EX-10.15 14 a2233117zex-10_15.htm EX-10.15 DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT
Exhibit 10.15
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT
THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made as of December 21, 2016 (the “Effective Date”) by and between RHYTHM PHARMACEUTICALS, INC., a Delaware corporation with offices at 000 Xxxxxxxx Xxxxxx, 00xx Xxxxx, Xxxxxx, XX 00000, XXX (“Rhythm”) and RECIPHARM MONTS SAS, a French corporation with an office at 00 xxxxx xx Xxxxxxxxx, 00 000 Xxxxx, Xxxxxx (“Manufacturer”).
AGREEMENT:
1.1 “Affiliate” means, with respect to either Rhythm or Manufacturer, any corporation, company, partnership, joint venture and/or firm which controls, is controlled by or is under common control with Rhythm or Manufacturer, as the case may be. As used in the definition of Affiliate, “control” means (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors (or such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction), and (b) in the case of non-corporate entities, the direct or indirect power to manage, direct or cause the direction of the management and policies of the non-corporate entity or the power to elect at least fifty percent (50%) of the members of the governing body of such non-corporate entity.
1.2 “Agreement” means this Development and Manufacturing Services Agreement, together with all Appendices attached hereto, as amended from time to time by the parties in accordance with Section 15.6, and all fully signed Work Orders entered into by the parties.
1.3 “API/Drug Substance” means the active pharmaceutical ingredient or drug substance identified on the applicable Work Order, or any intermediate or component of such active pharmaceutical ingredient or drug substance.
1.4 “Applicable Law” means all applicable UK, United States and European Union ordinances, rules, regulations, laws, guidelines, guidances, requirements and court orders of any kind whatsoever of any Authority, as amended from time to time including, without limitation, cGMP (if applicable) together with those of such additional jurisdictions as the parties may from time to time agree in writing.
1.5 “Authority” means any government regulatory authority responsible for granting approvals for the performance of Services under this Agreement or for issuing regulations pertaining to the Manufacture and/or use of Product in the intended country of use being at the date hereof the ANSM and the FDA, together with such additional government regulatory authorities as the parties may from time to time agree in writing.
CONFIDENTIAL
1.6 “Batch” means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch record.
1.7 “Batch Documentation” has the meaning set forth in Section 6.2.
1.8 “Certificate of Analysis” means a document signed by an authorized representative of Manufacturer, describing Specifications for, and testing methods applied to, Product, and the results of testing.
1.9 “Certificate of Compliance” means a document, signed by an authorized representative of Manufacturer, certifying that a particular Batch was Manufactured in accordance with cGMP (if applicable), all other Applicable Law, and the Specifications.
1.10 “cGMP” means current good manufacturing practices and regulations applicable to the Manufacture of Product that are promulgated by any Authority.
1.11 “Change Order” has the meaning set forth in Section 5.3.
1.12 “Confidential Information” has the meaning set forth in Section 10.
1.13 “Delivery “ means availability of a Batch at the Facility following Rhythm’s acceptance in accordance with Section 6.3.
1.14 “Develop” or “Development” means the studies and other activities conducted by Manufacturer under this Agreement to develop, implement and/or validate all or any part of a Manufacturing Process including, without limitation, analytical tests and methods, formulations and dosage forms and stability.
1.15 “Equipment” means any equipment or machinery, including Rhythm Equipment, used by Manufacturer in the Development and/or Manufacturing of Product, or the holding, processing, testing, or release of Product.
1.16 “Facility” means the facility(ies) of Manufacturer identified in the applicable Work Order.
1.17 “FDA” means the United States Food and Drug Administration, and any successor agency having substantially the same functions.
1.18 “FDCA” means the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §321 et seq., as amended from time to time.
1.19 “force majeure” has the meaning set forth in Section 15.2.
1.20 “Improvements” means all Technology and discoveries, inventions, developments, modifications, innovations, updates, enhancements, improvements, writings or rights (whether or not protectable under patent, trademark, copyright or similar laws) that are conceived, discovered, invented, developed, created, made or reduced to practice in the performance of Services under this Agreement.
1.21 “IND” means an Investigational New Drug application filed with the FDA in accordance with Applicable Law.
1.22 “Manufacture” and “Manufacturing” means any steps, processes and activities necessary to produce Product including, without limitation, the manufacturing, processing, primary packaging, labeling (except for investigational materials for clinical trials), quality control testing, stability testing, release, storage or supply of Product.
1.23 “Manufacturer Indemnitees” has the meaning set forth in Section 12.2.
1.24 “Manufacturer Technology” means the Technology of Manufacturer (a) existing prior to the Effective Date, or (b) developed or obtained by or on behalf of Manufacturer independent of this Agreement and without reliance upon the Confidential Information of Rhythm.
1.25 “Manufacturing Process” means any and all processes and activities (or any step in any process or activity) used or planned to be used by Manufacturer to Manufacture Product, as evidenced in the Batch Documentation or master Batch Documentation.
1.26 “New Drug Application” means a New Drug Application filed with the FDA in accordance with Applicable Law.
1.27 “Product” means any API/Drug Substance or drug product comprised of API/Drug Substance in each case as specified in the applicable Work Order, including, if applicable, bulk packaging and/or labeling as provided in such Work Order.
1.28 “Quality Agreement” has the meaning set forth in Section 2.2.
1.29 “Records” has the meaning set forth in Section 5.4(a).
1.30 “Representative” has the meaning set forth in Section 3.1.
1.31 “Reprocess” and “Reprocessing” means introducing a Product back into the process and repeating appropriate manipulation steps that are part of the established Manufacturing Process. Continuation of a process step after an in-process control test show the process to be incomplete is not considered reprocessing.
1.32 “Rework” and “Reworking” means subjecting a Product to one or more processing steps that are different from the established Manufacturing Process.
1.33 “Rhythm Equipment” means the Equipment, if any, identified on the applicable Work Order as being provided by Rhythm or purchased or otherwise acquired by Manufacturer at Rhythm’s expense.
1.34 “Rhythm Indemnitees” has the meaning set forth in Section 12.1.
1.35 “Rhythm Materials” means the materials identified in the applicable Work Order as being provided by Rhythm, including labels (if any) for Product.
1.36 “Rhythm Technology” means (a) Rhythm Materials and any intermediates, components, or derivatives of Rhythm Materials, (b) Product and any intermediates, components, or derivatives of Product, (c) Specifications, and (d) the Technology of Rhythm or its Affiliates (i)
existing prior to the Effective Date, or (ii) developed or obtained by or on behalf of Rhythm or its Affiliates independent of this Agreement and without reliance upon the Confidential Information of Manufacturer.
1.37 “Services” means the Development, Manufacturing and/or other services described in a Work Order entered into by the parties.
1.38 “Specifications” means the list of tests, references to any analytical procedures and appropriate acceptance criteria which are numerical limits, ranges or other criteria for tests described in order to establish a set of criteria to which Product at any stage of Manufacture should conform to be considered acceptable for its intended use that are provided by or approved by Rhythm, as such specifications are amended or supplemented from time to time by the parties in writing.
1.39 “Technology” means all methods, techniques, trade secrets, copyrights, know-how, data, documentation, regulatory submissions, specifications and other intellectual property of any kind (whether or not protectable under patent, trademark, copyright or similar laws).
1.40 “Work Order” means a written work order referencing this Agreement, substantially in the form attached hereto as Appendix A. for the performance of Services by Manufacturer under this Agreement.
2. Engagement of Manufacturer.
2.1 Services and Work Orders. From time to time, Rhythm may wish to engage Manufacturer to perform Services for Rhythm. Such Services will be set forth in a Work Order. Each Work Order will be appended to this Agreement, will include the material terms for the project, and may include the scope of work, specified Services, Specifications, deliverables, timelines, milestones (if any), quantity, budget, payment schedule and such other details and special arrangements as are agreed to by the parties with respect to the activities to be performed under such Work Order. No Work Order will be effective unless and until it has been agreed to and signed by authorized representatives of both parties. Documents relating to the relevant project, including without limitation Specifications, proposals, quotations and any other relevant documentation, will only be effective if attached to the applicable Work Order and incorporated in the Work Order by reference. Each fully signed Work Order will be subject to the terms of this Agreement and will be incorporated herein and form part of this Agreement. Manufacturer will perform the Services specified in each fully signed Work Order, as amended by any applicable Change Order(s), and in accordance with the terms and conditions of such Work Order and this Agreement. Notwithstanding the foregoing, nothing in this Agreement will obligate either party to enter into any Work Order under this Agreement.
in accordance with the Specifications and cGMP (if applicable), and in such a way as to be able at all times to clearly distinguish such materials from products and materials belonging to Manufacturer, or held by it for a third party’s account. Manufacturer will ensure that Rhythm Materials, Product, any intermediates and components of any Rhythm Materials or Product, and any work in process are free and clear of any liens or encumbrances. Manufacturer will at all times take such measures as are required to protect the Rhythm Materials, Product, any intermediates and components of any Rhythm Materials or Product, and any work in process from risk of loss or damage at all stages of the Manufacturing Process. Manufacturer will immediately notify Rhythm if at any time it believes any Product or Rhythm Materials, or any intermediates and components of any Rhythm Materials or Product, have been damaged, lost or stolen.
5. Development and Manufacture of Product.
5.1 Resources; Applicable Law. Manufacturer will comply with all Applicable Law in performing Services.
(a) Performance of Services. Manufacturer will perform all Services at the Facility, provide all staff necessary to perform the Services in accordance with the terms of the applicable Work Order and this Agreement, and hold at such Facility all Equipment, Rhythm Equipment, Rhythm Materials and other items used in the Services. Manufacturer will not change the location of such Facility or use any additional facility for the performance of Services under this Agreement without at least one hundred fifty (150) days prior written notice to, and prior written consent from, Rhythm, which consent will not be unreasonably withheld or delayed (it being understood and agreed that Rhythm may withhold consent pending satisfactory completion of a quality assurance audit and/or regulatory impact assessment of the new location or additional facility, as the case may be). Manufacturer will maintain, at its own expense, the Facility and all Equipment required for the Manufacture of Product in a state of repair and operating efficiency consistent with the requirements of cGMP (if applicable) and all Applicable Law.
(c) Licenses and Permits. Manufacturer will be responsible for obtaining, at its expense, any Facility or other licenses or permits, and any regulatory and government approvals necessary for the performance of Services by Manufacturer under this Agreement. At Rhythm’s request, Manufacturer will provide Rhythm with copies of all such approvals and submissions to Authorities, and Rhythm will have the right to use any and all information contained in such approvals or submissions in connection with regulatory approval and/or commercial development of Product.
(d) Access to Facility. Manufacturer will permit Rhythm or its duly authorized representatives, upon reasonable advance written notice, to observe and consult with Manufacturer during the performance of Services under this Agreement, including without limitation the Manufacturing of any Batch of Product. Manufacturer also agrees that Rhythm and its duly authorized agents will have continuous access, during operational hours and during active Manufacturing, to inspect the Facility and Manufacturing Process, with reasonable scope and frequency, to ascertain compliance by Manufacturer with the terms of this Agreement, including, without limitation, inspection of (i) the Equipment and materials used in the performance of Services, (ii) the holding facilities for such materials and Equipment, and (iii) all Records relating to such Services and the Facility. Rhythm will also have the right, at its expense, to conduct “mock” pre-approval audits upon reasonable notice to Manufacturer, and Manufacturer agrees to cooperate with Rhythm in such “mock audits.” A “mock audit” will not be conducted more than once a year during maximum 2 days with 2 persons. The cost of any other audits shall be quoted and agreed.
5.3 Changes to Work Orders. Manufacturing Process and Specifications.
(b) Process/Specifications Changes. Any change or modification to the Manufacturing Process or Specifications for any Product must be approved in advance by Rhythm and will be made in accordance with the change control provisions of the applicable Quality Agreement. In the event that the parties’ compliance with Applicable Law (including but not limited to any change thereto or change in interpretation thereof by any Authority) requires any change to the Product or Manufacturing Process, the parties shall negotiate in good faith with respect to an appropriate amendment to this Agreement and associated documentation (including any applicable Work Order and applicable Quality Agreement) to implement such change.
5.4 Record and Sample Retention.
(b) Sample Retention. Manufacturer will take and retain, (i) for such period and in such quantities as may be required by cGMP (or other applicable Authority), and (ii) for such additional period and in such additional quantities as may be required by the applicable Quality Agreement, samples of Product from the Manufacturing Process produced under this Agreement. Further, upon Rhythm’s written request, Manufacturer will submit such samples to Rhythm, except to the extent that Manufacturer is required by applicable cGMP to retain possession of any such samples pursuant to the preceding clause (i).
(a) Regulatory Approvals. Rhythm will be responsible for obtaining, at its expense, all regulatory and governmental approvals and permits necessary for Rhythm’s use of any Product Developed and/or Manufactured under this Agreement, including, without limitation, IND, ANDA, and NDA submissions and any analogous submissions filed with the appropriate Authority of a country other than the United States. Manufacturer will be responsible for providing Rhythm with all supporting data and information relating to the Development and/or Manufacture of Product necessary for obtaining such approvals, including, without limitation, all Records, raw data, reports, authorizations, certificates, methodologies, Batch Documentation, raw material specifications, SOPs, standard test methods, Certificates of Analysis, Certificates of Compliance and other documentation in the possession or under the control of Manufacturer relating to the Development and Manufacture of Product (or any intermediate, or component of Product).
(b) Regulatory Inspections. Manufacturer will permit Rhythm or its agents to be present and participate in any visit or inspection by any Authority of the Facility (to the extent it relates in any way to any Product) or the Manufacturing Process. Manufacturer will to the extent the same relates to or affects the Development and/or Manufacture of Product give as much advance notice as possible to Rhythm of any such visit or inspection described in the preceding sentence. Manufacturer will provide Rhythm with a copy of any report or other written communication received from such Authority in connection with such visit or inspection, and any written communication received from any Authority relating to any Product, the Facility (if it relates to or affects the Development and/or Manufacture of Product) or the Manufacturing Process, within twenty-four (24) hours after receipt, and will consult with, and require approval from, Rhythm before responding to each such communication; provided, that the copies of such communications
and responses so provided to Rhythm by Manufacturer may be redacted as necessary to remove customer names and product or manufacturing information unrelated to the Development and/or Manufacture of Product. Rhythm shall provide its responses in a timely manner to enable Manufacturer to comply with any timeframes for response to imposed by such Authority. Manufacturer will provide Rhythm with a copy of its final responses within five (5) business days after submission.
5.7 Safety Procedures. Manufacturer will be solely responsible for implementing and maintaining health and safety procedures for the performance of Services and for the handling of any materials or hazardous waste used in or generated by the Services. Manufacturer, in consultation with Rhythm, will develop safety and handling procedures for API/Drug Substance and Product as specified in the Specifications; provided, however, that Rhythm will have no responsibility for Manufacturer’s health and safety program.
6. Testing and Acceptance Process.
and/or was not Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process. Within eight (8) working days following Rhythm’s delivery of written notice of acceptance of a Batch, Rhythm shall provide to Manufacturer the information required by Section 7(a) and (b) and arrange for collection of the Batch by it or its designee.
(a) refund in full the fees and expenses paid by Rhythm for such Batch, including, but not limited to, the cost of Rhythm Materials used in the Manufacture of such Batch; or
(b) at Manufacturer’s cost and expense, including, but not limited to, the cost of Rhythm Materials used in the Manufacture of such Batch, Manufacture a new Batch of Product as soon as reasonably possible; or
(c) where deemed possible by Manufacturer Rework or Reprocess the Product, at Manufacturer’s cost and expense, so that the Batch can be deemed to have been Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process, and to conform to Specifications.
The parties agree that the table in Schedule 1 is indicative of the responsibility for such a failure, Moreover, the parties will meet to discuss, evaluate and analyze the reasons for and implications of the failure to comply with cGMP (if applicable) and/or the Manufacturing Process and will decide whether to proceed with or to amend the applicable Work Order via a Change Order, or to terminate such Work Order.
Rhythm in accordance with Section 6.3, and (b) in accordance with the instructions for shipping and packaging specified by Rhythm in the applicable Work Order or as otherwise agreed to by the parties in writing. Delivery terms will be EXW Recipharm Monts site (Incoterms 2010). All required information to permit shipment and a xxxx of lading will be furnished to Rhythm with respect to each shipment.
(a) Where the parties intend that Manufacturer will bear the VAT cost of the importing of excipients into France on behalf of Rhythm, Manufacturer shall invoice the amount of such anticipated VAT (as determined by Manufacturer in good faith) (plus an administration fee of 5%) to Rhythm three (3) weeks in advance of the anticipated payment date of such VAT. Rhythm shall pay such invoice as soon as reasonably practicable so as to assure that Manufacturer has received cleared funds prior to making the payment of such VAT. Upon determination of the actual amount of such VAT due and payable, Manufacturer shall promptly (i) pay such amount to the applicable taxing authority; (ii) provide documentation reasonably acceptable to Rhythm with respect to both the actual amount of such VAT and Manufacturer’s payment thereof; and (iii) refund to Rhythm the excess amount (if any) previously paid by Rhythm pursuant to the first two sentences of this Section 8.2(a) over such actual amount of such VAT paid by Manufacturer, or, if such actual amount of such VAT paid by Manufacturer exceeds such amounts previously paid by Rhythm, invoice Rhythm for the amount of such deficiency (any such invoice shall be due thirty (30) days after receipt of such invoice and reasonable supporting documentation by Rhythm).
9. Intellectual Property Rights.
other right to Rhythm Technology except for the limited purpose of carrying out its duties and obligations under this Agreement and that such limited, non-exclusive, license will expire upon the completion of such duties and obligations or the termination or expiration of this Agreement, whichever is the first to occur.
Information will not be deemed to be part of the “public domain” by reason solely that it is known to only a few of those people to whom it might be of commercial interest, and a combination of two (2) or more portions of the Confidential Information shall not be deemed to be generally available to the public by reason solely of each separate portion being so available.
11. Representations and Warranties.
11.1 Manufacturer’s Representations and Warranties. Manufacturer represents and warrants to Rhythm that:
(a) it has the full power and right to enter into this Agreement and that there are no outstanding agreements, assignments, licenses, encumbrances or rights of any kind held by other parties, private or public, that are inconsistent with the provisions of this Agreement;
(b) the execution and delivery of this Agreement by Manufacturer has been authorized by all requisite corporate action and this Agreement is and will remain a valid and binding obligation of Manufacturer, enforceable in accordance with its terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of debtors;
(c) the Services will be performed with requisite care, skill and diligence, in accordance with Applicable Law and industry standards, and by individuals who are appropriately trained and qualified;
(d) it has and shall continue to have written agreements with its directors, officers, employees, agents, permitted subcontractors and representatives to effectuate the terms of this Agreement, including without limitation Sections 9 and 10 hereof, and shall enforce such agreements to provide Rhythm with the benefits thereof;
(e) the conduct and the provision of the Services will not violate any patent, trade secret or other proprietary or intellectual property rights of any third party and it will promptly notify Rhythm in writing should it become aware of any claims asserting such violation;
(f) it shall not knowingly use or incorporate any invention, discovery, technology, know-how and/or other intellectual property that is not owned by, or otherwise assignable by, Manufacturer in the performance of the Services without the prior written consent of Rhythm;
(g) at the time of delivery to Rhythm, the Product Manufactured under this Agreement (i) will have been Manufactured in accordance with cGMP (if applicable) and all other Applicable Law, the Manufacturing Process, the applicable Quality Agreement, and Specifications, and (ii) will not be adulterated or misbranded under the FDCA or other Applicable Law; and
(h) Manufacturer, its Affiliates, approved subcontractors, and each of their respective officers and directors, as applicable, and any person used by Manufacturer, its Affiliates or approved subcontractors to perform Services under this Agreement (i) have not been debarred and are not subject to a pending debarment, and will not use in any capacity in connection with the Services any person who has been debarred or is subject to a pending debarment pursuant to section 306 of the FDCA, 21 U.S.C. § 335a, (ii) are not ineligible to participate in any federal and/or state healthcare programs or federal procurement or non-procurement programs (as that term is defined in 42 U.S.C. 1320a-7b(f)), (iii) are not disqualified by any government or regulatory agencies from performing specific services, and are not subject to a pending disqualification proceeding, and (iv) have not been convicted of a criminal offense related to the provision of healthcare items or services and are not subject to any such pending action. Manufacturer will notify Rhythm immediately if Manufacturer, its Affiliates, approved subcontractors, or any of their respective officers or directors, as applicable, or any person used by Manufacturer, its Affiliates or approved subcontractors to perform Services under this Agreement is subject to any of the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best of Manufacturer’s knowledge, is threatened.
11.2 Rhythm Representations and Warranties. Rhythm represents and warrants to Manufacturer that:
(a) it has the full power and right to enter into this Agreement and that there are no outstanding agreements, assignments, licenses, encumbrances or rights held by other parties, private or public, that are inconsistent with the provisions of this Agreement; and
(b) the execution and delivery of this Agreement by Rhythm has been authorized by all requisite corporate action and this Agreement is and will remain a valid and binding obligation of Rhythm, enforceable in accordance with its terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of debtors.
(a) NEITHER PARTY WILL BE LIABLE TO THE OTHER UNDER ANY LEGAL THEORY (WHETHER TORT, CONTRACT OR OTHERWISE) FOR SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, HOWEVER CAUSED, EVEN IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, EXCEPT AS A RESULT OF A BREACH OF THE CONFIDENTIALITY AND NON-USE OBLIGATIONS IN SECTION 10. NOTHING IN THIS SECTION 12.5 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY.
(b) Subject to Section 12.5(a), 12.5(c) and 12.6, the total liability of Manufacturer to Rhythm with respect to Services to be performed and Product supplied pursuant to this Agreement shall not exceed 100% of the amounts paid or payable by Rhythm to Manufacturer in respect of such Product under a Work Order, plus any applicable interest and/or legal fees. For avoidance of doubt, the limitation of liability contained in this Section 12.5(b) shall not apply to any indemnity obligations of Manufacturer pursuant to Section 12.1.
(c) The total liability of Manufacturer to Rhythm with respect to any inability of Manufacturer to return any API/Drug Substance and/or Rhythm Materials (a) supplied to Manufacturer by Rhythm, and (b) not incorporated into finished Product delivered to Rhythm hereunder, shall not exceed 50,000 Euros.
(a) Commercial General Liability, including coverage for contractual liability assumed by Manufacturer and coverage for Manufacturer’s independent contractor(s), with a general aggregate limit of not less than Two Million United States Dollars ($2,000,000);
(b) Public and Products Liability, exclusive of the coverage provided by the Commercial General Liability policy, with at least Two Million United States Dollars ($2,000,000) per occurrence and an aggregate limit of Two Million United States Dollars ($2,000,000);
(c) “All Risk” Property, valued at replacement cost, covering loss or damage to the Facility and Rhythm’s property and materials in the care, custody, and control of Manufacturer; and
(d) Contingent Motor Liability and Employer’s Liability, in such amounts and under such terms as are customary for similar companies providing like services.
(a) Rhythm and its Affiliates are named as an additional insured with respect to matters arising from this Agreement;
(b) such insurance is primary and non-contributing to any liability insurance carried by Rhythm.
In addition, Manufacturer shall provide written notice to Rhythm within 20 days following any material change or cancellation of any of its insurance coverages referenced in Section 13.1.
13.3 Insurance Information. Manufacturer will comply, at Rhythm’s expense, with reasonable requests for information made by Rhythm’s insurance provider representative(s), including permitting such representative(s) to inspect the Facility during operational hours and upon reasonable notice to Manufacturer. In regard to such inspections, the representative(s) will adhere to such guidelines and policies pertaining to safety and non-disclosure as Manufacturer may reasonably require.
(a) the other party files a petition in bankruptcy, or enters into an agreement with its creditors, or applies for or consents to the appointment of a receiver or trustee, or makes an assignment for the benefit of creditors, or becomes subject to involuntary proceedings under any bankruptcy or insolvency law (which proceedings remain undismissed for sixty (60) days);
(b) the other party fails to start and diligently pursue the cure of a material breach of this Agreement within thirty (30) days after receiving written notice from the other party of such breach; or
(c) a force majeure event that will, or continues to, prevent performance (in whole or substantial part) of this Agreement or any pending Work Order for a period of at least ninety (90) days. In the case of a force majeure event relating solely to a pending Work Order, the right to terminate will be limited to such Work Order.
(a) immediately cancel, to the greatest extent possible, any third party obligations;
(b) promptly inform Rhythm of any irrevocable commitments made in connection with any pending Work Order(s) prior to termination;
(c) to the greatest extent possible promptly return to the vendor for a refund all unused, unopened materials in Manufacturer’s possession that are related to any pending Work Order; provided, that Rhythm will have the option, but not the obligation, to take possession of any such materials;
(d) promptly inform Rhythm of the cost of any remaining unused, unreturnable materials ordered pursuant to any pending Work Order(s) according to minimum order quantity of Manufacturer’s suppliers, and either deliver such materials to Rhythm (or its designee) or properly dispose of them, as instructed by Rhythm; and
(e) perform only those services and activities mutually agreed upon by Rhythm and Manufacturer as being necessary or advisable in connection with the close-out of any pending Work Order(s).
has pre-paid to Manufacturer more than the amount in a final invoice then Manufacturer agrees to promptly refund that money to Rhythm, or to credit the excess payment toward another existing or future Work Order, at the election of Rhythm.
If to Manufacturer, to:
Recipharm Monts SAS
18 xxxxx xx Xxxxxxxxx
00 000 Xxxxx
Xxxxxx
Attention: General Manager
With a copy to :
Recipharm AB
Laxxxxxxxx 0,
XX-000 00 Xxxxxxx,
Xxxxxx
Attention : Legal
If to Rhythm, to:
Rhythm Pharmaceuticals, Inc.
500 Xxxxxxxx Xxxxxx, 00xx Xxxxx
Xxxxxx, XX 00000
XXX
Attention: President
matters shall be governed by the laws of England, and all rights and remedies shall be governed by such laws without reference to choice of law doctrine. The parties expressly reject any application to this Agreement of (a) the United Nations Convention on Contracts for the International Sale of Goods, and (b) the 1974 Convention on the Limitation Period in the International Sale of Goods, as amended by that certain Protocol, done at Vienna on April 11, 1980.
Schedule 1
Main Reason for Failure |
|
Recipharm Batch Cost |
|
Cost of Components |
|
Cost of MPEG |
|
Cost API |
Stability Out of Specification, with all SOPS/process followed |
|
Rhythm |
|
Rhythm |
|
Rhythm |
|
Rhythm |
Batch fails assay or other chemical test, with all SOPS/process followed |
|
Rhythm |
|
Rhythm |
|
Rhythm |
|
Rhythm |
Fails due to Rhythm Equipment operated by Recipharm |
|
Recipharm |
|
Recipharm |
|
Rhythm |
|
Rhythm |
Fails Sterility, from facility, utilities, water, components, disposable/Recipharm eqt |
|
Recipharm |
|
Recipharm |
|
Recipharm |
|
Recipharm |
Recipharm non compliant with SOPs or cGMPs |
|
Recipharm |
|
Recipharm |
|
Recipharm |
|
Recipharm |
[Signature page follows]
RHYTHM PHARMACEUTICALS, INC. |
RECIPHARM MONTS SAS | |||
|
| |||
By |
/s/ Xxxx Xxxxxxxxx |
|
By |
/s/ Michel SAUDEMON |
|
|
|
|
|
Print Name |
Xxxx Xxxxxxxxx |
|
Print Name |
Michel SAUDEMON |
|
|
|
|
|
Title |
President |
|
Title |
General Manager |
|
|
|
|
|
Date |
12/27/16 |
|
Date |
2016, December 23rd |
|
|
|
|
|
|
|
|
By |
/s/ Xxxxx XXXXXXXXX |
|
|
|
|
|
|
|
|
Print Name |
Xxxxx XXXXXXXXX |
|
|
|
|
|
|
|
|
Title |
President, Manuf. Services EU |
|
|
|
|
|
|
|
|
Date |
5/1-2017 |
APPENDIX A
SAMPLE WORK ORDER
THIS WORK ORDER is by and between RHYTHM PHARMACEUTICALS, INC., (“Rhythm”) and RECIPHARM XXXXX XX (“Manufacturer”), and upon execution will be incorporated into the Development and Manufacturing Services Agreement between Rhythm and Manufacturer dated December 21, 2016 (the “Agreement”). Capitalized terms in this Work Order will have the same meanings as set forth in the Agreement.
Rhythm hereby engages Manufacturer to provide Services, as follows:
1. API/Drug Substance and Product.
Describe the specific API/Drug Substance(s) and Product(s).
2. Services. Manufacturer will render to Rhythm the following Services:
Describe the specific Services to be conducted by Manufacturer or attach Manufacturer’s proposal.
3. Facilit(ies). The Services described above will be rendered at the following facilities of Manufacturer:
Include Facility address(es).
Describe specific materials, including without limitation API, being provided by Rhythm to Manufacturer.
Include any equipment that will be provided by Rhythm to Manufacturer to be used by Manufacturer in performance of the Services.
6. Manufacturer Representative. Name and Title
7. Rhythm Representative. Name and Title
All other terms and conditions of the Agreement will apply to this Work Order.
WORK ORDER AGREED TO AND ACCEPTED BY:
RHYTHM PHARMACEUTICALS, INC. |
RECIPHARM XXXXX XX | |||
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