SERVICES
- Client acknowledges that Powdersize, LLC, and/or its affiliates (together, “Powdersize”) performs various pharmaceutical product development activities including, but not limited to, the following: preformulation activities, analytical development services, formulation development, cGMP manufacturing, clinical packaging, stability storage and stability testing (together, the “Services”). Client further acknowledges that all Services are performed as outlined in approved agreements and/or protocols. Powdersize does not design, warrant, supervise or monitor compliance of products except as specifically agreed to in writing prior to the performance of the Services.
- Client will provide an MSDS for drug substance prior to shipment of samples and project initiation unless safety assessment is provided to Powdersize or is on file at Powdersize. Powdersize reserves the right to withdraw this Agreement upon safety assessment of the drug substance.
- Excipient and/or microbial limits testing, if necessary, will be subcontracted to a third party laboratory.
- Shipments to Client will be delivered ex-works Powdersize loading dock (Incoterms 2000).
- Upon completion of project, the remaining product samples and study supplies will be retained for 30 days. Unless Powdersize is otherwise advised within that time, the samples and study supplies will be discarded.
- Prior to Powdersize performing cGMP manufacturing Services for Client under this Agreement, the Parties shall enter into a Quality Agreement governing the quality systems used in connection with such Services.
LIABILITY
- Powdersize is not an insurer or a guarantor. Powdersize represents that the Services shall be performed within the limits mutually agreed to, in writing, and in a manner consistent with the level of care and skill ordinarily exercised by providers of similar services under similar circumstances. No other representations or warranties, expressed or implied, are included or intended in this Agreement, or in any report, opinion or document related to the Services provided hereunder.
- Should Powdersize fail to perform the Services in this Agreement, Powdersize’s sole liability and obligation shall be to re-perform such Services without charge for its time expended, provided that Client shall supply additional drug substance at Client’s cost, and further provided that Client has provided Powdersize with written notice of such failure during the ten (10) day period after the conclusion of the. A final determination by Powdersize that it is not possible to develop a pharmaceutical formulation(s) comprising the drug substance as detailed in this Agreement shall not be deemed a “failure to perform Services”. Client agrees that Powdersize shall have no liability if the non-complying Services are due to any action or inaction on the part of Client, any affiliate of Client or any third party under contract with or subject to the control or direction of Client or any affiliate of Client.
- Client understands and agrees that Powdersize, in entering into this Agreement and by performing Services, does not assume, abridge, abrogate or undertake to discharge any duty or responsibility of Client to any other party or parties.
- Client shall indemnify, defend and hold Powdersize, its affiliates and their respective officers, directors, employees and agents (each, an “Indemnified Party”) harmless from and against any and all losses, fines, fees, settlements, payments, obligations, penalties, deficiencies, liabilities, damages, costs and expenses (including reasonable attorneys’ fees) (“Losses”) suffered, incurred or sustained by any Indemnified Party, by reason of any third party claim, action, suit, proceeding or arbitration, including any governmental authority action or investigation (“Claim”) to the extent arising out of or resulting from Client’s (i) breach of the representation and warranties in this Agreement; (ii) gross negligence or willful misconduct in connection with this Agreement; (iii) the use, packaging, labeling, distribution, marketing, promotion, sale and disposal of a product or drug substance; or (iv) resulting from the inherent risk of a product or drug substance; provided however, that Client shall have no obligation of indemnity hereunder with respect to any Losses to the extent caused by the gross negligence or willful misconduct on the part of Powdersize.
- Client shall also defend, indemnify, and hold harmless an Indemnified Party from and against any and all claims, suits, and/or proceedings (including any assertion of an intellectual property right, regardless of whether the assertion has been or will be adjudicated), as well as all damages, losses, liabilities, and expenses (including reasonable attorneys’ fees and costs), of whatever nature resulting from, arising out of, or relating to a claim or allegation that a product, or any part thereof, infringes, misappropriates, or otherwise violates a patent, copyright, trade secret, trademark or other intellectual property right of any third party.
- NEITHER CLIENT, POWDERSIZE, NOR AFFILIATES AND THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES AND SHALL BE LIABLE FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT (OR THE TERMINATION HEREOF), INCLUDING, WITHOUT LIMITATION, LOSS OF PROFITS OR ANTICIPATED SALES. TO THE FULLEST EXTENT PERMITTED BY LAW, AND NOTWITHSTANDING ANY OTHER PROVISION OF THIS PURCHASE ORDER, THE TOTAL LIABILITY, IN THE AGGREGATE, OF POWDERSIZE, ITS AFFILIATES, AGENTS, AND SUBCONTRACTORS, AND ANY OF THEM, TO CLIENT AND ANYONE CLAIMING BY OR THROUGH CLIENT, FOR ANY AND ALL CLAIMS, LOSSES, COSTS, DAMAGES OR FEES, INCLUDING WITHOUT LIMITATION, ATTORNEYS’ FEES RESULTING FROM OR IN ANY WAY RELATED TO THIS AGREEMENT FROM ANY CAUSE OR CAUSES SHALL NOT EXCEED THE TOTAL FEES RECEIVED BY POWDERSIZE UNDER THIS PURCHASE ORDER.
- During the term of this Agreement and for a period of two (2) years after the termination of this Agreement or the expiry date of the last batch manufactured, whichever is later, each Party shall obtain and maintain, at its sole expense adequate product liability insurance as it deems necessary and appropriate, but in an amount of not less than two million dollars ($2,000,000) in coverage. Evidence of coverage, in the form of certificates of insurance, shall be provided promptly upon the reasonable request of the other Party.
- Whenever performance by either Party is delayed or prevented by war, insurrection, terrorism, epidemic, acts of God, flood, volcanic eruption, fire or other casualty, strikes, industrial disputes, embargoes, equipment or machinery breakdown, unavailable or nonconforming vendor-supplied raw materials, shortage of transportation facilities, acts of government or any other similar or dissimilar causes, beyond the control of such Party and not due to its acts or omissions, such delay or prevention shall be excused and the time of performance hereunder extended for the duration of the causative factor.
PAYMENTS
- Prices quoted are valid for 45 days, after which they must be reconfirmed.
- Client agrees to pay all invoices within 30 days of invoice date.
- In the event that a payment is not received within 30 days of invoice date, Client agrees to pay a late payment charge on the unpaid balance equal to 1½ % per month.
MISCELLANEOUS
- Client acknowledges that Powdersize’s information relating to milling and milling processes is confidential and proprietary to Powdersize, and Client agrees to maintain the confidentiality of any such information disclosed by Powdersize for a period of ten (10) years from the date of disclosure and to use such information.
- Powdersize shall assign, at Client’s request, all rights, title and interest in all data, discoveries, inventions, improvements, new uses, processes, copyrights, trade secrets, techniques, whether patentable or not, (“Inventions”) arising from the Services performed under this purchase order that are directly linked to Client’s drug substance. Except as expressly provided in the preceding sentence, neither anything contained in a purchase order, nor the delivery of any information to a Party hereto, shall be deemed to grant the receiving party any right or license under any Invention of the disclosing party existing prior to or after the Effective Date, including any Invention developed independently of the Services performed under this purchase order.
- The Parties shall comply with all applicable treaties, laws, statutes, rules, regulations, judicial opinions or administrative findings or orders (“Laws”) that affect their respective performance and activities under this Agreement.
- Powdersize shall promptly notify and forward to Client any information concerning any potentially serious or unexpected side effect, injury, toxicity or sensitivity reaction or any unexpected incidence or other adverse experience related to a cGMP-manufactured product (an “Adverse Experience”) reported to it. Client agrees that it shall be solely responsible to review, analyze and respond to any Adverse Experience. Powdersize shall have no obligation with respect to an Adverse Experience other than the obligation to notify Client.
- Powdersize advises, and Client acknowledges that, the products resulting from the Services performed under this Agreement may not be used in the production, encapsulation, packaging or marketing of any product which is in violation of any applicable Laws or with any person or entity on any applicable government sanction, restricted party or denial list without a license or otherwise in violation of applicable Laws.
- Client represents, warrants, covenants and agrees that (i) it is not, and will not, in connection with any Powdersize product, do business with or sell directly or indirectly to the Government of Iran, the Iranian Military or Iranian military or law enforcement purchasers or importers, Iran’s petroleum sector or Iran’s development of weapons of mass destruction, Iranian Specially Designated Nationals, or entities considered by the U.S. to be supporters of terrorism or proliferators of weapons of mass destruction (which entities can be identified by accessing the U.S. Office of Foreign Asset Control “Blocked Persons and Specifically Designated Nationals List” http://sdnsearch.ofac.treas.gov/); and (ii) it is aware of and, hereby confirms its compliance with, all applicable economic sanctions, including, without limitation, any applicable U.S. economic sanctions.
- Client represents, warrants and covenants that no pharmaceutical product that is based on or results from the Services will be released for public use or consumption until all requisite governmental approvals thereof have been obtained for such use and consumption.
- This Agreement and any and all claims and disputes hereunder or related thereto shall be governed by the internal laws of the State of New York, USA.
- In the event that Powdersize prevails in any dispute or claim, Client agrees that Client will pay any and all expenses, including attorney’s fees, reasonably incurred in the prosecution or defense of such claim or dispute.
These terms and conditions and the offer of Services to Client, and Client’s acceptance of such offer, shall constitute the entire agreement between Powdersize and Client. Any conflicting terms contained in any order or acceptance submitted by Client shall be null and void.