Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) Files An 8-K Entry into a Material Definitive AgreementItem 1.01.
On March28, 2018, Alnylam Pharmaceuticals, Inc. (the “Company”) and Agilent Technologies, Inc. (“Agilent”) entered into a Manufacturing Services Agreement (the “Agreement”) providing for the commercial supply of patisiran drug substance by Agilent.
to the Agreement, Agilent has agreed to manufacture and supply to the Company, and the Company has agreed to purchase from Agilent, subject to any conflicting obligations under the Company’s third-party agreements, a specified percentage of the active pharmaceutical ingredients required for patisiran for commercial sale (the “Product”). The Company will be required to provide rolling forecasts for the Product on a quarterly basis, a portion of which will be considered a binding, firm order. The firm order portion will be adjusted after the first-year post-marketing authorization of the Product in the United States. Agilent will be required to reserve sufficient capacity (including labor, materials and equipment) to ensure that it can supply the Product in the amounts specified under such firm orders, including a certain percentage of the remaining, non-binding portions of each forecast, as well as a specified number of batches each year. Under the Agreement, pricing of the Product is to be determined in each statement of work. The Company will be required to provide an initial payment to cover raw material purchases and reserve appropriate resources. Final payment for any batch of Product shall only be made by the Company following acceptance of the Product.
The Agreement has an initial term of five years, which is subject to automatic renewal terms of two years absent earlier termination by either party during a renewal term in accordance with the terms of the Agreement.
The Company may terminate the Agreement or any purchase order thereunder (subject, in certain instances, to penalties), (a) upon sixty days prior written notice: (i)if Agilent is or will be unable to perform the services in accordance with agreed upon terms; (ii)in the event Agilent fails to obtain or maintain any material licenses or approvals; or (iii)if Agilent materially breaches certain of its obligations relating to maintenance of its business, subject to Agilent’s right to cure such breach; and (b)upon thirty days prior written notice if the Company determines patisiran is not commercially viable.
Each party also has the right to terminate the Agreement for other customary reasons such as material breach and bankruptcy.
The Agreement contains provisions relating to compliance by Agilent with current Good Manufacturing Practices, certain business operating standards, cooperation with regulatory efforts, audit rights, indemnification and limitations of liability, confidentiality, dispute resolution, assignment and other customary matters for an agreement of this kind.
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the Agreement, a copy of which the Company expects to file as an exhibit to its Quarterly Report on Form 10-Q for the quarter ended March31, 2018.
About Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY)
Alnylam Pharmaceuticals, Inc. is a biopharmaceutical company. The Company is engaged in developing therapeutics based on ribonucleic acid (RNA) interference (RNAi). The Company is focused on the use of its N-acetylgalactosamine (GalNAc)-conjugate strategy for delivery of small interfering RNAs (siRNAs). Its investigational RNAi therapeutics focus on Strategic Therapeutic Areas (STArs), including Genetic Medicines, with a pipeline of RNAi therapeutics for the treatment of diseases; Cardio-Metabolic Disease, with a pipeline of RNAi therapeutics toward genetically validated, liver-expressed disease in cardiovascular and metabolic diseases, such as dyslipidemia, hypertension, non-alcoholic steatohepatitis (NASH) and type II diabetes, and Hepatic Infectious Disease, with a pipeline of RNAi therapeutics for the treatment of hepatic infectious diseases. Its Genetic medicines include Patisiran (ALN-TTR02) and Fitusiran (ALN-AT3), and additional genetic programs, including ALN-AAT.
