Technology Research Analyst Job# 1810 General Characteristics
Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement or the Prospectus, or the results of which are referred to in the Registration Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMA, Health Canada and other comparable regulatory agencies outside of the U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
Manufacturing Technology Transfer Except as provided in Section 4.3(f)(iii)(1) and Section 6.10, with respect to any Collaboration Product (or LGC Reserved Product, if applicable) for which LGC (or its Affiliate) performed CMC Development or CMC Manufacturing, if (a) Cue does not elect for LGC to perform CMC Step 2, CMC Step 3, or CMC Step 4 (or with respect to LGC Reserved Products, upon completion of CMC Step 1), or (b) upon failure of the Parties to reach agreement with respect to a Clinical Supply Agreement or a Commercial Supply Agreement or (c) [***] under this Agreement and does not cure such breach within [***] days (provided, that if such breach is not reasonably capable of cure within such [***] day period, then such cure period shall be automatically extended for an additional [***] day period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan and if such breach is not reasonably capable of cure within such combined [***] day period, then Cue shall reasonably consider consenting to any extension of such cure period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan), as applicable, then, in each case upon the written request of Cue, LGC shall use Commercially Reasonable Efforts to make a technology transfer to an Approved CMO the Manufacturing processes (including materials and such other information) but solely as is necessary to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC or its Affiliate or CMO, provided that neither Cue, LGC or any Third Party shall perform such a technology transfer to any CMO [***] without LGC’s consent, not to be unreasonably withheld, conditioned or delayed if LGC has approved the CMO to manufacture Collaboration Products (or LGC Reserved Products, if applicable). LGC shall conduct such technology transfer as soon as reasonably practicable after receiving such written notice, using good faith efforts to support supply needed to achieve timelines in the Cue Territory Development Plan (or Cue’s development plan for LGC Reserved Products, if applicable) or Cue Territory Commercialization Plan, as applicable. LGC shall conduct the first technology transfer for each Collaboration Product (or LGC Reserved Products, if applicable) [***] (provided that [***]) for a period of up to [***] months from the date Cue or its designee has provided notice it is ready to receive the technology transfer, provided, that such [***] month period [***]. After the expiration of the initial such [***] month period for a Collaboration Product (or LGC Reserved Products, if applicable), if required to complete the technology transfer to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC, LGC shall continue to provide support to Cue for up to an additional [***] period for up to [***] hours at the FTE Rate and thereafter at [***]. Thereafter, LGC will also provide [***] for such Collaboration Product (or LGC Reserved Products, if applicable). Neither Cue nor its Affiliates or Cue Collaborators shall reverse engineer any materials provided hereunder by LGC. Notwithstanding anything in this Agreement to the contrary, LGC’s CMC information may only be shared with an Approved CMO.
Technology Transfer Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be or have been submitted to FDA or other comparable governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, applicable Authorizations, and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and, for studies submitted to regulatory authorities for approval, in all material respects, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete and fairly present the data derived from such studies and trials in all material respects; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes materially call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
