= Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. CONTRACT...
Exhibit 10.18
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CONTRACT MANUFACTURING AND SUPPLY AGREEMENT
Dated as of July 3, 2012
By and Among
DSM PHARMACEUTICALS, INC.
and
ONYX PHARMACEUTICALS, INC.
and
ONYX PHARMACEUTICALS INTERNATIONAL GMBH
TABLE OF CONTENTS
ARTICLE 1: |
DEFINITIONS |
1 |
ARTICLE 2: |
SALE AND PURCHASE OF PRODUCT |
6 |
ARTICLE 3: |
COORDINATORS; DIVESTMENT |
8 |
ARTICLE 4: |
EQUIPMENT; API; EXCIPIENTS; ARTWORK |
9 |
ARTICLE 5: |
WARRANTIES; SPECIFICATIONS; QUALITY |
12 |
ARTICLE 6: |
FORECASTS; ORDERS |
14 |
ARTICLE 7: |
PURCHASE OF PRODUCT; DELIVERIES |
16 |
ARTICLE 8: |
PRICE; PRICE INCREASES; ADDITIONAL PAYMENTS |
17 |
ARTICLE 9: |
RECALLS |
19 |
ARTICLE 10: |
VALIDATION; REGULATORY |
19 |
ARTICLE 11: |
TERM; TERMINATION |
20 |
ARTICLE 12: |
CLAIMS |
22 |
ARTICLE 13: |
INDEMNIFICATION OF THIRD PARTY CLAIMS |
23 |
ARTICLE 14: |
CONFIDENTIALITY |
24 |
ARTICLE 15: |
INTELLECTUAL PROPERTY |
26 |
ARTICLE 16: |
FORCE MAJEURE |
26 |
ARTICLE 17: |
LEGAL COMPLIANCE; AUTHORIZATION |
27 |
ARTICLE 18: |
PRESS RELEASES; USE OF NAMES |
27 |
ARTICLE 19: |
DISPUTE RESOLUTION; VENUE |
27 |
ARTICLE 20: |
MISCELLANEOUS |
27 |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CONTRACT MANUFACTURING
AND SUPPLY AGREEMENT
By and Among
DSM Pharmaceuticals, Inc., Onyx Pharmaceuticals, Inc., and
Onyx Pharmaceuticals International GmbH
This CONTRACT MANUFACTURING AND SUPPLY AGREEMENT (this “Agreement”) is made effective as of this 3rd day of July, 2012 (the “Effective Date”), by and among DSM Pharmaceuticals, Inc., a Delaware corporation with principal place of business at 0000 Xxxxxx Xxxxxx Xxxx Xxx, Xxxxxxxxxx, Xxxxx Xxxxxxxx 00000 (“DSM”), Onyx Pharmaceuticals, Inc., a Delaware corporation with principal place of business at 000 Xxxx Xxxxx Xxxxxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000, and Onyx Pharmaceuticals International GmbH, a Swiss corporation with principal place of business at Xxxxxxxxxxx 00, 0000 Xxx Xxxxxxxxxxx (collectively, “Onyx”); (each individually a “Party” and collectively the “Parties”).
The following terms, whether used in the singular or plural, shall have the meanings assigned to them below for purposes of this Agreement:
1.2 Active Pharmaceutical Inaredients/API. “Active Pharmaceutical Ingredients” or “API” shall mean the active pharmaceutical ingredients for the Product to be manufactured hereunder, as set forth in the product addendum in ANNEX 1, including the specifications and the analytical methodology related thereto, as such specifications may be amended from time to time by mutual agreement of the Parties.
1.4 Agreement. “Agreement” shall mean this Contract Manufacturing and Supply Agreement.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
1.6 Batch. “Batch” shall have the same meaning as Lot.
1.11 Coordinators. “Coordinators” shall have the meaning set forth in Section 3.1.
1.13 Designated Vendors. “Designated Vendors” shall have the meaning set forth in Section 4.4.
1.15 Divested Product. “Divested Product” shall have the meaning set forth in Section 3.2.
1.16 DSM Exclusive IP. “DSM Exclusive IP” shall mean any Intellectual Property of DSM that was owned or licensed by DSM prior to the Effective Date of this Agreement, or that was obtained, generated or created outside of the scope of this Agreement or any developments or improvements thereto (“DSM Exclusive IP”).
1.17 DSM Facility. “DSM Facility” shall mean DSM’s manufacturing facility located at 5900 Xxxxxx Xxxxxx Xxxx Highway, Greenville, North Carolina, or any other of DSM’s manufacturing facilities located in Greenville, North Carolina that may be designated by DSM and approved by Onyx.
1.19 EMA. “EMA” shall mean the European Medicines Agency, or any successor entity.
1.21 Expected Yield. “Expected Yield” shall have the meaning set forth in Section 4.2.4.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
1.22 FD&C Act. “FD&C Act” shall mean the United States Federal Food, Drug and Cosmetic Act, as amended.
1.23 FDA. “FDA” shall mean the United States Food and Drug Administration, or any successor entity.
1.26 Force Majeure Event. “Force Majeure Event” shall have the meaning set forth in Section 16.1.
1.27 [*] Reservation Fee. “[*] Reservation Fee” shall mean that portion of the Product Price which relates to the reservation of [*] for production of Product hereunder based on Onyx’s Monthly Forecast.
1.28 GAAP. “GAAP” shall mean United States generally accepted accounting principles.
1.29 ICH. “ICH” shall mean the International Conference of Harmonization, and any successor agency or authority thereto
1.30 IMPD. “IMPD” shall mean any investigational medicinal product dossier filed with the EU pursuant to EudraLex, Volume 10, Chapter I to begin clinical studies of the Product in humans, or any successor application(s) thereto.
1.34 Long Term Forecast. “Long Term Forecast” shall have the meaning set forth in Section 6.1 hereof.
1.35 Lot. “Lot” shall mean Commercial Product at the lot size mutually agreed upon by the Parties and stated in ANNEX 1.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
1.37 Regulatory Approval Application. “Regulatory Approval Application” shall mean any NDA, MAA or other application seeking regulatory approval to market and sell the Product in any country or territory in the Territory.
1.38 Monthly Forecast. “Monthly Forecast” shall have the meaning set forth in Section 6.2 hereof.
1.39 NDA. “NDA” shall mean any New Drug Application (or supplemental NDA) for the Product, as filed with the FDA.
1.42 Onyx Regulatory Documentation. “Onyx Regulatory Documentation” shall mean documentation that Onyx has filed with Regulatory Authorities relating to the Product or its formulation, development manufacture, use or sale, and any supplements to such documentation as may be filed during the Term hereof, including any IND or any IMPD (or any other foreign equivalent thereto), any NDA, any MAA and any other Regulatory Approval Application.
1.45 Party. “Party” or “Parties” shall refer to either DSM or Onyx, or both, as the context so requires.
1.47 Process Requirements. “Process Requirements” shall have the meaning set forth in Section 5.7.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
1.54 Purchase Order. “Purchase Order” shall have the meaning set forth in Section 7.1.
1.57 Regulatory Authorities. “Regulatory Authorities” shall mean the government regulatory entities with regulatory authority over the development, review for approval, manufacture, storage, testing, use or sale of pharmaceutical products (including the Product), as well as any successor entity thereto, including, without limitation, the FDA and the EMA.
1.60 SKU. “SKU” shall refer to individual stock keeping units of the Product hereunder.
1.62 Term. “Term” shall have the meaning set forth in Section 11.1.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
1.65 Unit. “Unit” shall mean a unit of Product according to ANNEX 1.
ARTICLE 2: SALE AND PURCHASE OF PRODUCT
(a) A minimum [*] of [*], which [*] shall be modified to a mutually agreed upon [*] after the [*] of each [*] hereunder. For purposes of this Section 2.1(a), the [*] shall be determined by calculating the [*];
(b) Each Batch manufactured by DSM shall: (i) meet the Specifications and all requirements of the Quality Agreement; and (ii) have no media fill failures which might affect such Batch; and
(c) Each Batch shall be delivered no later than [*] after the Delivery Date set forth in the specific Purchase Order and meeting the requirements in 5.1.1.
2.4.1 unloading, handling and, for the period necessary to timely manufacture and Release the Product, storing Excipients, any Onyx Materials, all materials provided by DSM, and all packaging and labeling materials at the DSM Facility,
2.4.2 proper use, operation, maintenance and storage of any Onyx Equipment in accordance with Section 4.1 for so long as the Onyx Equipment remains at the DSM Facility;
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
2.4.3 employing its existing manufacturing processes and logistics, or if the Parties agree after good faith discussions and provided that Onyx reimburses DSM for any costs and expenses incurred, adopting Onyx’s manufacturing processes and logistics or establishing new production methods and logistics;
2.4.4 collecting and retaining samples of the Product as provided in the Quality Agreement;
2.4.5 without limitation of Section 5.4(c), packaging and labeling the Product;
2.4.6 handling and storing the bulk and packaged Product while in DSM’s possession;
2.4.7 preparing the Product for shipment;
2.4.8 making the Product available to a common carrier;
2.4.9 cooperating with Onyx in any PAI as provided in the Quality Agreement or otherwise agreed to in writing by the Parties;
2.4.10 keeping records and reporting to Onyx and to applicable Regulatory Authorities as required by this Agreement, the Quality Agreement and/or applicable Law; and
2.4.11 handling, storing, treating and disposing of wastes generated by DSM in connection with DSM’s performance under this Agreement as required by applicable Law.
2.5.1 DSM shall maintain a valid FDA establishment number for the DSM Facility during the Term of this Agreement, together with all other permits and licenses required under applicable Law in order to perform its obligations under this Agreement and the Quality Agreement, and will maintain all records as required by applicable law.
2.5.2 DSM will promptly notify Onyx in writing if the FDA, the EMA or any other Regulatory Authority issues a finding or order that impairs or in any way affects DSM’s ability to perform its obligations under this Agreement.
2.5.3 DSM shall permit representatives of Onyx who are bound by obligations of confidentiality in accordance with Article 14, to visit the DSM Facility, and DSM shall also permit the FDA, the EMA and other Regulatory Authorities to inspect the DSM Facility, all in accordance with and subject to the terms of the Quality Agreement.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
subcontractor. For the avoidance of doubt, Third Parties from which DSM procures commercially-available Excipients are not subcontractors.
2.7.1 transferring any necessary Onyx Intellectual Property (to the extent not already transferred pursuant to the Development Agreement) to DSM;
2.7.2 providing supply and operations planning including forecasts and Purchase Orders as provided in Article 6;
2.7.3 providing on-site support in connection with Product as set forth in the Quality Agreement or as otherwise agreed upon by the Parties in writing from time to time;
2.7.4 completing any and all regulatory reports or filings and obtaining any and all approvals required of the sponsor of the Product in the Territory; and
2.7.5 providing advance review copies of any CMC information to be included in any IND, IMPD, NDA, or the equivalent for any MAA.
2.8 Disclosure/Development of Health Risk Data. Onyx agrees to disclose to DSM any information which is or becomes available to Onyx regarding health risks which may be involved in manufacturing the Product, including information regarding the specified API, Captisol®, and any Product Components. Such information shall include, without limitation, OSHA required information, information regarding occupational exposure limits, toxicology studies and reports, and other health-related data. If reasonable industrial hygiene data is not available, DSM and Onyx will cooperate to develop necessary and reasonable data as mutually agreed. Notwithstanding the foregoing, the Parties agree that Onyx shall not be responsible for disclosing information relating to health risks to DSM for Excipients or Product Components purchased by DSM on behalf of Onyx hereunder.
ARTICLE 3: COORDINATORS; COMMUNICATIONS; PRODUCT DIVESTMENT
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
appointed. Each Party may replace its Coordinators at any time for any reason by providing written notice to the other Party in accordance with Section 20.11 hereof.
3.3.1 If during the Term of this Agreement, Onyx elects to assign or otherwise divest to any Third Party its drug rights to the Product in all or any portion of the Territory (the “Divested Product”), Onyx shall so advise DSM. Although the terms and conditions of such divestment shall be completely within the control of Onyx, the Parties agree that the terms and conditions of further development and/or manufacturing by DSM of such Divested Product under this Agreement shall [*].
3.3.2 Pending transfer of any Divested Product hereunder to a Third Party, Onyx agrees to be responsible for any Firm Purchase Commitments, take-or-pay, or minimum purchase requirements which have accrued hereunder in respect of such Divested Product. Onyx also agrees to be responsible for payment of purchased Product and sponsor compliance with respect to any Divested Product until such time as Onyx and the Third Party have completed the transfer of such rights by formal written assignment which is in form reasonably acceptable to DSM and applicable Regulatory Authorities.
ARTICLE 4: EQUIPMENT AND MATERIALS; API; ARTWORK
4.1 Equipment. Equipment owned by DSM and located at the DSM Facility, excluding the Onyx Equipment listed on ANNEX 2 which has been paid for by Onyx, shall not be dedicated to any single customer, but shall be available for manufacturing of product according to DSM’s manufacturing process requirements. Subject to the remainder of this Section 4.1, DSM shall be responsible for installing and qualifying at the DSM Facility, any and all new or used equipment, molds, and tooling necessary for the manufacturing, packaging, and labeling of the Product.
4.1.2 Maintenance. DSM shall be responsible for routine maintenance and servicing of Onyx Equipment so long as such Onyx Equipment remains at the DSM Facility. Onyx shall be responsible for the cost of non-routine maintenance and servicing of such Onyx Equipment (such as major repairs and parts replacement). DSM shall notify and seek prior approval from Onyx, such approval not to be unreasonably withheld, prior to the performance of any non-routine maintenance or servicing, and Onyx shall directly pay or promptly reimburse DSM (as the case may be) for any such maintenance or servicing costs that Onyx has authorized to be incurred and for which it is responsible hereunder.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
4.1.3 Onvx Eauioment and Onvx Materials. With regard to any Onyx Materials and Onyx Equipment provided by Onyx to DSM pursuant to this Agreement, Onyx shall provide DSM with all data and information as may be necessary to apprise DSM of the stability, proper storage, use, maintenance, safety and other characteristics and requirements of such Onyx Materials and Onyx Equipment as applicable, prior to their delivery to DSM, and Onyx shall supply any such Onyx Materials and Onyx Equipment in a manner that complies with applicable Law (including any permits necessary to ship such Onyx Materials and Onyx Equipment). DSM shall utilize Onyx Materials and Onyx Equipment solely for purposes of manufacturing pursuant to this Agreement, and shall use all such Onyx Materials and Onyx Equipment strictly in accordance with the terms and conditions of this Agreement (including compliance with CGMP). DSM shall not transfer any Onyx Materials and Onyx Equipment to any Third Party except pursuant to permitted subcontracting pursuant to Section 2.4 or with Onyx’s prior written consent in its sole discretion. At Onyx’s request, DSM shall account to Onyx for all Onyx Materials and Onyx Equipment provided to DSM hereunder. Subject to Section 13.5., DSM shall be responsible for replacing any Onyx Materials and Onyx Equipment, at DSM’s cost, in the event of any damages to any Onyx Materials or Onyx Equipment while at the DSM Facility. All Onyx Materials and Onyx Equipment shall be and remain the property of Onyx.
4.2 Active Pharmaceutical Ingredients and Excipients Supply.
4.2.1 Supply of API, Excipients. Onyx shall supply Active Pharmaceutical Ingredients and Captisol® meeting the specifications set forth or referenced in ANNEX 1 for production of the Product hereunder. DSM will supply Excipients and all other Product Components required to manufacture, test, package, label, and Release the Product; and such Excipients and other Product Components shall meet the applicable Specifications set forth or referenced in ANNEX 1.
4.2.2 Title to Materials. Onyx shall retain all rights, title and interest in and to Active Pharmaceutical Ingredients, Captisol®, and any other Onyx Materials supplied by Onyx for the production of Product hereunder.
4.2.3 Timely Delivery of API. In accordance with Section 6.4 hereinafter, Onyx agrees to supply API and Captisol® to DSM on a timely basis, with lead times as set forth in ANNEX 1, so as to enable DSM to receive, inspect, and prepare such API and Captisol® for production according to the schedule established by DSM in accordance with the terms of this Agreement. Onyx shall be responsible for any non-conforming API or Captisol® and/or production delays resulting therefrom except to the extent such production delays result on the part of DSM.
4.2.4 Consumption/Loss of API and Captisol. The expected yield of finished Product per unit of API utilized in the production of Product hereunder (excluding any validation Lots pursuant to the Development Agreement) on a per-SKU basis shall be [*] (the “Expected Yield”). The actual yield of finished Product (the “Average Consumption Ratio”) shall be determined on an annual basis as the average consumption of API per unit of finished Product for all Batches produced during the Contract Year. On an annual basis, DSM shall not be responsible for any loss of API so long as the Average Consumption Ratio is at least [*] of the Expected Yield. For loss of API in whole-Batch quantities, the Parties shall negotiate in good faith to allocate the responsibility for any such loss on the basis of the cause of the loss and the relative control of either Party over such causes. In the event that Onyx requires changes in the Specifications and/or production processes, the Expected Yield shall be modified [*] using the changed Specifications and/or production processes. In no event shall DSM’s liability for loss of API or Captisol in whole or partial batch quantities [*].
4.2.5 API Certificate of Compliance. For each shipment of API supplied hereunder by Onyx for sterilized Products, Onyx or its supplier shall provide a certificate of compliance to DSM stating that the API has been manufactured and tested for compliance with Specifications and cGMPs and
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
all other applicable terms and conditions of this Agreement and the Quality Agreement, and including such other terms as the parties may agree upon in writing.
4.2.6 Reimbursement of Costs. Onyx further agrees to reimburse DSM for (i) reasonable costs incurred by DSM in decontaminating its production facilities as a result of contamination caused by Onyx’s API and (ii) any direct damages suffered by DSM from a third party claim resulting from such contamination.
4.2.7 Latent Defects in API. Subject to Article 13, Onyx shall be responsible for ail rejected Lots and recall expenses relating to latent defects in the API which could not reasonably have been discovered by DSM in the course of inspection and testing of material according to cGMP and applicable SOPs.
4.3 Artwork. Unless an alternate time frame is mutually agreed upon by the parties, at least [*] prior to the Delivery Date for which new or modified artwork is required, Onyx shall provide at no cost to DSM, final camera ready artwork for all packaging components to be used in the manufacture of the Product, which artwork shall meet the Packaging Specifications.
4.4.4 Delayed/Rescheduled Runs. DSM shall work in conjunction with Onyx to use all reasonable commercial efforts to re-schedule any production run which is delayed due to Designated Vendor problems but the inability to do so shall not constitute a breach of this Agreement. If the production run cannot reasonably be rescheduled, then, upon Onyx’s payment of the Cancelled Production Fee, Onyx will accept the next available slot in DSM’s manufacturing schedule, but in no event shall DSM be obligated to re-schedule production if the next available slot is [*]. If DSM is unable to reschedule the cancelled production [*], then upon [*], the quantities so cancelled shall be deducted from the Firm Purchase Commitment. If DSM is able to reschedule the cancelled production [*], then the full Product Price shall be charged for such rescheduled quantities upon release of Qualified Lots, [*].
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
ARTICLE 5: WARRANTIES; SPECIFICATIONS; QUALITY
5.1.1 DSM represents and warrants to Onyx that the Commercial Product, at the time of sale and shipment to Onyx by DSM, (a) will conform to the Specifications as then in effect; (b) will have been manufactured in compliance with all applicable Laws and in accordance with CGMP, this Agreement and the Quality Agreement; (c) will be conveyed with good title, free and clear from any lawful security interest, lien or encumbrance; and (d) will not be (i) adulterated or misbranded by DSM within the meaning of the FD&C Act nor (ii) an article that may not be introduced into interstate commerce under the provisions of Sections 404 or 505 of the FD&C Act. In addition, DSM will use best efforts to ensure that Commercial Product, at the time of sale and shipment to Onyx shall (except for pre-launch Lots) have a minimum of [*] of the Product shelf life as per the applicable Product registrations still available at the time of delivery to Onyx. Such percentage is specifically based on [*] expiry for the Product. In the event that the expiry for the Product changes to be [*], DSM will use best efforts to ensure that Commercial Product, at the time of sale and shipment to Onyx shall (except for pre-launch Lots) have a minimum of [*] of the Product shelf life, provided Onyx provide DSM with written notice of such change in the expiry for the Product. DSM shall provide the Batch records for a Batch of Product within [*] of the date of manufacture of such Batch. If Onyx elects to conduct its own Batch record reviews, the remaining shelf life required hereunder shall be correspondingly reduced for the period of time required by Onyx for such review.
5.1.2 DSM further represents and warrants to Onyx that (a) neither DSM nor any of its officers, directors and employees, nor any person or entity used by DSM to perform services under this Agreement is (i) an individual who has been debarred by the FDA pursuant to Section 306 of the Act, 21 U.S.C. § 335), or (ii) a corporation, partnership or association that has been debarred by FDA pursuant to Section 306 of the Act, 21 U.S.C. § 335; (b) the handling, storage, destruction and disposal of all materials, including without limitation all waste, used or generated by DSM in connection with its performance under this Agreement will be conducted in compliance with all applicable Laws; and (c) any DSM Intellectual Property utilized in the methods and processes of manufacture of the Product by DSM under this Agreement shall not infringe any intellectual property rights of any Third Party, and DSM has not received any notice of any such claimed infringement (including without limitation patent infringement) by any Third Party. If at any time during the Term of this Agreement, DSM becomes aware that DSM or any person employed by DSM has been or is in the process of being debarred, DSM will immediately notify Onyx thereof in writing.
5.2 Additional Representations and Warranties.
5.2.1 DSM warrants and represents to Onyx that DSM has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof, and that the execution, delivery and performance of this Agreement by DSM does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor does it violate any Law of any court, governmental body or administrative or other agency having jurisdiction over it. DSM covenants to Onyx that DSM will not grant any right to any Third Party that would conflict with the rights granted to Onyx under this Agreement.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
5.2.2 Onyx warrants and represents to DSM that Onyx has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof, and that the execution, delivery and performance of this Agreement by Onyx does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor does it violate any Law of any court, governmental body or administrative or other agency having jurisdiction over it. Onyx covenants to DSM that Onyx will not grant any right to any Third Party that would conflict with the rights granted to DSM under this Agreement.
5.3 Disclaimer bv DSM. DSM expressly disclaims (a) any warranty that the Products (i) will be merchantable, (ii) will be fit for any particular purpose, or (iii) will not violate or infringe the patent or other intellectual property rights of any Third Party to the extent that they relate to any Onyx Intellectual Property, including the Product’s formulation or composition; (b) any other warranties with respect to the Product, express or implied, except as expressly stated in this Agreement; and (c) any warranties in respect of the formulation, composition, use, or distribution of the Product or in respect of the marketing and/or sale of the Product to third parties.
5.5.1 If, for any reason, during the Term Onyx changes the Specifications, Onyx shall provide DSM with prompt written notice of such changes; and if such changes directly impact DSM’s scheduling or costs, DSM shall promptly notify Onyx in writing as to any scheduling and/or price adjustments caused by such changes. Prior to implementation of such changes, the Parties agree to negotiate in good faith in an attempt to reach agreement on (a) the new price for any Product which embodies such changes, provided that the price shall not change more than the direct effect of such changes on DSM’s costs for the Product, and (b) any other amendments to this Agreement which may be necessitated by such changes (i.e., an adjustment to the lead time for Purchase Orders).
5.5.2 Onyx agrees to reimburse DSM for the reasonable expenses incurred by DSM as a result of such changes as set forth in Section 5.5.1, including, but not limited to, reimbursing DSM for its validation and development costs, capital expenditure costs and costs for any packaging components or other materials rendered unusable as a result of such changes.
5.5.3 If during the Term of this Agreement Onyx amends or is required by Law to amend the Specifications so as to render the Active Pharmaceutical Ingredients, Captisol®, Excipients, labeling and/or packaging components for any Product obsolete, Onyx shall (a) at Onyx’s option, purchase from DSM, at DSM’s Acquisition Cost, that amount of inventory of Excipients, labeling,
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
and packaging components so rendered obsolete, or (b) accept DSM’s return of such materials to Onyx and reimburse DSM any restocking fees incurred; and Onyx shall also purchase from DSM, at the applicable Product Price, that amount of inventory of Product which is rendered obsolete. Notwithstanding the foregoing, DSM shall in good faith try to use or resell such Excipients, labeling, or packaging components to manufacture a product for another customer, and DSM shall credit Onyx the Acquisition cost for any Excipients, labeling, or packaging components so used or resold. If DSM is unable to use or resell such Excipients, labeling, or packaging components, then Onyx shall, in addition to reimbursement of DSM’s Acquisition Cost for obsolete inventories, pay DSM a [*] service fee for return or destruction of product, plus the costs of any shipment or destruction of such inventories.
5.5.4 DSM shall not make any changes to Specifications without Onyx’s prior written consent.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
month rolling basis. If Onyx fails to update the Monthly Forecast by such deadline, then DSM shall be entitled to apply Onyx’s most recently forecasted requirements for such time frame in planning the production schedule for the Firm Commitment Period (as defined in Section 6.3); and in such event Onyx shall be obligated to purchase such quantities consistent with Onyx’s most recently forecasted requirements for such time frame to the extent that they become part of the Firm Purchase Commitment period as provided herein. If DSM is unable to accept (i) quantities stated for any new month in the Monthly Forecast, or (ii) quantities in excess of previously forecasted quantities (collectively, the quantities in (i) and (ii) referred to as “Additional Quantities”), then DSM shall notify Onyx in writing within [*] after receipt of the Monthly Forecast; otherwise such Additional Quantities shall be deemed to have been approved and accepted by DSM. The Parties shall negotiate in good faith to resolve any issues in respect of the Additional Quantities which DSM is unable to accept for any month(s) stated in the Monthly forecast, according to DSM’s available capacity.
6.4 Materials/Lead Times. DSM shall have the right, at any time, to order Excipients, and other materials necessary for the manufacture of Products in accordance with the lead-times set forth in ANNEX 1 hereto. In addition, if due to unanticipated circumstances, any Excipients require a longer lead-time, DSM shall be entitled to order such materials as it deems appropriate to fulfill its obligations hereunder; provided that DSM shall notify Onyx before any such order.
6.5 Quantities in Excess of Forecasts. Should any Purchase Order seek to purchase Product in amounts up to [*] in excess of the amounts set forth in the most recent Monthly Forecast provided by Onyx to DSM pursuant to Section 6.2 hereof, or should Onyx desire to increase the amount of Product to be manufactured pursuant to any Purchase Order already submitted, then DSM shall use reasonable commercial efforts to comply with such requested changes; but DSM shall not be liable to Onyx for any inability, despite its reasonable best efforts, to manufacture such excess quantities.
6.6 [*] Quantities. If Onyx forecasts [*] quantities for a [*] period during the term of this Agreement (the “[*] Forecast Period”), then DSM shall have the option, at its sole discretion, to provide a [*] notice to Onyx of DSM’s intention to terminate the Agreement on a stated day within the [*] Forecast Period; and Onyx shall thereafter have [*] either (i) to withdraw the [*] forecasts and re-submit a [*] forecast, or (ii) to negotiate other terms and conditions on which this Agreement shall remain in force and effect; otherwise, DSM shall have the right to terminate this Agreement at the end of the [*] notice period, effective on written notice of termination from DSM to Onyx.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
6.7.1 First (1st) priority: Medical necessity products over non-necessity products;
6.7.2 Second (2nd) priority: Products where there is no alternative therapy available over products where alternatives are available; and
6.7.3 Third (3rd) priority: Stock out of product over non-stock out of product.
ARTICLE 7: PURCHASE OF PRODUCT; RELEASE; DELIVERIES
7.1 Purchase Orders.
7.1.1 Except to the extent the Parties may otherwise agree with respect to a particular shipment, all Product shall be ordered by Onyx pursuant to one (1) or more written Purchase Orders (each, a “Purchase Order”), stating the Product, Unit quantities, and Delivery Dates, which shall be sent to DSM not less than [*] prior to the Delivery Dates specified in such Purchase Orders. Subject to Section 6.5, the Purchase Orders shall be consistent with the Firm Commitment Period of the then-current Monthly Forecast. Upon receipt of each Purchase Order by DSM hereunder, DSM shall be deemed to have automatically accepted all Purchase Orders consistent with the then-current Firm Commitment Period, and DSM shall use all commercially reasonable best efforts to supply the Product, in such quantities (with any variances permitted hereunder) and shall use its best efforts to deliver such Product to Onyx no later than [*] after the Delivery Dates specified in such Purchase Order.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
ARTICLE 8: PRICE; PRICE INCREASES; ADDITIONAL PAYMENTS
8.2 Price Increases/Decreases.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
8.5 Communication.
8.5.1 DSM shall provide Onyx with information reasonably required to satisfy Onyx’s financial reporting requirements under GAAP, as well as all information reasonably required for Onyx to satisfy applicable Law (including, without limitation, internal control testing and other requirements under the Xxxxxxxx-Xxxxx Act, as well as any applicable anti-slavery or human trafficking laws, ), including by providing the monthly inventory and transaction summaries provided in Section 8.5.2. Subject to Section 10.7, Onyx and its designees (subject to the remaining requirements of this Section 8.5.1) shall be entitled to audit DSM as to all such information reasonably required to satisfy Onyx’s requirements under applicable Law or in connection with Onyx’s financial reporting requirements under GAAP. In the event that Onyx requests that a third party designee audit DSM, DSM shall evaluate each request on a case by case basis and may require that each such third party designee execute a confidentiality agreement with confidentiality obligations at least as stringent as those contained in this Agreement. Notwithstanding execution of such an agreement between DSM and an Onyx designee, Onyx shall be [*] liable to DSM for any breach of that agreement by or any action or inaction of its third party designee.
8.5.2 The Parties will identify and implement appropriate communication tools under their respective information management systems such that DSM shall provide Onyx with appropriate inventory and transaction information on a monthly basis, including an adequate inventory of Product inventory (including API, Captisol®, Excipients, work-in-progress, completed but not yet Released Product, and Released Product that is not yet shipped) as well as a Product shipment transaction summary from the previous month.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
9.5 Over-Labeling. DSM shall not be responsible for reimbursing Onyx for Product recalls which result from over-labeling or re-labeling of Product which is effected by Onyx or any Third Party, after Product has been delivered by DSM to Onyx.
10.1 Validation. The Parties recognize that the validation lots of the Product have been manufactured pursuant to the Development Agreement.
10.2 Regulatory.
10.2.1 DSM will provide Onyx with standard regulatory support as identified in ANNEX 4 attached hereto, at no additional charge to Onyx. Additional regulatory services and/or documentation may be provided by DSM, subject to the agreement of the Parties and subject to additional charges.
10.2.2 Onyx shall provide to DSM a copy of Onyx’s annual report with respect to the manufacture and control of the Product; and Onyx shall take into consideration any DSM comments to such annual report with respect to the Product. DSM shall provide comments on the Annual Report to Onyx within three (3) business days after receipt. Notwithstanding the foregoing or anything in this Agreement to the contrary, Onyx shall be solely responsible for all regulatory strategy relating to the Product, including CMC matters.
10.3 Analytical and Validation Methodology. Any analytical and validation methodology supplied by Onyx and required for use by DSM in the production of Product hereunder (i) must be certified by Onyx to be appropriate for the intended use (e.g., cleaning verification, product release, in-process testing, and stability testing), (ii) must be validated per current regulatory guidelines, and (iii) must be readily available to DSM personnel during any regulatory inspection in the DSM Facility. Periodic re-certification of methods
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
validations may be required in accordance with CGMP. Required analytical and validation methodology which is not supplied by Onyx (or not previously developed by DSM for Onyx) will be developed by DSM, at Onyx’s expense, according to DSM’s standard rates for development.
10.4 Reference Standards. Reference standards required for API and key components of the Product which are readily available through the U.S. Pharmacopaeia shall be provided by DSM. If such reference standards are not readily available or must be made to order, they shall be obtained at Onyx’s expense, including any re-certifications thereof.
10.5 Stability Studies. DSM and Onyx acknowledge that stability studies will be conducted by a third party laboratory. DSM agrees to cooperate and support such stability studies and any associated activities; however, DSM shall not be responsible for any stability studies unless otherwise mutually agreed upon between the Parties.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Documentation arising under or otherwise resulting from DSM’s performance under this Agreement or for which DSM was reimbursed by Onyx under this Section 11.2.
11.4.1 The entry of a decree or order for relief by a court having jurisdiction in respect of the other Party in an involuntary case under the Federal Bankruptcy Code, as now constituted or hereafter amended, or under any other applicable federal or state insolvency or other similar law and the continuance of any such decree or order unstayed and in effect for a period of [*]; or
11.4.2 The filing by the other Party of a petition for relief under the Federal Bankruptcy Code, as now constituted or hereafter amended, or any other applicable federal or state insolvency or other similar law.
11.4.3 Immediately upon written notice from Onyx to DSM in the event that (a) Onyx does not receive Product Approval of the Product, or (b) the Product Approval for Product as submitted for approval by the FDA or any other Regulatory Authority is withdrawn, either by Onyx or the Regulatory Authorities.
11.4.4 Without limitation of each Party’s indemnification obligations set forth in Article 13, immediately by either Party, if a court of applicable jurisdiction orders a final judgment in that jurisdiction, that DSM’s manufacture, sale, or distribution of the Product as contemplated hereby, or Onyx’s exportation, manufacture, packaging, marketing, sale and/or distribution of the Product, as applicable, infringes any patent or other proprietary right of any other person, firm or corporation, and such judgment renders such Party unable to perform its material obligations under this Agreement; or
11.4.5 Immediately by either Party, if any proceeding in bankruptcy, reorganization or arrangement for the appointment of a receiver or a trustee to take possession of the other Party’s assets or any
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
similar proceeding under the law for the relief of creditors shall be instituted against the other Party; or if the other Party shall make an assignment for the benefit of its creditors.
11.5 Termination for [*] Forecasts. This Agreement may also be terminated by DSM in the event of [*] of [*] forecasts by Onyx, in accordance with Section 6.6 above.
12.1 Claims.
12.1.1 The Quality Agreement sets forth the procedures and standards the Parties will use in all determinations of whether or not Product manufactured and supplied under this Agreement is conforming or non-conforming Product for purposes of this Agreement, including without limitation DSM’s warranties under Section 5.1 hereof. In accordance with the terms of the Quality Agreement, promptly upon receipt of each shipment of the Product under this Agreement, Onyx shall use all commercially reasonable efforts to inspect (or cause to be inspected and tested if Product is shipped to a Third Party) such Product (and associated Release Documentation) for any damage, defect, deviation from Specifications, CGMP or the terms of this Agreement or the Quality Agreement, or any shortage in Product and Onyx shall provide DSM with prompt written notice of any damage, defect or deviation. DSM shall use all commercially reasonable efforts to resolve all deviations and discrepancies (if any) to the mutual reasonable satisfaction of the Parties in compliance with the Quality Agreement.
12.1.2 If the Product is non-conforming and it is determined under the Quality Agreement that the nonconformity is due to damage to the Product caused by Onyx or its agents, then DSM shall have no liability to Onyx with respect thereto. If the nonconformity is otherwise caused by DSM’s breach of this Agreement or the Quality Agreement or by negligent or grossly negligent acts or omissions or willful misconduct by DSM or its Affiliates, subcontractors, directors, officers, employees, or agents, then in addition to the provisions of Section 13.2, DSM shall credit Onyx’s
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
account for the price invoiced for such nonconforming Product as well as the Acquisition Costs (or, if applicable, pre-agreed designated costs) of the Active Pharmaceutical Ingredients and any other materials supplied by Onyx to DSM hereunder which were used in such nonconforming Product, together with all out-of-pocket expenses (including, without limitation, all shipping charges) associated with the purchase and return of the Product, and shall take title to and lawfully dispose of all of the non-conforming Product at DSM’s cost and expense. Notwithstanding the foregoing, in lieu of a credit, Onyx may request reimbursement of the amounts referenced in the immediately preceding sentence if there is no ongoing business between the Parties at the time that the foregoing amounts become due.
12.1.3 If payment for non-conforming Product has previously been made by Onyx, DSM shall, at Onyx’s option, (i) apply such credit against future orders, (ii) offset the amount thereof against other amounts then due DSM by Onyx hereunder, or (iii) replace such nonconforming Product with equal amounts of conforming Product at no additional cost to Onyx. In the alternative, Onyx may request that DSM return the total amount of the payment to Onyx within [*] of the request in the event that there is no ongoing business between the Parties at such time.
12.3 Product Holds/Rejects. DSM will notify Onyx of Product holds and/or rejects that may have an impact on the manufacturing process and that may require Onyx approval prior to resolution.
ARTICLE 13: INDEMNIFICATION OF THIRD PARTY CLAIMS
13.1 Indemnification by Onyx. Onyx shall indemnify, defend and hold DSM, its Affiliates and their respective directors, officers, employees, agents, successors and assigns, harmless from and against any damages, judgments, claims, suits, actions, liabilities, costs and expenses (including, but not limited to, reasonable attorneys’ fees) arising out of or in connection with any Third Party claim or suit arising solely out of (a) after passage of title and risk of loss for the Product to Onyx or its designee, the use, handling, distribution, marketing or sale of any Product manufactured by DSM hereunder, including claims of illness, injury, or death caused by the use of the Product, except to the extent such claim or suit is covered by DSM’s indemnification obligations under Section 13.2 below; (b) any alleged infringement of Third Party design, trademark, trade name or copyright rights, provided that the allegedly infringing design, trademark, trade name or copyrighted material appears on materials at Onyx’s request; (c) any alleged infringement of Third Party patent rights or any other proprietary rights by the manufacture or use of Product or other materials under this Agreement, provided that the allegedly infringing technology is Intellectual Property of Onyx or otherwise concerns proprietary rights claimed by Onyx and utilized by DSM in the production of the Product; (d) any negligent or grossly negligent act or omission or willful misconduct by Onyx or its Affiliates, directors, officers, employees or agents under this Agreement; (e) any claim by any employee of DSM, its subcontractors, or any third party of illness, injury or death arising out of Onyx’s failure to inform DSM of health risks pursuant to Section 2.8; (f) Onyx’s breach of this Agreement or the Quality Agreement; or (g) any liability related to over-labeling as provided in Section 9.5.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
judgments, claims, suits, actions, liabilities, costs and expenses (including, but not limited to, reasonable attorneys’ fees) arising out of or in connection with any Third Party claim or suit arising solely out of (a) DSM’s breach of this Agreement or the Quality Agreement; (b) any negligent or grossly negligent act or omission or willful misconduct of DSM or its Affiliates, subcontractors, directors, employees, contractors or agents under this Agreement; or (c) any alleged infringement of Third Party patent rights by the manufacture of the Product under this Agreement, provided that the allegedly infringing technology is Intellectual Property of DSM.
ARTICLE 14: CONFIDENTIALITY
14.1 During the term of this Agreement and for a period of [*] following termination or expiration of this Agreement, each of Onyx and DSM agrees not to publish, disclose or use for any purpose other than its performance hereunder, any information disclosed by the other Party which is Intellectual Property of the Disclosing Party (hereinafter defined), or which is designated as proprietary or confidential (“Confidential Information”) of the Disclosing Party, including, without limitation, information stored on audio or video tapes and disks, or information or knowledge visually acquired by or generated by Onyx or DSM personnel in the form of written notes and memoranda memorializing information or knowledge acquired visually, aurally or orally in the course of either Party’s performance hereunder.
14.2 Each Party (the “Receiving Party”) shall limit disclosure of Confidential Information received hereunder from the disclosing party (the “Disclosing Party”) to only those officers, employees and agents of the Receiving Party (or its Affiliates’) who are directly concerned with the performance of this Agreement. Each Party shall advise such officers, employees or agents upon disclosure of any Confidential Information
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
to them of the confidential nature of the Confidential Information and the terms and conditions of this Article 14, and shall use all reasonable safeguards to prevent unauthorized disclosure of the Confidential Information by such officers, employees and agents.
14.3 Both Parties agree that the following shall not be considered Confidential Information subject to this Agreement:
14.3.1 information that is in the public domain by publication or otherwise, provided that such publication is not in violation of this Agreement or any other confidentiality agreement;
14.3.2 information that the Receiving Party can establish in writing was in the Receiving Party’s possession prior to the time of disclosure by the Disclosing Party and was not acquired, directly or indirectly, from the Disclosing Party;
14.3.3 information that the Receiving Party lawfully receives from a Third Party; provided, however, that such Third Party was not obligated to hold such information in confidence;
14.3.4 information that, prior to the Disclosing Party’s disclosure thereof, was independently developed by employees of the Receiving Party without access to or reference to any Confidential Information as established by appropriate documentation; and
14.3.5 information that the Receiving Party is compelled to disclose by a court, administrative agency, or other tribunal or to comply with applicable Law; provided however, that in such case the Receiving Party shall immediately give as much advance notice as feasible to the Disclosing Party to enable the Disclosing Party to exercise its legal rights to prevent and/or limit such disclosure. In any event, the Receiving Party shall disclose only that portion of the Confidential Information that, in the opinion of the Receiving Party’s legal counsel, is legally required to be disclosed and will exercise reasonable best efforts to ensure that any such information so disclosed will be accorded confidential treatment by said court, administrative agency or tribunal, if available.
14.4 All Confidential Information shall remain the property of the Disclosing Party. Upon the termination or expiration of this Agreement, or at any time upon the request of the other Party, the Receiving Party shall immediately return or destroy any Confidential Information of the disclosing Party that is in the Receiving Party’s possession, custody or control, except that the Receiving Party may keep one (1) copy for archival purposes. The Disclosing Party’s failure to request the return of Confidential Information shall not relieve the Receiving Party of its confidentiality obligations under this Agreement.
14.5 Each Party acknowledges and expressly agrees that the remedy at law for any breach by it of the terms of this Article 14 shall be inadequate and that the full amount of damages which would result from such breach are not readily susceptible to being measured in monetary terms. Accordingly, in the event of a breach or threatened breach by either Party of this Article 14, the other Party may be entitled to immediate injunctive relief prohibiting any such breach and requiring the immediate return of all Confidential Information. The remedies set forth in this Section 14.5 shall be in addition to any other remedies available for any such breach or threatened breach, including the recovery of damages from the breaching Party.
14.6 The terms and conditions of this Agreement, but not the fact of its existence, shall constitute Confidential Information of Onyx, except that either Party may disclose such terms and conditions to its Affiliates or as required by applicable Law in accordance with Sections 14.2 or 14.3.5 hereof.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
ARTICLE 15: OWNERSHIP; INTELLECTUAL PROPERTY; LICENSE GRANTS
15.1 Intellectual Prooertv of DSM. All Intellectual Property (including, without limitation, Confidential Information) of DSM owned or licensed by DSM as of the Effective Date is and shall remain the exclusive property of DSM. All Intellectual Property generated or derived by DSM (or any of its subcontractors, if any) in the course of performing any services under this Agreement which has general application to manufacturing processes or formulation development of drug products or drug delivery systems shall be the exclusive property of DSM.
15.4 In the event that DSM proposes to use any process, technology, material or information in connection with the performance by DSM or any of its subcontractors (if any) of any services under this Agreement which is Intellectual Property (including know-how) outside the scope of the Development Agreement or this Agreement, DSM shall first notify Onyx in writing describing such proposal, and DSM shall incorporate such process, technology, material or information into services rendered pursuant to this Agreement only with Onyx’s prior written consent to such incorporation. In connection with any such use, DSM hereby grants to Onyx a fully paid-up, royalty-free, perpetual, irrevocable, fully transferable, worldwide, non-exclusive license (with the right to sublicense) to use any such process, technology, material or information as part of the grant of rights to Onyx under Section 15.3 above.
15.5 This Article 15 shall survive the termination or expiration of this Agreement.
16.1 Effects of Force Majeure. Neither Party shall be held liable or responsible for failure or delay in fulfilling or performing any of its obligations under this Agreement in case such failure or delay is due to any condition beyond the reasonable control of the affected Party including, Acts of God, strikes or other labor disputes, war, riot, earthquake, tornado, hurricane, fire, civil disorder, explosion, accident, flood, sabotage, lack of or inability to obtain adequate fuel, power, materials, labor, containers, transportation, supplies or equipment, breakage or failure of machinery or apparatus, national defense requirements, or supplier strike, lockout or injunction (a “Force Majeure Event”). Such excuse shall continue as long as the Force Majeure Event continues, provided, however, that Onyx may cancel without penalty any and all Purchase Orders in the event DSM is unable to fulfill an outstanding Purchase Order within [*] of its scheduled delivery date due to a Force Majeure Event and Onyx shall receive an extension to its Firm Purchase Commitment commensurate to the period of time for such Force Majeure Event. Upon cessation of such Force Majeure Event, such Party shall promptly resume performance on all Purchase Orders which have not been terminated.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
17.1 Legal Compliance. Each Party shall comply in all material respects with all Laws applicable to the conduct of its business pursuant to this Agreement, including, but not limited to, the FD&C Act and CGMP.
ARTICLE 18: PRESS RELEASES; USE OF NAMES
18.1 Press Releases. Any press release, publicity or other form of public written disclosure related to this Agreement prepared by one Party shall be submitted to the other Party prior to release for approval, which approval shall not be unreasonably withheld or delayed by such other Party; provided, however, that Onyx and DSM’s parent company Affiliate may announce the signing of this Agreement in their quarterly results release without prior approval.
18.2 Use of Names. Except as expressly provided or contemplated hereunder and except as otherwise required by applicable Law, no right is granted pursuant to this Agreement to either Party to use in any manner the trademarks or name of the other Party, or any other trade name, service xxxx, or trademark owned by or licensed to the other Party in connection with the performance of this Agreement. Notwithstanding the above, as may be required by applicable Law, Onyx, DSM and their Affiliates shall be permitted to use the other Party’s name and to disclose the existence and terms of this Agreement in connection with securities or other public filings or to comply with applicable Law.
ARTICLE 19: DISPUTE RESOLUTION
ARTICLE 20: MISCELLANEOUS
20.1 Insurance.
20.1.1 ONYX Insurance. During the Term of this Agreement, Onyx shall procure and maintain (a) Commercial General Liability Insurance, including Contractual Liability, and (b) Global Products Liability coverage (collectively, the “Onyx Insurance”). The Onyx Insurance shall cover amounts not less than [*] combined single limit and shall be with an insurance carrier with an A.M. Best rating of A-VII or better. Onyx promptly shall deliver a certificate of Onyx Insurance and endorsement of additional insured to DSM evidencing such coverage. Any deductible and/or self-insurance retention shall be the sole responsibility of Onyx.
20.1.2 DSM Insurance. During the Term of this Agreement and until final acceptance by Onyx of all work performed in connection with this Agreement (should such final acceptance occur later than expiration of the Term) for [*] thereafter, DSM shall procure and maintain (i) Commercial General Liability Insurance, including Contractual Liability, and (ii) Global Products Liability coverage (collectively, the “DSM Insurance”). The DSM Insurance shall cover amounts not less than [*] combined single limit and shall be with an insurance carrier with an A.M. Best rating of
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
A-VII or better. Onyx shall be named as an additional insured on the DSM Insurance and DSM promptly shall deliver a certificate of DSM Insurance and endorsement of additional insured to Onyx evidencing such coverage. Any deductible and/or self-insurance retention shall be the sole responsibility of DSM.
20.3 Assistance from Onvx. To assist DSM in its performance of this Agreement, Onyx shall provide DSM, in a timely fashion, with all relevant information, documentation and data (including without limitation any information, documentation and data relating to Product safety and information, documentation and data, including NDA and/or other Regulatory Documentation numbers, NDC codes, etc., necessary for DSM to drug list the Product) which is necessary or appropriate for DSM’s performance hereunder. If requested by DSM to provide support or information, Onyx shall provide such support or information (or an explanation of the legitimate reason for any delay and a projected date by which such support or information will be provided) within [*] of DSM’s request. In the event Onyx is to review or approve any information, documentation, data or samples prepared or supplied by or on behalf of DSM, it shall complete such review and approval process within [*].
20.4 Assignment. This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party, which consent shall not unreasonably be withheld, except that either Party may assign this Agreement in the event of a change of control, including a merger or acquisition, provided that the other Party is provided with written notice within [*] of any such merger or acquisition. Any purported assignment in violation of the preceding sentence shall be void. Any permitted assignee shall assume all obligations of its assignor under this Agreement, and no assignment shall relieve either Party of responsibility for the performance of any obligation which accrued prior to the effective date of such assignment. Upon any notice from DSM to Onyx pursuant to this Section 20.4, DSM or its assignee of this Agreement shall provide Onyx with the opportunity to purchase up [*] Product during the eighteen (18) month advance notice period at the pricing then in effect at the time of the notice of assignment.
20.5 Continuing Obligations. Termination, assignment or expiration of this Agreement shall not relieve either Party from full performance of any obligations incurred prior thereto.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
If to DSM: DSM Pharmaceuticals, Inc.
0000 Xxxxxx Xxxxxx Xxxx Xxx.
Xxxxxxxxxx, XX 00000
Attn: Xxxxx Xxxxx, President
If to Onyx Pharmaceuticals International GmbH:
Xxxxxxxxxxx 00
0000 Xxx Xxxxxxxxxxx
Attn: General Manager
If to Onyx Pharmaceuticals, Inc.:
000 Xxxx Xxxxx Xxxxxx
Xxxxx Xxx Xxxxxxxxx, XX 00000
Attn: General Counsel
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
shall be effected by the acknowledgment or acceptance of any Purchase Order or shipping instruction forms or similar documents containing terms or conditions at variance with or in addition to those set forth herein.
20.16 Annexes. The following annexes are attached hereto and incorporated herein by reference:
ANNEX 1: Product Specifications, Packaging Specifications, and Other Information
ANNEX 2: Onyx Materials and Equipment and Other Capital Equipment
ANNEX 3: Quality Agreement
ANNEX 4: Additional Regulatory Support
ANNEX 5: Product Pricing
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
ANNEX 1:
PRODUCT SPECIFICATIONS, PACKAGING SPECIFICATIONS, PRICING,
AND OTHER INFORMATION
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
ANNEX 2: ONYX MATERIALS AND EQUIPMENT AND OTHER CAPITAL EQUIPMENT
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
ANNEX 3: QUALITY AGREEMENT
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
ANNEX 4: REGULATORY SUPPORT
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.