Call for EOIs: Transfer of Technology of a Recombinant Multi-Stage Malaria Vaccine (India)

Objectives

• To license the ‘Technology’ for “A recombinant chimeric multi-stage malaria vaccine (AdFalciVax) against Plasmodium falciparum” useful in Preventing Plasmodium falciparum infection in humans and minimizing its community transmission, for commercialization and marketing activities.

Scope of Work

• ICMR is willing to collaborate with eligible organizations, companies, and manufacturers for undertaking transfer of technology for commercialization of “A recombinant chimeric multi-stage malaria vaccine (AdFalciVax) against Plasmodium falciparum”.
• The Company would be granted rights to undertake further development, manufacture, sell, and commercialize the Technology/Product entitled “A recombinant chimeric multi-stage malaria vaccine (AdFalciVax) against Plasmodium falciparum”.
• An Agreement following EoI is proposed to be executed on a Non-Exclusive basis with single/multiple companies to enable wider outreach of “A recombinant chimeric multistage malaria vaccine (AdFalciVax) against Plasmodium falciparum” (Technology/Product) for societal benefit and public health use. All the related issues shall be governed by ICMR IP Policy, as revised and approved by the Competent Authority.
• ICMR- Regional Medical Research Center, Bhubaneswar, has expertise in various techniques, methods and information relating to aforesaid technology which could be used for the production of the “A recombinant chimeric multi-stage malaria vaccine (AdFalciVax) against Plasmodium falciparum”.

Support from ICMR

• ICMR- Regional Medical Research Center Bhubaneswar (RMRCBB) will provide expert guidance & technical support for the production of “A recombinant chimeric multi-stage malaria vaccine (AdFalciVax) against Plasmodium falciparum”, in all phases. Such technical oversight by ICMR- Regional Medical Research Center Bhubaneswar (RMRCBB) would accelerate the development of the Product and its commercialization.
• ICMR would provide technical support through its team of experienced scientists in study planning, product development, development of study protocol, results/data analysis, outcome assessment, safety & efficacy assessment, product improvement, etc., if deemed fit upon the mutual understanding between ICMR and collaborative company.
• ICMR through its Institutes would provide support and facilitation to conduct the R&D/clinical study of new technology/product in India through its Affiliates/Institutes, in collaboration with the company/institutions in a professional and mutually agreed-upon manner and timelines, which will be decided later under the Agreement.
• ICMR would provide technical support in development of technology/product and will also facilitate the validation, if required, as per the terms & conditions of the Agreement.
• ICMR shall have no financial implications unless otherwise specified.

Pre-Qualification Criteria

• General Criteria
  • The proponent shall be a legal entity, registered as Institution/Company/LLP/Society/partnership firm/proprietorship firm under respective acts in India.
  • The proponent must be registered in India with taxation and other administrative authorities.
  • The proponent should have proven prior experience of manufacturing and/or R&D with manufacturing during the last three years, either in-house or through agreed collaboration and must have marketed same/similar products in the past with a good track record.
  • The proponent has to be profitable and should not have incurred overall loss in past three (3) years. (applicable on commercial firms/organizations only)
  • The proponent should have good track record and currently not black-listed/barred by any Central/State Government/Public Sector Undertaking, Govt. of India, (applicable on commercial firms/organizations only).
  • The proponent should have a manufacturing unit in India.
  • The proponent and its promoters should not have been convicted for any offence in India by any competent court or judicial body during the past 3 years.
  • GMP/quality certification (ISO or approved Indian certification) of manufacturing facility and GLP/necessary certifications for R & D
• Specific Criteria (Based on the nature of the Proposal)
  • The proponent should have functional laboratory to carryout R&D for the product development
  • Capacity to produce at least………………(quantity) per week

Rejection Criteria

• The application is liable to be rejected if:
  • The proposal is not submitted as per the requirements indicated in the EoI.
  • Not in the prescribed format.
  • Not properly stamped and signed.
  • Received after the expiry of due date and time.
  • All relevant supporting documents are not furnished with the Pre-Qualification Criteria (PQC).
  • The proposal shall be substantially responsive without any material deviation, failing which the proposal shall be summarily rejected.
  • Applications not fulfilling the terms of the document will be summarily rejected.
  • Any other non-compliance

For more information, visit ICMR.