolerance of delay in complying with any of the obligations set forth herein shall be construed as mere liberality, not implying accepted, novation or precedent, remaining intact and unaltered those rights or powers. It is clarified that all rights provided herein are cumulative and not alternative for their effects.
j) Declare that the parties had wide latitude as to this contract, which was made in strict compliance to the limits of their economic or social order, the good-faith or morals, considering they are not even in a situation of urgent need and have extensive experience to fulfill all the terms and conditions that constitute their rights and obligations contained herein.
12 Legal Venue
12.1. Any doubts or disagreements resulting from the execution of this contract will be brought before the Court of the São Paulo County (Foro da Comarca de São Paulo), by mutual agreement and renouncing any other venue
13.1 The following documents are considered part of this Agreement:
Annex I: List of Themes of Interest for this Agreement
Annex II: General Guidance for the Call for Research Proposals
Annex III – FAPESP Procedures for review and selection of proposals
In full and mutual agreement, this Agreement of Cooperation is signed in two copies.
São Paulo, October 24, 2013
Fundação de Amparo à Pesquisa do Estado de São Paulo - FAPESP
Prof. Celso Lafer
Glaxo SmithKline Brasil Ltda. – GSK
Annex I: List of Themes of Interest for this Agreement
The themes of interest of FAPESP and GSK to be addressed in CFP under this Agreement are:
More efficient synthesis:
Mass efficiency of typical pharmaceutical synthetic processes is currently less than 1%1. The aim is to increase this to 5%. More efficient routes requiring fewer synthetic manipulations can be facilitated by innovative chemistry. For example, novel approaches to C-H activation have the potential to cut multiple steps from syntheses.
Further renewable solvents are required with different properties, and the advantages and limitations of the chemistry which can be conducted in these solvents will need to be scoped out. For example alternatives could be sought to dipolar aprotic solvents with reproductive toxicity (e.g. DMF, NMP, DMAc). Such research might include finding less toxic, more sustainable solvents as a direct replacement, or alternatively finding alternative approaches to the chemistry most currently conducted in the non-preferred solvents, which is compatible with more benign alternatives.
There is a goal to eliminate usage of hazardous materials from pharmaceutical manufacture. Alternative reagents for common transformations2 will need to be developed. Guidance can be offered on the type of substrates most likely to be of pharmaceutical relevance.
Over a third of GSK’s supply chain carbon footprint is attributable to materials, and more research is required into how this can be reduced. For example innovative approaches to extraction and reaction of the high value chiral molecules abundant in agricultural waste, has the potential to reduce costs, and carbon footprint.
1 R. A. Sheldon, Chem. Ind., 1997, 12 – 15
2 Some examples can be found in P. J. Dunn et al Green Chem., 2007, 9, 411–420
The themes of interest can be modified by decision of the Joint Steering Committee at any time. Approval of a Call for Proposals by the Joint Steering Committee shall have the effect of amending this section.
Annex II: General Guidance for the Call for Research Proposals
1. General Provisions
a. Call for Research Proposals will be prepared by the Joint Steering Committee for the FAPESP - GSK cooperation following the guidelines set forth below.
b. The Call for Research Proposals will invite researchers from public or private institutions of higher education and research, in the State of São Paulo to submit Research Proposals in research areas of interest of GSK and FAPESP.
c. Each Call for Research Proposals will contain the list of research themes of interest as set forth, according to the decision of the Joint Steering Committee FAPESP-GSK.
d. Call for Research Proposals should make clear:
1. The themes to be prioritized in each call,
2. The format for proposals,
3. The process of evaluating and selection of proposals as set forth in Annex III and
4. The schedule for submission of proposals and assessment phases in compliance with the specifications contained herein.
2. The Contributions of the Parties
a. The total cost of all research selected in each Call for Research Proposals will be financed with 50% of funds from FAPESP and 50% from GSK. The percentages for each individual project may vary depending on the degree of innovation and technological risks of each proposal, using the criteria from FAPESP.
b. FAPESP’s funds will be directed to the institutions of higher education and research in the State of Sao Paulo and can be applied according to the rules for use of research funds awarded by FAPESP.
c, The funds contributed by the GSK will be disbursed to the Host Institution or to the Support Institution indicated by the Host Institution for the following functions:
c.1)Capital goods or equipment, necessary to the research, provided they stay under the ownership of Institutions of the public or private Higher Education and Research Institutions in the State of São Paulo, after the completion of the research activity supported;
c.2)Scholarships for undergraduate, Masters, Doctoral and Post-Doctoral students, with values at least equal to the grants FAPESP provides for these arrangements, including contingency funds;
c.3)Acquisition of consumables, travel and services where directly necessary to the research activity;
c.4)Expenditures directed to the infrastructure necessary to the research activity;
c.5)Resources to supplement wages of faculty or researchers employed by institutions of Higher Education and Research that host the research activity;
c.6)Resources for the hiring, for the period of the project, of researchers and technical support needed for research work associated with the research activity;
c.7)Other items as specifically approved by the Scientific Director of FAPESP.
3. Format for the CFRP
a. Each Call for Research Proposals will invite research proposals from researchers from institutions of higher education and research in the State of São Paulo.
b. Each proposal will have a Principal Investigator associated with an institution of higher education and research in the State of São Paulo.
c. The Principal Investigator must have a Ph.D. degree or equivalent and proven experience in the subject of the proposal.
d. For each Research Proposal selected, the cooperation between FAPESP, GSK., and the institution of higher education and research in the State of São Paulo to which the Principal Investigator is associated will be determined by a separate agreement which will define:
d.1) The schedule of disbursements and financial reports;
d.2) The definition and timing of expected results at each stage of the research;
d.3) Clauses on Intellectual Property, commercial exploitation and confidentiality
d.5) Legal venue.
e. The participation of the GSK, and/or its indicated scientists, in the approved research will be discussed by FAPESP with the Principal Investigators of the selected proposals after the end of the selection procedure.
Annex III – FAPESP Procedures for review and selection of proposals
1. Proposals are received by FAPESP.
2. For the cases of Calls for Research Proposals issued by FAPESP as a result of an Agreement with other organizations the proposals are analyzed by the Joint Steering Committee for that cooperative agreement to examine their compliance with the terms of the Call for Proposals.
3. Proposals are submitted to a panel called an “Area Coordination” of FAPESP, according to the predominant area of knowledge of the proposal, for the indication of reviewers.
3.1. Proposals with a budget of less than three hundred thousand Brazilian Reais require at least one reviewer. Above this budget value each proposal requires a minimum of three reviewers. A number of reviewers larger than the specified minimum can be used at “Area Coordination’s” discretion.
4. Proposals with reviews are submitted to the “Area Coordination” of the Scientific Directorate for the issuance of a recommendation regarding its approval and, in positive, the suggested budget.
5. Proposals are then submitted to a second panel, called the “Adjunct Coordination”, for additional review regarding compliance with FAPESP’s regulations, consistence between reviews and recommendation by the “Area Coordination”. The “Adjunct Coordination” issues a recommendation regarding the approval and the budget, in case of a positive recommendation.
6. For the cases of Calls for Research Proposals issued by FAPESP as a result of an Agreement with other organizations the proposals are analyzed by the Joint Steering Committee for that cooperative agreement. The JSC analyzes the proposal, the reviews, the recommendations by the “Area Coordination” and by the “Adjunct Coordination” and then issues a final recommendation to the Scientific Director.
7. The Scientific Director issues the decision for the proposal.