ATCC Licensed Derivative Criteria
Obtaining a License for Use of the ATCC Licensed Derivative® Emblem
Companies operating in quality control microbiology and wishing to include ATCC microorganisms in their commercial products may join the ATCC Licensed Derivative program. Prior to doing so, however, they must undergo a rigorous audit process before a non-exclusive biological material and trademark license can be executed. The audit process and its associated acceptance criteria ensure that the company has the capability to maintain the integrity of the ATCC ingredient in their product and to manufacture such products according to relevant quality standards.
Only those companies that meet the quality requirements of the audit process will be allowed to enter into licensing negotiations that will permit them to place the ATCC Licensed Derivative emblem on their product literature. A brief outline of the process follows:
After an initial contact by a company with interest in obtaining a license from ATCC, representatives from both entities enter into a non-disclosure agreement to protect the confidentiality of the quality audit and to allow full discussion of the specifics of the possible licensing arrangement.
The potential licensee discloses to ATCC the intended use and field of use of the ATCC material within the licensee company's product.
ATCC collects documentation about the facilities, human resources, manufacturing, customer services and technical capabilities of the interested company.
ATCC conducts a quality audit of the company according to a pre-established audit plan, analyzes the results, and provides the interested company with a confidential report.
One of three audit outcomes is possible — an approval, a conditional approval or a denial.
An approval allows the negotiation of a non-exclusive biological materials and trademark license to resume. A conditional approval allows the company to take corrective and preventive action before a license can be negotiated. A denial means ATCC will not enter into license negotiations until one year later, when the deficiencies cited in the confidential audit report have been remediated, as demonstrated by a new quality audit.
In line with federal requirements established by FDA on current good manufacturing practices, ATCC also encourages companies to establish compliance with 21 CFR Part 820 of the U.S. federal regulations.