; and (B) does not include— (i) base chemical subunits, such as individual nucleotides or nucleosides, or oligonucleotides shorter than the screening threshold typically used as polymerase chain reaction primers, as determined by the Secretary; (ii) by-products generated during sequencing that are not useful for assembly or cloning, as determined by the Secretary; or (iii) products generated from cloning or assembling of existing gene or gene fragment material, in circumstances in which the gene synthesis provider has no access or notice to the sequence design, as determined by the Secretary. (3) Gene synthesis provider The term gene synthesis provider means an entity that synthesizes and distributes gene synthesis products, including bacteria, viruses, or fungi containing recombinant or synthetic nucleic acid molecules, for delivery to a customer. (4) Manufacturer of gene synthesis equipment The term manufacturer of gene synthesis equipment means an entity that produces and sells equipment for synthesizing gene synthesis products.