Common use of Representations and Warranties of Merck Serono Clause in Contracts

Representations and Warranties of Merck Serono. Merck Serono represents and warrants to BioMarin as of the Agreement Date and the Transfer Time, as follows: (a) Merck Serono is a corporation duly organized, validly existing and in good standing under the laws of Switzerland. (b) Merck Serono has full corporate power and authority to execute and deliver this Agreement and to perform its obligations and consummate the transactions contemplated hereby. All corporate acts required to be taken to authorize such execution, delivery, performance and consummation have been duly and properly taken and obtained. (c) This Agreement has been duly executed and delivered by Merck Serono and constitutes the legal, valid and binding obligations of Merck Serono enforceable against Merck Serono in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other Laws of general application affecting enforcement of creditors’ rights generally, and (ii) general principals of equity. (d) Except for, if required, the filings under any applicable competition Law in the Territory, and the expiration of the waiting periods thereunder, no notice to, filing with, permit of, authorization of, exemption by, or consent of, any Governmental Body or other Person is required for the execution and delivery by Merck Serono of this Agreement, the performance by Merck Serono of its obligations hereunder or the consummation by Merck Serono of the transactions contemplated hereby (other than the transfer of the Regulatory Approvals, the Transferred Clinical Trial Authorizations and the Transferred Orphan Designations as contemplated hereby). (e) None of the execution, delivery or performance of this Agreement by Merck Serono (i) conflicts with or results in a breach under the certificate of incorporation, articles of association, bylaws or other similar governing instruments and organizational documents of Merck Serono, (ii) assuming the receipt of all approvals, authorizations, consents or other order of any Governmental Body, the making of all registrations, notifications, declarations or filings with Governmental Bodies, and the termination or expiration of any waiting periods thereunder required to be made by or with respect to Merck Serono or any of its Affiliates (as and to the extent contemplated by Section 7.01(e)), conflicts with or results in a violation of any Law applicable to Merck Serono or the Transferred Assets, or (iii) conflicts with any agreement, instrument or understanding to which it or its Affiliates is a party or by which it or its Affiliates is bound or will result in the creation of an Encumbrance on the Transferred Assets. (f) Merck Serono has, or its Affiliates have, good, valid and marketable title to, or valid Contract rights in, as applicable, the Transferred Assets, free and clear of all Encumbrances. (g) Merck Serono and its Affiliates, with respect to the Transferred Assets and business operations related thereto, are and during the past [*] have been in compliance in all material respects with all Laws, including any Laws governing the development, approval, sale, marketing, promotion, or distribution of drugs and the purchase or prescription of or reimbursement for drugs by any Governmental Body, private health plan or entity, or individual. (h) Merck Serono has made available to BioMarin [*] information [*] relating to the safety of the Products in the Territory, and all such information is true and correct in all material respects. (i) There is no, and within the past [*] there has not been any, Proceeding pending or, to Merck Serono’s knowledge, threatened, in which Merck Serono or any of its Affiliates or sublicensees is a party relating to or involving the Transferred Assets, the Products or the Product Business. There are no, and there has not been any, judicial orders, writs, injunctions, decrees, judgments or stipulations in force against Merck Serono or any of its Affiliates or sublicensees with respect to the Transferred Assets or the Product Business. No claim or demand of any Person has been made or threatened, nor is there any Proceeding that is pending or threatened, that (i) challenges the rights of Merck Serono or any of its Affiliates in respect of any of the Transferred Assets or the Product Business, or (ii) asserts that the operation of the Product Business or the Exploitation of any Product or the processes used to make any Product is, was or will be infringing or otherwise in violation of any Intellectual Property of any Person or is, was or will be required to pay any royalty, license fee, charge or other amount with regard to any Intellectual Property of any Person. (j) All fees, taxes, annuities and other payments associated with filing, prosecuting, issuing, recording, registering or maintaining all Transferred Intellectual Property that has been issued or granted by, or that has been applied for and are pending issuance or grant with, any Governmental Body have been paid in full in a timely manner to the proper Governmental Body. All Transferred Intellectual Property is owned solely by Merck Serono or an Affiliate of Merck Serono, is active, is [*] valid and enforceable (if granted), and the ownership of the entire right, title and interest is recorded (through its entire chain of title beginning with and including each inventor) with the applicable Governmental Body solely in the name of Merck Serono or an Affiliate of Merck Serono. (k) Merck Serono has not received a written notice from any Person that asserts that the Exploitation of Kuvan infringes or would infringe the Patent Rights of any Person. The transfer, reproduction or disclosure of the Transferred Assets to BioMarin pursuant to the terms of this Agreement, and [*] BioMarin’s Exploitation of the Transferred Assets in connection with its Exploitation of Kuvan consistent with Merck Serono’s Exploitation of Kuvan prior to the Transfer Time does not and would not reasonably be expected to infringe the Copyrights or misappropriate the trade secret rights of any other Person. To Merck Serono’s knowledge, no Person has infringed, misappropriated or otherwise violated any of the Transferred Intellectual Property. (l) Except as disclosed by Merck Serono to BioMarin in the Dataroom prior to the Agreement Date, there are no Contracts to which Merck Serono or any of its Affiliates is a party relating to the Product Business or the Transferred Assets of the following nature: (i) any license, covenant not to xxx, immunity from suit or similar right granted from any Person to Merck Serono or any of its Affiliates of any Intellectual Property contained within, necessary for, or reasonably useful to the development, manufacturing, seeking or obtaining Regulatory Approval for, or commercialization of any Product or other Exploitation of the Product Business or the Transferred Assets; (ii) any license, covenant not to xxx, immunity from suit or similar right relating to any of the Transferred Assets granted from Merck Serono or any of its Affiliates to any other Person which is individually or in the aggregate material to the business, operations, assets, financial condition, results of operations or prospects of the Product Business; (iii) any other agreement in effect as of the Agreement Date directly related to the development, manufacturing, seeking or maintaining Regulatory Approval for, or commercialization or clinical trial of any Product or other Exploitation of the Product Business or the Transferred Assets which is individually or in the aggregate material to the business, operations, assets, financial condition, results of operations or prospects of the Product Business; (iv) any agreement with any Governmental Body or university or similar institution which is individually or in the aggregate material to the business, operations, assets, financial condition, results of operations or prospects of the Product Business; or (v) any other agreement that is material to the business, operations, assets, financial condition, results of operations or prospects of the Product Business. (m) Each of the Assigned Contracts is in effect and constitutes a legal, valid and binding Contract of Merck Serono or an Affiliate of Merck Serono and, to Merck Serono’s knowledge, each other party thereto, enforceable in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other Laws of general application affecting enforcement of creditors’ rights generally, and (ii) general principals of equity. Merck Serono is not and, to Merck Serono’s knowledge, no other party thereto is, in material default in the performance, observance or fulfillment of any material obligation or covenant contained in any Assigned Contract, and Merck Serono has not given or received written notice to or from any Person relating to any such alleged material default. Neither Merck Serono nor any of its Affiliates has, nor, to Merck Serono’s knowledge, any other party to any Assigned Contract has, waived any of its material rights thereunder or modified any material terms thereof. Neither Merck Serono nor any of its Affiliates has received any written notice from a Third Party stating that such Third Party intends to terminate any Assigned Contract. True and complete copies of all Assigned Contracts (including all amendments thereto) have been provided or made available to BioMarin prior to the Agreement Date on the Datawebsite, or will be provided by Merck Serono within [*] days after the Agreement Date. (n) EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, MERCK SERONO MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO [*].

Representations and Warranties of Merck Serono. Merck Serono represents and warrants to BioMarin as of the Agreement Date and the Transfer TimeLicense Terminate Date, as follows: (a) Merck Serono is a corporation duly organized, validly existing and in good standing under the laws of Switzerland. (b) Merck Serono has full corporate power and authority to execute and deliver this Agreement and to perform its obligations and consummate the transactions contemplated hereby. All corporate acts required to be taken to authorize such execution, delivery, performance and consummation have been duly and properly taken and obtained. (c) This Agreement has been duly executed and delivered by Merck Serono and constitutes the legal, valid and binding obligations of Merck Serono enforceable against Merck Serono in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other Laws of general application affecting enforcement of creditors’ rights generally, and (ii) general principals of equity. (d) Except for, if required, the filings under any applicable competition Law in the Territory, and the expiration of the waiting periods thereunder, no notice to, filing with, permit of, authorization of, exemption by, or consent of, any Governmental Body or other Person is required for the execution and delivery by Merck Serono of this Agreement, the performance by Merck Serono of its obligations hereunder or the consummation by Merck Serono of the transactions contemplated hereby (other than the transfer of the Regulatory Approvals, the Transferred Clinical Trial Authorizations and the Transferred Orphan Designations as contemplated hereby). (e) None of the execution, delivery or performance of this Agreement by Merck Serono (i) conflicts with or results in a breach under the certificate of incorporation, articles of association, bylaws or other similar governing instruments and organizational documents of Merck Serono, (ii) assuming the receipt of all approvals, authorizations, consents or other order of any Governmental Body, the making of all registrations, notifications, declarations or filings with Governmental Bodies, and the termination or expiration of any waiting periods thereunder required to be made by or with respect to Merck Serono or any of its Affiliates (as and to the extent contemplated by Section 7.01(e)), conflicts with or results in a violation of any Law applicable to Merck Serono or the Transferred Assets, or (iii) conflicts with any agreement, instrument or understanding to which it or its Affiliates is a party or by which it or its Affiliates is bound or will result in the creation of an Encumbrance on the Transferred Assets. (f) Merck Serono has, or its Affiliates have, good, valid and marketable title to, or valid Contract rights in, as applicable, the Transferred Assets, free and clear of all Encumbrances. (g) Merck Serono and its Affiliates, with respect to the Transferred Assets and business operations related thereto, are and during the past [*] have been in compliance in all material respects with all Laws, including any Laws governing the development, approval, sale, marketing, promotion, or distribution of drugs and the purchase or prescription of or reimbursement for drugs by any Governmental Body, private health plan or entity, or individual. (h) Merck Serono has made available to BioMarin [*] information [*] relating to the safety of the Products in the Territory, and all such information is true and correct in all material respects. (i) There is no, and within the past [*] there has not been any, Proceeding pending or, to Merck Serono’s knowledge, threatened, in which Merck Serono or any of its Affiliates or sublicensees is a party relating to or involving the Transferred Assets, the Products or the Product Business. There are no, and there has not been any, judicial orders, writs, injunctions, decrees, judgments or stipulations in force against Merck Serono or any of its Affiliates or sublicensees with respect to the Transferred Assets or the Product Business. No claim or demand of any Person has been made or threatened, nor is there any Proceeding that is pending or threatened, that (i) challenges the rights of Merck Serono or any of its Affiliates in respect of any of the Transferred Assets or the Product Business, or (ii) asserts that the operation of the Product Business or the Exploitation of any Product or the processes used to make any Product is, was or will be infringing or otherwise in violation of any Intellectual Property of any Person or is, was or will be required to pay any royalty, license fee, charge or other amount with regard to any Intellectual Property of any Person. (j) All fees, taxes, annuities and other payments associated with filing, prosecuting, issuing, recording, registering or maintaining all Transferred Intellectual Property that has been issued or granted by, or that has been applied for and are pending issuance or grant with, any Governmental Body have been paid in full in a timely manner to the proper Governmental Body. All Transferred Intellectual Property is owned solely by Merck Serono or an Affiliate of Merck Serono, is active, is is[*] valid and enforceable (if granted), and the ownership of the entire right, title and interest is recorded (through its entire chain of title beginning with and including each inventor) with the applicable Governmental Body solely in the name of Merck Serono or an Affiliate of Merck Serono. (k) Merck Serono has not received a written notice from any Person that asserts that the Exploitation of Kuvan infringes or would infringe the Patent Rights of any Person. The transfer, reproduction or disclosure of the Transferred Assets to BioMarin pursuant to the terms of this Agreement, and and[*] BioMarin’s Exploitation of the Transferred Assets in connection with its Exploitation of Kuvan consistent with Merck Serono’s Exploitation of Kuvan prior to the Transfer Time License Termination Date does not and would not reasonably be expected to infringe the Copyrights or misappropriate the trade secret rights of any other Person. To Merck Serono’s knowledge, no Person has infringed, misappropriated or otherwise violated any of the Transferred Intellectual Property. (l) Except as disclosed by Merck Serono to BioMarin in the Dataroom prior to the Agreement Date, there are no Contracts to which Merck Serono or any of its Affiliates is a party relating to the Product Business or the Transferred Assets of the following nature: (i) any license, covenant not to xxx, immunity from suit or similar right granted from any Person to Merck Serono or any of its Affiliates of any Intellectual Property contained within, necessary for, or reasonably useful to the development, manufacturing, seeking or obtaining Regulatory Approval for, or commercialization of any Product or other Exploitation of the Product Business or the Transferred Assets; (ii) any license, covenant not to xxx, immunity from suit or similar right relating to any of the Transferred Assets granted from Merck Serono or any of its Affiliates to any other Person which is individually or in the aggregate material to the business, operations, assets, financial condition, results of operations or prospects of the Product Business; (iii) any other agreement in effect as of the Agreement Date directly related to the development, manufacturing, seeking or maintaining Regulatory Approval for, or commercialization or clinical trial of any Product or other Exploitation of the Product Business or the Transferred Assets which is individually or in the aggregate material to the business, operations, assets, financial condition, results of operations or prospects of the Product Business; (iv) any agreement with any Governmental Body or university or similar institution which is individually or in the aggregate material to the business, operations, assets, financial condition, results of operations or prospects of the Product Business; or (v) any other agreement that is material to the business, operations, assets, financial condition, results of operations or prospects of the Product Business. (m) Each of the Assigned Contracts is in effect and constitutes a legal, valid and binding Contract of Merck Serono or an Affiliate of Merck Serono and, to Merck Serono’s knowledge, each other party thereto, enforceable in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other Laws of general application affecting enforcement of creditors’ rights generally, and (ii) general principals of equity. Merck Serono is not and, to Merck Serono’s knowledge, no other party thereto is, in material default in the performance, observance or fulfillment of any material obligation or covenant contained in any Assigned Contract, and Merck Serono has not given or received written notice to or from any Person relating to any such alleged material default. Neither Merck Serono nor any of its Affiliates has, nor, to Merck Serono’s knowledge, any other party to any Assigned Contract has, waived any of its material rights thereunder or modified any material terms thereof. Neither Merck Serono nor any of its Affiliates has received any written notice from a Third Party stating that such Third Party intends to terminate any Assigned Contract. True and complete copies of all Assigned Contracts (including all amendments thereto) have been provided or made available to BioMarin prior to the Agreement Date on the Datawebsite, or will be provided by Merck Serono within [*] days after the Agreement Date. (n) EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, MERCK SERONO MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO [*].

Representations and Warranties of Merck Serono. Merck Serono represents and warrants to BioMarin as of the Agreement Date and the Transfer TimeLicense Termination Date, as follows: (a) Merck Serono is a corporation duly organized, validly existing and in good standing under the laws of Switzerland. (b) Merck Serono has full corporate power and authority to execute and deliver this Agreement and to perform its obligations and consummate the transactions contemplated hereby. All corporate acts required to be taken to authorize such execution, delivery, performance and consummation have been duly and properly taken and obtained. (c) This Agreement has been duly executed and delivered by Merck Serono and constitutes the legal, valid and binding obligations of Merck Serono enforceable against Merck Serono in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other Laws of general application affecting enforcement of creditors’ rights generally, and (ii) general principals of equity. (d) Except for, if required, the filings under any applicable competition Law in the Territory, and the expiration of the waiting periods thereunder, no notice to, filing with, permit of, authorization of, exemption by, or consent of, any Governmental Body or other Person is required for the execution and delivery by Merck Serono of this Agreement, the performance by Merck Serono of its obligations hereunder or the consummation by Merck Serono of the transactions contemplated hereby (other than the transfer of the Regulatory Approvals, the Transferred Clinical Trial Authorizations and the Transferred Orphan Designations as contemplated hereby). (e) None of the execution, delivery or performance of this Agreement by Merck Serono (i) conflicts with or results in a breach under the certificate of incorporation, articles of association, bylaws or other similar governing instruments and organizational documents of Merck Serono, (ii) assuming the receipt of all approvals, authorizations, consents or other order of any Governmental Body, the making of all registrations, notifications, declarations or filings with Governmental Bodies, and the termination or expiration of any waiting periods thereunder required to be made by or with respect to Merck Serono or any of its Affiliates (as and to the extent contemplated by Section 7.01(e5.01(e)), conflicts with or results in a violation of any Law applicable to Merck Serono or the Transferred Assets, or (iii) conflicts with any agreement, instrument or understanding to which it or its Affiliates is a party or by which it or its Affiliates is bound or will result in the creation of an Encumbrance on the Transferred Assetsbound. (f) Merck Serono has, or its Affiliates have, good, valid and marketable title to, or valid Contract rights in, as applicable, the Transferred Assets, free and clear of all Encumbrances. (g) Merck Serono and its Affiliates, with respect to the Transferred Assets and business operations related thereto, are and during the past [*] have been in compliance in all material respects with all Laws, including any Laws governing the development, approval, sale, marketing, promotion, or distribution of drugs and the purchase or prescription of or reimbursement for drugs by any Governmental Body, private health plan or entity, or individual. (h) Merck Serono has made available to BioMarin [*] information [*] relating to the safety of the Products in the Territory, and all such information is true and correct in all material respects. (i) There is no, and within the past [*] there has not been any, Proceeding pending or, to Merck Serono’s knowledge, threatened, in which Merck Serono or any of its Affiliates or sublicensees is a party relating to or involving the Transferred Assets, the Products or the Product Business. There are no, and there has not been any, judicial orders, writs, injunctions, decrees, judgments or stipulations in force against Merck Serono or any of its Affiliates or sublicensees with respect to the Transferred Assets or the Product Business. No claim or demand of any Person has been made or threatened, nor is there any Proceeding that is pending or threatened, that (i) challenges the rights of Merck Serono or any of its Affiliates in respect of any of the Transferred Assets or the Product Business, or (ii) asserts that the operation of the Product Business or the Exploitation of any Product or the processes used to make any Product is, was or will be infringing or otherwise in violation of any Intellectual Property of any Person or is, was or will be required to pay any royalty, license fee, charge or other amount with regard to any Intellectual Property of any Person. (j) All fees, taxes, annuities and other payments associated with filing, prosecuting, issuing, recording, registering or maintaining all Transferred Intellectual Property that has been issued or granted by, or that has been applied for and are pending issuance or grant with, any Governmental Body have been paid in full in a timely manner to the proper Governmental Body. All Transferred Intellectual Property is owned solely by Merck Serono or an Affiliate of Merck Serono, is active, is [*] valid and enforceable (if granted), and the ownership of the entire right, title and interest is recorded (through its entire chain of title beginning with and including each inventor) with the applicable Governmental Body solely in the name of Merck Serono or an Affiliate of Merck Serono. (k) Merck Serono has not received a written notice from any Person that asserts that the Exploitation of Kuvan infringes or would infringe the Patent Rights of any Person. The transfer, reproduction or disclosure of the Transferred Assets to BioMarin pursuant to the terms of this Agreement, and [*] BioMarin’s Exploitation of the Transferred Assets in connection with its Exploitation of Kuvan consistent with Merck Serono’s Exploitation of Kuvan prior to the Transfer Time does not and would not reasonably be expected to infringe the Copyrights or misappropriate the trade secret rights of any other Person. To Merck Serono’s knowledge, no Person has infringed, misappropriated or otherwise violated any of the Transferred Intellectual Property. (l) Except as disclosed by Merck Serono to BioMarin in the Dataroom prior to the Agreement Date, there are no Contracts to which Merck Serono or any of its Affiliates is a party relating to the Product Business or the Transferred Assets of the following nature: (i) any license, covenant not to xxx, immunity from suit or similar right granted from any Person to Merck Serono or any of its Affiliates of any Intellectual Property contained within, necessary for, or reasonably useful to the development, manufacturing, seeking or obtaining Regulatory Approval for, or commercialization of any Product or other Exploitation of the Product Business or the Transferred Assets; (ii) any license, covenant not to xxx, immunity from suit or similar right relating to any of the Transferred Assets granted from Merck Serono or any of its Affiliates to any other Person which is individually or in the aggregate material to the business, operations, assets, financial condition, results of operations or prospects of the Product Business; (iii) any other agreement in effect as of the Agreement Date directly related to the development, manufacturing, seeking or maintaining Regulatory Approval for, or commercialization or clinical trial of any Product or other Exploitation of the Product Business or the Transferred Assets which is individually or in the aggregate material to the business, operations, assets, financial condition, results of operations or prospects of the Product Business; (iv) any agreement with any Governmental Body or university or similar institution which is individually or in the aggregate material to the business, operations, assets, financial condition, results of operations or prospects of the Product Business; or (v) any other agreement that is material to the business, operations, assets, financial condition, results of operations or prospects of the Product Business. (m) Each of the Assigned Contracts is in effect and constitutes a legal, valid and binding Contract of Merck Serono or an Affiliate of Merck Serono and, to Merck Serono’s knowledge, each other party thereto, enforceable in accordance with its terms, except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other Laws of general application affecting enforcement of creditors’ rights generally, and (ii) general principals of equity. Merck Serono is not and, to Merck Serono’s knowledge, no other party thereto is, in material default in the performance, observance or fulfillment of any material obligation or covenant contained in any Assigned Contract, and Merck Serono has not given or received written notice to or from any Person relating to any such alleged material default. Neither Merck Serono nor any of its Affiliates has, nor, to Merck Serono’s knowledge, any other party to any Assigned Contract has, waived any of its material rights thereunder or modified any material terms thereof. Neither Merck Serono nor any of its Affiliates has received any written notice from a Third Party stating that such Third Party intends to terminate any Assigned Contract. True and complete copies of all Assigned Contracts (including all amendments thereto) have been provided or made available to BioMarin prior to the Agreement Date on the Datawebsite, or will be provided by Merck Serono within [*] days after the Agreement Date. (n) EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, MERCK SERONO MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO [*].