Common use of Client Clause in Contracts

Client. The Client covenants, represents and warrants that: (a) the Specifications for the Drug Product are its or its Affiliate’s property and that the Client may lawfully disclose the Specifications to Patheon; (b) the Specifications for the Drug Product conform to all cGMPs, and Applicable Laws; (c) all Active Compounds or Granulations (as the case may be) and Components supplied by Client hereunder will comply in all material respects with the Specifications, cGMP, the Quality Agreement, and Applicable Laws; (d) it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtained.

Appears in 5 contracts

Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)

AutoNDA by SimpleDocs

Client. The Client covenantsrepresents, represents warrants and warrants covenants to Catalent that: A. the API and any other materials supplied by Client to Catalent (a“Client-supplied Materials”) will comply with all applicable API Specifications, will have been produced in compliance with the Specifications for Applicable Laws, and will be provided in accordance with the Drug Product terms and conditions of this Agreement; B. it has all necessary authority and all right, title and interest in and to any intellectual property related to the Client-supplied materials; C. no specific safe handling instructions, health and environmental information or material safety data sheets are its applicable to the Product, API, or its Affiliate’s property to and that any Client-supplied materials, except as disclosed to Catalent in writing by the Client may lawfully disclose the Specifications in sufficient time for review and training by Catalent prior to Patheondelivery; (b) D. all Product and Packaged Product delivered to Client by Catalent will be held, used and/or disposed of by the Specifications for the Drug Product conform to Client in accordance with all cGMPs, and Applicable Laws; (c) all Active Compounds or Granulations (as the case may be) and Components supplied by E. Client hereunder will comply in with all material respects with the Specificationslaws, cGMPrules, the Quality Agreement, regulations and Applicable Laws; (d) it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon guidelines applicable to perform its obligations Client’s performance under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The its use of any formulas, documents, materials, compounds analytical methods Products or other intellectual property Packaged Product provided by Client Catalent under this Agreement Agreement; F. Client will not release any Batch of Product or Packaged Product if the required certificates of analysis indicate that the Product or Packaged Product does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance comply with the Specifications; (g) G. the Drug Productcontent of all artwork, if labelled packaging, and manufactured labeling provided to Catalent complies with all Applicable Laws; H. Client has all necessary authority and right, title and interest in accordance with and to any copyrights, trademarks, trade secrets, patents, inventions and developments related to the Specifications Product and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit any Product artwork necessary for the purpose intended, and (iii) will be safe for human consumptionperformance of this Agreement; (h) I. to the entering into knowledge of Client, the work to be performed by Catalent under this Agreement by Client will not (i) violate or infringe upon any provision of lawtrademark, statutetradename, rule or regulation or any rulingcopyright, writ, injunction, order, judgment or decree of any court, administrative agency patent or other governmental body rights held by any person or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affectedentity; and (i) J. Client shall not market or sell, or license any other party to market or sell, the Product without first making every reasonable effort to ensure that the Product and Packaged Product is safe and effective for its intended purpose or any other purpose for which such Product or Packaged Product might reasonably be utilized. Client will be solely responsible for and will obtain all necessary corporate governmental approvals, permits and other authorizations, consents and approvals which are licenses necessary or desirable in connection with the testing, marketing, sale, advertising or distribution of the Product and Packaged Product in the Territory. K. Client shall have obtained all applicable licenses, permits, and registrations required for the entering into transport and distribution of this Agreement by Client have been duly obtainedAPI and supplies to Catalent.

Appears in 4 contracts

Samples: Softgel Commercial Manufacturing and Packaging Agreement, Softgel Commercial Manufacturing and Packaging Agreement (Insys Therapeutics, Inc.), Softgel Commercial Manufacturing and Packaging Agreement (Insys Therapeutics, Inc.)

Client. The Subject to Sections 10.1 and 10.2, the Client covenantsagrees to defend, represents indemnify and warrants that: hold Patheon, its officers, employees and agents (together “Patheon Indemnitees”) harmless against any and all Losses resulting from, or relating to (a) any claim of personal injury or property damage to the extent that such injury or damage is the result of a breach of this Agreement by the Client, including, without limitation, any representation or warranty of Client contained herein, (b) any claim that the Specifications for the Drug Product are its or its Affiliate’s property and that the Client may lawfully disclose the Specifications to Patheon; (b) the Specifications for the Drug Product do not conform to all applicable cGMPs, laws and Applicable Laws; regulations and (c) all Active Compounds or Granulations (as any claim that the case may be) and Components supplied by Client hereunder will comply in all material respects with the Specifications, cGMP, the Quality Agreement, and Applicable Laws; (d) it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may not be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, or (ii) will be fit for the purpose intended, and (iii) will be is not safe for human consumption; (h, except to the extent that any such Losses are due to the gross negligence or wrongful act(s) of Patheon, its officers, employees or agents or Affiliates. Subject to Sections 10.1 and 10.2, Client agrees to defend, indemnify and hold the entering into Patheon Indemnitees harmless against any and all Losses resulting from or relating to any claim that the manufacture, use or sale of this Agreement by Client will not (i) violate the Product infringes any provision of lawThird Party Rights, statute, rule except to the extent such infringement or regulation or any ruling, writ, injunction, order, judgment or decree alleged infringement results from Patheon’s manufacturing processes. In the event of any courtclaim described in this Section 10.4, administrative agency or other governmental body or Patheon shall: (iia) conflict with or result in any breach promptly notify the Client of any such claims; (b) use commercially reasonable efforts to mitigate the effects of such claim; (c) reasonably cooperate with the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result Client in the creation defence of any liensuch claim; (d) permit the Client to control the defence and settlement of such claim, security interestall at the Client's cost and expense. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, charge or encumbrance upon any of the properties or assets of Client under its organizational documentsMARKED BY BRACKETS, as amended to dateHAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedAS AMENDED.

Appears in 3 contracts

Samples: Manufacturing Services and Supply Agreement, Manufacturing Services and Supply Agreement (Jazz Pharmaceuticals Inc), Manufacturing Services and Supply Agreement (Jazz Pharmaceuticals Inc)

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) A. all Client-supplied Materials shall have been produced in accordance with Applicable Laws, shall comply with all applicable specifications, including the Specifications for Specifications, shall not be adulterated, misbranded or mislabeled within the Drug Product are its or its Affiliate’s property meaning of Applicable Laws, and that shall have been provided in accordance with the Client may lawfully disclose the Specifications to Patheonterms and conditions of this Agreement; (b) B. the Specifications for the Drug Product conform content of all artwork provided to Catalent shall comply with all cGMPs, and Applicable Laws; C. all Product delivered to Client by Catalent shall be held, used and disposed of by or on behalf of the Client in accordance with all Applicable Laws, and Client will otherwise comply with all Applicable Laws in Client’s performance under this Agreement; D. Client will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications or if Client does not hold all necessary Regulatory Approvals to market and sell the Product; E. Client has all necessary authority to use and to permit Catalent to use pursuant to this Agreement all intellectual property related to Product or Client-supplied Materials (c) all Active Compounds or Granulations (as the case may beincluding artwork) and Components supplied the Processing of the foregoing, including any copyrights, trademarks, trade secrets, patents, inventions and developments; and to the best of Client’s knowledge, there are no patents owned by others related to the Client hereunder will comply in all material respects IP utilized with the SpecificationsProduct that would be infringed or misused by Client’s performance of the Agreement; and, cGMPto its knowledge, no trade secrets or other proprietary rights of others related to the Client IP utilized with the Product that would be infringed or misused by Client’s performance of this Agreement; and F. to the best of Client’s knowledge, the Quality Agreementservices to be performed by Catalent under this Agreement will not violate or infringe upon any trademark, and Applicable Laws; (d) it owns or possesses adequate licenses tradename, copyright, patent, trade secret, or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided right held by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement person or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedentity.

Appears in 3 contracts

Samples: Commercial Supply Agreement, Commercial Supply Agreement (Kala Pharmaceuticals, Inc.), Commercial Supply Agreement (Kala Pharmaceuticals, Inc.)

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) A. this Agreement has been duly executed and delivered by Client’s authorized representative and, assuming the Specifications for due authorization, execution and delivery hereof by Catalent, constitutes and will at all times constitute the legal, valid and binding obligation of Client enforceable against Client in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity; B. Client has no obligations, contractual or otherwise, that would conflict with Client entering into and performing its obligations set forth in this Agreement; C. at the time of delivery hereunder, to Client’s knowledge, all Drug and other Client-supplied Materials supplied by it or its Affiliates hereunder shall have been manufactured in accordance with Applicable Laws, shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws and shall meet the applicable specifications and will continue to do so until the applicable expiration date; D. Client has provided to Catalent all safe handling instructions, health and environmental information and material safety data sheets applicable to the Drug Product are its and other Client-supplied Materials supplied by it or its Affiliate’s property Affiliates hereunder in sufficient time for review and that the Client may lawfully disclose the Specifications to Patheontraining by Catalent; (bi) to Client’s knowledge and except pursuant to which Client has a valid license, it has all necessary authority to use and to permit Catalent to use pursuant to the Specifications for terms of this Agreement and the performance of services contemplated hereunder, all Client IP related to the Drug Product conform and all other Client-supplied Materials, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to all cGMPsClient’s knowledge and except pursuant to which Client has a valid license, there are no patents owned by others that would be infringed or misused by Client’s performance of the Agreement; and Applicable Laws(iii) to Client’s knowledge and except pursuant to which Client has a valid license, no trade secrets or other proprietary rights of others related to the Client IP utilized with the Drug or other Client-supplied Materials that would be infringed or misused by Client’s performance of this Agreement; F. all Products, Supplies, results, data, samples and other materials and deliverables provided to Client by Catalent hereunder shall be held, used and disposed of by or on behalf of Client as set forth in the Development Program and otherwise in accordance with all Applicable Laws (c) including, in connection with any Supplies or other Products that are not labeled, 21 CFR § 201.150 and equivalent non-U.S. regulations); specifically, Client shall not permit the human consumption of any Supplies or other Products, except to the extent such consumption occurs in the course of clinical studies that expressly permit such use and that have been approved by appropriate governmental authorities; and Client will otherwise comply with all Active Compounds or Granulations (as the case may be) and Components supplied by Client hereunder will comply in all material respects with the Specifications, cGMPApplicable Laws applicable to Client’s performance under this Agreement; G. to Client’s knowledge, the Quality Agreementservices to be performed by Catalent under this Agreement will not violate or infringe upon any trademark, and Applicable Laws; (d) it owns or possesses adequate licenses trade name, copyright, patent, trade secret, or other intellectual property that are necessary for Patheon to perform its obligations or other right held by any person or entity; and H. no transactions or dealings under this Agreement and shall be conducted with or for an individual or entity that it is unaware designated as the target of any assertion sanctions, restrictions or claim challenging embargoes administered by the ownershipUnited Nations, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulasEuropean Union, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, United Kingdom or the sale, use or other disposition United States of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedAmerica.

Appears in 3 contracts

Samples: Zydis Development and License Agreement (Biohaven Pharmaceutical Holding Co Ltd.), Zydis Development and License Agreement (Biohaven Pharmaceutical Holding Co Ltd.), Zydis Development and License Agreement (Biohaven Pharmaceutical Holding Co Ltd.)

Client. The Client covenants, represents and warrants thatwarrants: (ai) that it (and the Specifications for the Drug Product are person executing this Agreement on its or its Affiliate’s property behalf, if applicable) is duly authorized and that the Client may lawfully disclose the Specifications empowered to Patheonexecute, deliver and perform this Agreement; (bii) the Specifications for the Drug Product conform to all cGMPs, and Applicable Laws; (c) all Active Compounds or Granulations (as the case may be) and Components supplied by Client hereunder will comply in all material respects with the Specifications, cGMP, the Quality Agreement, and Applicable Laws; (d) it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware performance of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement conflict with or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreementregulation, contract, purchase order deed of trust, or other instrument, document or agreement in instrument to which Client it is a party or by to which it or any of its properties property is subject; (iii) that this Agreement is a valid and binding obligation enforceable in accordance with its terms, except to the extent its enforcement is limited by bankruptcy, insolvency, reorganization of other laws relating to or assets affecting the enforcement of creditors’ rights generally and by general principles of equity; (iv) that, except to the extent it has notified the Advisor in writing, the Assets in the Account belong to the Client free and clear of any liens or encumbrances, and it will not pledge or encumber any Assets in the Account; (v) that it is bound experienced in engaging investment advisers and is aware of the risks associated with such engagements in general, and that it understands the risks associated with investments in a Certificate and Loans in particular, including the fact that such instruments are highly illiquid, the risk of default by underlying consumer borrowers and the risk that the Account could suffer substantial diminution in value, including complete loss; (vi) that it has been provided a copy of the Private Placement Memorandum relating to Certificates, has reviewed such Private Placement Memorandum, has had the opportunity to ask questions regarding the disclosures contained therein and understands the risk factors identified therein; (vii) that it has reviewed all other offering materials and agreements provided by the Advisor relating to the Account and to investments in Loans, understands such materials and agreements and has had the opportunity to ask questions regarding such materials and agreements; (viii) that it understands that (A) the Loans underlying the Certificate that are to be purchased for the benefit of the Client are being sold by Lending Club, the parent company of the Advisor; (B) the grading system for Loans is determined and administered by Lending Club and not by an independent third party; and (C) the Trust, which creates and issues Certificates, was created by Lending Club. It further understands that these relationships create conflicts of interest for the Advisor in performing its services under this Agreement. It hereby acknowledges that it has been made aware of such conflicts of interest, consents to the use of the grading system for Loans described herein, consents to and waives each of the conflicts of interest described in this subparagraph and agrees to hold the Advisor harmless from claims arising from the existence of such conflicts of interest. (ix) (not applicable where the Client is an XXX account) that it is not and at no time during the term of this Agreement will be an “employee benefit plan” that is subject to Part 4 of Title I of the U.S. Employee Retirement Income Security Act of 1974, as amended (“ERISA”), or affecteda plan subject to Section 4975 of the Internal Revenue Code of 1986, as amended, or an entity that has a class of equity interests that is 25%-owned (or more) by one or more “benefit plan investors” as defined under ERISA, unless it has notified the Advisor in writing of its status as such an entity; (x) that it is an “accredited investor” as that term is or may in the future be defined in Rule 501 under the Securities Act of 1933, as amended; (xi) that it will provide to the Advisor such verification of its identity as the Advisor may request in connection with its anti-money laundering obligations; and (xii) if the Client is a trust, the Client and the individual executing this Agreement on behalf of such Client represent and warrant that: (i) all necessary corporate the name and other authorizations, consents contact information for each trustee has been provided to the Advisor and approvals which are the Client will promptly provide new contact information to the Advisor as necessary or required appropriate; (ii) if the trust has multiple trustees, the parties executing this agreement are sufficient to bind the trust to the terms of this agreement; (iii) the trust was validly established and has not been revoked, modified or amended in a manner that would question or limit the validity or enforceability of this agreement against the Client; (iv) the Advisor has been provided with the correct title under which trust assets are to be held under the terms of the trust; and (v) the opening of the Account and purchase of the Certificate for the entering into purposes and on the terms described in this Agreement are in compliance with the terms of the trust as in effect at the time of such purchase and Account opening. The representations, warranties and certain covenants of the Client (and, as applicable, the XXX Accountholder) set forth in this Agreement are made with the intent that they be relied upon by the Advisor and shall be deemed to be reaffirmed by the Client (and XXX Accountholder) each time the Client invests in Loans underlying a Certificate, with each purchase of a Loan being deemed conclusive evidence of such reaffirmation. The Client (and, as applicable, the XXX Accountholder) undertakes to notify the Advisor immediately in the event that any representation, warranty or covenant set forth herein shall cease to be true or correct. The Client (or, as applicable, the XXX Accountholder) acknowledges that it received, at least forty-eight (48) hours prior to the execution of this Agreement by Agreement, a copy of Part 2 of the Advisor’s Form ADV, and has had the opportunity to ask questions of the Advisor regarding the contents of such Form ADV Part 2, including but not limited to the discussion of the Advisor’s allocation practices set forth therein. The Client have been duly obtained(or, as applicable, the XXX Accountholder) further acknowledges that it has received a copy of the Advisor’s privacy policy (i.e., the policies and procedures regarding the Advisor’s use and safekeeping of personal information).

Appears in 3 contracts

Samples: Investment Advisory Agreement, Investment Advisory Agreement (LendingClub Corp), Investment Advisory Agreement (LendingClub Corp)

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to PCI that: (a) the Specifications for the Drug Product are its or its Affiliate’s property Client-supplied Materials (including artwork and that the Client may lawfully disclose the Specifications to Patheonlabeling) shall have been produced in accordance with and not violate Applicable Laws and shall comply with all applicable specifications; (b) no Client-supplied Materials shall, at the Specifications for time of delivery, be (i) adulterated or misbranded within the Drug Product conform to all cGMPsmeaning of the FD&C Act, and Applicable Lawsor any similar law of any other jurisdiction, or (ii) an article which may not, under the provisions of the FD&C Act, or any similar law of any other jurisdiction, be introduced into interstate commerce; (c) all Active Compounds no specific safe handling instructions, health and environmental information or Granulations (material safety data sheets are applicable to any other Client-supplied Materials, except as the case may be) and Components supplied provided to PCI in writing by Client hereunder will comply in all material respects with the Specifications, cGMP, the Quality Agreement, sufficient time for review and Applicable Lawstraining by PCI; (d) it owns all Packaged Product delivered to Client by PCI will be held, used and disposed of by or possesses adequate licenses or other intellectual property that are necessary for Patheon on behalf of the Client in accordance with all Applicable Laws, and Client will otherwise comply with all laws, rules, regulations and guidelines applicable to perform its obligations Client’s performance under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The its use of any formulas, documents, materials, compounds analytical methods or other intellectual property Packaged Product provided by Client PCI under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rightsAgreement; (e) the provision Client will not release any Batch of the Manufacturing Services by Patheon in respect of the Drug Packaged Product pursuant to this Agreement if Client knows or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement can reasonably determine that Packaging does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance comply with the Specifications; (gf) the Drug Product, if labelled Client has all necessary authority to use and manufactured in accordance with the Specifications to permit PCI to use pursuant to this Agreement all Intellectual Property related to Client-supplied Materials (including artwork and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intendedlabeling), and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate Packaging, including any provision of lawcopyrights, statutetrademarks, rule or regulation or any rulingtrade dress, writtrade secrets, injunctionpatents, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affectedinventions and developments; and (ig) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of work to be performed by PCI under this Agreement will not violate or infringe upon any trademark, trade name, copyright, patent, trade secret, trade dress or other Intellectual Property or other right held by Client have been duly obtainedany person or entity.

Appears in 2 contracts

Samples: Commercial Packaging Agreement, Commercial Packaging Agreement (Neurocrine Biosciences Inc)

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) A. at the Specifications for time of delivery to Catalent, all Client-supplied Materials shall have been produced in accordance with Applicable Laws, shall comply with all applicable specifications, including the Drug Product are its Specifications, shall not be adulterated, misbranded or its Affiliate’s property mislabeled within the meaning of Applicable Laws, and that shall have been provided in accordance with the Client may lawfully disclose the Specifications to Patheonterms and conditions of this Agreement; (b) B. the Specifications for the Drug Product conform content of all artwork provided to Catalent shall comply with all cGMPs, and Applicable Laws; (c) C. all Active Compounds Product delivered to Client by Catalent shall be held, used and disposed of by or Granulations (as on behalf of the case may be) Client in accordance with all Applicable Laws, and Components supplied by Client hereunder will otherwise comply in with all material respects laws, rules, regulations and guidelines applicable to Client’s performance under this Agreement; D. Client will not release any Batch of Product if the required Certificate of Conformance indicates that Product does not comply with the Specifications, cGMP, Specifications or if Client does not hold all necessary Regulatory Approvals to market and sell the Quality AgreementProduct; E. Client has all necessary authority to use and to permit Catalent to use pursuant to this Agreement all intellectual property related to Product or Client-supplied Materials (including artwork), and Applicable Laws;the Processing of the foregoing, including any copyrights, trademarks, trade secrets, patents, inventions and developments; and to the best of Client’s knowledge there are no patents owned by others related to the Client Background IP utilized with the Product that would be infringed or misused by Client’s performance of the Agreement; and, to its knowledge, no trade secrets or other proprietary rights of others related to the Client Background IP utilized with the Product that would be infringed or misused by Client’s performance of this Agreement; and (d) it owns F. Catalent’s performance of the services to be performed by Catalent in accordance with the terms and conditions of this Agreement will not violate or possesses adequate licenses infringe upon any trademark, tradename, copyright, patent, trade secret, or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided right held by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement person or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affectedentity; and G. Client has all authorizations and permits required to deliver API (ior have delivered) all necessary corporate and other authorizations, consents and approvals which are necessary or required for to Catalent’s Facility; and H. Client has the entering right to enter into of this Agreement by Client have been duly obtained.Agreement

Appears in 2 contracts

Samples: Commercial Supply Agreement (Omthera Pharmaceuticals, Inc.), Commercial Supply Agreement (Omthera Pharmaceuticals, Inc.)

Client. The In addition to the general representations set forth in Section 11(A) hereof, the Client covenantsalso represents, represents warrants and warrants covenants to the Custodian that: (a) i. Its principal place of business is in Massachusetts, and it will notify the Specifications for Custodian before changing its principal place of business to another jurisdiction; ii. It has the Drug Product are its requisite power and authority to enter into this Agreement and establish the Custody Account; iii. Any factual information heretofore or its Affiliate’s property and that contemporaneously furnished by or on behalf of the Client may lawfully disclose in writing to the Specifications to Patheon; (b) Custodian for purposes of or in connection with the Specifications for the Drug Product conform to all cGMPs, services contemplated by this Agreement is true and Applicable Laws; (c) all Active Compounds or Granulations (as the case may be) and Components supplied by Client hereunder will comply accurate in all material respects on the date as of which such information is dated or certified and not incomplete by omitting to state any fact necessary to make such information not misleading in any material respect at such time; provided that, with the Specifications, cGMPrespect to forecasts or projections, the Quality AgreementClient represents only that such information was prepared in good faith based upon assumptions believed to be reasonable at the time; iv. There is no claim pending, or to the Client’s knowledge, threatened, and Applicable Lawsno encumbrance or other lien, in each case, that may adversely affect any delivery of Assets made by Client in accordance with this Agreement; v. It has not relied on any oral or written representation or warranty made by the Custodian or any other person on the Custodian’s behalf, other than those explicitly set forth in Section 11.A. hereof; vi. It will not grant any liens, claims, security interests and encumbrances (dexcept those granted herein) over the Custody Accounts or the assets therein and it owns or possesses adequate licenses or other intellectual property that are has all rights, title and interest in and to the Assets in the Custody Account as necessary for Patheon the Custodian to perform its obligations under this Agreement Agreement; vii. It acknowledges that Digital Assets are new forms of assets, that the law regarding their ownership, custody and transfer is developing and uncertain, and that custody of such assets poses certain risks that are not present in the case of more traditional asset classes, including the risks of fraud and theft; and it understands that it will bear such risks and the potential loss or diminution in value of Digital Assets due to (a) changes or developments in the Law or conditions under existing Law in which its rights in and to such Digital Assets are not adequately protected, (b) changes in the Custodian’s policies or procedures made in the Custodian’s sole discretion in light of legal, regulatory, operational, security or reputational risks, (c) an Ineligibility Determination or (d) fraud and theft by third parties; viii. It is unaware not, and to its knowledge no transferee of Assets pursuant to any Digital Asset Debit Request is, (a) the target of any assertion economic, financial or claim challenging trade sanctions or embargoes, export controls or other restrictive measures imposed by the ownershipUnited States of America (including those administered by the United States Department of the Treasury’s Office of Foreign Assets Control), use the European Union, any member state of the European Union, the United Kingdom or validity the United Nations (the “Sanctions”), or (b) located, organized or resident in a country or territory with which dealings are broadly restricted or prohibited by any Sanctions (as of any intellectual property of Client to be utilized hereunderthe date hereof, Crimea, Cuba, Iran, North Korea and Syria)(any such country, territory, entity or individual described in this clause (ix), a “Sanctioned Party”); ix. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe know or have any reason to suspect that (a) any part of the valid rights Assets are or will be derived from, held for the benefit of, or related in any way to transactions with or on behalf of, any Sanctioned Party, and (b) any Sanctioned Party has or will have any legal or beneficial interest in the Client or any of any third party including inter alia intellectual property rightsthe Assets; x. The Client does not know or have any reason to suspect that (a) any part of the Assets was derived from unlawful activities, or (b) any part of the Assets or proceeds of the Assets will be used to finance any unlawful activities; xi. If the Client is a non-U.S. banking institution (a “Non-U.S. Bank”) or is holding its security entitlement to the Assets credited to the Custody Account directly or indirectly on behalf of or for the benefit of a Non-U.S. Bank, such Non-U.S. Bank (a) maintains a place of business at a fixed address, other than solely a post office box or an electronic address, in a country where the Non-U.S. Bank is authorized to conduct banking activities; (b) at such location, employs one or more individuals on a full-time basis; (c) maintains operating records related to its banking activities; (d) is subject to inspection by the banking authority that licensed the Non-U.S. Bank; and (e) does not provide banking services to any other Non-U.S. Bank that does not have a physical presence in any country and that is not a registered affiliate of such Non-U.S. Bank; xii. The Client recognizes the provision importance of guarding against the use of the Manufacturing Services Client for money laundering activities. The Client intends to conduct its business activities in a manner reasonably designed to prevent money laundering activity transacted by Patheon in respect or through the Client. Each Authorized Participant is a U.S. broker-dealer, or financial institution regulated under federal and state banking laws and regulations and exempt from broker-dealer registration requirements, that is required to maintain policies and procedures reasonably designed to achieve compliance with the U.S. Bank Secrecy Act of 1970, as amended by Title III of the Drug Product pursuant USA PATRIOT Act of 2001 and other laws, and related regulations (collectively, the “BSA”). Each such Authorized Participant will be required to this Agreement represent and warrant to the Client that no fund or use assets that such investor contributes to the Client were or are derived from, or related to, any activity that is deemed criminal under United States law or shall cause the Client or its general partner to be in violation of the BSA, the U.S. Money Laundering Control Act of 1986, the U.S. International Money Laundering Abatement and Anti-Terrorism Financing Act of 2001 (also known as Title III of the USA Patriot Act of 2001) or economic sanctions promulgated by the Office of Foreign Assets Control, each as amended from time to time, and that such investor will provide the Client’s general partner with any additional information regarding the investor that the Client’s general partner deems necessary or appropriate to ensure compliance with all applicable laws concerning money laundering and similar activities. If at any time it is discovered that any of such representations by the investor are incorrect, or if otherwise required by applicable law or regulation related to money laundering and similar activities, the Client’s general partner may in its sole discretion undertake appropriate actions to ensure compliance with applicable law or regulation, including but not limited to freezing, segregating or withdrawing the investor’s subscription in the Client; xiii. If the Client is an entity holding its security entitlement to the Assets on behalf of any of its own customers, whether or not expressly identified to the Custodian from time to time, any such customers of the Client shall not be customers or indirect customers of the Custodian by virtue of the services provided hereunder; xiv. It acknowledges that the Custodian may, with or without prior notice to the Client, “freeze” the Client’s Custody Account, or any other Assets of the Client in the Custodian’s possession or control, including, but not limited to, prohibiting transfers, declining any Cash Debit Request, Cash Credit Request, Digital Asset Debit Request or Digital Asset Credit Request, and/or segregating Assets or property, if the Custodian determines, suspects, or is advised that such actions are necessary or advisable to comply with any applicable anti-money laundering, OFAC or other disposition of laws or regulations in any relevant jurisdiction. The Client acknowledges that the Drug Product by Patheon as Custodian may be required to perform report transactions that raise suspicions of money laundering or OFAC violations and to disclose the identity of the Client and any related parties to appropriate government authorities; xv. It does conduct and intends to continue to conduct its obligations business in material compliance with all applicable Laws, and has obtained all regulatory licenses, approvals and consents necessary to carry on its business as now conducted; without limiting the generality of the foregoing, it will not use the services provided by Custodian hereunder in any manner that is, or would result in, a violation of any applicable Law; xvi. It is aware of and familiar with, and has been fully informed of, the risks associated with giving Proper Instructions, and is willing to accept such risks, and it shall (and shall cause each Authorized Person to) safeguard and treat with extreme care any devices or credentials related to Proper Instructions, understands that there may be alternative methods of giving or delivering the same than the methods selected by the Custodian, agrees that the security procedures (if any) to be followed in connection therewith provide a commercially reasonable degree of protection in light of its particular needs and circumstances, and acknowledges and agrees that a deposit or withdrawal request may conclusively be presumed by the Custodian to have been given by Authorized Person(s) duly authorized to do so, and may be acted upon as given; and xvii. It has determined, and agrees that it is solely responsible for ensuring, that the services offered by the Custodian under this Agreement does not are sufficient for all legal, regulatory, contractual, operational and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any requirements and obligations of the SpecificationsClient, and that such services are appropriate and desirable for the Client, including, but not limited to, determining whether the services provided by the Custodian hereunder are sufficient for satisfying any obligation of the Client to arrange for a qualified custodian to maintain Client funds and securities under the Investment Advisers Act of 1940, as amended, if applicable. The Custodian makes no express or implied warranty, guarantee, or representation that the services offered by the Custodian under this Agreement satisfy any legal or regulatory requirements applicable to the custody of Client Assets. The Custodian shall have no liability whatsoever for, and the Client shall indemnify and hold the Custodian harmless against, any loss in value of the Active CompoundsAssets held by the Custodian on the Client’s behalf and any other loss, Granulations and expense, cost or liability of any kind incurred by the Components, Custodian arising directly or the sale, use or other disposition indirectly out of the Drug Product made in accordance Client’s failure or alleged failure to comply with any Law, contract or operational requirements applicable to the Specifications; (g) Client, including, but not limited to, any Law applicable to the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets custody of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedAssets.

Appears in 2 contracts

Samples: Custodial Services Agreement (Fidelity Wise Origin Bitcoin Fund), Custodial Services Agreement (Fidelity Ethereum Fund)

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) A. all Client-supplied Materials shall have been produced in accordance with Applicable Laws, shall comply with all applicable specifications, including the Specifications for Specifications, shall not be adulterated, misbranded or mislabeled within the Drug Product are its or its Affiliate’s property meaning of Applicable Laws, and that shall have been provided in accordance with the Client may lawfully disclose the Specifications to Patheonterms and conditions of this Agreement; (b) B. the Specifications for the Drug Product conform content of all artwork provided to Catalent shall comply with all cGMPs, and Applicable Laws; (c) C. all Active Compounds Product delivered to Client by Catalent shall be held, used and disposed of by or Granulations (as on behalf of the case may be) Client in accordance with all Applicable Laws, and Components supplied by Client hereunder will otherwise comply in with all material respects laws, rules, regulations and guidelines applicable to Client’s performance under this Agreement; D. Client will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications, cGMP, Specifications or if Client does not hold all necessary Regulatory Approvals to market and sell the Quality AgreementProduct; E. Client has all necessary authority to use and to permit Catalent to use pursuant to this Agreement all intellectual property related to Product or Client-supplied Materials (including artwork), and Applicable Lawsthe Processing by Catalent of the foregoing, including any copyrights, trademarks, trade secrets, patents, inventions and developments; to Client’s knowledge there are no patents owned by others related to the Client IP utilized with the Product that would be infringed or misused by Client’s performance of the Agreement; and, to its knowledge, no trade secrets or other proprietary rights of others related to the Client IP utilized with the Product that would be infringed or misused by Client’s performance of this Agreement; (d) it owns F. To Client’s knowledge the services to be performed by Catalent under this Agreement will not violate or possesses adequate licenses infringe upon any trademark, tradename, copyright, patent, trade secret, or other intellectual property or other right held by any person or entity; provided that are necessary for Patheon Client makes no representation with respect to the Catalent IP; G. Client has all authorizations and permits required to deliver API (or have delivered) to Catalent’s Facility. H. Client has the full power and authority to execute and deliver this Agreement and perform its covenants, duties, and obligations described in this Agreement, and once executed, this Agreement will be a valid, legal, and binding obligation upon Client; and I. no transactions or dealings under this Agreement and shall be conducted with or for an individual or entity that it is unaware designated as the target of any assertion sanctions, restrictions or claim challenging embargoes administered by the ownershipUnited Nations, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulasEuropean Union, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the ComponentsUnited Kingdom, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedUnited States.

Appears in 1 contract

Samples: Softgel Commercial Supply Agreement (TherapeuticsMD, Inc.)

Client. The Client covenantsrepresents, represents warrants, and warrants covenants as of the date this Agreement is entered into and as of the date any custodial service herein is requested or used that: (ai) the Specifications for the Drug Product are its or its Affiliate’s property It is duly organized and that the Client may lawfully disclose the Specifications to Patheon; (b) the Specifications for the Drug Product conform to all cGMPsin good standing in every jurisdiction where required by Applicable Law, and Applicable Laws; (c) all Active Compounds or Granulations (as it has the case may be) power and Components supplied by Client hereunder will comply in all material respects with the Specifications, cGMP, the Quality Agreement, authority to sign and Applicable Laws; (d) it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rightsAgreement; (eii) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which It is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which organized under the Client markets such Drug Productlaws of Delaware, (ii) will be fit for a validly existing statutory trust under the purpose intendedlaws of the State of Delaware, and (iii) will be safe for human consumptionis licensed under the laws of the State of New York; 1 (iii) This Agreement has been duly authorized, executed, and delivered, and this Agreement is the legal, valid and binding obligation of the Client enforceable against the Client in accordance with its terms; (hiv) Any consent, authorization or instruction required in connection with the entering into Client’s obligations under this Agreement has been provided by any relevant third party (and will be renewed if necessary), including any act required by any relevant governmental or other authority; (v) Its performance of this Agreement by Client will not (i) violate any provision of law, statute, rule Applicable Law or regulation or breach any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational constitutive documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contractjudgment, purchase order or other instrument, document or agreement in decree to which the Client is a party or by which it is bound; (vi) The Client has authority to deposit the Assets received in the Securities Account and the Cash Account, and there is no claim, security interest, lien or other encumbrance of any kind that adversely affects any delivery or payment of Assets made in accordance with this Agreement; (vii) except as provided in this Agreement, it has not granted any person a lien, security interest, charge or similar right or claim against Securities or Cash held pursuant to this Agreement; (viii) The Client has not relied on any oral or written representation made by the Bank or any person on its behalf and acknowledges that this Agreement sets out to the fullest extent the duties of its properties or assets is bound or affectedthe Bank; and (iix) all necessary corporate and other authorizations, consents and approvals It will not knowingly do anything or authorize a third party to do anything which are necessary would or required for might prejudice or bring into disrepute in any manner the entering into business or reputation of this Agreement by Client have been duly obtainedthe Bank or the any of the directors of the same or damage the goodwill or reputation attaching to the Bank.

Appears in 1 contract

Samples: Custodial Services Agreement (Asset Management Fund)

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) the Specifications for the Drug Product are its or its Affiliate’s property and that the Client may lawfully disclose the Specifications to Patheon; (b) the Specifications for the Drug Product conform to : A. all cGMPs, and Client-supplied Materials shall have been produced in accordance with Applicable Laws; (c) , shall comply with all Active Compounds or Granulations (as the case may be) and Components supplied by Client hereunder will comply in all material respects with applicable specifications, including the Specifications, cGMPshall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws, and shall have been provided in accordance with the terms and conditions of this Agreement; B. the content of all artwork provided to Catalent shall comply with all Applicable Laws; C. all Product delivered to Client by Catalent shall be held, used and disposed of by or on behalf of the Client in accordance with all Applicable Laws, and Client will otherwise comply with all laws, rules, regulations and guidelines applicable to Client’s performance under this Agreement; D. Client will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications or if Client does not hold all necessary Regulatory Approvals to market and sell the Product (except to the extent such consumption occurs in the course of clinical studies that expressly permit such use and that have been conducted in accordance with Applicable Laws); E. Client has all necessary authority to use and to permit Catalent to use pursuant to this Agreement all intellectual property related to Product or Client-supplied Materials (including artwork), and to its knowledge, the Quality Processing of the foregoing, including any copyrights, trademarks, trade secrets, patents, inventions and developments; there are no patents owned by others related to the Client IP utilized with the Product that would be infringed or misused by Client’s performance of the Agreement; and, to its knowledge, no trade secrets or other proprietary rights of others related to the Client IP utilized with the Product that would be infringed or misused by Client’s performance of this Agreement; and Applicable Laws; (d) it owns F. To its knowledge, the services to be performed by Catalent under this Agreement will not violate or possesses adequate licenses infringe upon any trademark, tradename, copyright, patent, trade secret, or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided right held by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement person or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedentity.

Appears in 1 contract

Samples: Commercial Supply Agreement

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) the Specifications for the Drug Product are its or its Affiliate’s property and that the Client may lawfully disclose the Specifications to Patheon; (b) the Specifications for the Drug Product conform to all cGMPs, and A. All Client-supplied Materials shall have been produced in accordance with Applicable Laws; (c) , shall comply with all Active Compounds or Granulations (as the case may be) and Components supplied by Client hereunder will comply in all material respects with applicable specifications, including the Specifications, cGMPshall not be adulterated, misbranded or mislabeled within the Quality Agreementmeaning of Applicable Laws, and shall have been provided in accordance with the terms and conditions of this Agreement. B. The content of all artwork provided by or on behalf of Client to Catalent shall comply with all Applicable Laws;. C. All Product delivered to Client by Catalent shall be held, used and disposed of by or on behalf of Client in accordance with Applicable Laws, and Client will otherwise comply with Applicable Laws relating to Client’s performance under this Agreement. D. Client will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications or if Client does not hold all necessary Regulatory Approvals to market and sell the Product. E. Client has all necessary authority to use and to permit Catalent to use for the purposes of this Agreement all Intellectual Property related to Product, Client-supplied Materials (dincluding artwork) it owns or possesses adequate licenses the Processing of either of them, including all applicable copyrights, trademarks, trade secrets, patents, inventions and developments. F. To its knowledge, there is (i) no valid patent owned by a third party related to the Client IP used to Process Product that would be infringed or other intellectual property that are necessary for Patheon to perform its obligations misused by performance under this Agreement and (ii) no trade secret or other proprietary right of a third party related to the Client IP used to Process Product that it is unaware of any assertion would be infringed or claim challenging misused by performance under this Agreement. G. To its knowledge, the ownership, use or validity of any intellectual property of Client services to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided performed by Client Catalent under this Agreement does will not violate or infringe the upon any valid rights of trademark, tradename, copyright, patent, trade secret, or other right held by any third party including inter alia intellectual property rights;party. H. Client has (eor will have prior to delivery) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be all authorizations and permits required to perform its obligations deliver (or have delivered) API to the Facility. I. No transaction or dealing under this Agreement does not and will not infringe shall be conducted with or for an individual or entity that is designated as the target of any Third Party Rights; (f) there are no actions sanction, restriction or other legal proceedingsembargo administered by the United Nations, the subject of which is the infringement of Third Party Rights related to any of the SpecificationsEuropean Union, United Kingdom, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedUnited States.

Appears in 1 contract

Samples: Manufacturing Preparation and Commercial Supply Agreement (Avadel Pharmaceuticals PLC)

Client. The Client covenantsrepresents, represents warrants, and warrants covenants as of the date this Agreement is entered into and as of the date any custodial service herein is requested or used that: (ai) the Specifications for the Drug Product are its or its Affiliate’s property It is duly organized and that the Client may lawfully disclose the Specifications to Patheon; (b) the Specifications for the Drug Product conform to all cGMPsin good standing in every jurisdiction where required by Applicable Law, and Applicable Laws; (c) all Active Compounds or Granulations (as it has the case may be) power and Components supplied by Client hereunder will comply in all material respects with the Specifications, cGMP, the Quality Agreement, authority to sign and Applicable Laws; (d) it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rightsAgreement; (eii) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which It is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which organized under the Client markets such Drug Productlaws of Delaware, (ii) will be fit for a validly existing statutory trust under the purpose intendedlaws of the State of Delaware, and (iii) will be safe for human consumptionis licensed under the laws of the State of New York;1 (iii) This Agreement has been duly authorized, executed, and delivered, and this Agreement is the legal, valid and binding obligation of the Client enforceable against the Client in accordance with its terms; (hiv) Any consent, authorization or instruction required in connection with the entering into Client’s obligations under this Agreement has been provided by any relevant third party (and will be renewed if necessary), including any act required by any relevant governmental or other authority; (v) Its performance of this Agreement by Client will not (i) violate any provision of law, statute, rule Applicable Law or regulation or breach any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational constitutive documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contractjudgment, purchase order or other instrument, document or agreement in decree to which the Client is a party or by which it is bound; (vi) The Client has authority to deposit the Assets received in the Securities Account and the Cash Account, and there is no claim, security interest, lien or other encumbrance of any kind that adversely affects any delivery or payment of Assets made in accordance with this Agreement; (vii) except as provided in this Agreement, it has not granted any person a lien, security interest, charge or similar right or claim against Securities or Cash held pursuant to this Agreement; (viii) The Client has not relied on any oral or written representation made by the Bank or any person on its behalf and acknowledges that this Agreement sets out to the fullest extent the duties of its properties or assets is bound or affectedthe Bank; and (iix) all necessary corporate and other authorizations, consents and approvals It will not knowingly do anything or authorize a third party to do anything which are necessary would or required for might prejudice or bring into disrepute in any manner the entering into business or reputation of this Agreement by Client have been duly obtainedthe Bank or the any of the directors of the same or damage the goodwill or reputation attaching to the Bank.

Appears in 1 contract

Samples: Custodial Services Agreement (Asset Management Fund)

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) A. all Client-supplied Materials shall have been produced in accordance with Applicable Laws, shall comply with all applicable specifications, including the Specifications for Specifications, shall not be adulterated, misbranded or mislabeled within the Drug Product are its or its Affiliate’s property meaning of Applicable Laws, and that shall have been provided in accordance with the Client may lawfully disclose the Specifications to Patheonterms and conditions of this Agreement; (b) B. the Specifications for the Drug Product conform content of all artwork provided to Catalent shall comply with all cGMPs, and Applicable Laws; (c) C. all Active Compounds Product delivered to Client by Catalent shall be held, used and disposed of by or Granulations (as on behalf of the case may be) Client in accordance with all Applicable Laws, and Components supplied by Client hereunder will otherwise comply in with all material respects laws, rules, regulations and guidelines applicable to Client’s performance under this Agreement; D. Client will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications, cGMP, Specifications or if Client does not hold all necessary Regulatory Approvals to market and sell the Quality AgreementProduct; E. Client has all necessary authority to use and to permit Catalent to use pursuant to this Agreement all intellectual property related to Product or Client-supplied Materials (including artwork), and Applicable Laws;the Processing by Catalent of the foregoing, including any copyrights, trademarks, trade secrets, patents, inventions and developments; to Client’s knowledge there are no patents owned by others related to the Client IP utilized with the Product that would be infringed or misused by Client’s performance of the Agreement; and, to its knowledge, no trade secrets or other proprietary rights of others related to the Client IP utilized with the Product that would be infringed or misused by Client’s performance of this Agreement; CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. EXECUTION VERSION (d) it owns F. To Client’s knowledge the services to be performed by Catalent under this Agreement will not violate or possesses adequate licenses infringe upon any trademark, tradename, copyright, patent, trade secret, or other intellectual property or other right held by any person or entity; provided that are necessary for Patheon Client makes no representation with respect to the Catalent IP; G. Client has all authorizations and permits required to deliver API (or have delivered) to Catalent’s Facility; H. Client has the full power and authority to execute and deliver this Agreement and perform its covenants, duties, and obligations described in this Agreement, and once executed, this Agreement will be a valid, legal, and binding obligation upon Client; and I. no transactions or dealings under this Agreement and shall be conducted with or for an individual or entity that it is unaware designated as the target of any assertion sanctions, restrictions or claim challenging embargoes administered by the ownershipUnited Nations, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulasEuropean Union, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the ComponentsUnited Kingdom, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedUnited States.

Appears in 1 contract

Samples: Softgel Commercial Supply Agreement

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) A. all Client-supplied Materials shall have been produced in accordance with Applicable Laws, shall comply with all applicable specifications, including the Specifications for Specifications, shall not be adulterated, misbranded or mislabeled within the Drug Product are its or its Affiliate’s property meaning of Applicable Laws, and that shall have been provided in accordance with the Client may lawfully disclose the Specifications to Patheonterms and conditions of this Agreement; (b) B. the Specifications for the Drug Product conform content of all artwork provided to Catalent shall comply with all cGMPs, and Applicable Laws; (c) C. all Active Compounds Product delivered to Client by Catalent will be held, used and disposed of by or Granulations (as on behalf of the case may be) Client in accordance with all Applicable Laws, and Components supplied by Client hereunder will otherwise comply in with all material respects laws, rules, regulations and guidelines applicable to Client’s performance under this Agreement; D. Client will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications, cGMP, Specifications or if Client does not hold all necessary Regulatory Approvals to market and sell the Quality AgreementProduct; E. Client has all necessary authority to use and to permit Catalent to use pursuant to this Agreement all intellectual property related to Product or Client-supplied Materials (including artwork), and Applicable Laws;the Processing of the foregoing, including any copyrights, trademarks, trade secrets, patents, inventions and developments; there are no patents owned by others related to the Client IP utilised with the Product that would be infringed or misused by Client’s performance of the Agreement; and, to its knowledge, no trade secrets or other proprietary rights of others related to the Client IP utilised with the Product that would be infringed or misused by Client’s performance of this Agreement; and (d) it owns F. the work to be performed by Catalent under this Agreement will not violate or possesses adequate licenses infringe upon any trademark, tradename, copyright, patent, trade secret, or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided right held by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement person or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedentity.

Appears in 1 contract

Samples: Commercial Supply Agreement (Minerva Neurosciences, Inc.)

Client. The Client covenantsSubject to Sections 10.1 and 10.2, represents and warrants that: (a) the Specifications for the Drug Product are its or its Affiliate’s property and that the Client may lawfully disclose the Specifications agrees to defend, indemnify and hold Patheon; , its officers, employees and agents harmless against any and all losses, damages, costs, claims, demands, judgments and liability to, from and in favour of third parties (bother than Affiliates) the Specifications for the Drug Product conform resulting from, or relating to all cGMPs, and Applicable Laws; (c) all Active Compounds any claim of infringement or Granulations (as the case may be) and Components supplied by Client hereunder will comply in all material respects with the Specifications, cGMP, the Quality Agreement, and Applicable Laws; (d) it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware alleged infringement of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon Third Party Rights in respect of the Drug Product pursuant Products, and any claim of personal injury or property damage to this Agreement the extent that such injury or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which damage is the infringement result of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into a breach of this Agreement by the -27- <PAGE> Client, including, without limitation, any representation or warranty contained herein, except to the extent that any such losses, damages, costs, claims, demands, judgments and liability are due to the negligence or wrongful act(s) of Patheon, its officers, employees or agents. In the event of a claim, Patheon shall: (a) promptly notify the Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any courtsuch claims; (b) use commercially reasonable efforts to mitigate the effects of such claim; (c) reasonably cooperate with the Client in the defence of such claim; (d) permit the Client to control the defence and settlement of such claim, administrative agency or other governmental body or (ii) conflict with or result in any breach of any all at the Client's cost and expense. ARTICLE 11 CONFIDENTIALITY 11.1 The parties agree that the provisions of the Confidentiality Agreement shall apply to all confidential information disclosed by the parties under this Agreement, which agreement remains in effect in accordance with its terms; provided, conditions however, that in the event the Confidentiality Agreement expires or provisions ofis terminated prior to the expiration or termination of this Agreement, or constitute a default (or give rise the terms of the Confidentiality Agreement shall continue to govern the parties' obligations of confidentiality with respect to any right confidential or proprietary information disclosed by the parties hereunder, for the term of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documentsthis Agreement, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or though such agreement remained in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate full force and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedeffect.

Appears in 1 contract

Samples: Manufacturing Services Agreement

AutoNDA by SimpleDocs

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) the Specifications for the Drug Product are its or its Affiliate’s property and that the A. Client may lawfully disclose the Specifications is authorized to Patheon; (b) the Specifications for the Drug Product conform to all cGMPs, and Applicable Laws; (c) all Active Compounds or Granulations (as the case may be) and Components supplied by Client hereunder will comply in all material respects with the Specifications, cGMP, the Quality enter into this Agreement, and Applicable Laws; (d) it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon to perform its performance of its obligations under this Agreement and that it is unaware of or any assertion Quotation or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Quality Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product executed pursuant to this Agreement will not violate Applicable Laws or use or other disposition any contract with any Third-Party; B. Client will not in the performance of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe use the services of any Third Party RightsPerson debarred or suspended under 21 U.S.C. § 335(a) or (b); (f) there are no actions or other legal proceedingsC. all Client-supplied Materials shall have been produced and provided to Catalent in accordance with Applicable Laws, the subject of which is the infringement of Third Party Rights related to any of shall comply with all applicable specifications, including the Specifications, shall not be adulterated, misbranded, or mislabeled within the meaning of Applicable Laws, and shall have been provided in accordance with the terms and conditions of this Agreement; D. the content of all artwork, if any, provided by or on behalf of Client to Catalent shall comply with all Applicable Laws; E. all Product delivered to Client by Catalent shall be held, used, and disposed of by or on behalf of Client in accordance with Applicable Laws, and Client will otherwise comply with Applicable Laws relating to Client’s performance under this Agreement; F. Client will not release to the market any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications or if Client does not hold all necessary Regulatory Approvals to market and sell the Product; G. Client has all necessary authority, including Intellectual Property rights to use, and to permit Catalent to use in accordance with this Agreement or any of Quotation or Quality Agreement executed pursuant to this Agreement, the Active Compounds, Granulations Client-supplied Materials (including artwork and other Intellectual Property) and Process the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug ProductH. to its knowledge, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs there is (i) may be lawfully sold and distributed in every jurisdiction in which no patent owned by a Third-Party related to the Client markets such Drug ProductBackground IP used to Process Product that would be infringed or misused by performance under this Agreement and (ii) no trade secret or other proprietary right of a Third-Party related to the Client Background IP used to Process Product that would be infringed or misappropriated by Catalent’s performance under this Agreement; I. to Client’s knowledge following commercially reasonable due diligence, the Services requested by Client to be performed by Catalent under this Agreement will not violate or infringe upon any trademark, tradename, copyright, patent, trade secret, or other Intellectual Property or other right held by any Person or entity; J. Client has all authorizations, licenses, and permits required by Applicable Laws to deliver (or have delivered) API or other Client- supplied Material to the Facility; K. no transaction or dealing under this Agreement shall be conducted with or for any Person or entity that is designated as the target of any comprehensive sanctions, restrictions, or embargoes administered by the United Nations, the European Union, the United Kingdom, or the United States of America; and L. Client understands that Catalent is required to comply with the Anti-Corruption Laws. Client represents and warrants that no one acting on its behalf will give, offer, agree, promise to give, or authorize the giving directly or indirectly, of any money or other quid pro quo as an inducement or reward for favorable action or forbearance from action or the exercise of influence (i) to any governmental official or employee (including employees of government-owned and government-controlled corporations or agencies), (ii) will be fit for the purpose intendedto any political party, and official of a political party, or candidate, (iii) will be safe to an intermediary for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of payment to any of the terms, conditions or provisions offoregoing, or constitute a default (or give rise iv) to any right of termination, cancellation other Person in a corrupt or acceleration) under, improper effort to obtain or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, retain business or any material notecommercial advantage, indenturesuch as receiving a permit, mortgage, lease, agreement, contract, purchase order authorization or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedlicense.

Appears in 1 contract

Samples: Commercial Supply Agreement (Ardelyx, Inc.)

Client. The Subject to Sections 10.1 and 10.2, the Client covenantsagrees to defend, represents indemnify and warrants thathold Patheon, its Affiliates, officers, employees and agents (collectively, “Patheon Indemnitees”) harmless from and against any and all Third Party Claims resulting from, or relating to any claim of personal injury or property damage to the extent that such injury or damage is the result of: (a) the Specifications for the Drug Product are its any misrepresentation, negligence or its Affiliate’s property and that wilful misconduct by the Client may lawfully disclose the Specifications to Patheon;Indemnities; or (b) any breach by the Specifications for Client of the Drug Product conform to all cGMPs, and Applicable Laws;Client’s obligations or warranties under this Agreement; or (c) all Active Compounds any claim of infringement or Granulations (as the case may be) and Components supplied by Client hereunder will comply in all material respects with the Specifications, cGMP, the Quality Agreement, and Applicable Laws; (d) it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware alleged infringement of any assertion or claim challenging Third Party Rights resulting from the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision performance of the Manufacturing Services by Patheon in respect hereunder, to the extent such infringement specifically results from Patheon’s use of the Drug Product formulation and Specifications in each case in the form provided by Client. This indemnity shall not apply to the extent that such Third Party Claims are: (x) determined to have resulted from the negligence or willful misconduct of Patheon; or (y) that is subject to Patheon’s obligation to indemnify the Client Indemnitees pursuant to Section 10.3. In the event that the Patheon seeks indemnification under this Agreement Section 10.4 for a Third Party Claim, Patheon shall: (a) promptly notify Client of such Third Party Claim; (b) use commercially reasonable efforts to mitigate the effects of such Third Party Claim; (c) reasonably cooperate with Client in the defense of such Third Party Claim; (d) permit Client to control the defense and settlement of such Third Party Claim, all at Client’s cost and expense. Notwithstanding the foregoing, Client shall not enter into any settlement agreement for a Third-Party Claim that attributes fault or use negligence to Patheon or other disposition restricts the future actions or activities of the Drug Product by Patheon as may Patheon, without Patheon’s prior written consent, with such consent not to be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedunreasonably withheld.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Transcept Pharmaceuticals Inc)

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (aA. this Agreement has been duly executed and delivered by Client’s authorized representative and, assuming the due authorization, execution and delivery hereof by Catalent, constitutes and will at all times constitute the legal, valid and binding obligation of Client enforceable against Client in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity; B. Client has no obligations, contractual or otherwise, that would conflict with Client entering into and performing its obligations set forth in this Agreement; C. at the time of delivery hereunder, to Client’s knowledge, all Drug and other Client-supplied Materials supplied by it or its Affiliates hereunder shall have been CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(B)(4) and 230.406 manufactured in accordance with Applicable Laws, shall not be adulterated, misbranded or mislabeled within the Specifications for meaning of Applicable Laws and shall meet the applicable specifications and will continue to do so until the applicable expiration date; D. Client has provided to Catalent all safe handling instructions, health and environmental information and material safety data sheets applicable to the Drug Product are its and other Client-supplied Materials supplied by it or its Affiliate’s property Affiliates hereunder in sufficient time for review and that the Client may lawfully disclose the Specifications to Patheontraining by Catalent; (bi) to Client’s knowledge and except pursuant to which Client has a valid license, it has all necessary authority to use and to permit Catalent to use pursuant to the Specifications for terms of this Agreement and the performance of services contemplated hereunder, all Client IP related to the Drug Product conform and all other Client-supplied Materials, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to all cGMPsClient’s knowledge and except pursuant to which Client has a valid license, there are no patents owned by others that would be infringed or misused by Client’s performance of the Agreement; and Applicable Laws(iii) to Client’s knowledge and except pursuant to which Client has a valid license, no trade secrets or other proprietary rights of others related to the Client IP utilized with the Drug or other Client-supplied Materials that would be infringed or misused by Client’s performance of this Agreement; F. all Products, Supplies, results, data, samples and other materials and deliverables provided to Client by Catalent hereunder shall be held, used and disposed of by or on behalf of Client as set forth in the Development Program and otherwise in accordance with all Applicable Laws (c) including, in connection with any Supplies or other Products that are not labeled, 21 CFR § 201.150 and equivalent non-U.S. regulations); specifically, Client shall not permit the human consumption of any Supplies or other Products, except to the extent such consumption occurs in the course of clinical studies that expressly permit such use and that have been approved by appropriate governmental authorities; and Client will otherwise comply with all Active Compounds or Granulations (as the case may be) and Components supplied by Client hereunder will comply in all material respects with the Specifications, cGMPApplicable Laws applicable to Client’s performance under this Agreement; G. to Client’s knowledge, the Quality Agreementservices to be performed by Catalent under this Agreement will not violate or infringe upon any trademark, and Applicable Laws; (d) it owns or possesses adequate licenses trade name, copyright, patent, trade secret, or other intellectual property that are necessary for Patheon to perform its obligations or other right held by any person or entity; and H. no transactions or dealings under this Agreement and shall be conducted with or for an individual or entity that it is unaware designated as the target of any assertion sanctions, restrictions or claim challenging embargoes administered by the ownershipUnited Nations, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulasEuropean Union, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, United Kingdom or the sale, use or other disposition United States of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedAmerica.

Appears in 1 contract

Samples: Zydis Development and License Agreement

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to PCI that: (a) the Specifications for the Drug Product are its or its Affiliate’s property Client-supplied Materials (including artwork and that the Client may lawfully disclose the Specifications to Patheonlabeling) shall have been produced in accordance with and not violate Applicable Laws and shall comply with all applicable specifications; (b) no Client-supplied Materials shall, at the Specifications for time of delivery, be (i) adulterated or misbranded within the Drug Product conform to all cGMPsmeaning of the FD&C Act, and Applicable Lawsor any similar law of any other jurisdiction, or (ii) an article which may not, under the provisions of the FD&C Act, or any similar law of any other jurisdiction, be introduced into interstate commerce; (c) all Active Compounds no specific safe handling instructions, health and environmental information or Granulations (material safety data sheets are applicable to any other Client-supplied Materials, except as the case may be) and Components supplied provided to PCI in writing by Client hereunder will comply in all material respects with the Specifications, cGMP, the Quality Agreement, and Applicable Laws[***]; (d) it owns all Packaged Product delivered to Client by PCI will be held, used and disposed of by or possesses adequate licenses or other intellectual property that are necessary for Patheon on behalf of the Client in accordance with all Applicable Laws, and Client will otherwise comply with all laws, rules, regulations and guidelines applicable to perform its obligations Client’s performance under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The its use of any formulas, documents, materials, compounds analytical methods or other intellectual property Packaged Product provided by Client PCI under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rightsAgreement; (e) Client will not release any Batch of Packaged Product if Client knows [***] that Packaging does not comply with the provision of the Manufacturing Services by Patheon in respect of the Drug Product Specifications; US-DOCS\111993788.6 054663-0011 (f) Client has all necessary authority to use and to permit PCI to use pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights all Intellectual Property related to any of the SpecificationsClient-supplied Materials (including artwork and labeling), or any of the Active Compounds, Granulations and the ComponentsPackaging, or the saleincluding any copyrights, use or other disposition of the Drug Product made in accordance with the Specifications;trademarks, trade dress, trade secrets, patents, inventions and developments; and (g) the Drug Productwork to be performed by PCI under this Agreement, if labelled and manufactured in accordance with to the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Productextent based on Client’s Intellectual Property, (ii) will be fit for the purpose intendedproducts or components of Client, including Client-supplied Materials, and (iii) will be safe for human consumption; (h) the entering into of this Agreement information provided by Client or otherwise caused by Client, will to its knowledge not (i) violate or infringe upon any provision of lawtrademark, statutetrade name, rule or regulation or any rulingcopyright, writpatent, injunctiontrade secret, order, judgment or decree of any court, administrative agency trade dress or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order Intellectual Property or other instrument, document right held by any person or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedentity.

Appears in 1 contract

Samples: Commercial Packaging Agreement (Aimmune Therapeutics, Inc.)

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) A. the Specifications for the Drug Product are its or its Affiliate’s property API and that the Client may lawfully disclose the Specifications to Patheon; (b) the Specifications for the Drug Product conform to all cGMPs, and other Client-supplied Materials shall have been produced in accordance with Applicable Laws; (c) , shall comply with all Active Compounds or Granulations (as the case may be) and Components supplied by Client hereunder will comply in all material respects with applicable specifications, including the Specifications, cGMPshall not be adulterated, misbranded or mislabeled within the Quality Agreementmeaning of Applicable Laws, and shall have been provided in accordance with the terms and conditions of this Agreement; B. no specific safe handling instructions, health and environmental information or material safety data sheets are applicable to Product, API or any other Client-supplied Materials, except as provided to Catalent in writing by Client in sufficient time for review and training by Catalent; C. all Product delivered to Client by Catalent will be held, used and disposed of by or on behalf of the Client in accordance with all applicable laws, including Applicable Laws; (d) it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon , and Client will otherwise comply with all laws, rules, regulations and guidelines applicable to perform its obligations Client’s performance under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The its use of any formulas, documents, materials, compounds analytical methods or other intellectual property Product provided by Client Catalent under this Agreement Agreement; D. Client will not release any Batch of Product if the required certificates of analysis indicate that Product does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance comply with the Specifications; (g) E. Client shall not market or sell, or license any other party to market or sell, the Drug Product without first making every reasonable effort to ensure that Product is safe and effective for its intended purpose or any other purpose for which such Product might reasonably be utilized; F. Client has all necessary authority to use and to permit Catalent to use pursuant to this Agreement all intellectual property related to Product, if labelled API, all other Client-supplied Materials (including artwork), and manufactured the Processing of the foregoing, including any copyrights, trademarks, trade secrets, patents, inventions and developments; G. the content of all artwork provided to Catalent shall comply with all Applicable Laws; and H. the work to be performed by Catalent under this Agreement will not violate or infringe upon any trademark, trade name, copyright, patent, trade secret, or other intellectual property or other right held by any person or entity. I. with respect to the Construction Work, all materials shall be new, and both workmanship and materials shall be of first class quality; the Building Contractor and all architects, contractors and subcontractors shall be duly licensed and insured and all workmen shall be skilled in accordance with the Specifications their profession and trades. All Construction Work shall he performed in compliance with applicable cGMPs (i) may be lawfully sold the Design Documents, the Construction Contract and distributed all Applicable Law. [**] Certain information in every jurisdiction in which this document has been omitted and filed separately with the Client markets such Drug Product, (ii) will be fit for Securities and Exchange Commission. Confidential treatment has been requested with respect to the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedomitted portions.

Appears in 1 contract

Samples: Build Out and Commercial Supply Agreement (Pharmacyclics Inc)

Client. The Client covenants(I) will be provided with local, represents and warrants that: (a) the Specifications for the Drug Product are its or its Affiliate’s property and that the Client may lawfully disclose the Specifications to Patheon; (b) the Specifications for the Drug Product conform to all cGMPslong distance, and Applicable Laws; international services and moves, adds and changes at Company's published rates; (cii) all Active Compounds or Granulations understands that it has chosen to use telephone services exclusively provided by Company, which is acting as a multi-tenant service provider; (as the case may beiii) and Components supplied by Client hereunder will comply in all material respects with the Specifications, cGMP, the Quality Agreement, and Applicable Laws; (d) it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and understands that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision a member of the Manufacturing Services general public, is not protected by Patheon in respect the Public Utilities Commission and waives any right to such protection; (iv) shall direct any requests for service, or complaints, to Company and not the local telephone company; (v) shall provide Company with a forwarding address so that residual xxxxxxxx can be mailed to Client; and (vi) agrees that Company may increase the telephone use deposit at any time during the Term to an amount not to exceed Client's highest monthly telephone billing during the preceding portion of the Drug Product pursuant Term. FAZ --- INITIAL (REV GSA 010197 MV) 7 Services offered by Company are subject to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not human, electrical and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedingsmechanical error, the subject of which is the infringement of Third Party Rights related to any of the Specificationsfailure, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) illness which may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation delay or discontinuance of any lienthese services. Client hereby represents that Client has read and agrees to the provisions of Section C, security interestParagraph 2 (Limitation of Liability) and Section, charge or encumbrance upon any of C, Paragraph 3, (Indemnity), included in the properties or assets of Client under its organizational documentsGeneral Provisions and incorporated herein. IN THE EVENT THIS GSA TERMINATES, as amended to dateOR CLIENT IS IN DEFAULT UNDER THIS GSA COMPAPNY MAY, or any material noteAT ITS ELECTION; REFUSE TO PROVDE ANY SERVICE INCLUDING WITHOUT LIMITATION, indentureTELEPHONE SERVICE; AND COMPANY SHALL NOT BE IN BREACH OF ANY OF ITS OBLIGATIONS HEREUNDER, mortgageOR UNDER ANY OTHER AGREEMENT, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedNOR SHALL SUCH REFUSAL BE DEEMED AN EVICTION OF CLIENT UNDER THE LEASE.

Appears in 1 contract

Samples: Office Lease and General Service Agreement (Majestic Companies LTD)

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) A. all Client-supplied Materials shall have been produced in accordance with Applicable Laws, shall comply with all applicable specifications, including the Specifications for Specifications, shall not be adulterated, misbranded or mislabeled within the Drug Product are its or its Affiliate’s property meaning of Applicable Laws, and that shall have been provided in accordance with the Client may lawfully disclose the Specifications to Patheonterms and conditions of this Agreement; (b) B. the Specifications for the Drug Product conform content of all artwork provided to Catalent shall comply with all cGMPs, and Applicable Laws; (c) C. all Active Compounds Product delivered to Client by Catalent shall be held, used and disposed of by or Granulations (as on behalf of the case may be) Client in accordance with all Applicable Laws, and Components supplied by Client hereunder will otherwise comply in with all material respects laws, rules, regulations and guidelines applicable to Client’s performance under this Agreement; D. Client will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the SpecificationsSpecifications or if Client does not hold all necessary Regulatory Approvals to market and sell the Product (except to the extent such consumption occurs in the course of clinical studies that expressly permit such use and that have been conducted in accordance with Applicable Laws); E. Client has all necessary authority to use and to permit Catalent to use pursuant to this Agreement all intellectual property related to Product or Client-supplied Materials (including artwork), cGMPand to its knowledge, the Quality Processing of the foregoing, including any copyrights, trademarks, trade secrets, patents, inventions and developments; there are no patents owned by others related to the Client IP utilized with the Product that would be infringed or misused by Client’s performance of the Agreement; and, and Applicable Laws;to its knowledge, no trade secrets or other proprietary rights of others related to the Client IP utilized with the Product that would be infringed or misused by Client’s performance of this Agreement; and (d) it owns F. To its knowledge, the services to be performed by Catalent under this Agreement will not violate or possesses adequate licenses infringe upon any trademark, tradename, copyright, patent, trade secret, or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided right held by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement person or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedentity.

Appears in 1 contract

Samples: Commercial Supply Agreement (Adamas Pharmaceuticals Inc)

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) A. all Client-supplied Materials shall have been produced in accordance with Applicable Laws, shall comply with all applicable specifications, including the Specifications for Specifications, shall not be adulterated, misbranded or mislabeled within the Drug Product are its or its Affiliate’s property meaning of Applicable Laws, and that shall have been provided in accordance with the Client may lawfully disclose the Specifications to Patheonterms and conditions of this Agreement; (b) B. the Specifications for the Drug Product conform content of all artwork provided to Catalent shall comply with all cGMPs, and Applicable Laws; (c) C. all Active Compounds Product delivered to Client by Catalent shall be held, used and disposed of by or Granulations (as on behalf of the case may be) Client in accordance with all Applicable Laws, and Components supplied by Client hereunder will otherwise comply in with all material respects laws, rules, regulations and guidelines applicable to Client’s performance under this Agreement; D. Client will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications, cGMP, Specifications or if Client does not hold all necessary Regulatory Approvals to market and sell the Quality AgreementProduct; E. Client has all necessary authority to use and to permit Catalent to use pursuant to this Agreement all intellectual property related to Product or Client-supplied Materials (including artwork), and Applicable Laws;the Processing by Catalent of the foregoing, including any copyrights, trademarks, trade secrets, patents, inventions and developments; to Client’s knowledge there are no patents owned by others related to the Client IP utilized with the Product that would be infringed or misused by Client’s performance of the Agreement; and, to its knowledge, no trade secrets or other proprietary rights of others related to the Client IP utilized with the Product that would be infringed or misused by Client’s performance of this Agreement; CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.EXECUTION VERSION (d) it owns F. To Client’s knowledge the services to be performed by Catalent under this Agreement will not violate or possesses adequate licenses infringe upon any trademark, tradename, copyright, patent, trade secret, or other intellectual property or other right held by any person or entity; provided that are necessary for Patheon Client makes no representation with respect to the Catalent IP; G. Client has all authorizations and permits required to deliver API (or have delivered) to Catalent’s Facility; H. Client has the full power and authority to execute and deliver this Agreement and perform its covenants, duties, and obligations described in this Agreement, and once executed, this Agreement will be a valid, legal, and binding obligation upon Client; and I. no transactions or dealings under this Agreement and shall be conducted with or for an individual or entity that it is unaware designated as the target of any assertion sanctions, restrictions or claim challenging embargoes administered by the ownershipUnited Nations, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulasEuropean Union, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the ComponentsUnited Kingdom, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedUnited States.

Appears in 1 contract

Samples: Softgel Commercial Supply Agreement (TherapeuticsMD, Inc.)

Client. The Client covenantsIn addition to the general representations set forth in Section 11(A) hereof, represents and warrants that: (a) the Specifications for the Drug Product are its or its Affiliate’s property and that the Client may lawfully disclose also represents, warrants and covenants to the Specifications to Patheon; (b) the Specifications for the Drug Product conform to all cGMPsCustodian that: i. Its principal place of business is in New York State, and Applicable Laws; (c) all Active Compounds it will notify the Custodian before changing its principal place of business to another jurisdiction; ii. It has the requisite power and authority to deposit the Assets in the Custody Account; iii. Any factual information heretofore or Granulations (as contemporaneously furnished by or on behalf of the case may be) Client in writing to the Custodian for purposes of or in connection with the services contemplated by this Agreement is to the best of its knowledge true and Components supplied by Client hereunder will comply accurate in all material respects on the date as of which such information is dated or certified and not incomplete by omitting to state any fact necessary to make such information not misleading in any material respect at such time; provided that, with the Specifications, cGMPrespect to forecasts or projections, the Quality AgreementClient represents only that such information was prepared in good faith based upon assumptions believed to be reasonable at the time; iv. There is no claim pending, or to the Client’s knowledge, threatened, and Applicable Laws; (d) it owns or possesses adequate licenses no encumbrance or other intellectual property lien, in each case, that are may adversely affect any delivery of Assets made in accordance with this Agreement; v. It owns the Assets in the Custody Account free and clear of all liens, claims, security interests and encumbrances (except those granted herein) and it has all rights, title and interest in and to the Assets in the Custody Account as necessary for Patheon the Custodian to perform its obligations under this Agreement Agreement; vi. It acknowledges that Digital Assets are new forms of assets, that the law regarding their ownership, custody and transfer is developing and uncertain, and that custody of such assets poses certain risks that are not present in the case of more traditional asset classes, including the risks of fraud and theft; and it understands that it will bear such risks and the potential loss or diminution in value of Digital Assets due to (a) changes or developments in the Law or conditions under existing Law in which its rights in and to such Digital Assets are not adequately protected, (b) changes in the Custodian’s policies or procedures made in the Custodian’s sole discretion in light of legal, regulatory, operational, security or reputational risks, (c) an Ineligibility Determination or (d) fraud and theft to the extent not the result of the Custodian’s gross negligence, willful misconduct or fraud; vii. It is unaware not, and no transferee of Assets pursuant to any Digital Asset Debit Request is, (a) the target of any assertion economic, financial or claim challenging trade sanctions or embargoes, export controls or other restrictive measures imposed by the ownershipUnited States of America (including those administered by the United States Department of the Treasury’s Office of Foreign Assets Control), use the European Union, any member state of the European Union, the United Kingdom or validity the United Nations (the “Sanctions”), or (b) located, organized or resident in a country or territory with which dealings are broadly restricted or prohibited by any Sanctions (as of any intellectual property of Client to be utilized hereunderthe date hereof, Crimea, Cuba, Iran, North Korea and Syria)(any such country, territory, entity or individual described in this clause (ix), a “Sanctioned Party”); viii. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by Client under this Agreement does not infringe the valid rights of know or have any third party including inter alia intellectual property rights; reason to suspect that (ea) the provision any part of the Manufacturing Services by Patheon Assets are or will be derived from, held for the benefit of, or related in respect of any way to transactions with or on behalf of, any Sanctioned Party, and (b) any Sanctioned Party has or will have any legal or beneficial interest in the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, Client or any of the Active Compounds, Granulations and Assets; ix. The Client does not know or have any reason to suspect that (a) any part of the ComponentsAssets was derived from unlawful activities, or the sale, use or other disposition (b) any part of the Drug Product made Assets or proceeds of the Assets will be used to finance any unlawful activities; x. If the Client is a non-U.S. banking institution (a “Non-U.S. Bank”) or is holding the Assets directly or indirectly on behalf of or for the benefit of a Non-U.S. Bank, such Non-U.S. Bank (a) maintains a place of business at a fixed address, other than solely a post office box or an electronic address, in accordance with a country where the Specifications; Non-U.S. Bank is authorized to conduct banking activities; (gb) at such location, employs one or more individuals on a full-time basis; (c) maintains operating records related to its banking activities; (d) is subject to inspection by the banking authority that licensed the Non-U.S. Bank; and (e) does not provide banking services to any other Non-U.S. Bank that does not have a physical presence in any country and that is not a registered affiliate of such Non-U.S. Bank; xi. If the Client is an entity holding the Assets on behalf of third parties, (a) the Drug Product, if labelled and manufactured in accordance with the Specifications and Client is in compliance in all material respects with Sanctions and, as applicable cGMPs to the Client, the U.S. Bank Secrecy Act, as amended, the U.S. Money Laundering Control Act of 1986, as amended, the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001, as amended, or any similar U.S. federal, state or foreign law or regulation, (ib) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for has anti-money laundering policies and procedures in place reasonably designed to verify the purpose intendedidentity of its customers and investors and their sources of funds, and (iii) will be safe for human consumption; (hc) the entering into Client has established the identities of this Agreement and conducted due diligence required by Client Laws applicable to it with respect to all of its customers or investors who beneficially own or will not (i) violate any provision of lawbeneficially own, statutedirectly or indirectly, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtained.Assets;

Appears in 1 contract

Samples: Custodial Services Agreement (wShares Bitcoin Fund)

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) the A. all Client-supplied Materials shall have been produced in accordance with Applicable Laws, shall comply with all applicable Specifications for such Client-supplied Materials, shall not be adulterated, misbranded or mislabeled within the Drug Product are its or its Affiliate’s property meaning of Applicable Laws, and that shall have been provided in accordance with the Client may lawfully disclose the Specifications to Patheonterms and conditions of this Agreement; (b) B. the Specifications for the Drug Product conform content of all artwork provided to Catalent shall comply with all cGMPs, and Applicable Laws; (c) C. all Active Compounds Client Product delivered to Client by Catalent shall be held, used and disposed of by or Granulations (as on behalf of the case may be) Client in accordance with all Applicable Laws, and Components supplied Client will otherwise comply with all Applicable Laws with respect to Client’s performance under this Agreement; D. Client will not release any Batch of Client Product if the required Certificates of Conformance indicate that such Client Product does not comply with the Specifications or if Client does not hold all necessary Regulatory Approvals to market and sell the Client Product in a given portion of the Territory; E. Client has all necessary authority to use and to permit Catalent to use pursuant to this Agreement all intellectual property controlled by Client hereunder will comply in all material respects related to Client Product or Client-supplied Materials (including artwork) that is necessary for the Processing of the foregoing, including any copyrights, trademarks, trade secrets, patents, inventions and developments; and to Client’s actual knowledge (without inquiry), as of the Effective Date, there are no patents owned by others and existing as of the Effective Date that are directly related to the Client intellectual property that is utilized with the SpecificationsClient Product and that would be infringed or misused by Client’s performance of the Agreement; F. the Client Equipment is capable of producing Client Product in conformance with the Specifications and Applicable Laws (including cGMP) when operated and/or conducted in accordance with the SRA, applicable batch records and cGMP; and G. to Client’s actual knowledge (without inquiry) as of the Effective Date, the Quality AgreementProcessing to be performed by Catalent in accordance with this Agreement will not violate or infringe upon any trademark, and Applicable Laws; (d) it owns or possesses adequate licenses tradename, copyright, patent, trade secret, or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided right held by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement person or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications; (g) the Drug Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs (i) may be lawfully sold and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption; (h) the entering into of this Agreement by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedentity.

Appears in 1 contract

Samples: Commercial Supply Agreement (Acelrx Pharmaceuticals Inc)

Client. The Client covenantsrepresents, represents warrants and warrants undertakes to Catalent that: (a) A. All Client-supplied Materials shall have been produced in accordance with Applicable Laws, shall comply with all applicable specifications, including the Specifications for shall not be adulterated, misbranded or mislabeled within the Drug Product are its or its Affiliate’s property and that the Client may lawfully disclose the Specifications to Patheon; (b) the Specifications for the Drug Product conform to all cGMPsmeaning of Applicable Laws, and Applicable Laws; (c) all Active Compounds or Granulations (as the case may be) and Components supplied by Client hereunder will comply in all material respects with the Specifications, cGMP, the Quality Agreement, and Applicable Laws; (d) it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Client to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property shall have been provided by Client under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (e) the provision of the Manufacturing Services by Patheon in respect of the Drug Product pursuant to this Agreement or use or other disposition of the Drug Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to any of the Specifications, or any of the Active Compounds, Granulations and the Components, or the sale, use or other disposition of the Drug Product made in accordance with the Specifications;terms and conditions of this Agreement. B. The content of all artwork provided by or on behalf of Client to Catalent shall comply with all Applicable Laws. C. All Product delivered to Client by Catalent shall be held, used and disposed of by or on behalf of Client in accordance with Applicable Laws, and Client will otherwise comply with Applicable Laws relating to Client’s performance under this Agreement. D. Client will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications or if Client does not hold all necessary Regulatory Approvals to market and sell the Product. E. Client has all necessary authority to use and to permit Catalent to use pursuant to and in accordance with this Agreement all Client IP related to Product or Client-supplied Materials (gincluding artwork) or the Drug ProductProcessing of either of them, including all applicable copyrights, trademarks, trade secrets, patents, inventions and developments. F. To its knowledge, there is (i) no patent owned by a third party related to the Client IP used to Process Product that would be infringed or misused by performance under and in accordance with this Agreement and (ii) no trade secret or other proprietary right of a third party related to the Client IP used to Process Product that would be infringed or misused by performance under and in accordance with this Agreement. G. To its knowledge, the services to be performed by Catalent under this Agreement if labelled and manufactured performed in strict accordance with the Specifications will not violate or infringe upon any trademark, tradename, copyright, patent, trade secret, or other Intellectual Property or other right held by any person or entity. Client has all authorizations and in compliance permits required to deliver (or have delivered) API to the Facility. H. No transaction or dealing under this Agreement shall be conducted with applicable cGMPs (i) may be lawfully sold or for an individual or entity that is designated as the target of any sanction, restriction or embargo administered by the United Nations, European Union, United Kingdom, or United States. I. Client has full power and distributed in every jurisdiction in which the Client markets such Drug Product, (ii) will be fit for the purpose intendedauthority to enter into this Agreement, and (iii) will be safe for human consumption; (h) the entering into of this Agreement has been duly authorized by Client will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Client under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement in which Client is a party or by which it or any of its properties or assets is bound or affected; and (i) all necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Client have been duly obtainedis binding upon it.

Appears in 1 contract

Samples: Commercial Supply Agreement (Acadia Pharmaceuticals Inc)

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!