Attachment_9_-_Advance_Understandings.pdf

ATTACHMENT 9: ADVANCE UNDERSTANDINGS

EVALUATION AND TESTING SERVICES (ETS) FOR VACCINES AND OTHER

BIOLOGICS FOR INFECTIOUS DISEASES

75N93024R00019

There are NO Advance Understandings applicable to this solicitation.

The below Advance Understandings are applicable to this solicitation.

DATA RIGHTS

Because the goal of this preclinical development contract is to promote the development of vaccine candidates and other related biologics, it will be necessary to restrict certain rights of the Contractor and its subcontractors to enable NIAID to attract Third Party Suppliers of proprietary compositions. It is anticipated that the great majority of materials that will be submitted for evaluation and further development will be proprietary in nature, and NIAID’s experience has demonstrated that third parties are reluctant to provide their proprietary materials or ideas without complete assurance that their intellectual property rights are protected. Therefore, NIAID requires the Contractor and its subcontractors to agree to protect the proprietary materials, data and other information of these Third Party Suppliers.

Furthermore, the Government reserves the right to have complete access to the databases, provide access to third parties and to transfer all rights and custody to a successor Contractor.

CONFIDENTIALITY, PUBLICATIONS AND INVENTIONS

Because the Contractor and its subcontractors will utilize and evaluate proprietary materials, data and other information provided to NIAID by Third Party Suppliers, it is essential to include provisions in the contract that will protect the intellectual property and other proprietary rights of those third parties. The Contractor and all subcontractors are required to maintain the confidentiality of proprietary data and other information provided to them during the performance of this contract. The Contractor and all subcontractors are required to abide by the terms of agreements between the Third Party Suppliers and NIAID, which have been authorized by the Director of the NIAID Division of Microbiology and Infectious Diseases (DMID); copies of the agreements will be provided to the Contractor prior to, or simultaneous with, the delivery of the proprietary materials, data and other information covered by those agreements. All data and other information provided by a Third Party Supplier or the Project Officer should be assumed to be confidential unless specifically identified as non-confidential in writing by the Project Officer. The Contractor and its subcontractors shall utilize all materials supplied under this contract solely for contract-related purposes and no unauthorized use or distribution of these materials is permitted.

No later than one month following award, the Contractor shall provide a plan describing the specific procedures it will employ to safeguard any proprietary data and other information obtained or generated under this contract, including the restricted-access files that are required.

The Contractor shall require all subcontractors to employ these procedures.

Should subject inventions arise under this contract and any subcontracts, they will be subject to federal laws and regulations governing federally-funded inventions. Any U.S. patent applications filed on these subject inventions and any resulting U.S. patents are required to include the following language: “This invention was made with government support under contract [insert contract number] awarded by the National Institute for Allergy and Infectious Diseases, NIH, HHS. The government has certain rights in the invention.” Please see HHSAR clauses 352.227- 11, Patent Rights-Exceptional Circumstances (SEPT 2014) and 352.227-14, Rights in Technical Date-Exceptional Circumstances (SEPT 2014).

PLANNED DEVIATIONS TO REQUIRED GENERAL CONTRACT CLAUSES FAR

52.227-11 AND FAR 52.227-14

The NIAID proposes to seek a deviation from FAR clause 52.227-11, Patent Rights-Retention by the Contractor (Short Form) (December 2007). Pursuant to a Determination of Exceptional Circumstances (DEC) as required by FAR 27.303, the NIAID proposes to modify this FAR clause to restrict the Contractor's rights to subject inventions arising under the contract. Subcontracts at all tiers awarded by the prime contractor would need to comply with the deviated Patent Rights FAR clause if a DEC is implemented. Specifically, the Contractor and its subcontractors at all tiers would be required to assign to the Government or, if deemed appropriate by the NIAID and subject to certain rights reserved by the Government in the fields of antimicrobial (anti-bacterials, anti-fungals, anti-parasitics and anti-virals) and anti-toxin therapeutics, to a Third Party Supplier or other collaborating party designated by the Government, the entire right, title, and interest throughout the world to each subject invention, except to the extent that rights are retained by the Contractor under the Greater Rights Determination provision of the clause. The NIAID recognizes that inventions in areas outside of the antimicrobial (anti-bacterials, anti-fungals, anti-parasitics and anti-virals) and anti-toxin therapeutics fields may be of significant benefit to U.S. public health objectives and therefore, the Contractor would be encouraged to request greater rights to identified inventions outside the fields of antimicrobial (anti-bacterials, anti-fungals, anti-parasitics and anti-virals) and anti-toxin therapeutics. Further, the NIAID/NIH would consider whether granting the requested rights would interfere with the rights of the Government or any Third Party Supplier or other collaborating party or might otherwise impede the ability of the Government or others to develop new candidates for antimicrobial (anti-bacterials, anti-fungals, anti-parasitics and anti-virals) and anti-toxin therapeutics as well as potential enabling technologies that may result from data ensuing from evaluations performed under the contract useful for antimicrobial (anti-bacterials, anti-fungals, anti-parasitics and anti-virals) and anti-toxin therapeutics discovery and development. The Contractor would also be encouraged to request greater rights for inventions that relate to technology outside the NIAID's program and for which the Contractor has negotiated with a Third Party Supplier for the disposition of patent rights concerning a subject invention related to the compound for a field of use outside of antimicrobial (anti-bacterials, anti-fungals, anti-parasitics and anti-virals) and anti-toxin therapeutics. Furthermore, the timing of data publication would need to be restricted to allow adequate time for patent applications to be filed on inventions arising from the proposed contract. The NIAID intends to accomplish this restriction by a deviation from FAR clause 52.227-14, Rights in Data-General (December 2007). Specifically, although the NIAID encourages the publication of articles on research results, this FAR clause would be narrowly modified to restrict the Contractor's right to use, release to others, reproduce, distribute, and publish data produced or used by the Contractor in the performance of this contract to allow adequate time for the filing of patent applications and to protect data that would be submitted as part of a regulatory filing. The NIAID would reserve the right to coordinate the timing of data publication so that appropriate domestic and international intellectual property applications may be filed as appropriate. The deviated data rights FAR clause would apply to the Contractor and subcontractors at all tiers. Potential Offerors are afforded an opportunity herewith to comment on the proposed use of these deviations and to identify the impact these deviations may have on their conduct of the work should they be awarded a contract. Comments should be provided, in writing, to the Point of Contact for this RFP, whose name and other information appears at the bottom of the first page of this RFP. Comments should be provided within 30 calendar days of the issue date of this RFP. Thereafter, the NIAID will consider this input and determine whether alternative courses of action may be appropriate.

On-Ramping Procedures

To ensure the success of the Evaluation and Testing Services for Vaccines and Other Biologics for Infectious Diseases (ETSV) contract program and to maintain and maximize competition in the various contract Task Area pools, the Government reserves the unilateral right to on-ramp additional Contractors at any time during the ordering period of the IDIQ contract. The criteria for on-ramping may include, but are not limited to: lack of robust competition in a Task Area pool, the shrinking of a Task Area pool as a result of the Government’s exercise of off-ramping procedures, and/or changes in industry. The Government may initiate on-ramping procedures for any Task Area pool.

If the Government determines that it is in its best interest to initiate an on-ramp procedure, it shall publish a notice in SAM.gov in accordance with FAR Part 5, “Publicizing Contract Actions”. The announcement will identify the total anticipated number of new contracts the Government intends to award. The Government may issue a solicitation with substantially the same evaluation factors for award, however, it will reserve the right to modify or update the evaluation factors, if deemed to be in the Government’s best interest. Existing Contractors may submit proposals in response to the on-ramp solicitation, if they are not an existing Contractor in the Task Area pool undergoing on-ramping.

The period of performance of any new contracts awarded as part of an on-ramp procedure will be co-terminous with the existing period of performance for all other IDIQ contracts. Any new award made as part of the on-ramp process will not extend the existing Ordering Period of the IDIQ contract.

Immediately upon on-ramping, the contractor is eligible to submit a proposal in response to any RTOPs, with the same rights and obligations of any other contractor. The newly on-ramped contractor will be eligible for the original guaranteed minimum and will be subject to the original contract ceiling.

The government will notify the existing Contractors of any newly on-ramped Contractors. The government will not consider unsolicited proposals or unsolicited requests for additional on-ramping.

Off-Ramping Procedures

To ensure the success of the Evaluation and Testing Services for Vaccines and Other Biologics for Infectious Diseases (ETSV) contract program and to maintain and maximize competition in the various contract Task Area pools, all contractors are encouraged to be active in reviewing Requests for Task Order Proposals (RTOPs) and submitting proposals within a Contractor’s awarded Task Area/functional area of expertise.

The Contracting Officer will conduct an annual review of Contractor participation in RTOPs and performance of awarded Task Orders (TOs) to determine if the contractor is meeting the expectations of the contract. The Government, in its sole discretion, reserves the right to off-ramp a contractor. At the time of off-ramping, the Contracting Officer shall ensure that the Contractor is not actively performing on any Task Orders in the pool, from which it will be off-ramped. Contractors in multiple Task Area pools will be off-ramped from the pool(s) where non-performance has been identified by the Contracting Officer. The Contractor shall satisfactorily complete all previously awarded task orders.

The Government will provide a 30-calendar day written notice of its intent to off-ramp a Contractor.