CONTRACT FOR TRANSFER OF MARKETING AUTHORISATION
Between the undersigned
|1||The company [[name of the owner]]|
|[[owner society form]] with a capital of [[share capital of the owner]], with its registered office at [[head office owner]] registered in [[TCR city owner]] Trade and Companies Register under number [[TCR number owner]] Represented by [[rep name owner]] in his/her capacity as [[rep capacity owner]] Hereinafter referred to as “the Owner”|
|Of the first part,|
|2||The company [[name of the transferee]]|
|[[transferee society form]] with a capital of [[share capital of the transferee]], with its registered office at [[head office transferee]] registered in [[TCR city transferee]] Trade and Companies Register under number [[TCR number transferee]] Represented by [[rep name transferee]] in his/her capacity as [[rep capacity transferee]] Hereinafter referred to as “the Transferee”|
|Of the second part|
Hereinafter referred to as “the Parties”
- The Owner specialises in the development and manufacture of specialist pharmaceutical products.
- The Owner manufactures medicinal product(s) (hereinafter “the Product(s)”), as defined in Appendix [[Characteristics of the Product(s)]], for which the Owner has obtained an Authorisation from the Competent Authority, a certified copy of which is appended in Appendix [[Authorisation(s) relating to the Product(s)]].
- The Transferee is a pharmaceutical company that markets pharmaceutical products.
- The Transferee is interested in acquiring the Authorisation in question.
- The Transferee declares that it is familiar with the Product(s) and has the commercial, technical and regulatory skills and resources to effectively market the Product(s) in compliance with the legislation.
Consequently, the Parties have decided to enter into this Transfer Contract.
THIS BEING STATED, THE FOLLOWING HAS BEEN AGREED:
1.1 “MA” means: the marketing authorisation issued by the C/A
- “ANSM” means: National Drug and Health Products Safety Agency in France.
1.3 “Competent authority” or “C/A” means: any competent health authority, for all countries including France
1.4 “Authorisation” means: any marketing authorisation obtained from the competent authorities, including the ANSM for France, whether the procedure is national, centralised, mutual recognised or decentralised, as referred to in Appendix [[Authorisation(s) relating to the Product(s):]]. The MA is therefore an Authorisation.
1.5 “Files” means: all the toxicological and clinical data relating to the Product(s), an exhaustive list of which is given in Appendix [[List of data comprising the File(s)]].
- “Party(ies)” means: the Owner and/or the Transferee.
- “Product(s)” means: the medicinal product(s) whose Authorisation is the subject of this transfer, the details of which are given in Appendix [[Characteristics of the Product(s)]].
The contractual documents are listed in decreasing order of priority:
- Characteristics of the Product(s)
- Authorisation(s) relating to the Product(s)
- List of data comprising the File(s)
Hereinafter referred to together as “The Contract”.
The Contract prevails over any other prior document of any kind, and/or over any correspondence between the Parties with the same purpose, so that this Contract alone shall govern the subject of the Contract between the Parties, unless expressly decided otherwise in writing by the Parties.
In addition, all amendments which, where necessary, will be made to the terms of the Contract must be made in the form of a supplementary agreement, signed by both Parties or by the representatives duly authorised by them.
- PURPOSE / SCOPE OF CONTRACT
3.1 The purpose of this Contract is to grant to the Transferee, who accepts, ownership of:
– the Authorisation
– the File as defined at Article 1 above, relating to the Product(s)
Hereinafter “the Transferred Elements”.
In order to operate the Products that are the subject of the said Authorisation.
3.2 With effect from this transfer, the Transferee shall be solely subrogated to all the Owner’s rights, actions, and privileges over the Transferred Elements, and shall acquire full and entire ownership and possession of the said Elements, which it may make use of in the future as it wishes, and enter into any contract of any kind, in order to operate the Transferred Elements within the limits of the applicable legislation. The Transferee may market the Products under the name of its choice.
3.3 This Contract shall not be interpreted as granting the Transferee any intellectual and/or industrial property rights, or any know-how relating to the Product, which will specifically remain the Owner’s property.
- EFFECTIVE DATE
This Contract will enter into force on the date of completion of the conditions precedent referred to at Article 13.
5.1 This transfer is granted and accepted by the Parties subject to the price, excluding taxes, of [[price excluding tax of the transfer]] Euros. Transfer of ownership of the Transferred Elements will only take place after full payment of the price by the Transferee and signature of the manufacturing contract.
5.2 The transfer price will be invoiced upon completion of the last condition precedent referred to at Article 13.
This invoice will be payable 30 days from the issue date of the invoice, otherwise the Contract will be deemed terminated.
6.1 The Owner declares that it owns the Transferred Elements.
6.2 The Owner declares that it has not granted to any third party any operating licence, pledge or right over the Transferred Elements.
6.3 The Owner declares that the Authorisation has been properly obtained and that it is still in force on the date of signature of this Contract.
- THE OWNER’S OBLIGATIONS
- the manufacturing formulae for the Product(s), very concise information on the manufacturing and control methods and processes.
8.1 With effect from the authorisation given by the General Director of the ANSM or by any other Competent Authority, regarding transfer of the Authorisation:
– the Transferee will bear full responsibility for all the pharmaceutical obligations relating to ownership and operation of the Product(s), in particular in terms of pharmacovigilance. In the case of operation outside France, the Transferee will send the Owner the contact details of its European Qualified Person responsible for pharmacovigilance (“EUQPPV”).
The Transferee declares that it is fully familiar with all the national and European legislation on the matter and intends to comply with it.
– The Transferee will also be liable for any loss likely to result from the administration or use of the Product(s) and waives its right to any recourse against the Owner as a result.
8.2 The Transferee will bear all the costs, taxes, levies, charges, contributions, fees and other charges of any kind whatsoever, which this Contract is likely to incur, as well as the costs of any legal instrument that is the result or consequence thereof. This refers specifically to the costs of transfer and maintenance of the Authorisations.
8.3 The Transferee undertakes to pay the taxes, charges and contributions of any kind for which it may be liable as a result of the ownership and/or future operation of the Transferred Elements, so that the Owner will not be troubled on this matter. In this respect, it undertakes to carry out all the necessary declarative formalities relating to transfer of the Transferred Elements.
8.4 The Transferee is informed that the Owner retains in France, or abroad, one or more Authorisations relating to products containing the same Active Substance(s), whether in a different dosage or not, or in a different medicinal form or not, and that these Authorisations may result in operation under brand names other than those used by the Transferee.
In order to enable the Owner to perform its pharmacovigilance obligations, the Transferee undertakes to:
- immediately inform the Owner in writing of the suspension, removal or non-renewal of the Authorisation;
- directly send the Owner the vigilance information immediately, as soon as it is aware of it, under the following conditions: by e-mail, fax or any other appropriate means, in the form of a report containing a written declaration of the result of the investigations and any actions taken by the Transferee and/or the Competent Authority in order to reduce the risk(s) of undesirable effect(s) related to the Product.
- In all cases, send the Owner at the same time as the Competent Authority, a copy of all the periodical pharmacovigilance reports required by the local legislation.
In the same way, the Owner undertakes to send the Transferee, at the same time as any Competent Authority, any periodical pharmacovigilance report it is required to produce in respect of any specialist product comprising the same INN as the Product(s).
8.5 If an Authorisation over which the Owner has retained a right, pursuant to Article 8.4 above, is amended during this contract, on request from the Competent Authority or on the Owner’s initiative, the Owner shall inform the Transferee thereof, who undertakes to immediately request from the Competent Authority the same changes to the transferred Authorisation, so that the Owner can manufacture according to a single set of specifications, in the context of the manufacturing contract signed between the Parties. The costs and taxes for which the Transferee may be liable as a result of said changes will be its responsibility, if the changes in question were requested by the Competent Authority, and divided between the Parties equally, if they came from the Owner.
- GUARANTEES – LIABILITY
9.1 Guarantees concerning the Authorisation
9.1.1 With the exception of any other guarantee, and on the date of this Contract:
– The Owner guarantees the physical existence and validity of the Authorisation / subject of this transfer;
– The Owner guarantees the physical existence and accuracy on the date of signature of this Contract of the information and results contained in the File.
9.1.2 The Owner does not give any guarantee to the Transferee concerning the maintenance over time and/or renewal of the said Authorisation, which is transferred without any other guarantee than that referred to at Article 9.1.1.
9.2 Contractual Liability
9.2.1 Each Party will only be liable for direct losses caused to the other Party as a result of performing this Contract, to the exclusion of any indirect losses, including loss of turnover, loss of profits or loss of earnings.
9.2.2 The Parties agree to limit their liability to the amount of the Transfer as set out in Article 9 hereafter.
9.2.3 In all cases, the Owner shall not be held liable for any removal of an Authorisation or failure to renew an Authorisation.
9.3 Product Liability
9.3.1 In accordance with Article 7.2 of this Contract, the Transferee will be solely liable for any loss that might result from the use or administration of the Product under the conditions set out in Directive 85/374/EEC of 25 July 1985 concerning liability for defective products and the texts by which the Directive has been transposed into national law.
9.3.2 The Transferee may not exercise any recourse of any kind against the Owner.
10.1 This Contract will be terminated as of right and with immediate effect in the event of breach of its obligations by one of the Parties, if not remedied within a period of [[time limit for termination of the contract in case of breach of obligations, in days]] days from a formal notice sent by registered letter with return receipt.
10.2 In the event of termination due to breach, the Transferee and the Owner shall return, at no cost, all the elements and documents which the other Party has sent it in order to perform this Contract. In particular, the Transferee shall carry out any necessary steps in respect of the Competent Authority, or assist the latter in any steps, together with the Owner, in order to transfer the Authorisation to the Owner. In order to comply with this obligation, it is agreed that the Transferee will pay the Owner the sum of €[[penalty amount, per month of delay, for failure to return the MA]] per month of delay, if the transfer of the MA or the Authorisation does not take place within [[time, in months, to return the MA following termination of the contract]] months of termination of the Contract.
- FORCE MAJEURE
11.1 Force majeure that justifies breach of one or more of the contractual obligations means an event beyond the control of the Party claiming it, which is unforeseeable and inevitable.
11.2 The Parties agree that the debtor of an obligation under this Contract will be released from it if an event of force majeure can be proved. If the force majeure is temporary, the Contract will be suspended for a period that may not exceed ninety (90) days. At the end of this period, if the force majeure continues, the Parties shall meet to agree a solution that will enable each to comply with its obligations of pharmacovigilance.
11.3 Any amendment to a legislative or regulatory provision that makes it legally or economically impossible to continue the Contract, shall be considered an event of force majeure.
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11.4 The following are considered elements of force majeure: [[force majeure list]]
12.1 The Transferee undertakes to treat as confidential for a period of ten (10) full, consecutive years, with effect from the day it is disclosed, all information received from the Owner under this Contract, with the exception of:
- information which was in the public domain at the time it was disclosed to the other Transferee;
- information which, after disclosure, entered the public domain, in any way, without the Transferee being at fault;
- information which the Transferee can prove was in its possession at the time of disclosure;
- information received by a third party not bound by a secrecy obligation.
12.2 In addition, the Transferee shall impose the same confidentiality obligations on the members of its personnel and/or its contractors and sub-contractors who may gain knowledge of this information.
- CONDITIONS PRECEDENT
This Contract will enter into force subject to the following conditions precedent:
Authorisation of the change in holder of the MA by the C/A or positive conclusion to any other procedure relating to the Authorisation or registration of the change in holder of the Authorisation by any Competent Authority.
In respect of paragraph 2) above, the Parties undertake to cooperate fully in order to produce and file any necessary documents.
ARTICLE 14 NOTIFICATIONS
Any notification that shall be made in respect of this Contract shall be deemed given if it has been sent by e-mail to:
- for the Owner, for all matters other than pharmacovigilance: to the Regulatory Affairs Department: [[transferor’s email address for all questions other than pharmacovigilance]];
- for the Owner, regarding pharmacovigilance: to the address [[email for any question concerning pharmacovigilance]]
- for the Transferee: [[email information transferee]]
to be duplicated by a registered letter with return receipt, sent to the head office or the last known address of the recipient.
The Parties undertake to mutually inform each other of any change of registered address and contact person.
ARTICLE 15 ADDRESS FOR SERVICE
Each Party designates address for service at the registered office stated in the header of this Contract.
ARTICLE 16 FORMALITIES / COSTS
16.1 Full authority is given to the bearer of a copy of this document to register the transfer with the tax authorities within one (1) month of signature of the Contract.
16.2 All costs, charges and fees resulting from these formalities and those that must be carried out to obtain the transfer from the Competent Authority will be borne by the Transferee, who is liable for payment thereof.
ARTICLE 17 MISCELLANEOUS
17.1 Nullity and independence of the clauses
17.1.1. The nullity of one clause of this Contract shall not affect the validity thereof, unless it disrupts its economic balance.
17.1.2 In this case, the Parties undertake to replace the clause affected by nullity with a clause whose effect is as close as possible to the void clause, which will maintain the economic balance of the contract.
17.1.3 In the event of difficulties of interpretation between one of the titles and the content of one of the clauses, the clause shall prevail.
17.2. Agreement of proof
The Parties declare that they may exchange the information necessary to perform the services that are the subject of the Contract by e-mail and fax, unless otherwise specified. E-mails and faxes will have the value of written evidence and will serve as proof, until proved otherwise.
The fact that one of the Parties does not take advantage of a breach by the other Party of any of the obligations of this Contract shall not be interpreted as a waiver of the relevant obligation in the future.
ARTICLE 18 APPLICABLE LAW
This Contract is subject to French law.
ARTICLE 19 DISPUTES
Any disputes relating to the negotiation, signature, interpretation or performance of this Contract will be the sole jurisdiction of the [[city commercial court of jurisdiction]] Commercial Court, France, following an obligatory mediation procedure, entrusted to the Paris Mediation and Arbitration Centre (CMAP, 39 avenue Franklin Roosevelt 75008 Paris) by the party that is first to take action. The payment for mediation and the mediator’s scale of costs and fees will be those of CMAP (www.cmap.fr).
Done in Amiens, in two (2) original counterparts
For the Transferee
[[rep name transferee]]
[[rep capacity transferee]]
For the Owner
[[rep name owner]]
[[rep capacity owner]]
LIST OF APPENDICES
- Appendix [[Characteristics of the Product(s)]]: Characteristics of the Product(s)
- Appendix [[Authorisation(s) relating to the Product(s)]]: Authorisation(s) relating to the Product(s)
- Appendix [[List of data comprising the File(s)]]: List of data comprising the File(s)