1.1 These General Supply and Distribution Terms and Conditions (the "General Terms") govern the contractual relationships between Biofarma S.r.l. with registered office in Via Castelliere 2 - 33036 Mereto di Tomba (UD) – Italy VAT: 02895910301 (the "Manufacturer") and any party (the "Distributor") who purchases Products from the Manufacturer for distribution and sale in the Territory.
1.2 The submission of an order by the Distributor constitutes unconditional acceptance of these General Terms. Any general terms and conditions of the Distributor shall not be applicable, unless accepted in writing by the Manufacturer.
1.3 Any derogation from or modification to these General Terms must be agreed in writing and signed by both Parties.
Affiliate: any corporation or other business entity which, directly or indirectly, is controlled by, controls, or is under common control with a party. For such purposes, "control" shall mean the direct or indirect ownership of at least fifty percent (50%) of the voting interest in such corporation or other entity or the power in fact to control the management directions of such entity.
Country of Origin: the territory of Italy.
Improvement: any improvement, development, enhancement, modification or derivative of the Product, or its design or manufacturing process, which would make the Products cheaper, more effective, more useful or more valuable, or would in any other way render the Products more commercially competitive. Working Day: a day other than Saturday, Sunday or a public holiday in Italy.
Manufacturing Law: all health and safety requirements provided for by the applicable legislation in the Country of Origin (Italy) aimed at ensuring the safety and suitability of the Products for human use and, if required by the nature of the Products, for human consumption.
Local Law: all laws and regulations in force in the Territory.
Local Regulatory Requirements: all mandatory requirements, technical specifications, quality standards or manufacturing processes established by the Local Law or by any Regulatory Authority of the Territory (including but not limited to those relating to toxicity, safety, efficacy, labelling, packaging, registration, and marketing of the Products) that the Products must comply with in order to be legally marketed, promoted and distributed in the Territory.
Marketing Authorisation: the authorization, if required by Local Law, to place the Products on the market in the Territory, or any equivalent authorization issued by a Regulatory Authority in the Territory.
Month: a calendar month according to the Gregorian calendar.
Regulatory Authority: any competent authority in the Territory that regulates the market for the Products.
Order: purchase order issued by the Distributor according to the procedures set out in Article 5.
Products: the products ordered by the Distributor and specified in the Order.
Specifications: the technical and quality specifications of the Products agreed in writing between the Parties.
Territory: the geographic territory or territories in which the Distributor is authorized to sell, market, distribute and commercialize the Products.
Order Lead Time: the time required from Order confirmation to availability for delivery, generally 120 working days (excluding summer and Christmas holidays), unless otherwise agreed.
Trade Marks: any trademark, trade name, service mark, service name, brand, business name, trade dress, logo, domain name or other indicator of the origin of goods or services that is legally registered or established by use, including both registered and unregistered trademarks, and all applications and rights to apply for registration, renewals, extensions, continuations, divisions, or reissues thereof, together with all goodwill associated therewith.
Manufacturer Trade Marks: the Trade Marks owned by the Manufacturer and that will be used from time to time within the Territory in respect of the Products.
Distributor Trade Marks: the Trade Marks owned by the Distributor and that will be used from time to time within the Territory in respect of the Products.
Year: any period of 12 consecutive Months from 1 January to the following 31 December.
The Manufacturer appoints the Distributor as its non-exclusive distributor in the Territory and the Distributor shall purchase the Products from the Manufacturer in accordance with these General Terms. The appointment shall be non-assignable and personal to Distributor.
The relationship between Manufacturer and Distributor is and shall remain that of seller and purchaser. Distributor is not the legal representative or agent of Manufacturer for any purpose whatsoever and shall have no right or authority to bind Manufacturer or to contract, assume or create any obligation of any kind in the name of or on behalf of Manufacturer.
The Distributor shall distribute the Products solely under the Trade Marks that have been expressly approved in writing by the Manufacturer prior to any use by the Distributor. The Distributor agrees to submit for the Manufacturer's written approval, prior to their use, any and all Trade Marks under which the Distributor will market, distribute, or sell the Products within the Territory. The Manufacturer reserves the right, in its sole and absolute discretion, to withhold approval of any Trade Marks proposed by the Distributor if the Manufacturer determines, in its reasonable judgment, that such use could be detrimental to the Manufacturer's reputation or to the goodwill associated with the Manufacturer Trade Marks.
Unless otherwise agreed in writing, the Distributor shall not sell, market or distribute the Products: (a) on the Duty-Free Market; or (b) in any region or country outside the Territory, unless the foregoing restriction would violate any applicable law in such region or country; or (c) to any customer who requires (or who the Distributor could reasonably be 2 expected to know requires) it for export or sale in a region or country outside the Territory unless the foregoing restriction would violate any applicable law in such region or country.
The Manufacturer represents and warrants that: (a) it possesses all approvals, licenses, permits and authorizations necessary to manufacture and store the Products in the Country of Origin; (b) the Products comply with: the Manufacturing Law; the Specifications agreed in writing with the Distributor; the quality standards provided for in the Quality Agreement; (c) the Products are free from defects in materials and workmanship and are adequately packaged to reach their destination in good condition.
The Distributor represents and warrants that: (a) it possesses all approvals, licenses, permits and authorizations necessary in accordance with Local Law to distribute and sell the Products in the Territory; (b) it will obtain at its own expense all licenses, permits, consents and Marketing Authorisations necessary for the distribution and sale of the Products in the Territory, and will establish all related applications in full cooperation with the Manufacturer; (c) it warrants and will ensure that the Products, as distributed and sold by it, comply with all Local Regulatory Requirements of the Territory, including but not limited to: mandatory requirements relating to toxicity, safety and efficacy; technical specifications required by Local Law; quality standards required by the Regulatory Authorities of the Territory; labelling, packaging and registration requirements specific to the Territory market; any other standard or requirement different from those provided for by the Manufacturing Law or the agreed Specifications.
(a) The Distributor acknowledges that the Manufacturer's obligation is limited to compliance with the Manufacturing Law and the agreed Specifications. Any additional requirements imposed by Local Law or Local Regulatory Requirements are the sole responsibility of the Distributor. (b) The Distributor is responsible for bearing all costs relating to: obtaining Marketing Authorisations and other regulatory approvals in the Territory; preparation and approval of artwork, labelling and packaging compliant with Local Regulatory Requirements; any modifications, tests, validations or additional documentation required to comply with Local Regulatory Requirements; regulatory fees and charges in the Territory. (c) The Distributor shall not file any application to record the Products with the Regulatory Authority, including any application for Marketing Authorisation, without the previous written consent of the Manufacturer. (d) The Distributor shall immediately inform the Manufacturer of any prospective or actual changes in Local Law and Local Regulatory Requirements and in case any necessary permits required by the Regulatory Authorities are cancelled, revoked, suspended or not renewed. (e) The Distributor shall promptly provide the Manufacturer with copies of all communications relating to the Products with any regulatory, industry or other authority, including any Regulatory Authority.
The Manufacturer may terminate the contract with immediate effect, without liability to the Distributor and by written notice, if the Distributor commits a breach of the warranties under Article 4.2 or if the Manufacturer considers, in its sole discretion, that the Local Regulatory Requirements make it commercially unfeasible or legally impractical to supply the Products to the Territory.
The Distributor and the Manufacturer cooperate in good faith to: promptly identify any applicable Local Regulatory Requirements; assess the feasibility of compliance with Local Regulatory Requirements; agree on any necessary adjustments to the Specifications or supply arrangements; define responsibilities and costs for any necessary adjustments.
No less than 5 days before the start of each Month, the Distributor must provide the Manufacturer with a 12-month rolling forecast indicating the monthly quantities of each Product it expects to order, to be used for planning the Manufacturer's production capacity and procurement. Such forecasts shall be accepted or rejected by the Manufacturer within 15 Working Days, without liability.
The first 4 full Months in each updated forecast represent a firm commitment to purchase the forecasted volumes.
Each Order must: be sent in writing at least 5 days before the start of the month; specify the Products, quantities, the requested delivery date (which must comply with the Order Lead Time) and any other necessary information; be accompanied, if applicable, by forecasts over 12 months for planning the Manufacturer's production capacity.
The Manufacturer will confirm acceptance or rejection of the Order within 7 Working Days of receipt. Orders are binding only after written confirmation from the Manufacturer. The Manufacturer shall be obliged to accept Orders not exceeding 115% of the quantities of Products specified within the last accepted forecast. For quantities exceeding the above, the Manufacturer shall make commercially reasonable efforts to supply the Distributor with the ordered quantities but in no event shall be liable to the Distributor for a refusal to supply such exceeding quantity.
Requests to modify the delivery date will be evaluated by the Manufacturer who, if feasible, will provide a new date within 10 Working Days. The Distributor will reimburse any additional costs for storage, production or financial losses.
The Manufacturer may deliver up to 15% more or less than the quantity ordered, with corresponding pro-rata adjustment of the price.
Unless otherwise agreed in writing: the Products are supplied ex-works at the Manufacturer's premises (Incoterms® 2020); title and risk transfer to the Distributor upon loading onto the carrier's vehicle at the Manufacturer's premises; 3 the Distributor must collect the Products within 2 Working Days of notification of availability.
Delays of up to 20 days from the agreed delivery date do not entitle the Distributor to refuse the Order, claim damages or terminate the contract. The Manufacturer shall have no liability for any failure or delay in delivering an Order to the extent that any failure or delay is caused by the Distributor's failure to comply with any of its obligations under the contract.
If the Distributor does not collect the Order within 5 Working Days of notification of availability, unless the failure to collect is caused by the Manufacturer's breach, the Manufacturer may, at its sole discretion: store the Products charging all related storage costs; apply a penalty of 1% of the Order value for each week of delay, up to a cumulative maximum equal to 100% of the Order value; without prejudice to any additional and greater damages and applicable interest.
The Manufacturer maintains quality control systems compliant with industry best practices and the Manufacturing Law. For each batch it will provide a Certificate of Analysis (CoA).
The Distributor may inspect the Manufacturer's production facilities and equipment and, at its own expense, the Manufacturer's records to the extent necessary to verify compliance with contractual obligations: maximum 1 time per year during working hours; maximum duration 1 working day; upon 3 Months' written notice. Additional inspections (beyond 1 every 3 years) are possible at the Distributor's expense, which will reimburse all related costs incurred by the Manufacturer.
The Distributor shall inspect the Products sample on arrival to ascertain whether Products have any defects before being distributed in the Territory.
The Distributor may reject Products that do not comply with the warranties under Article 4.1 only if: (a) written notice of rejection is given to the Manufacturer: - in case of defect apparent upon normal visual inspection: within 5 Working Days of delivery; - in case of latent defect: within 8 Working Days from the time the defect became evident; (b) none of the exclusions under Article 7.5 is applicable; and (c) the Products were delivered to the Distributor less than 12 months before the notice of rejection. If the Distributor fails to give notice of rejection in accordance with this Article 7.4, it shall be deemed to have accepted the Products.
The Manufacturer is not liable for non-compliance of the Products with the warranties under Article 4.1 if: (a) the Distributor makes further use of the Products after having given notice of rejection; (b) the defect arises from the Distributor's failure to comply with the Manufacturer's oral or written instructions for storage, use and maintenance of the Products; (c) the Distributor alters the Products without the Manufacturer's written consent; (d) the defect arises from normal wear and tear, wilful damage, negligence or abnormal storage or transport conditions; (e) the defects are below the Acceptance Quality Limit specified in the Quality Agreement.
If the Distributor legitimately rejects the Products and the Manufacturer does not dispute the notice of rejection, the Distributor is exclusively entitled to: (a) require the Manufacturer to rework the Products to make them compliant with the Specifications or, if not feasible, to dispose of and replace them at the Manufacturer's expense; or (b) require the Manufacturer to fully refund the price of the rejected Products. Once performed, the Manufacturer has no further liability for the rejected Products, except in cases of wilful misconduct or gross negligence.
The Distributor shall immediately investigate and report to the Manufacturer in writing details of all problems encountered in connection with the Products.
The Distributor shall prepare, maintain and update a crisis management plan for the Products, in conformity with the Manufacturer's guidelines and procedures.
If the Distributor receives a request, court order or other directive from a governmental or regulatory authority to recall the Products from the market (Recall Notice), or if any Product either creates or is likely to give rise to a risk to the health and safety of consumers or users, the following will apply: (a) the Party becoming aware of the problem will promptly notify the other Party by telephone, email or other form of immediate communication. Such notification shall include: - the identity, location and quantity of the Product involved; - the relevant Product or packaging coding; - all other data that will assist in tracing the Product or identifying the cause of the problem; (b) the Distributor shall take such steps as are reasonable to mitigate the losses which the Manufacturer or the Distributor are reasonably likely to incur; (c) representatives of the Parties shall meet as soon as practicable to discuss measures to be taken to remedy or mitigate the problem. Such measures may include the interruption of the distribution of the Product; (d) the Distributor may only initiate a Product recall after prior written consent from the Manufacturer and in strict conformity with the Manufacturer's instructions; (e) the Distributor must inform the Manufacturer of all measures taken to ensure rapid and comprehensive containment of the Products in all affected markets.
The Manufacturer shall pay for the costs of recall only if the Product is off-standard due to the Manufacturer's gross negligence or wilful misconduct. In all other cases, the costs shall be borne by the Distributor.
During the term of the contract, the Distributor must keep the Manufacturer duly and promptly informed of: any adverse medical event in a subject to whom a Product has been administered, including events not necessarily caused by the Product; side effects or other drug-related problems detected or suspected concerning the Products; serious complaints; non-conformities that may impact the quality and safety of the Products.
The Distributor shall notify the Regulatory Authority and other relevant regulatory authorities in the Territory of any recall, serious issue or incident as required by Local Law, and shall keep the Manufacturer informed of all such notifications and communications.
The prices of the Products are specified in accepted Orders or in price lists communicated by the Manufacturer and are exclusive of: VAT, excise duties and customs duties; transport and insurance costs; taxes and other ancillary costs; costs for the first printing of artwork and subsequent modifications; additional services or documentation required by the Distributor to obtain Marketing Authorisations in the Territory; tests, laboratory analyses, validations and regulatory documentation.
The Manufacturer reserves the right to modify the prices of the Products: (a) Annual review: each Year, giving written notice to the Distributor with 2 Months' notice before the end of the Year. The notified prices will come into effect on January 1st of the following Year. (b) Adjustment for cost increase: when the aggregate price of materials and energy used in production increases by 3% or more between the time the prices of the Products were established and the time such materials and energy must be purchased. In support of the adjustment, the Manufacturer will communicate in writing to the Distributor the costs of such materials before and after the adjustment, maintaining complete and accurate records.
(a) Invoicing: the Manufacturer is entitled to invoice the Distributor for each Order upon delivery or within 5 Working Days of notification of availability for collection. (b) Payment: the Distributor will pay invoices in full according to terms agreed in writing. In the absence of a specific agreement, payment is due within 30 days from the end of the month in which the invoice was issued. (c) Default interest: any amount due from the Distributor to the Manufacturer and not received will accrue interest, net of all taxes and duties, at the rate of 1.5% monthly until the date of receipt of full payment by the Manufacturer.
The Distributor acknowledges that all intellectual property rights (IPRs) related to the Products, the Specifications and any Technology shall remain the exclusive property of the Manufacturer or, where applicable, the third party licensor from whom the Manufacturer derives the right to use them.
Each Party retains full ownership of its own IPRs developed or acquired prior to the conclusion of the contract. Nothing in the contract will cause or may be interpreted as causing the transfer to the other Party of such pre-existing rights.
All IPRs relating to Improvements or Technologies belong to the Party from which they originate. For the purposes of this article, IPRs originating from a Party means all IPRs conceived, created, developed or acquired by that Party independently, regardless of whether such IPRs were subsequently proposed or suggested for use to the other Party or otherwise applied in the performance of the contract.
If, in the context of the contract, the Parties jointly develop IPRs, they will negotiate in good faith to agree on the terms under which such IPRs may be used, taking into account each Party's contribution to the development.
(a) During the term of the contract and after its termination, the Distributor shall refrain from doing any act that may prejudice the validity of the Manufacturer's title to the Manufacturer Trade Marks. (b) The Distributor declares that at present it has not, and will not claim in the future, any right whatsoever to the Manufacturer Trade Marks. (c) Subject only to the Distributor's rights as distributor, the Distributor acknowledges that the Manufacturer Trade Marks remain the absolute property of, and shall be maintained by, the Manufacturer, and that the Distributor's use and/or application of the Manufacturer Trade Marks shall accrue to the Manufacturer's rights in the Manufacturer Trade Marks. (d) The Distributor acknowledges and agrees that any goodwill which arises or accrues as a result of the use or application of the Manufacturer Trade Marks by the Distributor shall belong solely to the Manufacturer.
The Distributor represents and warrants that the Distributor Trade Marks do not infringe any intellectual property rights of third parties in the Territory and shall indemnify the Manufacturer against all liabilities, costs, expenses, damages and losses suffered or incurred by the Manufacturer and arising out of or in connection with the use by the Distributor of the Distributor Trade Marks or any other advertising campaign or promotion of the Products in the Territory, except to the extent that such liabilities and losses can be shown to be attributable to the Manufacturer's gross negligence or wilful misconduct.
All specifications, standards, formulas, prescriptions, recipes, processes, manufacturing methods, information, advice and all further data relating to business activities, goods, affairs, operations, plans, product information, customers or production, including Technology and Specifications ("Information") of a Party or its Affiliate, communicated by or on behalf of that Party ("Disclosing Party") to the other Party ("Receiving Party"), and all related documents and copies (digital or otherwise) made by the Receiving Party or its representatives or agents, shall remain at all times the property of the Disclosing Party.
The Receiving Party must: keep the Information strictly confidential, including the content of the contract; not disclose it to third parties; implement appropriate technical and organizational measures to protect such Information; limit access to the Information exclusively to its employees, directors or consultants who need to know it for the purposes of the contract (imposing the strictest confidentiality obligations on such persons); if the Receiving Party is the Distributor, not use the Information for purposes other than the 5 distribution and sale of the Products in the Territory; immediately return all Information to the Disclosing Party upon termination of the contract.
The obligations under Articles 11.1 and 11.2 do not apply to Information that: (a) at the time of disclosure is or subsequently becomes publicly available in ways other than through fault, acts or omissions of the Receiving Party; (b) at the time of disclosure is, or subsequently becomes, available to the Receiving Party on a non-confidential basis from a third party source, provided that such third party is not and was not prohibited from disclosing such Information to the Receiving Party by a confidentiality agreement with the Disclosing Party or by applicable legal provisions; (c) was or is independently developed by the Receiving Party, as established by documentary evidence, without reference to or use, in whole or in part, of any of the Information; (d) is disclosed by the Receiving Party by virtue of an obligation or duty of disclosure established by applicable law or order issued by competent courts, provided that the Disclosing Party is given reasonable opportunity to review the planned disclosure and discuss the necessity of such disclosure with the Receiving Party prior to disclosure.
The obligations set out in this article will continue to be in force for a period of 5 (five) years after the expiration or termination for any reason of the contract. However, the Receiving Party's obligations to protect previously received Information and the limited use obligation set out in this article will survive indefinitely from the expiration or termination of the contract where such Information meets the legal requirements, under applicable law, to qualify as trade secrets.
Upon the earlier of the termination or expiration of the contract or upon request at any time by the Disclosing Party, the Receiving Party must promptly destroy all copies of written Information in its possession, in the possession of its Affiliates or itsrepresentatives, and confirm such destruction in writing to the Disclosing Party.
Subject to the exceptions and limits set out in this Article 12, a Party shall be liable to the other Party for any breach or non-performance of any obligation, representation, warranty or undertaking assumed under the contract.
Nothing in the contract limits or excludes the liability of each Party for: (a) wilful misconduct, gross negligence or fraud; (b) breach of the warranties provided for in Articles 4.1(a) (Manufacturer's licenses and authorizations) and 4.2(c) (Distributor's warranties on local regulatory compliance).
Subject to Article 12.2 and except as otherwise expressly provided in the contract, no Party shall in any event be liable to the other for loss of profits, goodwill, reputation or business opportunities suffered by the other Party and arising from or in connection with the contract.
Subject to Articles 12.2 and 12.3 and except as otherwise expressly provided in the contract, the total liability of one Party to the other shall not exceed the aggregate amount of: €2,000,000 (two million) for each breach or non-performance giving rise to liability; up to an aggregate annual amount not exceeding €5,000,000 (five million).
During the term of the contract and for a period of one year thereafter, the Parties must maintain in force with reputable insurance companies the following insurance policies: product liability insurance with a limit of at least €2,000,000 (two million) for claims arising from a single event or series of related events in a single calendar year.
Upon written request by one Party, the other Party must provide copies of insurance policy certificates and details of the coverage provided.
The Distributor must comply with all anti-corruption and anti-money laundering laws applicable in the jurisdictions in which it operates or otherwise conducts its business and declares that it is fully aware of the Manufacturer's Code of Ethics (available at https://www.biofarmagroup.it/en/group/sustainability), undertaking to comply with the relevant provisions set out therein in the performance of its obligations under the contract. In the event of a breach by the Distributor of this Article 13.3, the Manufacturer shall have the right to terminate the contract with immediate effect by giving written notice to the other Party, pursuant to Article 1456 of the Italian Civil Code.
The contractual relationship shall begin on the date specified in writing between the Parties (Effective Date) and shall continue, unless terminated earlier in accordance with this Article 14, until the third anniversary of the Effective Date. It shall thereafter continue for an indefinite period of time unless terminated at any time by either Party by giving twelve (12) Months prior written notice to the other Party.
Without prejudice to any other right or remedy available under the contract and applicable law, each Party may terminate the contract with immediate effect by giving written notice to the other Party if: (a) the other Party does not pay an amount due under the contract by the payment due date and remains in default for not less than 14 days after being notified in writing to make such payment; (b) the other Party commits a material breach of any other term of the contract and (if such breach is remediable) fails to remedy it within a period of 30 days after being notified in writing to do so; (c) the other Party suspends, or threatens to suspend, payment of its debts or is unable to pay its debts as they fall due or goes into liquidation or has a receiver or similar officer appointed over all or part of its business, property or assets, or if a material or significant part of its business, property or assets is expropriated or confiscated by action of any government.
Without limiting other rights or remedies, the Manufacturer may suspend, without liability to the Distributor, the supply or delivery of the Products under the contract or any other contract between Distributor and Manufacturer, if the Distributor becomes subject to any of the 6 events listed in Article 14.2(c) or if the Distributor fails to pay, in whole or in part, an invoice within the due term.
The Manufacturer may also terminate the contract with immediate effect in the cases provided for in Article 4.4 (infeasibility of regulatory compliance in the Territory).
Upon termination or expiration of the contract, each Party must promptly: (a) return to the other Party all equipment, materials and property belonging to the other Party that the other Party had provided or supplied to one of its Affiliates in connection with the supply and purchase of the Products; (b) return to the other Party all documents and materials (and all copies) containing the other Party's Information; (c) delete all of the other Party's Information from its computer systems (to the extent possible); (d) upon request, certify in writing to the other Party that it has complied with the requirements of this Article 15; (e) cease using the other Party's IPRs and Trade Marks.
Upon termination of the contract for any reason, all debts of the Distributor to the Manufacturer will become immediately due and payable on the effective date of termination and the Manufacturer will cooperate with the Distributor and with any replacement supplier to the extent reasonably necessary to facilitate the smooth transition of supply of the Products from the Manufacturer to the Distributor or its replacement supplier.
Upon termination or expiration of the contract, the Distributor shall use all reasonable endeavours to transfer, upon the Manufacturer's request and free of any costs and charges to the Manufacturer, all permits, licences, applications and approvals (including any Marketing Authorisations) relating to the Products to the Manufacturer or its nominee, and shall consent to the Manufacturer and any other distributor or licensee of the Products cross-referring to the pharmaceutical, pre-clinical and clinical documents contained in any Marketing Authorisation applied for or obtained by the Distributor in the Territory.
Any provision of the contract that expressly or impliedly is intended to come into effect or to continue in effect upon termination or expiration of the contract shall remain in full force and effect.
Termination or expiration of the contract does not affect the rights, remedies, obligations or liabilities of the Parties accrued up to the date of termination or expiration, including the right to claim damages for any breach of the contract existing at the date of termination or expiration or prior thereto.
Force Majeure Event means, subject to any other exemption from liability provided by applicable law, any circumstance not within the reasonable control of a Party, including without limitation: (a) acts of God, floods, droughts, earthquakes or other natural disasters; (b) epidemics or pandemics; (c) terrorist attacks, civil war, civil commotion, armed conflicts, imposition of sanctions, embargo or breaking-off of diplomatic relations; (d) nuclear, chemical or biological contamination, or sonic boom; (e) any law or action taken by a government or public authority, including without limitation the imposition of export or import restrictions, quotas or prohibitions, or failure to grant a necessary license or consent; (f) collapse of buildings, fire, explosion or accident; (g) labour disputes or strikes, union action or lockouts; (h) interruption or failure of utility services.
Provided it has complied with Article 17.4, if a Party is prevented, hindered or delayed in the performance of any of its obligations under the contract by a Force Majeure Event (Affected Party), the Affected Party shall not be in default or otherwise liable for such failure to perform or delay in performance of such obligations. The time for performance of such obligations will be extended accordingly.
The corresponding obligations of the other Party will be suspended, and their time for performance extended, to the same extent as those of the Affected Party.
The Affected Party must: (a) as soon as reasonably practicable after the start of the Force Majeure Event, but not later than 15 Working Days from its commencement, notify the other Party in writing of the Force Majeure Event, the date on which it started, its likely or potential duration, and the effect of the Force Majeure Event on its ability to perform its obligations under the contract; (b) use all reasonable endeavours to mitigate the effect of the Force Majeure Event on the performance of its obligations.
If the Force Majeure Event prevents, hinders or delays the performance of the Affected Party's obligations for a continuous period exceeding 3 Months, the Party not affected by the Force Majeure Event may terminate the contract by giving 1 Month's written notice to the Affected Party.
Subject to Article 18.2, the Distributor may not assign, novate, transfer, mortgage, charge, subcontract, delegate, declare a trust over or deal in any other manner with any or all of its rights and obligations under the contract without the prior written consent of the Manufacturer.
The Distributor may subcontract distribution activities to its subsidiaries, and only throughout the Territory, provided that such subsidiary shall agree in writing to be bound by the provisions of the contract. The Distributor shall unconditionally and irrevocably guarantee the performance of all obligations of such subsidiary pursuant to the contract. A breach by the subsidiary shall be deemed to be a breach by the Distributor under the contract.
The Manufacturer may, at its sole discretion, subcontract the performance of any or all of its obligations under the contract to third parties. In such case, the 7 Manufacturer will be responsible for the activities of such third parties, ensuring their technical and professional suitability and compliance with all provisions of the contract.
No variation of the contract shall be effective unless it is in writing and signed by both Parties (or their authorized representatives).
(a) A waiver of any right or remedy is effective only if given in writing and shall not be deemed a waiver of any subsequent right or remedy. (b) A delay or failure to exercise any right or remedy will not constitute a waiver of such or any other right or remedy, nor will it prevent or restrict the further exercise of such or any other right or remedy.
(a) If any provision or part-provision of the contract is or becomes invalid, illegal or unenforceable, it shall be deemed deleted, but that shall not affect the validity and enforceability of the rest of the contract. (b) If any provision or part-provision of the contract is deemed deleted under Article 19.3(a), the Parties shall negotiate in good faith to agree a replacement provision that, to the greatest extent possible, achieves the intended commercial result of the original provision.
(a) Any notice given to a Party under or in connection with the contract must be in writing and must be: - delivered by hand or by pre-paid first-class post or other next working day delivery service to its registered office (if a company) or its principal place of business (in any other case); or - sent by email. (b) Any notice shall be deemed to be received: - if delivered by hand, at the time the notice is left at the proper address; - if sent by pre-paid first-class post or courier, on the date and at the time that the courier's delivery receipt is signed; - if sent by email, on the date and at the time that the receiving Party has expressly acknowledged receipt of such email by email or other written communication. (c) This article does not apply to the service of any proceedings or other documents in any legal action or, where applicable, arbitration or other method of dispute resolution.
(a) The contract constitutes the entire agreement between the Parties. (b) Each Party acknowledges that in entering into the contract it does not rely on any statement, representation, assurance or warranty (whether made innocently or negligently) that is not set out in the contract.
(a) The contract may be executed in any number of counterparts, each of which shall constitute a duplicate original, but all the counterparts shall together constitute the one agreement. (b) Transmission of an executed counterpart of the contract (but for the avoidance of doubt not just a signature page) by email (in PDF, JPEG or other agreed format) shall take effect as transmission of an original "wet ink" counterpart of the contract. If this method of transmission is adopted, without prejudice to the validity of the agreement thus made, each Party shall provide upon request to the other the original "wet ink" paper counterpart of its counterpart. (c) No counterpart shall be effective until each Party has provided to the other at least one executed counterpart.
The contract and any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with it or its subject matter or formation shall be governed by and construed in accordance with Italian law (the "Governing Law").
Any dispute, controversial matter or claim of any kind in relation to any matter arising out of, arising from or in connection with the contract shall be resolved by consultation between the Parties. If a solution cannot be reached through consultation within a period of 30 days from the date of commencement of such consultation, either Party may give the other Party written notice of such unresolved dispute, after which the dispute may be referred by either Party to the competent court pursuant to Article 20.3.
Each Party irrevocably agrees that the Courts of Milan shall have exclusive jurisdiction to settle any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with the contract or its subject matter or formation.
The Parties agree to enter into a Quality Agreement setting forth additional quality standards, testing procedures, inspection protocols and allocation of quality-related responsibilities. The Quality Agreement forms an integral part of the contract. In case of conflict or ambiguity between the provisions of the Quality Agreement and these General Terms, the provisions of the General Terms shall prevail.
If the Products require Marketing Authorisations in the Territory and such authorisations have not been already obtained, the Parties agree that the specific terms governing the licensing of regulatory data, product safety information and pharmacovigilance obligations shall be set forth in a separate Marketing License Agreement.
To the extent necessary for the Distributor to obtain Marketing Authorisations in the Territory, and subject to the terms of any separate Marketing License Agreement, the Manufacturer may, if considered suitable for the intended purpose, provide the Distributor with technical data, know-how, regulatory submissions and documentation in its possession (Licensed Results) to assist the Distributor in obtaining such Marketing Authorisations. The Distributor is required to send the Manufacturer the original request from the Regulatory Authority and/or references to the applicable legislation necessitating such information or documentation. Should confidential information need to be disclosed to the Regulatory Authority, the Manufacturer may, at its sole discretion, choose to respond directly to the Regulatory Authority, while keeping the Distributor duly informed about the progress and content of such communications.
The Distributor acknowledges that: (a) any Licensed Results provided by the Manufacturer to the Distributor are provided on an "as is" basis without warranties or guarantees; (b) the use and interpretation of the Licensed Results requires 8 specialist skills and knowledge; (c) the Distributor has that skill and knowledge and undertakes that it will exercise appropriate judgment when using the Licensed Results; (d) the Distributor shall be solely responsible for any opinions, recommendations, forecasts or conclusions made or actions taken by the Distributor or any third party based on the Licensed Results.
The Distributor shall indemnify and hold harmless the Manufacturer, without limitation of liability and to the maximum extent provided under applicable law, against all liabilities, costs, expenses, damages and losses suffered or incurred by the Manufacturer and arising out of or in connection with the marketing and sale by the Distributor of the Products in the Territory, except to the extent that such liabilities and losses are attributable to the Manufacturer's gross negligence or wilful misconduct.
The provisions of Article 15.3 shall apply to any Marketing Authorisations obtained by the Distributor during the term of the contract.
